Avonex Consumer Medicine Information

Interferon beta-1a (pronounced 'inter-FER-on beeta-won-ay')

What is in this Leaflet

This leaflet answers some common questions about AVONEX. It does not contain all the available information. It does not take the place of talking to your specialist, doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using AVONEX against the benefits it is expected to have for you.

If you have any questions about using this medicine, ask your doctor or pharmacist, or contact the Multiple Sclerosis (MS) Society. You can also telephone 0800 286 639 for additional assistance on using AVONEX.

Keep this leaflet with the medicine. You may need to read it again.

What AVONEX is used for

AVONEX contains the active ingredient interferon beta-1a. Interferons are a group of compounds that exist naturally in the body. They help fight viral infections and regulate the body's immunity.

AVONEX is used for the management of relapsing forms of Multiple Sclerosis (MS). It has been shown to reduce the progression of disability as well as reduce the frequency of relapses (exacerbations). It has also been shown to reduce the risk of clinically definite multiple sclerosis in people who have had a single symptom or sign of MS and also have a brain MRI scan showing characteristic features.

Your doctor may have prescribed AVONEX for another reason. Ask your doctor if you have any questions about why AVONEX has been prescribed for you.

The cause of MS is not yet known. MS affects the brain and spinal cord. In MS, the body's immune system reacts against its own myelin (the 'insulation' surrounding nerve fibres). In relapsing forms of MS, people have 'exacerbations' from time to time. (For example, blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). They are followed by periods of recovery. Recovery may be complete or incomplete. If it is incomplete there is 'progression of disability'.

AVONEX is a 'PRESCRIPTION ONLY MEDICINE'. Use only for the person for whom it has been prescribed.

How AVONEX works

Although the exact mechanism of interferons in MS is unknown, it is thought that AVONEX works in MS by decreasing the unwanted immune reaction against myelin.

AVONEX treatment has been shown to:

  • slow the usual progression of disability in MS
  • reduce the frequency of exacerbations in MS
  • reduce the risk of relapse in confirmed MS
  • delay the onset of definite MS after an illness suggesting MS

The positive effects of AVONEX are not seen immediately. They occur with long-term treatment. It is important to continue treatment with AVONEX unless your doctor tells you to stop.

There is no information from clinical studies on the safety and effectiveness of AVONEX beyond 3 years of treatment or the use of AVONEX in people with MS who are below 18 years of age.

Before you use AVONEX

When you must not use it

Do not use AVONEX if you are:

  • allergic to AVONEX or any of the interferons
  • allergic to human albumin
  • allergic to other ingredients in AVONEX (sodium chloride and monobasic and dibasic sodium phosphate)
  • pregnant or trying to become pregnant

Before you use it

Tell your doctor if you:

  • are or have been depressed
  • have considered committing suicide
  • have had fits (also known as seizures or convulsions)
  • have liver or kidney problems
  • have heart problems
  • have a blood disorder
  • are breastfeeding
  • are pregnant, or planning to become pregnant

If you become pregnant while on treatment with AVONEX, immediately tell your doctor. It is likely that he/she will recommend you stop using AVONEX.

If you are a female of childbearing age and are sexually active, you should use birth control during treatment with AVONEX.

If you wish to become pregnant and you are having treatment with AVONEX, please first discuss this with your doctor.

Tell your doctor if you are using any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

How to use AVONEX

How much to use

The dose of AVONEX is 30 micrograms (6 million International Units [IU]) in 1 mL.

How often to use it

AVONEX is given, by injection, once a week.

If you forget

If you miss an injection, you should have it as soon as possible. Then resume your regular weekly dosing schedule.

Do not use a double dose to make up for the dose that you missed. Do not use two injections within 2 days of each other.

How to use it

AVONEX is given by injection. It is only for injection into muscle.

One vial of AVONEX powder is prepared for injection by adding 1.1 mL of sterile Water for Injections.

Each vial of AVONEX and each pre-filled syringe of sterile Water for Injections is used once only. Discard any unused portion.

See also the 'Guide to reconstitution and injection' leaflet in the AVONEX pack for step-by-step instructions about how to prepare and inject AVONEX. Patient supports kits that include a step-by-step instruction video are available by telephoning 0800 286 639.

Talk to your specialist, doctor or pharmacist, or contact the MS Society or telephone 0800 286 639 if you have any questions about using AVONEX.

Self-injection (Self-administration)

AVONEX is given as an intramuscular injection. The intramuscular injection is a technique that may be learned by the person with MS or a carer. They will need to have instruction about how to do it.

In the USA, most people with MS who are being treated with AVONEX, either give their own injection (self-injection) or have the injection given by a carer.

To discuss how to self-inject, talk to your doctor or the MS Society or telephone 0800 286 639.

Self-injection needs to be taught and practised. It is important that a qualified health care professional supervises the first actual injection.

If you take too much (overdose)

Immediately telephone your doctor or the National Poisons Centre(0800 POISON or 0800 764 766) , or go to accident and emergency at your nearest hospital, if you think you or anyone else may have used too much AVONEX. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are on AVONEX treatment

Things you must do:

  • If you become pregnant while using AVONEX, immediately tell your doctor. It is likely that he/she will recommend you stop using AVONEX.
  • If, while on AVONEX, you experience a convulsion (also called a 'fit', 'seizure' or 'funny turn') for example loss of consciousness or a bout of uncontrollable twitching or of unusual confusion, tell your doctor immediately.
  • If you are or have become depressed, feel hopeless or considered committing suicide while using AVONEX immediately tell your doctor.
  • If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using AVONEX.

Things you must not do:

Do not give AVONEX to anyone else, even if they appear to have the same condition as you.

Do not stop using AVONEX or change the dosage, without checking with your doctor.

Side effects

All medicines have side effects. Sometimes they are serious, most of the time they are not.

Tell your doctor or pharmacist as soon as possible if you do not feel well while using AVONEX.

AVONEX helps most people with MS, but it may have unwanted effects in a few people.

If any of the following happen, stop using AVONEX and tell your doctor immediately, or go to accident and emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • hives
  • fainting
  • yellowing of the skin and eyes (also called jaundice)
  • abscesses, or lumps, at the injection site

These are very serious side effects. If you have them, you may have had a serious allergic reaction to AVONEX. You may need urgent medical attention or hospitalisation. These side effects are rare.

The most common side effect is to feel 'flu-like' symptoms, for example: headache, tiredness, muscle aches, shivering and fever. These side effects generally occur less often as therapy continues.

To treat flu-like symptoms you may find it useful to take paracetamol tablets at the recommended dosage. Do this before your AVONEX injection and for up to 24 hours (one day) afterwards. The usual adult dose for paracetamol is 500 mg to 1000 mg (1 to 2 tablets) every four to six hours to a maximum of 4.0 grams (8 tablets) daily.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you have any unpleasant effects after using AVONEX.

It is not known whether all of the following side effects are related to your general health, the MS process, to AVONEX or to a combination of these. Side effects associated with AVONEX treatment include flu-like symptoms and injection site pain.

Common side effects reported include: depression, diarrhoea, dizziness, joint pains, indigestion, lack of appetite, menstruation upsets, nausea, sleeplessness and soreness at the injection site.

Less common side effects reported include: blood disorders, eye pain, fits (convulsions), fainting, hair loss, skin rash, inflammation at the injection site and tendency to suicide.

Other side effects, which are not listed, may occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Product description

Ingredients

Each vial of AVONEX contains the active ingredient interferon beta-1a as a sterile, white to off-white powder.

AVONEX also contains:

  • human albumin
  • sodium chloride
  • monobasic and dibasic sodium phosphate

One pre-filled syringe of sterile Water for Injections is provided to dissolve the AVONEX powder ready for injection.

Please read carefully the 'Guide to reconstitution and injection' in the AVONEX pack for full details, including safe disposal after use.

After AVONEX powder has been dissolved, it contains 30 microgram (6 million International Units [IU]) of interferon beta-1a in one mL.

Each AVONEX pack provides medicine for once-weekly treatment for 4 weeks. Each pack contains 4 sealed blister trays. Each blister tray contains:

  • 1 vial of sterile AVONEX powder with attached BIO-SET device
  • 1 pre-filled syringe of sterile Water for Injections
  • 1 blue needle 23G, 11/4, to use when giving the injection.

AVONEX does not contain:

  • lactose
  • gluten
  • preservative

Storage

AVONEX should be stored below 25°C.

AVONEX MUST NOT BE FROZEN. Do not place in freezer or freezing compartment of a refrigerator.

This means AVONEX can be stored at room temperature. Do not expose it to high temperatures (such as found in a car glove box or on a window sill).

Keep AVONEX in the pack until required.

After AVONEX powder has been dissolved, use it as soon as possible. However, the dissolved product can be stored for up to six hours at 2-8°C (the temperature of most home refrigerators).

DO NOT FREEZE.

Keep AVONEX out of reach of children.

Note the expiry date on the pack. Do not use after this expiry date.

Further information

You can obtain more information from your doctor, pharmacist or the MS Society or by telephoning 0800 286 639.

This leaflet was updated in:
April 2004

AVONEX® is a registered trademark of Biogen Idec Inc.

BIO-SET™ is a trademark of BIODOME.