AVONEX 30 micrograms/0.5 ml solution for Injection
Even if you have used Avonex before, some of the information may have changed.
This leaflet is changed from time to time.
Please check every time you get your prescription refilled to see if the leaflet has been updated.
1. What AVONEX is and what it is used for
2. What you need to know before you use AVONEX
3. How to use AVONEX
4. Possible side effects
5. How to store AVONEX
6. Contents of the pack and other information
7. How to inject AVONEX
The active substance in Avonex is a protein called interferon beta-1a. Interferons are natural substances made in your body to help protect you from infections and diseases. The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.
Avonex is used to treat Multiple Sclerosis (MS). Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS.
Everyone has their own set of MS symptoms. These can include:
MS also tends to flare up from time to time: this is called a relapse.
Avonex works best when you use it at the same time, once a week, on a regular basis.
Do not stop your Avonex treatment without speaking to your neurologist.
Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS. Your doctor will advise you for how long you can use Avonex or when to stop.
Multiple sclerosis is linked to nerve (brain or spinal cord) damage. In MS, your body’s defence system reacts against its own myelin – the ‘insulation’ that surrounds nerve fibres. When myelin is damaged, the messages between the brain and other parts of the body are disrupted. This is what causes the symptoms of MS. Avonex seems to work by stopping your body’s defence system from attacking the myelin.
Talk to a doctor straight away if any of these apply to you.
Avonex and allergic reactions. Because Avonex is based on a protein, there is a small chance of an allergic reaction.
More about depression. If you have severe depression or thoughts about suicide, you must not use Avonex.
If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.
Talk to your doctor before using Avonex if you have or have had in the past:
Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex.
Blood clots in the small blood vessels may occur during your treatment. These blood clots could affect your kidneys. This might happen several weeks to several years after starting Avonex.
Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys.
Tell your doctor you are using Avonex:
Sometimes you will need to remind other medical staff that you are being treated with Avonex. For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.
Tell your doctor if you are using, have recently used or might use any other medicines, especially those used to treat epilepsy or depression. Avonex may affect other medicines or be affected by them. This includes any other medicines including medicines obtained without a prescription.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
No harmful effects on the breastfed newborn/infant are anticipated. Avonex can be used during breast-feeding.
If you feel dizzy, do not drive. Avonex makes some people feel dizzy. If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines.
This medicine is essentially ‘sodium-free’. It contains less than 23 mg (1 mmol) sodium in each weekly dose.
One injection of Avonex, once a week.
Try to use Avonex at the same time on the same day each week.
Avonex is not to be used in children below the age of 12 years.
If you have decided to start treatment with Avonex, your doctor may provide you with an Avostartclip titration kit. The Avostartclip attaches to the syringe and enables you to gradually increase your dose of Avonex when you first start treatment. This is to limit flu-like symptoms which some people experience when they start using Avonex. Your doctor or nurse will help you use the Avostartclip titration kit.
If you are new to Avonex, your doctor may advise you to gradually increase your dose so that you can adjust to the effects of Avonex before taking the full dose. You will be provided with an Avostartclip titration kit. Avostartclips can be attached onto the syringe enabling a reduced dose of Avonex to be injected at the start of treatment. Each Avostartclip should be used once and then discarded along with any remaining Avonex. For further details on use, speak with your doctor.
You can inject Avonex yourself without the help of your doctor, if they have trained you to do this. The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX).
If you have trouble handling the syringe, ask your doctor who may be able to help.
There are more details on how to inject Avonex at the end of this leaflet.
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 to see if this is appropriate for you.
If you have problems handling the syringe, talk to your doctor about using a syringe grip. This is a specially designed holder to help you with injecting Avonex.
Your doctor will tell you how long you need to keep using Avonex. It is important to continue using Avonex regularly. Do not make changes unless your doctor tells you.
You should only have one injection of Avonex, once a week. If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.
If you miss your usual weekly dose, inject a dose as soon as you can. Then leave a week before using Avonex again. Continue injecting on this new day every week. If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day. Do not use two injections to make up for a missed injection.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Although the list of possible side effects can seem worrying, it’s possible that you may not have any of them.
Serious allergic reactions
If you get any of these:
Call a doctor immediately. Do not use any more Avonex until you have spoken to a doctor.
If you get any symptoms of depression:
Call a doctor immediately.
If you get any of these symptoms:
Call a doctor immediately as they may be signs of a possible liver problem.
Side effects seen in clinical trials. These are the side effects that people reported when Avonex was being tested. The figures are based on how many people said they’d had them. It gives you an idea how likely you are to get similar side effects.
Very common side effects
(at least 1 in 10 people are affected)
Common side effects
(less than 1 in 10 people are affected)
Uncommon side effects
(less than 1 in 100 people affected)
Rare side effects
(less than 1 in 1,000 people affected)
If any of the effects trouble you, talk to your doctor.
These effects have been seen in people using Avonex, but we do not know how likely they are to happen.
If any of the effects trouble you, talk to your doctor.
Three simple ways to help reduce the impact of flu-like symptoms:
1. Use your Avonex injection just before bedtime. This may allow you to sleep through the effects.
2. Take paracetamol or ibuprofen half an hour before your Avonex injection and continue taking it for up to a day. Speak to your doctor or pharmacist about a suitable dose.
3. If you have a fever, drink plenty of water to keep you hydrated.
Some people find that after injecting Avonex, they feel like they have flu. Signs are:
These symptoms are not really flu.
You can’t pass it on to anyone else. They are more common when you first start using Avonex. Your doctor may provide you with an Avostartclip titration kit which enables you to gradually increase your dose at the start of treatment to help limit flu-like symptoms. As you keep using your injections, the flu-like symptoms gradually decrease.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
By reporting side effects you can help provide more information on the safety of this medicine.
In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label.
Store in the original package (sealed plastic tray) in order to protect from light.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Avonex can also be stored at room temperature (between 15°C and 30°C) for up to one week.
Do NOT use Avonex if you notice:
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substanceis: Interferon beta-1a 30 micrograms/0.5 ml
The other ingredients are: Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections.
Avonex Solution for Injection comes as a ready to use injection.
In a box of Avonex there are four or twelve ready to use (pre-filled) syringes, each with 0.5 ml of a clear, colourless liquid inside. Not all pack sizes may be marketed. Each syringe is packed in a sealed plastic tray. A separate needle to give the injection is also included in the tray.
The Marketing Authorisation Holder is:
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
You can get a larger print version of this leaflet by calling the local representatives.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in 09/2019
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
You should have had training in how to inject Avonex
These notes are a reminder. If there’s anything you’re not sure about, check with your doctor or pharmacist.
1. Remove one sealed plastic tray from the refrigerator
2. Leave the syringe to warm up
Tip: Do not use external heat sources such as hot water to warm the syringe.
3. Wash your hands thoroughly with soap and water and dry them.
4. Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Find a clean, hard surface to lay out the items needed for your injection. Lay the tray down on it.
Check the liquid in the syringe
It should be clear and colourless. If the solution is cloudy, coloured or contains any floating particles, do not use the pre-filled syringe.
Remove the syringe cap
The syringe has a white tamper-evident cap.
Make sure the cap is intact and has not been opened.
If it looks like it has been opened, do not use that syringe.
Hold the syringe so that the white cap is facing up.
Bend the cap at a right angle until it snaps off.
Do not touch the connection port.
Do not push on the plunger.
Fit the needle
Open needle to expose the connection port. Keep the cover on.
Press the needle onto the syringe.
Turn it clockwise until it locks into place.
Tip: Make sure the injection needle is firmly attached to the syringe.
Otherwise it may leak.
If you have been told to gradually increase your dose of Avonex, you may need to use an Avostartclip titration kit provided by your doctor.
For further details, speak with your doctor
Now pull off the plastic needle cover. Do not twist it.
Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Clean and stretch the injection site
If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen. Allow the skin to dry.
With one hand, stretch the skin around the injection site.
Relax your muscle.
Make the injection
Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle.
The needle must go all the way in.
Press the plunger slowly until the syringe is empty.
If you are using a syringe that has an Avostartclip attached, you will receive a lower dose of Avonex.
The syringe will not empty.
Pull the needle out
Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
If you use alcohol wipes, hold one on the injection site.
Put a plaster over the site of injection if you need to.
Dispose of the rubbish properly
After you have finished each injection, put the needle and syringe into a special container (such as a sharps bin), not in ordinary rubbish.
If you have used the Avostartclip, the syringe (and the Avostartclip) must be thrown away afterwards. The unused portion of Avonex must not be used.
Waste paper and used wipes can be put in an ordinary rubbish bin.