Rebif利比

Rebif

interferon beta-1a

Manufacturer:

Merck

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Recombinant human interferon β-1a (free of foetal bovine serum & human serum albumin)
Indications/Uses
Treatment of relapsing multiple sclerosis characterized by ≥2 acute exacerbations in the previous 2 yr. Patient w/ 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 clinically definite multiple sclerosis. Efficacy has not been demonstrated in patients w/ secondary progressive multiple sclerosis w/o ongoing relapse activity.
Dosage/Direction for Use
44 mcg SC 3 times wkly. Patient who cannot tolerate the higher dose 22 mcg SC 3 times wkly. When starting therapy for the 1st time, administer 8.8 mcg during the 1st 2 wk, then 22 mcg in wk 3 & 4, then 44 mcg from wk 5 onwards.
Contraindications
Severe depression &/or suicidal ideation. Childn <12 yr. Pregnancy.
Special Precautions
History of seizures not adequately controlled w/ antiepileptics. Cardiac disease eg, angina, CHF or arrhythmia, severe renal & hepatic failure, severe myelosuppression. Monitor serum ALT levels & FBC w/ differential & platelet counts at baseline, mth 1, 3 & 6 of therapy & periodically thereafter in the absence of clinical symptoms. Thyroid function testing at baseline & if abnormal, 6-12 mth after initiation of therapy. Periodic monitoring of sign of nephrotic syndrome. Reconsider the therapy if poor response w/ persistent neutralizing antibodies. Prompt treatment of thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome is required & discontinue of treatment if occurred. May impair ability to drive or operate machinery. Lactation.
Adverse Reactions
Flu-like syndrome, headache, inj site reactions, haematological abnormalities, asymptomatic transaminase increase, depression, insomnia, GI disturbances, pruritus, rash, erythematous rash, maculopapular rash, myalgia, arthralgia, rigors, fatigue, fever; severe elevations of transaminases; alopecia. Neutropenia, lymphopenia, leukopenia, thrombocytopenia, anaemia.
Drug Interactions
Narrow therapeutic index drugs, antiepileptics, antidepressants.
ATC Classification
L03AB07 - interferon beta-1a ; Belongs to the class of interferons. Used as immunostimulants.
Presentation/Packing
Form
Rebif inj 66 mcg
Packing/Price
4's
Form
Rebif inj 132 mcg
Packing/Price
4's
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