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

Mechanism of action

Sourced from openFDA

The mechanism(s) by which REBIF (interferon beta-1a) exerts its therapeutic effects in patients with multiple sclerosis is unknown.

Indications

Sourced from openFDA
  • REBIF 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. Rebif is an interferon beta 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.ICD-10: G35

Contraindications

Sourced from openFDA
  • REBIF is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.contraindicated

Dosage & administration

Sourced from openFDA

For subcutaneous injection only ( 2.1 ) The recommended dose is either 22 mcg or 44 mcg injected subcutaneously three times per week ( 2.1 ) Titration: Generally, the starting dose should be 20% of the prescribed dose three times per week, and increased over a 4 week period to the targeted recommended dose of either 22 mcg or 44 mcg injected subcutaneously three times per week ( 2.1 ) Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms ( 2.3 ) 2.1 Dosing Information The recommended dose of REBIF is either 22 mcg or 44 mcg injected subcutaneously three times per week. REBIF should be administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days (e.g., Monday, Wednesday, and Friday) at least 48 hours apart each week. Generally, patients should be started at 20% of the prescribed dose three times per week and increased over a 4-week period to the targeted dose, either 22 mcg three times per week (see Table 1 ) or 44 mcg three times per week (see Table 2 ). Patients prescribed a targeted dose of 22 mcg three times per week should use the prefilled syringes for titration. A Titration Pack containing 6 doses of 8.8 mcg (0.2 mL) and 6 doses of 22 mcg (0.5 mL) is available for use during the titration period in both REBIF prefilled syringes and REBIF Rebidose autoinjectors.

Warnings & precautions

Sourced from openFDA

Depression and Suicide: Advise patients to immediately report any symptoms of depression and/or suicidal ideation; consider discontinuation of REBIF if depression occurs ( 5.1 ) Hepatic Injury: Monitor liver function tests; monitor patients for signs and symptoms of hepatic injury; consider discontinuing REBIF if hepatic injury occurs ( 5.2 ) Anaphylaxis and Other Allergic Reactions: Discontinue REBIF if anaphylaxis occurs ( 5.3 ) Injection Site Reactions Including Necrosis: Do not administer REBIF into affected area until fully healed; if multiple lesions occur, change injections sites or discontinue REBIF until healing of skin lesions ( 5.4 ) Decreased Peripheral Blood Counts: Monitor complete blood counts ( 5.5 ) Thrombotic Microangiopathy: Cases of thrombotic microangiopathy have been reported. Discontinue REBIF if clinical symptoms and laboratory findings consistent with TMA occur ( 5.6 ). Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including REBIF. Discontinue REBIF if PAH is diagnosed ( 5.7 ) Seizures: Monitor for seizures when administering REBIF to patients, particularly those with pre-existing seizure disorders ( 5.8 ) 5.1 Depression and Suicide REBIF (interferon beta-1a) should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including REBIF.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in more detail in the Warnings and Precautions section of the label: Depression and Suicide [see Warnings and Precautions (5.1) ] Hepatic Injury [see Warnings and Precautions (5.2) ] Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions (5.3) ] Injection Site Reactions including Necrosis [see Warnings and Precautions (5.4) ] Decreased Peripheral Blood Counts [see Warnings and Precautions (5.5) ] Thrombotic Microangiopathy [see Warnings and Precautions (5.6) ] Pulmonary Arterial Hypertension [ see Warnings and Precautions (5.7) ] Seizures [see Warnings and Precautions (5.8) ] Laboratory Tests [see Warnings and Precautions (5.9) ] The most common adverse reactions in controlled clinical trials were injection site disorders, influenza-like symptoms, abdominal pain, depression, elevation of liver enzymes and hematologic abnormalities ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of REBIF cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. A total of 712 patients with relapsing-remitting multiple sclerosis (RRMS) in two controlled clinical trials took REBIF (22 mcg or 44 mcg given three times per week) [ see Clinical Studies (14) ]. Ages ranged from 18 to 55 years.

Use in specific populations

Sourced from openFDA

Pregnancy: Epidemiological data do not suggest a clear relationship between interferon beta use and major congenital malformations, but interferon beta may cause fetal harm based on animal data ( 8.1 ). 8.1 Pregnancy Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta in pregnancy have been inconsistent (see Data ) . It is unclear whether, as a class of products, administration of interferon beta therapies to pregnant animals at doses greater than those used clinically results in an increased rate of abortion. The potential for REBIF to have adverse effects on embryofetal development has not been fully assessed in animals [ see Data ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of REBIF (interferon beta-1a) in people with multiple sclerosis have not been evaluated. In healthy subjects, a single subcutaneous (sc) injection of 60 mcg of REBIF (liquid formulation) resulted in a peak serum concentration (C max ) of 5.1 ± 1.7 IU/mL (mean ± SD), with a median time of peak serum concentration (T max ) of 16 hours.

Approval history

Sourced from openFDA
  • May 17, 1996BLABLA103628Biogen
  • Mar 7, 2002BLABLA103780Serono Inc

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.
191,744 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. 1Multiple Sclerosis Relapse15,8268.3%
  2. 2Influenza Like Illness13,2466.9%
  3. 3Fatigue11,5376.0%
  4. 4Fall10,5895.5%
  5. 5Multiple Sclerosis9,3344.9%
  6. 6Gait Disturbance8,9134.6%
  7. 7Headache8,4104.4%
  8. 8Memory Impairment7,9874.2%
  9. 9Pain7,7394.0%
  10. 10Injection Site Pain6,3183.3%
  11. 11Asthenia6,2903.3%
  12. 12Hypoaesthesia5,5572.9%
  13. 13Depression5,4342.8%
  14. 14Malaise5,0992.7%
  15. 15Pain In Extremity5,0322.6%

Literature

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Recent PubMed references pinned to Interferon Beta-1a 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 243 ClinicalTrials.gov registrations naming Interferon Beta-1a as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Interferon Beta-1a work?
The mechanism(s) by which REBIF (interferon beta-1a) exerts its therapeutic effects in patients with multiple sclerosis is unknown.
What is Interferon Beta-1a used for?
According to FDA labeling, Interferon Beta-1a carries indications including: REBIF 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. Rebif is an interferon beta 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Interferon Beta-1a?
Interferon Beta-1a 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-1a?
Interferon Beta-1a is marketed under brand names including Avonex, Rebif.
What are the contraindications for Interferon Beta-1a?
Interferon Beta-1a labeling lists contraindications including: REBIF is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.. Always consult the full prescribing information and a clinician.
Note. Data for interferon-beta-1a 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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