Rebif Dosage/Direction for Use

interferon beta-1a




Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Treatment should be initiated under supervision of physician experienced in the treatment of the disease. Rebif is available in two strengths: 22 mcg and 44 mcg.
Posology: When first starting treatment with Rebif, in order to allow tachyphylaxis to develop thus reducing adverse reactions, it is recommended that 8.8 mcg (0.1 ml of the 44 mcg strength or 0.2 ml of the 22 mcg strength) be administered three times per week during the initial 2 weeks of therapy, 22 mcg (0.25 ml of the 44 mcg strength or the total of 22 mcg strength) be administered by subcutaneous injection three times per week in weeks 3 and 4, and the total of the 44 mcg strength be administered three times per week from the fifth week onwards.
First demyelinating event: The recommended posology for patients who have experienced a first demyelinating event is 44 mcg of Rebif given three times per week by subcutaneous injection.
Relapsing Multiple Sclerosis: The recommended posology of Rebif is 44 mcg given three times per week by subcutaneous injection. Rebif 22 mcg, also given three times per week by subcutaneous injection, is recommended for patients who cannot tolerate the higher dose in view of the treating specialist.
Children and adolescents: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Rebif 22 micrograms subcutaneously three times per week is similar to that seen in adults. There is very limited information on the use of Rebif in children under 12 years of age and therefore Rebif should not be used in this population.
Method of administration: Rebif is administered by subcutaneous injection. Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
At the present time, it is not known for how long patients should be treated. Safety and efficacy with Rebif have not been demonstrated beyond 4 years of treatment. It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating physician.
Rebif solution for subcutaneous injection in a cartridge is intended for multidose use with RebiSmart electronic injection device following adequate training of the patient and/or carer. The physician should discuss with the patient which device is the most appropriate.
For administration, the instructions provided in the instruction manual (Instructions for Use) provided with RebiSmart should be followed.
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