Using Extavia with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).

Extavia should be used with caution with:

◾medicines which need a certain liver enzyme system (known as cytochrome P450 system) for their removal from the body, for example medicines used to treat epilepsy (such as phenytoin).

◾medicines which affect the production of blood cells.

Using Extavia with food and drink

Extavia is injected under the skin so any food or drink you consume is not thought to have any effect on Extavia.

Pregnancy

Women at risk of becoming pregnant should use contraception during treatment with Extavia.

If you are pregnant or you think you may be, tell your doctor. Extavia therapy should not be started if you are pregnant see also Do not use Extavia.

If you wish to become pregnant, discuss this with your doctor first.

If you become pregnant while using Extavia, stop your treatment and contact your doctor immediately. Your doctor will decide together with you whether your Extavia treatment will be continued or not.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

It is not known whether interferon beta-1b passes into human breast milk. However, it is theoretically possible that a breast-fed baby could experience serious side effects to Extavia.

Discuss it with your doctor first to decide whether to stop breast-feeding or to stop using Extavia.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving or using machines

Extavia may cause side effects in the central-nervous system (see section 4 Possible side effects). If you are especially sensitive, this might influence your ability to drive or use machines.

How is it used?

Treatment with Extavia should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.

Always use Extavia exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Dose

The usual dose is:

Every other day (once every two days), 1.0 ml of the prepared Extavia solution (see Annex) injected under the skin (subcutaneously). This equals 250 microgram (8 million IU) interferon beta-1b.

In general, treatment should be started at a low dose of 0.25 ml (62.5 micrograms). Your doses will then be increased gradually to the full dose of 1.0 ml (250 micrograms).

The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml). Your doctor may decide together with you to change the time intervals for dose increase depending on side effects you may experience at the start of treatment.

Preparing the injectionBefore injection, the Extavia solution has to be prepared from a vial of Extavia powder and 1.2 ml of liquid from the pre-filled solvent syringe. This will either be done by your doctor or his/her assistant or by yourself after you have been carefully trained.

Detailed instructions for self-injectionof Extavia under the skin are provided in the Annex at the back of this leaflet. These instructions also tell you how to prepare the Extavia solution for injection.