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
Relapsing multiple sclerosis 44 mcg SC 3 times/wk. Patient who cannot tolerate the higher dose A lower dose of 22 mcg SC 3 times/wk. 44 mcg soln for inj Recommended dose titration when 1st starting treatment: Wk 1-2: 8.8 mcg SC 3 times/wk; wk 3-4: 22 mcg SC 3 times/wk; wk 5+: 44 mcg SC 3 times/wk. 1st demyelinating event 44 mcg SC 3 times/wk.
Contraindications
Hypersensitivity to natural or recombinant interferon-β. Current severe depression &/or suicidal ideation. Initiation of treatment in pregnancy.
Special Precautions
Monitor thrombotic microangiopathy, inj site necrosis, nephrotic syndrome, neutralising antibodies. 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 renal & hepatic failure; severe myelosuppression. Perform thyroid function testing at baseline & if abnormal, every 6-12 mth following initiation of therapy. Do not use in patients w/ primary progressive multiple sclerosis. Contains benzyl alcohol (must not 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. Lactation. Should not be used in childn <12 yr.
Adverse Reactions
Neutropenia, lymphopenia, leucopenia, thrombocytopenia, anemia; headache; increased asymptomatic transaminase; inj site inflammation & reaction, influenza-like symptoms. Depression, insomnia; diarrhoea, vomiting, nausea; severe elevations in transaminases; pruritus, rash, erythematous or maculopapular rash, alopecia; myalgia, arthralgia; inj site pain, fatigue, rigors, fever.
Drug Interactions
Drugs w/ narrow therapeutic index & are 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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