Classes
DEA Class; Rx
Common Brand Names; Avonex, Rebif, Rebif Rebidose, AVOSTARTGRIP
- Immunomodulators;
- Multiple Sclerosis Treatments
Description
Recombinant, glycosylated interferon beta; identical amino acid sequence to endogenous interferon beta
Indicated for relapsing forms of multiple sclerosis, such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
May increase the risk for depression, suicidal ideation, and suicide attempts
Indications
Indicated for the treatment of remitting-relapsing forms of multiple sclerosis (MS) such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Contraindications
Hypersensitivity to beta interferons, albumin (for albumin-containing formulations)
Adverse Effects
- Injection site reactions (83% [Rebif]; 28% [Avonex])
- Headache (67%)
- Flu-like syndrome (61%)
- Muscle ache (34%)
- Nausea (33%)
- URT infection (14%)
- Pain (24%)
- Fever (23%)
- Asthenia (21%)
- Diarrhea (16%)
- Dizziness (15%)
- Infection (11%)
- Dyspepsia (11%)
- Abdominal pain (9%)
- Anemia (8%)
- Chest pain (6%)
- Aggravation of seizure disorders
- Autoimmune disorders: Drug-induced lupus erythematosus, autoimmune hepatitis
- Blood and lymphatic system disorders: Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), hemolytic anemia
- Eye disorders: Retinal vascular disorders (ie, retinopathy, cotton wool spots or obstruction of retinal artery or vein)
- Skin and subcutaneous tissue disorders: Erythema multiforme, Stevens-Johnson syndrome
- Hyperhidrosis
- Injection site reactions including necrosis
Warnings
Flu-like symptoms may occur
Efficacy in primary progressive MS not demonstrated conclusively; not recommended
Anaphylaxis reported as a rare complication of therapy; other allergic reactions have included dyspnea, orolingual edema, skin rash, and urticaria; discontinue therapy if anaphylaxis or other allergic reactions occur
Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, reported from postmarketing experience in treated patients; in some cases, platelet counts were below10,000/microliter; some cases recurred with rechallenge; patients should be monitored for symptoms or signs of decreased blood counts
Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported; cases have been reported several weeks to years after starting interferon beta products; discontinue therapy if clinical symptoms and laboratory findings consistent with TMA occur; manage as clinically indicated
Seizures have been temporally associated with use of beta interferons in clinical trials and postmarketing safety surveillance; not known whether the events were related to the effects of multiple sclerosis alone, the drug, or to a combination of both
Pregnancy and Lactation
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 use during early pregnancy
Limited published literature has described the presence of interferon beta-1a products in human milk at low levels; there are no data on effects of interferon beta-1a on milk production
Maximum Dosage
For Rebif, 44 mcg subcutaneously every 48 hours; For Avonex, 30 mcg IM once a week.
For Rebif, 44 mcg subcutaneously every 48 hours; For Avonex, 30 mcg IM once a week.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Interferon beta-1a
prefilled IM syringe (Avonex)
30mcg/0.5mL
prefilled IM autoinjector pen (Avonex)
30mcg/0.5mL
powder for injection (Avonex)
30mcg/vial (30mcg/0.5 mL reconstituted)
prefilled SC syringes titration pack (Rebif)
8.8mcg/0.2mL (6 syringes)
22mcg/0.5mL (6 syringes)
prefilled SC syringe (Rebif)
22mcg/0.5mL
44mcg/0.5mL
prefilled SC autoinjector (Rebif Rebidose)
8.8mcg/syringe
22mcg/syringe
44mcg/syringe