Interferon Beta-1B

Interferon Beta-1B
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];

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Overview

Interferon Beta-1B is an immunologic adjuvant that is FDA approved for the treatment of relapsing forms of multiple sclerosis. Common adverse reactions include injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Multiple Sclerosis

BETASERON (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce 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.

• Dosing Information

• The recommended starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, with dose increases over a six week period to the recommended dose of 0.25 mg (1 mL) every other day

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and efficacy 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-1B in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation.

Warnings

Hepatic Injury

Severe hepatic injury including cases of hepatic failure, some of which have been due to autoimmune hepatitis, has been rarely reported in patients taking BETASERON. In some cases, these events have occurred in the presence of other drugs or comorbid medical conditions that have been associated with hepatic injury. Consider the potential risk of BETASERON used in combination with known hepatotoxic drugs or other products (eg., alcohol) prior to BETASERON administration, or when adding new agents to the regimen of patients already on BETASERON. Monitor patients for signs and symptoms of hepatic injury. Consider discontinuing BETASERON if serum transaminase levels significantly increase, or if they are associated with clinical symptoms such as jaundice.

Asymptomatic elevation of serum transaminases is common in patients treated with BETASERON. In controlled clinical trials, elevations of SGPT to greater than five times baseline value were reported in 12% of patients receiving BETASERON (compared to 4% on placebo), and increases of SGOT to greater than five times baseline value were reported in 4% of patients receiving BETASERON (compared to 1% on placebo), leading to dose-reduction or discontinuation of treatment in some patients. Monitor liver function tests.

Anaphylaxis and Other Allergic-Reactions

Anaphylaxis has been reported as a rare complication of BETASERON use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash and urticaria. Discontinue BETASERON if anaphylaxis occurs.

Depression and Suicide

Depression and suicide have been reported to occur with increased frequency in patients receiving interferon beta products, including BETASERON. Advise patients to report any symptom of depression and/or suicidal ideation to their healthcare provider. If a patient develops depression, discontinuation of BETASERON therapy should be considered.

In randomized controlled clinical trials, there were three suicides and eight suicide attempts among the 1532 patients on BETASERON compared to one suicide and four suicide attempts among 965 patients on placebo.

Congestive Heart Failure

Monitor patients with pre-existing congestive heart failure (CHF) for worsening of their cardiac condition during initiation of and continued treatment with BETASERON. While beta interferons do not have any known direct-acting cardiac toxicity, cases of CHF, cardiomyopathy, and cardiomyopathy with CHF have been reported in patients without known predisposition to these events, and without other known etiologies being established. In some cases, these events have been temporally related to the administration of BETASERON. Recurrence upon rechallenge was observed in some patients. Consider discontinuation of BETASERON if worsening of CHF occurs with no other etiology.

Injection Site Necrosis and Reactions

Injection site necrosis (ISN) was reported in 4% of BETASERON-treated patients in controlled clinical trials (compared to 0% on placebo) [see Adverse Reactions (6.1)]. Typically, ISN occurs within the first four months of therapy, although postmarketing reports have been received of ISN occurring over one year after initiation of therapy. The necrotic lesions are typically 3 cm or less in diameter, but larger areas have been reported. Generally the necrosis has extended only to subcutaneous fat, but has extended to the fascia overlying muscle. In some lesions where biopsy results are available, vasculitis has been reported. For some lesions, debridement, and/or skin grafting have been required. In most cases healing was associated with scarring.

Whether to discontinue therapy following a single site of necrosis is dependent on the extent of necrosis. For patients who continue therapy with BETASERON after injection site necrosis has occurred, avoid administration of BETASERON into the affected area until it is fully healed. If multiple lesions occur, discontinue therapy until healing occurs.

Periodically evaluate patient understanding and use of aseptic self-injection techniques and procedures, particularly if injection site necrosis has occurred.

In controlled clinical trials, injection site reactions occurred in 78% of patients receiving BETASERON with injection site necrosis in 4%. Injection site inflammation (42%), injection site pain (16%), injection site hypersensitivity (4%), injection site necrosis (4%), injection site mass (2%), injection site edema (2%) and nonspecific reactions were significantly associated with BETASERON treatment. The incidence of injection site reactions tended to decrease over time. Approximately 69% of patients experienced injection site reactions during the first three months of treatment, compared to approximately 40% at the end of the studies.

Leukopenia

In controlled clinical trials, leukopenia was reported in 18% of patients receiving BETASERON (compared to 6% on placebo), leading to a reduction of the dose of BETASERON in some patients [see Adverse Reactions (6.1)]. Monitoring of complete blood and differential white blood cell counts is recommended. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.

Flu-like Symptom Complex

In controlled clinical trials, the rate of flu-like symptom complex for patients on BETASERON was 57% [see Adverse Reactions (6.1)]. The incidence decreased over time, with 10% of patients reporting flu-like symptom complex at the end of the studies. The median duration of flu-like symptom complex in Study 1 was 7.5 days [see Clinical Studies (14)]. Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with BETASERON use.

Seizures

Seizures have been temporally associated with the use of beta interferons in clinical trials and postmarketing safety surveillance. It is not known whether these events were related to a primary seizure disorder, the effects of multiple sclerosis alone, the use of beta interferons, other potential precipitants of seizures (eg., fever), or to some combination of these.

Monitoring for Laboratory Abnormalities

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 at regular intervals (one, three, and six months) following introduction of BETASERON therapy, and then periodically thereafter in the absence of clinical symptoms.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Interferon Beta-1B Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Interferon Beta-1B Postmarketing Experience in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Interferon Beta-1B 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-1B Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Interferon Beta-1B 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.