Dosing and uses of Betaseron, Extavia (interferon beta 1b)
Adult dosage forms and strengths
lyophilized powder for injection
- 0.3mg/vial supplied with diluent for reconstitution
Relapsing/Remitting Multiple Sclerosis, Exacerbations
0.0625 mg SC every other day initially
Gradually increase over 6 wk to 0.25 mg (8 million U; 1 mL) SC every other day: may increase by 0.0625 mg q2wk
Betaconnect injectable devise
- No cost autoinjector for use only with Betaseron syringes
- Autoinjector offers customizable injection speed and depth settings
- Patients should speak to a healthcare provider or nurse before making any changes to injection depth or speed settings
- Automatic needle insertion and retraction Betaconnect has an optional backup reminder function to alert patient for next injection
- Device lets patients know when the injection is complete with a visual and audio end-of-dose indication
Non-A/Non-B Hepatitis (Orphan)
Treatment of acute non-A, non-B hepatitis
Orphan indication sponsor
- Biogen, Inc; 14 Cambridge Center; Cambridge, MA 02142
Dosing Considerations
Monitor Hgb, WBC, Plts, LFTs
Pediatric dosage forms and strengths
lyophilized powder for injection
- 0.3mg/vial supplied with diluent for reconstitution
Multiple Sclerosis (Off-label)
Safety and efficacy not established
Limited data suggests to titrate as in adults; children 10 years or older typically tolerate full adult doses, although decreased tolerance may occur in younger children
0.0625 mg SC every other day initially
Gradually increase over 6 wk to 0.25 mg (8 million U; 1 mL) SC every other day: may increase by 0.0625 mg q2wk
Betaseron, Extavia (interferon beta 1b) adverse (side) effects
>10%
Injection site reaction (85%)
Flu-like syndrome (60%)
Headache (57%)
Myasthenia (46%)
Fever (36%)
Nausea (27%)
Chills (25%)
Constipation (20%)
Abd pain (19%)
Leukopenia (18%)
Chest pain (11%)
1-10%
Malaise (8%)
Inj site necrosis (5%)
Hypersensitivity (3%)
Lymphopenia (>5%)
Myalgia (>5%)
Neutropenia (>5%)
Increased liver enzymes (>5%)
Hypertonia (>5%)
Pain (>5%)
Rash (>5%)
Insomnia (>5%)
Abdominal pain (>5%)
Asthenia (>5%)
<1%
Aggravation of seizure disorders
Abortifacient potentiaL
Postmarketing Reports
Blood and lymphatic system disorders: Anemia, thrombocytopenia
Endocrine disorders: Hypothyroidism, hyperthyroidism, thyroid dysfunction
Metabolism and nutrition disorders: Triglyceride increased, anorexia, weight decrease, weight increase
Psychiatric disorders: Anxiety, confusion, emotional lability
Nervous system disorders: Convulsion, dizziness, psychotic symptoms
Cardiac disorders: Cardiomyopathy, palpitations, tachycardia
Vascular disorders: Vasodilatation
Respiratory, thoracic and mediastinal disorders: Bronchospasm
Gastrointestinal disorders: Diarrhea, nausea, pancreatitis, vomiting
Hepatobiliary disorders: Hepatitis, increased GGt
Skin and subcutaneous tissue disorders: Alopecia, pruritus, skin discoloration, urticaria
Musculoskeletal and connective tissue disorders: Arthralgia, lupus erythematosus
Reproductive system and breast disorder: Menorrhagia
General disorders and administration site conditions: Fatal capillary leak syndrome
Warnings
Contraindications
Hypersensitivity to beta interferons, human albumin or other ingredients
Cautions
Risk of hepatotoxicity; injection site necrosis; leukopenia; monitor liver function tests and signs and symptoms of hepatic injury; consider discontinuing therapy if serious hepatic injury occurs
Discontinue if anaphylaxis occurs
Do not administer into affected area until fully healed; if multiple lesions occur, discontinue therapy until skin lesions heaL
Advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuing therapy if depression occurs
Abortifacient potentiaL
Flu-like symptoms may occur
Increased risk of infection
Betaseron & Extavia, although dosed similarly, not considered therapeutically equivalent
Monitor patients with CHF for worsening of cardiac symptoms; consider discontinuation of therapy if worsening of CHF occurs
Leukopenia may occur; monitor complete blood count
In addition to 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 interferon 1b therapy, and periodically thereafter in absence of clinical symptoms
Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, reported; some 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, and manage as clinically indicated
Consider analgesics and/or antipyretics on injection days if flu-like symptoms occur
Cases of drug-induced lupus erythematosus have reported;. discontinue therapy if patients develop new characteristic signs and symptoms
Removable rubber cap of the diluent (sodium chloride, 0.54% solution) pre-filled syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk, do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Betaseron, Extavia (interferon beta 1b)
Mechanism of action
Recombinant interferon; antiviral, antiproliferative, immunoregulatory protein; alters response to surface antigen and may inhance immune cell activities
Pharmacokinetics
Peak plasma time: 1-8 hr
Concentration: 40 IU/mL
Half-Life: 8 min - 4.3 hr
Onset: 6-12 hr
Bioavailability: 50%
Vd: 0.25-2.88 L/kg
Clearance: 9.4-28.9 mL/min
Administration
Instructions
Reconstitute with 1.2 mL of 0.54% NaCl diluent (provided); the removable diluent cap contains natural rubber latex
Rotate SC injection site between upper outer arm, thight, and abdomen
See prescribing information for detailed instructions for preparation
