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Hadlima Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled autoinjector, Single-dose prefilled syringe—2
Manufacturer
Generic Availability
Mechanism of Action
Hadlima Indications
Indications
To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in adults with moderately to severely active rheumatoid arthritis (RA); may be used alone or with methotrexate (MTX) or non-biologic DMARDs. To reduce signs/symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ≥2yrs of age; may be used alone or with MTX. To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in adults with active psoriatic arthritis (PsA); may be used alone or with non-biologic DMARDs. To reduce signs/symptoms of active ankylosing spondylitis (AS) in adults.
Hadlima Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 40mg every other week. May use with MTX, DMARDs, glucocorticoids, salicylates, NSAIDs, and/or analgesics. RA (without MTX): may increase to 40mg every week or 80mg every other week.
Children
RA, PsA, AS: <18yrs: not established. JIA: <2yrs (or <10kg): not established. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. 2–17yrs: (10–<15kg): 10mg every other week; (15–<30kg): 20mg every other week; (≥30kg): 40mg every other week. May use with MTX, glucocorticoids, NSAIDs, and/or analgesics.
Administration
Hadlima Contraindications
Not Applicable
Hadlima Boxed Warnings
Boxed Warning
Hadlima Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Elderly. Pregnancy. Nursing mothers.
Hadlima Pharmacokinetics
Absorption
Average absolute bioavailability: 64%.
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
Distribution volume: ranged from 4.7 to 6.0 L.
Elimination
Half-life: ~2 weeks (range: 10–20 days).
Systemic clearance: ~12 mL/hr.
Hadlima Interactions
Interactions
Hadlima Adverse Reactions
Adverse Reactions
Hadlima Clinical Trials
See Literature
Hadlima Note
Not Applicable
Hadlima Patient Counseling
See Literature
Hadlima Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled autoinjector, Single-dose prefilled syringe—2
Manufacturer
Generic Availability
Mechanism of Action
Hadlima Indications
Indications
In moderately to severely active Crohn's disease (CD) in adults and pediatric patients ≥6yrs of age. In moderately to severely active ulcerative colitis (UC) in adults.
Limitations of Use
UC: not established in patients who have lost response to or were intolerant to TNF blockers.
Hadlima Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. Initially 160mg on Day 1 (given in 1 day or divided over 2 days), followed by 80mg on Day 15. On Day 29, start maintenance of 40mg every other week. May continue aminosalicylates, corticosteroids, or immunomodulatory agents. UC: discontinue in those without evidence of clinical remission by 8 weeks of therapy.
Children
UC: not established. CD: <6yrs: not established. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥6yrs (17–<40kg): initially 80mg on Day 1, then 40mg on Day 15. On Day 29, start maintenance of 20mg every other week; (≥40kg): initially 160mg on Day 1 (given in 1 day or divided over 2 days), then 80mg on Day 15. On Day 29, start maintenance of 40mg every other week.
Administration
Hadlima Contraindications
Not Applicable
Hadlima Boxed Warnings
Boxed Warning
Hadlima Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Elderly. Pregnancy. Nursing mothers.
Hadlima Pharmacokinetics
Absorption
Average absolute bioavailability: 64%.
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
Distribution volume: ranged from 4.7 to 6.0 L.
Elimination
Half-life: ~2 weeks (range: 10–20 days).
Systemic clearance: ~12 mL/hr.
Hadlima Interactions
Interactions
Hadlima Adverse Reactions
Adverse Reactions
Hadlima Clinical Trials
See Literature
Hadlima Note
Not Applicable
Hadlima Patient Counseling
See Literature
Hadlima Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled autoinjector, Single-dose prefilled syringe—2
Manufacturer
Generic Availability
Mechanism of Action
Hadlima Indications
Indications
Moderate to severe hidradenitis suppurativa in adults.
Hadlima Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. Initially 160mg on Day 1 (given in 1 day or divided over 2 days), followed by 80mg on Day 15. On Day 29, start maintenance of 40mg every week or 80mg every other week.
Children
<18yrs: not established.
Administration
Hadlima Contraindications
Not Applicable
Hadlima Boxed Warnings
Boxed Warning
Hadlima Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Elderly. Pregnancy. Nursing mothers.
Hadlima Pharmacokinetics
Absorption
Average absolute bioavailability: 64%.
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
Distribution volume: ranged from 4.7 to 6.0 L.
Elimination
Half-life: ~2 weeks (range: 10–20 days).
Systemic clearance: ~12 mL/hr.
Hadlima Interactions
Interactions
Hadlima Adverse Reactions
Adverse Reactions
Hadlima Clinical Trials
See Literature
Hadlima Note
Not Applicable
Hadlima Patient Counseling
See Literature
Hadlima Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled autoinjector, Single-dose prefilled syringe—2
Manufacturer
Generic Availability
Mechanism of Action
Hadlima Indications
Indications
Non-infectious intermediate, posterior and panuveitis in adults.
Hadlima Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: initially 80mg, followed by 40mg every other week starting one week after initial dose.
Children
Administration
Hadlima Contraindications
Not Applicable
Hadlima Boxed Warnings
Boxed Warning
Hadlima Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Elderly. Pregnancy. Nursing mothers.
Hadlima Pharmacokinetics
Absorption
Average absolute bioavailability: 64%.
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
Distribution volume: ranged from 4.7 to 6.0 L.
Elimination
Half-life: ~2 weeks (range: 10–20 days).
Systemic clearance: ~12 mL/hr.
Hadlima Interactions
Interactions
Hadlima Adverse Reactions
Adverse Reactions
Hadlima Clinical Trials
See Literature
Hadlima Note
Not Applicable
Hadlima Patient Counseling
See Literature
Hadlima Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled autoinjector, Single-dose prefilled syringe—2
Manufacturer
Generic Availability
Mechanism of Action
Hadlima Indications
Indications
Moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
Hadlima Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: initially 80mg, followed by 40mg every other week starting one week after initial dose. Use beyond 1yr has not been evaluated.
Children
Administration
Hadlima Contraindications
Not Applicable
Hadlima Boxed Warnings
Boxed Warning
Hadlima Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Elderly. Pregnancy. Nursing mothers.
Hadlima Pharmacokinetics
Absorption
Average absolute bioavailability: 64%.
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
Distribution volume: ranged from 4.7 to 6.0 L.
Elimination
Half-life: ~2 weeks (range: 10–20 days).
Systemic clearance: ~12 mL/hr.
Hadlima Interactions
Interactions
Hadlima Adverse Reactions
Adverse Reactions
Hadlima Clinical Trials
See Literature
Hadlima Note
Not Applicable
Hadlima Patient Counseling
See Literature
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