Extavia 250 microgram/ml powder and solvent for solution forinjection

What is it and how is it used?

What Extavia is

Extavia is a type of medicine known as interferon used to treat multiple sclerosis. Interferons are proteins produced by the body that help it fight against attacks on the immune system such as viral infections.

How Extavia worksMultiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly. This is called demyelination.

The exact cause of MS is unknown. An abnormal response by the body?s immune system is thought to play an important part in the process which damages the CNS.

The damage to the CNS can occur within an MS attack (relapse). It can cause disability temporarily, such as difficulty walking. Symptoms may disappear completely or partly.

Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.

How Extavia helps fight your diseaseSingle clinical event indicating a high risk of developing multiple sclerosis: Extavia has been shown to delay progression to definite multiple sclerosis.

Relapsing-remitting multiple sclerosis: People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse. Extavia has been shown to cut down the number of attacks and make them less severe. It reduces the number of hospital stays due to the disease and prolongs the time without relapses.

Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses. Extavia can reduce the number and severity of the attacks, and slow the progression of disability.

What Extavia is used for

Extavia is for use in patients

- who have experienced for the first time symptoms which indicate a high risk of developing multiple sclerosis. Your doctor will rule out any other reasons which could explain these symptoms before you are treated.

- who suffer from relapsing-remitting multiple sclerosis, withat least two relapseswithin the last two years.

- who suffer from secondary progressive multiple sclerosis with active disease shown by relapses.

What do you have to consider before using it?

Do not use Extavia

◾if you are pregnant. You should not start treatment with Extavia (see ?Pregnancy?).

◾if you are allergic(hypersensitive) to natural or recombinant interferon beta, human albumin or any of the other ingredients of Extavia.

◾if you currently suffer from severe depression and/or suicidal thoughts (see ?Take special care? and section 4, ?Possible side effects?).

◾if you have a severe liver disease (see ?Take special care?, ?Using other medicines? and section 4, ?Possible side effects?).

Tell your doctor, if any of the above applies to you.

Take special care with Extavia

Your doctor also needs to know the following before you are given Extavia: