Rebif

Rebif

interferon beta-1a

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Recombinant human interferon β-1a
Indications/Uses
Relapsing multiple sclerosis. 44 mcg: Patients w/ a single demyelinating event w/ an active inflammatory process, if alternative diagnoses have been excluded, & if they are determined to be at high risk of developing relapsing multiple sclerosis.
Dosage/Direction for Use
SC Relapsing multiple sclerosis 44 mcg 3 times/wk. Patient who cannot tolerate the higher dose 22 mcg 3 times/wk. 44 mcg soln for inj Recommended dose titration when 1st starting treatment: Wk 1-2: 8.8 mcg 3 times/wk; wk 3-4: 22 mcg 3 times/wk; wk 5+: 44 mcg 3 times/wk. 1st demyelinating event 44 mcg 3 times/wk.
Contraindications
Hypersensitivity to natural or recombinant interferon-β. Current severe depression &/or suicidal ideation. 44 mcg: Initiation of treatment in pregnancy.
Special Precautions
Immediately discontinue use & promptly treat patient (considering plasma exchange) if thrombotic microangiopathy is diagnosed. Patients w/ previous or current depressive disorders in particular to those w/ antecedents of suicidal ideation; history of seizures; cardiac disease eg, angina, CHF or arrhythmia; severe myelosuppression. Advise patients to use an aseptic inj technique & rotate inj sites w/ each dose to minimize risk of inj site necrosis. Possible nephrotic syndrome; periodically monitor early signs or symptoms (eg, oedema, proteinuria & impaired renal function). Monitor liver enzyme, complete & differential blood cell counts, platelet counts at regular intervals (1, 3 & 6 mth) following introduction of therapy. Perform thyroid function testing at baseline & if abnormal, every 6-12 mth following initiation of therapy. Reassess the benefit/risk ratio of continued Rebif therapy if patient poorly responds to therapy & has neutralising Abs. Do not use in patients w/ primary progressive multiple sclerosis. Contains sodium (23 mg/dose); benzyl alcohol (not to be given to premature babies or neonates; may cause toxic reactions & anaphylactoid reactions in infants & childn up to 3 yr). May influence ability to drive or use machines. Severe renal or hepatic failure. History of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (>2.5 times ULN); discontinue use if icterus or other liver dysfunction symptoms appear. Pregnancy. Not to be used in childn <12 yr.
Adverse Reactions
Neutropenia, lymphopenia, leucopenia, thrombocytopenia, anemia; headache; inj site inflammation & reaction, flu-like symptoms; increased asymptomatic transaminase. Depression, insomnia; diarrhoea, vomiting, nausea; pruritus, rash, erythematous or maculopapular rash, alopecia; myalgia, arthralgia; inj site pain, fatigue, rigors, fever; severe elevated transaminases.
Drug Interactions
Drugs w/ narrow therapeutic index & largely dependent on the hepatic cytochrome P450 system for clearance (eg, antiepileptics & some classes of antidepressants).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
L03AB07 - interferon beta-1a ; Belongs to the class of interferons. Used as immunostimulants.
Presentation/Packing
Form
Rebif inj 22 mcg
Packing/Price
(multidose) 1.5 mL x 4 × 1's;0.5 mL x 12 × 1's;0.5 mL x 1's;0.5 mL x 3 × 1's
Form
Rebif inj 44 mcg
Packing/Price
(multidose) 1.5 mL x 4 × 1's;0.5 mL x 12 × 1's;0.5 mL x 1's;0.5 mL x 3 × 1's
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