EXTAVIA Powder and solvent for solution for injection Ref.[8863] Active ingredients: Interferon beta-1b

The treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease.

Posology

Adults and adolescents from 12-17 years of age

The recommended dose of Extavia is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.

Generally, dose titration is recommended at the start of treatment.

Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A). The titration period may be adjusted, if any significant adverse reaction occurs. In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.

Table A. Schedule for dose titration*

* The titration period may be adjusted if any significant adverse reaction occurs.

The optimal dose has not been fully clarified.

At the present time, it is not known for how long the patient should be treated. There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years. For relapsing-remitting multiple sclerosis, efficacy has been demonstrated for therapy for the first two years. The available data for the additional three years are consistent with sustained treatment efficacy of Extavia over the whole time period.

In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.

Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.

If the patient fails to respond, for example a steady progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or treatment with at least 3 courses of adrenocorticotropic hormone (ACTH) or corticosteroids during a one-year period is required despite Extavia therapy, treatment with Extavia should be stopped.

Paediatric population

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 17 years of age receiving Extavia 8.0 million IU subcutaneously every other day is similar to that seen in adults. No data are available on the use of Extavia in children under 12 years of age and therefore Extavia should not be used in this population.

Method of administration

The reconstituted solution is to be injected subcutaneously every other day.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Interferon beta-1b has been given to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week without serious adverse events compromising vital functions.

2 years.

After reconstitution immediate use is recommended. However, in-use stability has been demonstrated for 3 hours at 2°C-8°C.

Do not store above 25°C.

Do not freeze.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Powder: 3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal containing 300 microgram (9.6 million IU) of (recombinant interferon beta-1b) powder.

Solvent: 2.25 ml graduated (with dose marks of: 0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml) pre-filled syringe (type I glass) with 1.2 ml solvent.

Pack sizes:

Pack containing 5 vials with powder and 5 pre-filled syringes with solvent
Pack containing 14 vials with powder and 14 pre-filled syringes with solvent
Pack containing 15 vials with powder and 15 pre-filled syringes with solvent
Pack containing 14 vials with powder and 15 pre-filled syringes with solvent

3-month multipack containing 42 (3x14) vials with powder and 42 (3x14) pre-filled syringes with solvent
3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes with solvent
3-month multipack containing 42 (3x14) vials with powder and 45 (3x15) pre-filled syringes with solvent

Not all pack sizes may be marketed.

The tip cap of the pre-filled syringe contains a derivative of natural rubber latex. Therefore, the tip cap may contain natural rubber latex, which should not be handled by persons sensitive to this substance.

Reconstitution

To reconstitute the powder, the pre-filled syringe with solvent should be used with a needle or a vial adapter to inject the 1.2 ml of the solvent (sodium chloride 5.4 mg/ml (0.54%) solution for injection) into the Extavia vial. The powder should dissolve completely without shaking. After reconstitution, 1.0 ml of the solution should be drawn from the vial into the syringe for the administration of 250 microgram Extavia.

Inspection prior to use

The reconstituted product should be inspected visually before use. The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.

The medicinal product should be discarded before use if it contains particulate matter or is discoloured.

Disposal

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