Interferon Beta-1A

Interferon Beta-1A
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, M.B.B.S.

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Overview

Interferon Beta-1A is an immunologic adjuvant that is FDA approved for the treatment of multiple sclerosis. Common adverse reactions include flu-like symptoms including chills, fever, myalgia, and asthenia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Multiple Sclerosis, Relapsing forms

AVONEX (interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Interferon Beta-1A in adult patients.

Non–Guideline-Supported Use

Multiple sclerosis, Clinically Isolated Syndrome

Efficacy has been demonstrated in patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Interferon Beta-1A in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Interferon Beta-1A in pediatric patients.

Contraindications

AVONEX is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation.

The lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human).

Warnings

Depression, Suicide, and Psychotic Disorders

Patients treated with AVONEX and their caregivers should be advised to report immediately any symptoms of depression, suicidal ideation, and/or psychosis to their prescribing physicians. If a patient develops depression or other severe psychiatric symptoms, cessation of AVONEX therapy should be considered.

Depression and suicide have been reported to occur with increased frequency in patients receiving AVONEX. In Study 1, the incidence of depression was similar in placebo-treated and in AVONEX-treated patients, but suicidal tendency was seen more frequently in AVONEX-treated patients (4% in AVONEX group vs. 1% in placebo group). In Study 2, there was a greater incidence of depression in AVONEX-treated patients than in placebo-treated patients (20% in AVONEX group vs. 13% in placebo group) [see Clinical Studies (14)].

Additionally, there have been post-marketing reports of depression, suicidal ideation, and/or development of new or worsening of other pre-existing psychiatric disorders, including psychosis. For some of these patients, symptoms of depression improved upon cessation of AVONEX.

Hepatic Injury

Severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking AVONEX. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with AVONEX. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of AVONEX used in combination with known hepatotoxic drugs or other products (e.g., alcohol) should be considered prior to starting AVONEX, or before starting hepatotoxic drugs. Patients should be monitored for signs of hepatic injury.

Anaphylaxis and Other Allergic-Reactions

Anaphylaxis has been reported as a rare complication of AVONEX use. Other allergic reactions have included dyspnea, orolingual edema, skin rash and urticaria. Discontinue AVONEX if anaphylaxis or other allergic reactions occur.

Congestive Heart Failure

Patients with pre-existing congestive heart failure should be monitored for worsening of their cardiac condition during initiation of and continued treatment with AVONEX. While beta interferons do not have any known direct cardiac toxicity, during the post-marketing period cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other etiologies being established. In some cases, these events have been temporally related to the administration of AVONEX. In some of these instances recurrence upon rechallenge was observed.

Decreased Peripheral Blood Counts

Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported from postmarketing experience in AVONEX-treated patients. In some cases, platelet counts were below 10,000/microliter. Some cases recurred with rechallenge. Patients should be monitored for symptoms or signs of decreased blood counts.

Seizures

Seizures have been temporally associated with the use of beta interferons in clinical trials and postmarketing safety surveillance. In the two placebo-controlled studies in multiple sclerosis (Studies 1 and 2), 4 patients receiving AVONEX experienced seizures, while no seizures occurred in the placebo group. Three of these 4 patients had no prior history of seizure. 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

Post-marketing reports of autoimmune disorders of multiple target organs in AVONEX-treated patients included idiopathic thrombocytopenia, hyper- and hypothyroidism, and rare cases of autoimmune hepatitis. If AVONEX-treated patients develop a new autoimmune disorder, consider stopping the therapy.

Laboratory Tests

In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests, are recommended during AVONEX therapy.

Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. Thyroid function should be monitored periodically. If patients have or develop symptoms of thyroid dysfunction (hypo- or hyperthyroidism), thyroid function tests should be performed according to standard medical practice.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of AVONEX cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

Among 351 patients with relapsing forms of MS treated with AVONEX 30 micrograms (including 319 patients treated for 6 months and 288 patients treated for greater than one year) the most commonly reported adverse reactions (at least 5% more frequent on AVONEX than on placebo) were flu-like symptoms. Symptoms can include chills, fever, myalgia and asthenia occurring within hours to days following an injection. Most people who take AVONEX have flu-like symptoms early during the course of therapy. Usually, these symptoms last for a day after the injection. For many people, these symptoms lessen or go away over time. The most frequently reported adverse reactions resulting in clinical intervention (for example, discontinuation of AVONEX or the need for concomitant medication to treat an adverse reaction symptom) were flu-like symptoms and depression.

Table 2 enumerates adverse reactions that occurred with AVONEX-treated patients at an incidence of at least 2% more than that observed in the placebo-treated patients in the pooled placebo-controlled studies in patients with relapsing forms of MS.

Immunogenicity

Anaphylaxis and other allergic reactions have occurred in AVONEX-treated patients [see Warnings and Precautions (5.3)]. As with all therapeutic proteins, there is a potential for immunogenicity. In studies assessing immunogenicity in multiple sclerosis patients administered AVONEX for at least 1 year, 5% (21 of 390 patients) showed the presence of neutralizing antibodies at one or more times.

These data reflect the percentage of patients whose test results were considered positive for antibodies to AVONEX using a two-tiered assay (ELISA binding assay followed by an antiviral cytopathic effect assay), and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of neutralizing activity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to AVONEX with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of AVONEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Menorrhagia and metrorrhagia
• Rash (including vesicular rash)
• Rare cases of injection site abscess or cellulitis requiring surgical intervention

Drug Interactions

There is limited information regarding Interferon Beta-1A Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Interferon Beta-1A in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Interferon Beta-1A in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Interferon Beta-1A during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Interferon Beta-1A in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Interferon Beta-1A in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Interferon Beta-1A in geriatric settings.

Gender

There is no FDA guidance on the use of Interferon Beta-1A with respect to specific gender populations.

Race

There is no FDA guidance on the use of Interferon Beta-1A with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Interferon Beta-1A in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Interferon Beta-1A in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Interferon Beta-1A in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Interferon Beta-1A in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Interferon Beta-1A Administration in the drug label.

Monitoring

There is limited information regarding Interferon Beta-1A Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Interferon Beta-1A and IV administrations.

Overdosage

There is limited information regarding Interferon Beta-1A overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Interferon Beta-1A Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Interferon Beta-1A Mechanism of Action in the drug label.

Structure

There is limited information regarding Interferon Beta-1A Structure in the drug label.

Pharmacodynamics

There is limited information regarding Interferon Beta-1A Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Interferon Beta-1A Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Interferon Beta-1A Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Interferon Beta-1A Clinical Studies in the drug label.

How Supplied

There is limited information regarding Interferon Beta-1A How Supplied in the drug label.

Storage

There is limited information regarding Interferon Beta-1A Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Interferon Beta-1A Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Interferon Beta-1A interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Interferon Beta-1A Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Interferon Beta-1A Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.