Rebif

Rebif

interferon beta-1a

Manufacturer:

PT. Merck Tbk
Concise Prescribing Info
Contents
Recombinant human interferon β-1a
Indications/Uses
Relapsing multiple sclerosis (MS) w/ ≥2 acute exacerbations in the previous 2 yr.
Dosage/Direction for Use
SC When starting treatment, to allow tachyphylaxis & reduce AR: 20% of the total dose administered during the 1st 2 wk, 50% of the total dose be administered in wk 3 & 4, then full dose from the 5th wk onwards. Patient who cannot tolerate the higher dose 22 mcg SC 3 times wkly.
Contraindications
Hypersensitivity to natural or recombinant interferon-β. Current severe depression &/or suicidal ideation.
Special Precautions
Discontinue use if thrombotic microangiopathy is diagnosed; has multiple lesions; icterus or other clinical symptoms of liver dysfunction occur; nephrotic syndrome. Further testing of blood platelet level, serum, LDH, blood films & renal function is recommended if clinical features of TMA is observed. Monitor serum ALT prior to, at mth 1, 3 & 6 & periodically after treatment; early signs or symptoms eg, oedema, proteinuria & impaired renal function; liver enzyme & complete & differential blood cell counts & platelet counts at regular intervals (1, 3 & 6 mth) following initiation of therapy & periodically thereafter in the absence of clinical symptoms; thyroid function at baseline & if abnormal, every 6-12 mth following initiation of therapy. Evaluate patients at least every 2nd yr in the 4-yr period after initiation of treatment. Flu-like syndrome, previous or current depressive disorders, suicidal ideation. History of seizures, to those receiving treatment w/ anti-epileptics. Closely monitor patients w/ cardiac disease eg, angina, CHF or arrhythmia. Rotate inj site w/ each dose & use aseptic inj technique to minimize inj site necrosis (ISN). Patients w/ myelosuppression. Serum neutralising Abs against interferon β-1a may develop. Not to be used in patients w/ primary progressive multiple sclerosis. Might influence the patient’s ability to drive or use machines. Severe renal & hepatic failure. History of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (>2.5 x ULN). Pregnancy. Not to be used in childn <2 yr. Not to be given in premature babies or neonates. May cause toxic & anaphylactoid reactions in infants & childn up to 3 yr due to benzyl alcohol.
Adverse Reactions
Neutropenia, lymphopenia, leucopenia, thrombocytopenia, anaemia; asymptomatic transaminase increase; headache; inj site inflammation, reaction, influenza-like symptoms. Severe elevations in transaminases; depression, insomnia; diarrhoea, vomiting, nausea; pruritus, rash, erythematous rash, maculopapular rash, alopecia; myalgia, arthralgia; inj site pain, fatigue, rigors, fever.
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 soln for inj 22 mcg/0.5 mL
Packing/Price
3 × 1's
Form
Rebif soln for inj 44 mcg
Packing/Price
1 mL x 3 × 1's (Rp18,480,000/boks)
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