Posology : מינונים

4.2   Posology and method of administration

Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.

Rebif is available in two strengths: 22 micrograms and 44 micrograms.

Posology
When first starting treatment with Rebif, the dose should be gradually escalated in order to allow tachyphylaxis to develop thus reducing adverse reactions. It is recommended that patients be started according to the doctor recommended dose subcutaneously.


When first starting treatment it is recommended that 8.8 micrograms (0.1 ml of the 44 mcg strength or 0.2 ml of the 22 mcg strength) be administered by subcutaneous injection three times per week during the initial 2 weeks of therapy. Thereafter, 22 micrograms (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 micrograms strength be administered from the fifth week onwards.

First demyelinating event

The posology for patients who have experienced a first demyelinating event is 44 micrograms of Rebif given three times per week by subcutaneous injection.

Relapsing multiple sclerosis

The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection. A lower dose of 22 micrograms, 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.

Paediatric population

No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, a paediatric retrospective cohort study collected safety data with Rebif from medical records in children (n=52) and adolescents (n=255). The results of this study suggest that the safety profile in children (2 to 11 years old) and in adolescents (12 to 17 years old) receiving Rebif 22 micrograms or 44 micrograms subcutaneous three times per week is similar to that seen in adults.

The safety and efficacy of Rebif in children below 2 years of age have not yet been established. Rebif should not be used in this age group.

Method of administration

Rebif is administered by subcutaneous injection, in a pre-filled-syringe or in cartridge.
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.

Rebif solution for subcutaneous injection in cartridge is intended for multidose use with RebiSmart electronic injection device following adequate training of the patient and/or carer.
For administration, the instructions provided in the package leaflet and in the instruction manual provided with RebiSmart autoinjector should be followed.

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.