ACTHAR GEL Dosage & Rx Info | Uses, Side Effects

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Acthar Gel (repository corticotropin injection) is supplied as 5 mL multi-dose vial containing 80 USP Units per mL. Acthar Gel (repository corticotropin injection) should be warmed to room temperature before using. Do not over pressurize the vial prior to withdrawing the product.

Storage

Store Acthar Gel (repository corticotropin injection) under refrigeration between 2°C to 8°C (36°F to 46°F). Product is stable for the period indicated on the label when stored under the conditions described.

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

Serum sickness.

Acthar Gel Dosage and Administration

Adults and Children

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

Adults and Children

Individualize dose according to the disease and general medical condition of each patient. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
<2yrs: not recommended. ≥2yrs: usual dose: Inject 40 to 80 Units intramuscularly or subcutaneously every 24 to 72 hours.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Acthar Gel Contraindications

Contraindications

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

Short-term (acute episode or exacerbation) adjunctive therapy in psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis.

Acthar Gel Dosage and Administration

Adults and Children

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

Adults and Children

Individualize dose according to the disease and general medical condition of each patient. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
<2yrs: not recommended. ≥2yrs: usual dose: Inject 40 to 80 Units intramuscularly or subcutaneously every 24 to 72 hours.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

Severe erythema multiforme. Stevens-Johnson syndrome.

Acthar Gel Dosage and Administration

Adults and Children

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

Adults and Children

Individualize dose according to the disease and general medical condition of each patient. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
<2yrs: not recommended. ≥2yrs: usual dose: Inject 40 to 80 Units intramuscularly or subcutaneously every 24 to 72 hours.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus or systemic dermatomyositis (polymyositis).

Acthar Gel Dosage and Administration

Adults and Children

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

Adults and Children

Individualize dose according to the disease and general medical condition of each patient. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
<2yrs: not recommended. ≥2yrs: usual dose: Inject 40 to 80 Units intramuscularly or subcutaneously every 24 to 72 hours.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

Severe acute/chronic allergic and inflammatory processes involving the eye and its adnexa such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.

Acthar Gel Dosage and Administration

Adults and Children

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

Adults and Children

Individualize dose according to the disease and general medical condition of each patient. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
<2yrs: not recommended. ≥2yrs: usual dose: Inject 40 to 80 Units intramuscularly or subcutaneously every 24 to 72 hours.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

Symptomatic sarcoidosis.

Acthar Gel Dosage and Administration

Adults and Children

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

Adults and Children

Individualize dose according to the disease and general medical condition of each patient. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
<2yrs: not recommended. ≥2yrs: usual dose: Inject 40 to 80 Units intramuscularly or subcutaneously every 24 to 72 hours.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

To induce diuresis or remission of proteinuria in nephrotic syndrome without idiopathic type uremia or that due to lupus erythematosus.

Acthar Gel Dosage and Administration

Adults and Children

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

Adults and Children

Individualize dose according to the disease and general medical condition of each patient. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
<2yrs: not recommended. ≥2yrs: usual dose: Inject 40 to 80 Units intramuscularly or subcutaneously every 24 to 72 hours.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

Acute exacerbations of multiple sclerosis.

Acthar Gel Dosage and Administration

Adult

See full labeling. Individualize. 80–120 Units by IM or SC inj daily for 2–3 weeks.

Adult

Individualize dose according to the medical condition. Determine frequency and dose by considering severity of the disease and the initial response of the patient.
Recommended dose: Inject 80 to 120 Units daily intramuscularly or subcutaneously for 2 to 3 weeks for acute exacerbations.
While drug dependence does not occur, sudden withdrawal after prolonged use may lead to adrenal insufficiency or recurrent symptoms. May need to taper the dose and increase the injection interval to gradually discontinue the drug.

Children

Not recommended.

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

See Literature

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Pharmacological Class

Adrenocorticotropic hormone (ACTH) analogue.

How Supplied

Multi-dose vial (5mL)—1

How Supplied

Storage

Manufacturer

Mallinckrodt, Inc.

Generic Availability

Acthar Gel Indications

Indications

Monotherapy for the treatment of infantile spasms in infant and children <2yrs of age.

Acthar Gel Dosage and Administration

Adult

Not applicable.

Children

<2yrs: 75 Units/m² IM twice daily over a 2-week period; then gradually taper and discontinue over a 2-week period. ≥2yrs: not recommended.

Children

≥2yrs: not recommended.
<2yrs: 75 Units/m² IM twice daily over a 2-week period; then gradually taper and discontinue over a 2-week period to avoid adrenal insufficiency.
Suggested tapering schedule: 30 Units/m² in the morning for 3 days; 15 Units/m² in the morning for 3 days; 10 Units/m² in the morning for 3 days; and 10 Units/m2 every other morning for 6 days.
Dosing is typically based on body surface area (BSA).

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Not Applicable

Acthar Gel Warnings/Precautions

Warnings/Precautions

Infections

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic).
Closely observe patients with latent tuberculosis or tuberculin reactivity, and institute chemoprophylaxis if therapy is prolonged.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Monitor for HPA axis suppression and Cushings syndrome especially with chronic use. Suppression of the HPA may occur after therapy withdrawal following prolonged therapy.
Monitor for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.
Monitor for signs or symptoms of Cushing’s syndrome such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Dietary salt restriction and potassium supplementation may be necessary.
Use caution in patients with hypertension, congestive heart failure, or renal impairment.

Vaccination

Contraindicated to administer live or live attenuated vaccines in patients receiving Acthar Gel.
Killed or inactivated vaccines may be administered, but the response to such vaccines cannot be predicted.

Masking Symptoms of Other Diseases

Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
Monitor carefully during and after discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

Increased risk for perforation in patients with certain GI disorders.
Use caution if there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

May be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations.
May aggravate existing emotional instability or psychotic tendencies.

Comorbid Diseases

May worsen patients with a comorbid disease.
Use caution in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity.
Prolonged use of Acthar Gel may increase the risk of hypersensitivity reactions.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients.
Monitor growth in children on prolonged therapy.

Decrease in Bone Density

Increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and monitor bone density in patients on long term therapy.

Pregnancy Considerations

Risk Summary

May cause fetal harm.

Clinical Considerations

Fetal-Neonatal Adverse Reactions: Infants born to mothers receiving systemic corticosteroids during pregnancy have reported hypoadrenalism. Carefully observe for signs of hypoadrenalism.

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

Pediatric Considerations

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population.
The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial.
Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials.
While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.

Acthar Gel Pharmacokinetics

See Literature

Acthar Gel Interactions

Interactions

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

Clinical Trials

Single Blinded Clinical Trial

The efficacy of Acthar Gel as a treatment for infantile spasms was evaluated in a single blinded (video EEG interpreter blinded) clinical trial. Patients were randomly assigned to receive either a 2 week course of treatment with Acthar Gel 75 Units/m² IM twice daily or prednisone 1 mg/kg orally twice daily.
The primary outcome was the number of patients who were treatment responders, defined as a patient having complete suppression of both clinical spasms and hypsarrhythmia on a full sleep cycle video EEG performed 2 weeks following treatment initiation, rated by an investigator blinded to treatment.
After 2 weeks, results showed that:

13 of 15 patients (86.7%) responded to Acthar Gel compared with 4 of 14 patients (28.6%) who received prednisone (P <.002).

The 2-week treatment was followed by a 2-week taper, when nonresponders to prednisone were eligible to receive Acthar Gel. Among 8 patients who did not respond to prednisone, 7 (87.5%) responded to Acthar Gel.
Similarly, the 2 nonresponders from the Acthar Gel treatment were eligible to receive treatment with prednisone. Among the 2 patients who did not respond to Acthar Gel, 1 (50%) responded to prednisone.

Supportive Clinical Trial

Acthar Gel was also evaluated for the treatment of infantile spasms in infants and children less than 2 years of age in a supportive single-blind, randomized clinical trial. The trial compared a high-dose, long-duration treatment (150 U/m² once daily for 3 weeks, n=30) of Acthar Gel with low-dose, short-duration treatment (20 U once daily for 2 weeks, n=29). Nonresponders (defined as in the previously described study) in the low-dose group received a dose escalation at 2 weeks to 30 U once daily.
Results showed a nominal statistical superiority of the high dose treatment, as compared to the low dose treatment, observed for cessation of spasms but not for the resolution of hypsarrhythmia.

Acthar Gel Note

Not Applicable

Acthar Gel Patient Counseling

Patient Counseling

Infections

Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel.

Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal

Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing’s Syndrome.
Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel. Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain. Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention.

Vaccinations

Do not be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.

Masking Symptoms of Other Diseases

Advise patients that Acthar Gel may mask symptoms of other diseases/disorders without altering their course. Monitor carefully during and following discontinuation of therapy.

Gastrointestinal Perforation and Bleeding

Contact healthcare provider if the patient or the caregiver notices blood or a change in color of the patient’s stool.

Behavioral and Mood Disturbances

Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.

Negative Effects on Growth and Physical Development

Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.

Decrease in Bone Density

Prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents, and may cause osteoporosis and decreased bone density at any age. If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation

Infantile Spasms Additional Information

Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur (for example, Lennox-Gastaut Syndrome).
Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
Advise parents and caregivers to inform the patient’s healthcare provider of any new onset of seizures so that appropriate management can then be instituted.

Pregnancy

Advise pregnant women of the potential risk to a fetus.

Acthar Gel

PAGE CONTENTS

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Pharmacological Class

How Supplied

How Supplied

Storage

Manufacturer

Generic Availability

Acthar Gel Indications

Indications

Acthar Gel Dosage and Administration

Adults and Children

Adults and Children

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Acthar Gel Warnings/Precautions

Warnings/Precautions

Warnings/Precautions

Pregnancy Considerations

Nursing Mother Considerations

Pediatric Considerations

Acthar Gel Pharmacokinetics

Acthar Gel Interactions

Interactions

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

Acthar Gel Note

Acthar Gel Patient Counseling

Patient Counseling

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Pharmacological Class

How Supplied

How Supplied

Storage

Manufacturer

Generic Availability

Acthar Gel Indications

Indications

Acthar Gel Dosage and Administration

Adults and Children

Adults and Children

Acthar Gel Contraindications

Contraindications

Acthar Gel Boxed Warnings

Acthar Gel Warnings/Precautions

Warnings/Precautions

Warnings/Precautions

Pregnancy Considerations

Nursing Mother Considerations

Pediatric Considerations

Acthar Gel Pharmacokinetics

Acthar Gel Interactions

Interactions

Acthar Gel Adverse Reactions

Adverse Reactions

Acthar Gel Clinical Trials

Acthar Gel Note

Acthar Gel Patient Counseling

Patient Counseling

Acthar Gel Generic Name & Formulations

Legal Class

General Description

Pharmacological Class

How Supplied

How Supplied

Storage

Manufacturer

Generic Availability

Acthar Gel Indications

Indications

Acthar Gel Dosage and Administration

Adults and Children

Adults and Children