AVONEX Solution for injection Ref.[9684] Active ingredients: Interferon beta-1a

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 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 30 micrograms once a week should be reached and maintained after the initial titration period.

The AVOSTARTCLIP titration kit is designed for use with the pre-filled syringe only. It can be used to achieve the ¼ or ½ dose increments. Each AVOSTARTCLIP should be used once and then discarded along with any remaining AVONEX in the syringe.

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).

Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection.

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.

No case of overdose has been reported. However, in case of overdose, patients should be hospitalised for observation and appropriate supportive treatment given.

3 years.

Store in a refrigerator (2°C-8°C).

DO NOT FREEZE.

AVONEX can be stored at room temperature (between 15°C and 30°C) for up to one week.

Store in the original package (sealed plastic tray) in order to protect from light (see section 6.5).

1 ml pre-filled syringe made of glass (Type I) with a tamper evident cap and plunger stopper (bromobutyl) containing 0.5 ml of solution.

Pack size: box of four or twelve pre-filled syringes of 0.5 ml. Each syringe is packed in a sealed plastic tray, which also contains one injection needle for intramuscular use.

Not all pack sizes may be marketed.

AVONEX is provided as ready to use solution for injection in a pre-filled syringe.

Once removed from the refrigerator, AVONEX in a pre-filled syringe should be allowed to warm to room temperature (15°C-30°C) for about 30 minutes.

Do not use external heat sources such as hot water to warm AVONEX 30 micrograms solution for injection.

If the solution for injection contains particulate matter or if it is any colour other than clear colourless, the pre-filled syringe must not be used. The injection needle for intramuscular injection is provided. The formulation does not contain a preservative. Each pre-filled syringe of AVONEX contains a single dose only. Discard the unused portion of any pre-filled syringe.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.