pharmacopeia
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/api/v1/drug/interferon-beta-1b

Mechanism of action

Sourced from openFDA

The mechanism of action of BETASERON (interferon beta-1b) in patients with multiple sclerosis is unknown.

Indications

Sourced from openFDA
  • BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.ICD-10: G35

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

• For subcutaneous use only ( 2.1 ) • The recommended dose is 0.25 mg every other day. Generally, start at 0.0625 mg (0.25 mL) every other day, and increase over a six-week period to 0.25 mg (1 mL) every other day. ( 2.1 ) • Reconstitute lyophilized powder with supplied diluent ( 2.2 ) 2.1 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 (see Table 1 ). Table 1: Schedule for Dose Titration BETASERON Dose Dosed every other day, subcutaneously Percentage of recommended dose Volume Weeks 1-2 0.0625 mg 25% 0.25 mL Weeks 3-4 0.125 mg 50% 0.5 mL Weeks 5-6 0.1875 mg 75% 0.75 mL Week 7 and thereafter 0.25 mg 100% 1 mL If a dose of BETASERON is missed, then it should be taken as soon as the patient remembers or is able to take it. The patient should not take BETASERON on two consecutive days. The next injection should be taken about 48 hours (two days) after that dose. If the patient accidentally takes more than their prescribed dose, or takes it on two consecutive days, they should be instructed to call their healthcare provider immediately. 2.2 Reconstitution of the Lyophilized Powder (a) Prior to reconstitution, verify that the vial containing lyophilized BETASERON is not cracked or damaged. Do not use cracked or damaged vials. (b) To reconstitute lyophilized BETASERON for injection, attach the pre-filled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the BETASERON vial using the vial adapter.

Warnings & precautions

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• Hepatic Injury: Monitor liver function tests and signs and symptoms of hepatic injury; consider discontinuing BETASERON if serious hepatic injury occurs. ( 5.1 , 5.11 ) • Anaphylaxis and Other Allergic Reactions: Discontinue if anaphylaxis occurs. ( 5.2 ) • Depression and Suicide: Advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuation of BETASERON if depression occurs. ( 5.3 ) • Congestive Heart Failure (CHF): Monitor patients with CHF for worsening of cardiac symptoms; consider discontinuation of BETASERON if worsening of CHF occurs. ( 5.4 ) • Injection Site Reactions Including Necrosis: Do not administer BETASERON into affected area until fully healed; if multiple lesions occur, change injection site or discontinue BETASERON until healing of skin lesions. ( 5.5 ) • Leukopenia: Monitor complete blood count. ( 5.6 , 5.12 ) • Thrombotic Microangiopathy: Cases of thrombotic microangiopathy (TMA) have been reported. Discontinue BETASERON if clinical symptoms and laboratory findings consistent with TMA occur and a relationship to BETASERON is suspected. ( 5.7 ) • Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including BETASERON. Discontinue BETASERON if PAH is diagnosed. ( 5.8 ) • Flu-like Symptom Complex: Consider analgesics and/or antipyretics on injection days. ( 5.9 ) • Drug-induced Lupus Erythematosus: Cases of drug-induced lupus erythematosus have been reported.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are discussed in more details in other sections of labeling: • Hepatic Injury [see Warnings and Precautions ( 5.1 )] • Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions ( 5.2 )] • Depression and Suicide [see Warnings and Precautions ( 5.3 )] • Congestive Heart Failure [see Warnings and Precautions ( 5.4 )] • Injection Site Reactions Including Necrosis [see Warnings and Precautions ( 5.5 )] • Leukopenia [see Warnings and Precautions ( 5.6 )] • Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] • Pulmonary Arterial Hypertension [see Warnings and Precautions ( 5.8 )] • Flu-like Symptom Complex [see Warnings and Precautions ( 5.9 )] • Seizures [see Warnings and Precautions ( 5.10 )] • Drug Induced Lupus Erythematosus [see Warnings and Precautions ( 5.11 )] In controlled clinical trials, the most common adverse reactions (at least 5% more frequent on BETASERON than on placebo) were: injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of BETASERON to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose ( see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data The majority of the observational studies reporting on pregnancies exposed to interferon beta-1b did not identify an association between the use of interferon beta-1b during pregnancy and an increased risk of major birth defects Animal Data When BETASERON (doses ranging from 0.028 to 0.42 mg/kg/day) was administered to pregnant rhesus monkeys throughout the period of organogenesis (gestation days 20 to 70), a dose-related abortifacient effect was observed.

Pharmacokinetics

Sourced from openFDA
Metabolism
Because serum concentrations of interferon beta-1b are low or not detectable following subcutaneous administration of 0.25 mg or less of BETASERON, pharmacokinetic information in patients with MS receiving the recommended dose of BETASERON is not available. Following single and multiple daily subcutaneous administrations of 0.5 mg BETASERON to healthy volunteers (N=12), serum interferon beta-1b concentrations were generally below 100 IU/mL.

Approval history

Sourced from openFDA
  • Jul 23, 1993BLABLA103471Bayer Healthcare Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
19,028 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Influenza Like Illness1,4027.4%
  2. 2Multiple Sclerosis Relapse1,3427.1%
  3. 3Injection Site Pain1,1996.3%
  4. 4Fatigue1,1946.3%
  5. 5Multiple Sclerosis1,1666.1%
  6. 6Injection Site Erythema9785.1%
  7. 7Drug Ineffective9645.1%
  8. 8Pain8544.5%
  9. 9Headache8424.4%
  10. 10Injection Site Reaction8394.4%
  11. 11Fall8174.3%
  12. 12Depression8144.3%
  13. 13Gait Disturbance7784.1%
  14. 14Pyrexia7473.9%
  15. 15Death7263.8%

Literature

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Recent PubMed references pinned to Interferon Beta-1b as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 99 ClinicalTrials.gov registrations naming Interferon Beta-1b as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Interferon Beta-1b work?
The mechanism of action of BETASERON (interferon beta-1b) in patients with multiple sclerosis is unknown.
What is Interferon Beta-1b used for?
According to FDA labeling, Interferon Beta-1b carries indications including: BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Interferon Beta-1b?
Interferon Beta-1b is classified as Interferons, Interferon beta, Biological Response Modifiers, Unknown Cellular or Molecular Interaction, Cellular Growth Phase Arrest, Immunologically Active Molecule Activity Alteration, Increased Lymphocyte Activation, Increased Phagocytosis, Increased Transcription to RNA.
What are the brand names for Interferon Beta-1b?
Interferon Beta-1b is marketed under brand names including Betaseron, Extavia.
What are the contraindications for Interferon Beta-1b?
Interferon Beta-1b labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for interferon-beta-1b is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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