Avonex

— THERAPEUTIC CATEGORIES —
  • Multiple sclerosis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Avonex Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Interferon beta-1a 30mcg; per 0.5mL; soln for IM inj.

    Pharmacological Class

    Immunomodulator.

    How Supplied

    Single-use prefilled syringe, autoinjector (Avonex Pen)—1, 4 (w. supplies)

    How Supplied

    Avonex (interferon beta-1a) injection is a clear, colorless solution in a single-dose prefilled glass syringe or a single-dose prefilled autoinjector for intramuscular injection available in the following packaging configurations:

    • one single-dose prefilled Avonex syringe; one 23-gauge, 1¼-inch needle 

    • four single-dose prefilled Avonex syringes; four 23-gauge, 1¼-inch needles; four alcohol wipes; four gauze pads; four adhesive bandages 

    • one single-dose prefilled autoinjector (Avonex Pen); one 25-gauge, 5/8-inch needle; one Avonex Pen cover

    • four single-dose prefilled autoinjector (Avonex Pens); four 25-gauge, 5/8-inch needles; four Avonex Pen covers; four alcohol wipes; four gauze pads; four adhesive bandages 

    Storage

    • Refrigerate Avonex prefilled syringes and autoinjectors at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Once removed from the refrigerator, allow prefilled syringes and autoinjectors to warm to room temperature (about 30 minutes). Do not use external heat sources such as hot water to warm Avonex. 
    • Should refrigeration be unavailable, a prefilled syringe or autoinjector may be stored at room temperature up to 25°C (77°F) for a period up to 7 days. Do not expose to high temperatures. Once the product is removed from the refrigerator, it must not be stored above 25°C (77°F). If the product has been exposed to conditions other than those recommended, Discard the product and do not use. Do not use beyond the expiration date. 
    • Avonex prefilled syringe and Avonex pen contain natural rubber latex which may cause allergic reactions. 

    Manufacturer

    Biogen

    Generic Availability

    NO

    Mechanism of Action

    The mechanism of action by which Avonex exerts its effects in patients with multiple sclerosis is unknown.

    Avonex Indications

    Indications

    Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    Avonex Dosage and Administration

    Adult

    Pre-medicate with analgesics and/or antipyretics on treatment days to ameliorate flu-like symptoms. Rotate inj sites. ≥18yrs: 30mcg IM once weekly. May titrate dose to reduce severity of flu-like symptoms; dosed once weekly, IM: Week 1: 7.5mcg. Week 2: 15mcg. Week 3: 22.5mcg. Week 4: 30mcg.

    Children

    <18yrs: not established.

    Avonex Contraindications

    Not Applicable

    Avonex Boxed Warnings

    Boxed Warning

    Depression, Suicide, and Psychotic Disorders

    • Immediately report any symptoms of depression, suicidal ideation, and/or psychosis to physicians. Consider discontinuing therapy if depression or other severe psychiatric symptoms develop.

    Hepatic Injury

    • Severe hepatic injury, including cases of hepatic failure, has been reported rarely.

    • Consider the potential risk of Avonex in combination with known hepatotoxic drugs or other products (eg, alcohol) before starting Avonex or other hepatotoxic drugs. Monitor for signs of hepatic injury.

    Anaphylaxis and Other Allergic-Reactions

    • Discontinue if anaphylaxis or other allergic reactions (eg, dyspnea, orolingual edema, skin rash, urticaria).

    Injection Site Reactions Including Necrosis 

    • Injection site reactions (eg, abscesses, cellulitis, necrosis) may occur.

    • Evaluate periodically and use aseptic self-injection techniques and procedures.

    • For patients who continue therapy with Avonex after injection site necrosis has occurred, avoid administration into the affected area until it is fully healed.

    • If multiple lesions occur, change injection site or discontinue therapy until healing occurs.

    Congestive Heart Failure 

    • For patients with pre-existing CHF, monitor for worsening cardiac condition during initiation and during treatment.

    Decreased Peripheral Blood Counts 

    • Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported.

    • Monitor for signs or symptoms of decreased blood counts.

    Thrombotic Microangiopathy 

    • Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported.

    • Discontinue if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated. 

    Seizures

    • It is not known whether these events were related to the effects of multiple sclerosis alone, to Avonex, or to a combination of both.

    Autoimmune Disorders

    • Consider discontinuing treatment if new autoimmune disorder occurs.

    Laboratory Tests

    • Monitor CBCs, differential, platelets, blood chemistries, liver and thyroid function during treatment. 

     

    Avonex Warnings/Precautions

    Warnings/Precautions

    Depression. Suicidal ideation. Pre-existing psychiatric disorders (eg, psychosis). Seizure disorders. Monitor for hepatic injury. Pre-existing CHF: monitor for worsening cardiac function at initiation and during treatment. Risk for thrombotic microangiopathy; discontinue if occurs. Risk for pulmonary arterial hypertension (PAH); evaluate and discontinue if PAH confirmed. Myelosuppression. Monitor CBCs, differential, platelets, blood chemistries, liver and thyroid function. Consider discontinuing if new autoimmune disorder develops. Periodically evaluate patients for aseptic self-injection techniques. Latex allergy. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Depression, Suicide, and Psychotic Disorders

    • Immediately report any symptoms of depression, suicidal ideation, and/or psychosis to physicians. Consider discontinuing therapy if depression or other severe psychiatric symptoms develop.

    Hepatic Injury

    • Severe hepatic injury, including cases of hepatic failure, has been reported rarely.

    • Consider the potential risk of Avonex in combination with known hepatotoxic drugs or other products (eg, alcohol) before starting Avonex or other hepatotoxic drugs. Monitor for signs of hepatic injury.

    Anaphylaxis and Other Allergic-Reactions

    • Discontinue if anaphylaxis or other allergic reactions (eg, dyspnea, orolingual edema, skin rash, urticaria).

    Injection Site Reactions Including Necrosis 

    • Injection site reactions (eg, abscesses, cellulitis, necrosis) may occur.

    • Evaluate periodically and use aseptic self-injection techniques and procedures.

    • For patients who continue therapy with Avonex after injection site necrosis has occurred, avoid administration into the affected area until it is fully healed.

    • If multiple lesions occur, change injection site or discontinue therapy until healing occurs.

    Congestive Heart Failure 

    • For patients with pre-existing CHF, monitor for worsening cardiac condition during initiation and during treatment.

    Decreased Peripheral Blood Counts 

    • Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported.

    • Monitor for signs or symptoms of decreased blood counts.

    Thrombotic Microangiopathy 

    • Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported.

    • Discontinue if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated. 

    Pulmonary Arterial Hypertension

    • Cases of pulmonary arterial hypertension (PAH) have been reported, many of which have required hospitalization.

    • Assess for PAH in patients who develop unexplained symptoms (eg, dyspnea, new or increasing fatigue). Discontinue if PAH is confirmed and alternative etiologies have been ruled out.

    Seizures

    • It is not known whether these events were related to the effects of multiple sclerosis alone, to Avonex, or to a combination of both.

    Autoimmune Disorders

    • Consider discontinuing treatment if new autoimmune disorder occurs.

    Laboratory Tests

    • Monitor CBCs, differential, platelets, blood chemistries, liver and thyroid function during treatment. 

    Pregnancy Considerations

    Risk Summary

    • Available data, which includes large population-based cohort study, have not identified a drug-associated risk of major birth defects with interferon beta-1b during early pregnancy.

    Nursing Mother Considerations

    Risk Summary

    • Limited published literature has described the presence of interferon beta-1a products in human milk at low levels. Consider the developmental and health benefits of breastfeeding with the mother’s clinical need for Avonex and any potential adverse effects on the breastfed infant from Avonex or from the underlying maternal condition.

    Avonex Pharmacokinetics

    Absorption

    After an intramuscular dose, serum levels of Avonex generally peak at 15 hours post-dose (range: 6-36 hours).

    Elimination

    Half-life: 19 hours.

    Avonex Interactions

    Interactions

    Risk of hepatic injury with concomitant hepatotoxic drugs or alcohol.

    Avonex Adverse Reactions

    Adverse Reactions

    Flu-like symptoms, asthenia, headache, myalgia, fever, chills, GI upset, depression, blood dyscrasias, seizures, inj site reactions (necrosis, cellulitis, abscess, inflammation, pain); rare: hepatic injury, anaphylaxis (discontinue if occurs).

    Avonex Clinical Trials

    Clinical Trials

    The efficacy of Avonex was based on data from 2 randomized, multicenter, double-blind, placebo-controlled studies (Studies 1 and 2) in patients with relapsing forms of MS.

    Study 1 

    • The study included 301 patients who had a definite diagnosis of multiple sclerosis of at least 1 year duration and had at least 2 exacerbations in the 3 years prior to study entry. At entry, study participants were without exacerbation during the prior 2 months and had Kurtzke Expanded Disability Status Scale (EDSS3 ) scores ranging from 1.0 to 3.5. 

    • Patients received either Avonex 30mcg (n=158) or placebo (n=143) intramuscularly once weekly for up to 2 years, and continued to be followed until study completion. The primary outcome measure was time to progression in disability, measured as an increase in the EDSS score of at least 1 point that was sustained for at least 6 months.

    • Results showed that the time to onset of sustained progression in disability was significantly longer in Avonex-treated patients at the end of 2 years vs placebo-treated patients (22% vs 35%, respectively; P =.02); this correlated to a 37% relative reduction in the risk of accumulating disability in the Avonex treatment arm. 

    • A statistically significant difference was observed between the Avonex and placebo arms in confirmed change for patients with at least 2 scheduled visits (0.20 vs 0.50, respectively; P =.006).

    • For all patients included in the study, the annual exacerbation rate was 0.67 per year in the Avonex-treated arm and 0.82 per year in the placebo-treated arm (P =.04).

    • For the subset of patients who were enrolled in the study for at least 2 years, the frequency of exacerbations was significantly decreased in patients treated with Avonex (P =.03).

    • MRI Results: Treatment with Avonex had significantly lower Gd-enhanced lesion number after 1 and 2 years vs placebo (P ≤.05). The volume of Gd-enhanced lesions showed similar treatment effects in the Avonex and placebo arms (P ≤.03). Percentage change in T2-weighted lesion volume from study entry to Year 1 was significantly lower in Avonex-treated than placebo-treated patients (P =.02).

     

    Study 2

    • The study included 383 patients who had recently experienced an isolated demyelinating event involving the optic nerve, spinal cord, or brainstem/cerebellum, and who had lesions typical of multiple sclerosis on brain MRI. 

    • Patients received either Avonex 30mcg (n=193) or placebo (n=190) intramuscularly once weekly for up to 2 years, and followed for up to 3 years or until they developed a second clinical exacerbation in an anatomically distinct region of the central nervous system. The primary outcome measure was time to development of a second exacerbation in an  anatomically distinct region of the central nervous system.

    • Results showed that the time to development of a second exacerbation was significantly delayed in Avonex-treated vs placebo-treated patients (21% vs 39%, respectively; P =.002). The relative rate of developing a second exacerbation in the Avonex group was 0.56 of the rate in the placebo group (95% CI, 0.38-0.81).

    • MRI Results: Patients treated with Avonex achieved a lower actual and percentage change from baseline in T2 volume of lesions at 18 months vs those treated with placebo (both P <.001). Treatment with Avonex had a significantly lower number of Gd-enhancing lesions at 6 months vs placebo (P <.03). Avonex also had fewer new or enlarging T2 lesions at 18 months vs placebo (P <.001). 

    Avonex Note

    Notes

    Register pregnant patients exposed to Avonex by calling (800) 456-2255.

    Avonex Patient Counseling

    Patient Counseling

    • Patients should be advised of the importance of rotating injection sites with each dose. Do not inject area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.
    • Promptly report any break in the skin associated with blue-black discoloration, swelling, or drainage of fluid from the injection site.
    • Notify a healthcare provider if a patient becomes pregnant during treatment or plans to become pregnant.
    • Instruct patients on the symptoms of hepatic dysfunction, allergic reactions/anaphylaxis, depression, suicidal ideation, or psychotic disorders. Patients should report symptoms immediately.
    • Worsening pre-existing CHF is possible with Avonex treatment; patients should report symptoms of worsening cardiac condition immediately. 
    • Report seizures immediately.
    • Starting with a lower dose than 30mcg and increasing the dose over 3 weeks can reduce the incidence and severity of flu-like symptoms. 

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