This leaflet answers some common questions about AVONEX Solution for Injection (also known as 'Pre-Filled Syringe') and AVONEX Powder for Injection (also known as 'BIO-SET®'). 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 benefits and risks. Your doctor has weighed the benefits AVONEX is expected to have for you, against the risks of using it.

 

AVONEX is used for the management of relapsing forms of Multiple Sclerosis (MS). AVONEX treatment has been shown to:

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 (e.g. 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 belongs to a group of medicines called interferons. Interferons exist naturally in the body to help fight viral infections and regulate the body's immunity.

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

There is no information on the use of this medicine in those below 12 years of age.

Your doctor may have prescribed AVONEX for another reason.

AVONEX is available only with a doctor's prescription.

AVONEX Solution for Injection (Pre-Filled Syringe) does not contain human albumin.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.

Depression is common in people with MS and in those using medicines like AVONEX. You should always talk to your doctor if you are feeling depressed, or having suicidal thoughts. Your doctor can help you decide whether you should use AVONEX or not.

It may affect the development of your baby if you use it during pregnancy.

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

Do not use AVONEX after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. Do not use AVONEX if the medicine is cloudy, contains particles or is discoloured. It should be colourless or slightly yellow.

If you are not sure whether you should use this medicine, talk to your doctor or pharmacist.

It is recommended that you not use AVONEX if planning to breastfeed. Your doctor can discuss with you the possible risks involved.

They may differ from the information contained in this leaflet.

The dose of AVONEX is 30 micrograms once a week.

AVONEX Solution is given as a 0.5 mL injection.

AVONEX Powder is given as a 1mL injection.

Your doctor or MS nurse may provide you with an AVOSTARTCLIP titration kit to help gradually increase your dose of AVONEX during the first 3 weeks of treatment. This is to help limit flu-like symptoms. The AVOSTARTCLIP is designed for use with AVONEX solution for injection and attaches to the syringe to enable this gradual dose increase.

If you are new to AVONEX, your doctor or MS nurse may advise you to gradually increase your dose so as to minimise potential side effects of AVONEX before taking the full dose.

You will be provided with an AVOSTARTCLIP titration kit containing 3 different coloured clips (labelled week 1, 2 and 3). Each clip can be attached onto the AVONEX Pre-filled Syringe and enables either a quarter, a half or a three-quarter dose of AVONEX to be injected during your first 3 weeks of treatment.

Each AVOSTARTCLIP should be used once and then discarded along with any remaining AVONEX.

For further details on use, please follow the instructions provided with the AVOSTARTCLIP titration kit.

If you are commencing therapy on Powder for injection, you should speak to your doctor or MS nurse as to how to gradually increase your dose.

AVONEX is given by injection into muscle, usually in the thigh or upper arm. The buttock is not a suitable site for injection. Your doctor will recommend an injection site suitable for you. Many people with MS learn to give themselves the injection or have it given by a carer.

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

Your doctor may teach you to self-inject or arrange for an MS education nurse to do so.

AVONEX Solution for Injection is pre-mixed ready for you to use. It is recommended that you remove it from the refrigerator about half-an-hour before you want to use it. This allows the temperature of the medicine to approach room temperature.

Heating can damage this medicine.

AVONEX Powder for Injection must be mixed with Water for Injections before use.

Shaking can damage this medicine. Mix the AVONEX Powder with the sterile Water only when you are ready to use it. If you mix the Powder and are interrupted, you can keep the mixed product for a maximum of 6 hours but only if it is stored in the refrigerator at 2°C to 8°C.

The medicine should be clear and colourless or slightly yellow. Do not inject if the solution is discoloured or cloudy or contains particles.

 

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.

This may increase the chance of you getting an unwanted side effect.

 

It is important not to miss injections as this can affect the success of your treatment.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

You and your doctor will decide what is best for you and your baby. It is likely that your doctor will recommend you stop using AVONEX during your pregnancy.

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

If he or she recommends that you take a medication to reduce symptoms of pain and inflammation, follow their advice carefully. Do not take more than the recommended dose.

Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.

It may interfere with the results of some tests.

Your doctor may do blood tests before you start treatment and from time to time to monitor your progress and prevent unwanted side effects.

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.

Rarely, people treated with interferons including AVONEX, have experienced serious liver problems. It is not known whether this risk is increased by alcohol but it is possible.

AVONEX helps most people with MS but it may have unwanted effects in a few people. All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some side effects.

You may not experience any of them.

The most common side effect is to feel 'flu-like' symptoms, e.g. headache, tiredness, muscle aches, joint pain, shivering and fever. Your doctor or MS nurse may advise you to gradually increase your dose of AVONEX during the first 3 weeks of treatment to help reduce these symptoms. These side effects generally occur less often as therapy continues.

To help further reduce these symptoms, your doctor may advise you to take a medication to reduce pain and inflammation before your injection and for up to one day afterwards.

The above list includes the more common side effects of AVONEX, or these effects might be related to your general health or the MS process, or to a combination of these.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Other side effects not listed above may occur in some people.

Some side effects can only be found when your doctor does tests from time to time to check your progress. These include changes in thyroid function, liver function or blood counts.

The medicine will not keep as well if taken out of the sealed tray.

If necessary, you can keep AVONEX Solution out of the refrigerator for up to 7 days. If out of the refrigerator, store the sealed tray in a cool dry place where the temperature stays below 30°C.

Do not store AVONEX or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines.

Do not place in the freezer or freezing compartment of a refrigerator.

If your doctor tells you to stop using AVONEX or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Each pack of AVONEX contains 4 sealed blister trays. Use 1 blister tray for each weekly treatment. A pack of AVONEX provides treatment for 4 weeks.

Your pack of AVONEX already includes a needle for injection. It may be possible for your doctor to prescribe you a shorter and thinner needle depending on your body type. Talk to your doctor if you are interested in whether this is appropriate for you.

AVONEX Solution and Powder do not contain preservatives.

Do not reuse vials, needles or syringes.

Each Solution for Injection blister tray contains:

Each pre-filled syringe of AVONEX Solution contains 30 micrograms of interferon beta-1a in 0.5 mL of ready-to-use solution. It also contains:

 

Each Powder for Injection blister tray contains:

Each vial of AVONEX contains 30 micrograms of interferon beta-1a as a sterile, white to off-white powder. It also contains:

A syringe of sterile Water for Injections is provided with AVONEX Powder to dissolve the medicine ready for injection.