Avonex
interferon beta-1a
(interferon beta-1a)
Even if you have used Avonex before, some of the information may have changed.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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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. If there’s anything you’re not sure about, ask your doctor or pharmacist.
What AVONEX is and what it is used for
What you need to know before you use AVONEX
How to use AVONEX
Possible side effects
How to store AVONEX
Contents of the pack and other information
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.
Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness, numbness in the face, arms or legs
Acute or chronic pain, bladder and bowel problems, sexual problems and problems seeing things
Difficulty in thinking and concentrating, depression.
MS also tends to flare up from time to time: this is called a relapse.
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Do not stop your Avonex treatment without speaking to your doctor.
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.
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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.
Changes to your mood, thoughts about suicide, feeling unusually sad, anxious or worthless, should be reported to your doctor immediately.
Heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias).
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.
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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.
This medicine is essentially ‘sodium-free’. It contains less than 23 mg (1 mmol) sodium in each weekly dose.
Try to use Avonex at the same time on the same day each week.
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.
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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).
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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Although the list of possible side effects can seem worrying, it’s possible that you may not have any of them.
If you get any of these:
Swelling of the face, lips or tongue
Difficulty breathing
A rash.
If you get any symptoms of depression:
Feeling unusually sad, anxious or worthless.
If you get any of these symptoms:
Yellowing of your skin or the whites of your eyes (jaundice)
Itching all over
Feeling sick, being sick (nausea and vomiting)
Easy bruising of the skin.
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(may affect more than 1 in 10 people)
Flu-like symptoms – headache, muscle aches, chills or a fever: see Flu-like symptoms, below
Headache.
(may affect up to 1 in 10 people)
Loss of appetite
Feeling weak and tired
Difficulty sleeping
Depression
Flushing
Runny nose
Diarrhoea (loose stools)
Feeling or being sick (nausea or vomiting)
Numbness or tingling of skin
Rash, bruising of the skin
Increased sweating, night sweats
Pain in your muscles, joints, arms, legs or neck
Muscle cramps, stiffness in the joints and muscles
Pain, bruising and redness at the injection site
Changes to blood tests. Symptoms you might notice are tiredness, repeated infection, unexplained bruising or bleeding.
(may affect up to 1 in 100 people)
Hair loss
Changes to your monthly period
Burning feeling at the site of injection.
(may affect up to 1 in 1,000 people)
Difficulty breathing
Kidney problems including scarring that may reduce your kidney function If you get some or all of these symptoms:
Foamy urine
Fatigue
Swelling, particularly in the ankles and eyelids, and weight gain.
Blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uremic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness. Your doctor may find changes in your blood and the function of your kidneys.
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If you feel dizzy, do not drive
An underactive or overactive thyroid
Nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or hearing things that are not real), confusion or suicide
Numbness, dizziness, seizures or fits and migraines
An awareness of your heartbeat (palpitations), a rapid or irregular heartbeat, or heart problems which would have the following symptoms: a reduced ability to exercise, inability to lie flat in bed, shortness of breath or swollen ankles
Liver problems as described above
Nettle rash or blister-like rash, itching, worsening of psoriasis if you have it
Swelling or bleeding at the site of injection, or chest pain after an injection
Gaining or losing weight
Changes to test results, including changes to liver function tests
Pulmonary arterial hypertension: A disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with interferon beta-products.
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taking it for up to a day. Speak to your doctor or pharmacist about a suitable dose.
Headache
Muscle aches
Chills or a fever.
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 the national reporting system listed in Appendix V. 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.
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.
The pre-filled syringe is broken.
The sealed plastic tray is damaged or opened.
The solution is coloured or you can see particles floating in it.
The tamper evident cap has been broken.
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.
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.
Biogen Netherlands B.V. Prins Mauritslaan 13
1171 LP Badhoevedorp The Netherlands
FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek Allé 1,
DK-3400 Hillerød,
Denmark
Biogen Netherlands B.V. | ||
Prins Mauritslaan 13 | ||
1171 LP Badhoevedorp | ||
The Netherlands |
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.
Biogen Belgium NV/SA
+32 2 2191218
Biogen Lithuania UAB
+370 5 259 6176
ТП ЕВОФАРМА
+359 2 962 12 00
Biogen Belgium NV/SA
+32 2 2191218
Biogen (Czech Republic) s.r.o.
+420 255 706 200
Biogen Hungary Kft.
+36 1 899 9883
Biogen Denmark A/S
+45 77 41 57 57
Pharma. MT Ltd..
+356 21337008
Biogen GmbH
+49 (0) 89 99 6170
Biogen Netherlands B.V.
+31 20 542 2000
Biogen Estonia OÜ
+372 618 9551
Biogen Norway AS
+47 23 40 01 00
Genesis Pharma SA
+30 210 8771500
Biogen Austria GmbH
+43 1 484 46 13
Biogen Spain S.L.
+34 91 310 7110
Biogen Poland Sp. z o.o.
+48 22 351 51 00
Biogen France SAS
+33 (0)1 41 37 9595
Biogen Portugal
Sociedade Farmacêutica, Unipessoal Lda.
+351 21 318 8450
Biogen Pharma d.o.o.
+385 1 775 73 22
Johnson & Johnson Romania S.R.L.
+40 21 207 18 00
Biogen Idec (Ireland) Ltd.
+353 (0)1 463 7799
Biogen Pharma d.o.o.
+386 1 511 02 90
Icepharma hf
+354 540 8000
Biogen Slovakia s.r.o.
+421 2 323 34008
Biogen Italia s.r.l.
+39 02 584 9901
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+358 207 401 200
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+357 22 76 57 40
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+46 8 594 113 60
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+371 68 688 158
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+44 (0) 1628 50 1000
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
These notes are a reminder. If there’s anything you’re not sure about, check with your doctor or pharmacist.
muscle.
Check the expiry date on the lid of the tray. Do not use it if it is out-of-date.
Peel back the paper lid completely. Check the blister tray contains one pre-filled syringe and one injection needle (see picture “Contents of the plastic tray”).
Leave it at room temperature for half an hour. This makes the injection more comfortable than injecting straight from a refrigerator.
The syringe has a white tamper-evident cap.
Do not touch the connection port. Do not push on the plunger.
Open needle to expose the connection port. Keep the cover on.
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
If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen. Allow the skin to dry.
Relax your 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.
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.
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.