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.

Posology

Adults: The recommended dosage for the treatment of relapsing MS is 30 micrograms (0.5 ml solution), administered by intramuscular (IM) injection once a week (see section 6.6). No additional benefit has been shown by administering a higher dose (60 micrograms) once a week.
Titration: To help patients reduce the incidence and severity of flu-like symptoms (see section 4.8), titration can be performed at the initiation of treatment. Titration using the BIOSET or pre-filled syringe can be achieved by initiating therapy on ¼ dose increments per week reaching the full dose (30 micrograms/week) by the fourth week. An alternative titration schedule can be achieved by initiating therapy on approximately a ½ dose of AVONEX once a week before increasing to the full dose. In order to obtain adequate efficacy, a dose of 30mcg once a week should be reached and maintained after the initial titration period. Once a full dose is achieved patients may begin using AVONEX PEN.

Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with AVONEX administration. These symptoms are usually present during the first few months of treatment.

Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established. Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.

The safety and efficacy of AVONEX in children below 12 years of age have not yet been established. No data are available

Elderly: Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients. However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.

Method of administration

The intramuscular injection site should be varied each week (see section 5.3).At the present time, it is not known for how long patients should be treated. Patients should be clinically evaluated after two years of treatment and longer-term treatment should be decided on an individual basis by the treating physician. Treatment should be discontinued if the patient develops chronic progressive MS.

AVONEX PEN is a pre-filled pen, intended for single use, and should only be used following adequate training.

The recommended intramuscular injection site using the AVONEX PEN is the upper, outer thigh muscle. The injection site should be varied each week.

For administration of AVONEX via the AVONEX PEN, the instructions in the package leaflet should be followed.