30 micrograms / 0.5 ml solution for injection in a pre-filled pen
( Interferon beta-1a). Pre-filled pen
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
Even if you have used Avonex before, some information may have changed.
- Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
|This leaflet may be changed from time to time. Please check for a new update of the package leaflet each time you receive a new prescription.|
|If you have any further questions, ask your doctor or pharmacist.|
In this leaflet …
On the right pages is the information you need to be able to use the Avonex Pen correctly.
On the left, you will find useful tips and explanations on how to get the best out of your medicine.
On the inside of the back cover, there is a fold-out part with all the information you need to inject with the Avonex Pen.
This leaflet contains information about:
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 PEN
4. Possible side effects
5. How AVONEX PEN should be stored
6. Package Contents and other information
1. WHAT AVONEX IS AND WHAT IT IS USED FOR
|Avonex works best when you use it:at the same timeonce a weekregularlyDo not stop taking Avonex without talking to your neurologist first|
What AVONEX is
The Avonex Pen is used to inject Avonex. The active substance in Avonex is a protein called interferon -beta-1a. Interferons are natural body substances that protect you from infections and diseases. The protein in Avonex is made from exactly the same substances as the interferon beta found in the body.
What AVONEX is used for
Avonex is used to treat multiple sclerosis (MS). Avonex treatment can protect you from getting worse but does not cure MS.
The symptoms of MS are different between different people. These can be, for example:
- Feeling of instability or dizziness, difficulty walking, stiffness and muscle twitching, fatigue, numbness of the face, arms, or legs.
- Acute or chronic pain, bladder and bowel problems, sexual problems, and visual difficulties
- Difficulty thinking and concentrating on depression.
MS also tends to flare up from time to time: this is called a relapse.
Avonex can reduce the number of relapses and slow down the disabling effects of MS. Your doctor will tell you how long you can use Avonex or when to stop treatment.
How AVONEX works
Multiple sclerosis is associated with nerve damage (in the brain or spinal cord). In MS, the body’s immune system reacts to the body’s own myelin, ie. the “insulation” that surrounds the nerve fibers. When myelin is damaged, communication between the brain and other parts of the body is disrupted. This is what causes MS symptoms. Avonex seems to be able to prevent the body’s immune system from attacking myelin.
2. What you need to know before using AVONEX
Avonex and allergic reactionsBecause Avonex is based on a protein , there is a small risk of an allergic reaction .|
More on depression.If you have severe depression or suicidal ideation, do not use Avonex. If you have depression, your doctor may still prescribe Avonex to you, but it is important that you tell your doctor if you have had depression or similar problems that affect your mood.
Do not use AVONEX
- If you are allergic to interferon beta or any of the other ingredients of this medicine (listed in section 6).
- If you have severe depression or have suicidal thoughts.
Contact a doctor immediately if any of these apply to you.
Warnings and cautions
Talk to your doctor before using Avonex if you have or have had:
- Depression or problems affecting mood
- Suicidal thoughts.
If you experience a change in mood, suicidal ideation, or feel unusually sad, anxious, or worthless, consult a physician immediately.
- Epilepsy or other seizures that cannot be controlled with medication
- Severe kidney or liver problems
- A low number of white blood cells or platelets, which may increase the risk of infection, bleeding, or anemia
- Heart problems can cause symptoms such as chest pain ( angina ), especially after physical activity, swollen ankles, shortness of breath ( heart failure), or irregular heartbeat ( arrhythmia ).
Tell your doctor if you have any of these conditions or if they have worsened while you are taking Avonex.
During treatment, blood clots may form in the small blood vessels. Blood clots can affect your kidneys. This can happen several weeks or up to several years after you start taking Avonex.
Your doctor may want to check your blood pressure, blood count ( platelet count ), and kidney function.
Tell your doctor that you are using Avonex:
- If you are going to take a blood sample. Avonex may affect test results
|Sometimes you need to remind other healthcare professionals that you are being treated with Avonex. If you e.g. Using other medicines or taking a blood test Avonex may affect the other medicines or the blood test result.|
Other medicines and AVONEX
Tell your doctor if you are taking, have recently taken, or might take any other medicines, especially medicines for epilepsy or depression. Avonex can affect or be affected by other medicines. This also applies to over-the-counter medicines.
Pregnancy and breastfeeding
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 adverse effects are expected on the breast-fed infant/infant. Avonex can be used during breast-feeding.
Driving and using machines
Do not drive if you feel dizzy. Avonex may make some people feel dizzy. If this affects you or you get other side effects that affect your ability to drive, avoid driving, and using machines.
Important information about some of the ingredients of Avonex
This medicine is almost ‘sodium-free’ and contains less than 23 mg (1 mmol) sodium per week.
3. How to use AVONEX PEN
|There is more information on how to inject Avonex Pen in the expandable part at the back of the package leaflet.|
Recommended weekly dose
An injection of Avonex Pen, once a week. If possible, take Avonex at the same time and on the same day of the week each week.
Do not use on children
Children under 12 years of age should not use Avonex.
You can inject Avonex yourself with the Avonex Pen without the help of your doctor if you have been trained to do so. Instructions on how to inject yourself can be found at the end of this leaflet (see section 7, How to inject with Avonex Pen ).
If you have difficulty handling the Avonex Pen, ask your doctor for help.
How long to use Avonex
Your doctor will tell you how long to continue using Avonex. It is important that you continue to use Avonex regularly. Do not change the medication unless your doctor tells you to.
If you inject too much
You should inject with only one Avonex Pen, once a week. If you have used more than one Avonex Pen for a three-day period, consult a doctor or pharmacist immediately for advice.
If you forget an injection
If you miss your usual weekly dose, do the injection one as soon as you can. Then wait a week before using Avonex Pen again. Continue to inject on the new day of the week each week. If you prefer a particular day of the week to do the Avonex injection, you should talk to your doctor about how to handle the dosage one so that you can return to that day of the week. Do not take double injections to compensate for missed injections.
4. Possible side effects
|Although the list of possible side effects may seem worrying, you may not experience any side effects at all.|
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: seek medical attention
Severe allergic reactions
If you experience any of the following:
- Swelling of the face, lips, or tongue
- Breathing difficulties
Contact a doctor immediately. Do not take Avonex again until you have talked to a doctor.
If you get symptoms of depression:
- Feeling unusually sad, anxious, or useless.
Contact a doctor immediately.
If you experience any of the following symptoms:
- The skin or whites of the eyes turn yellow ( jaundice )
- Itching all over the body
- Nausea ( nausea and vomiting )
- Easily get bruises.
Contact a doctor immediately as these symptoms may be signs of liver problems.
Side effects have been demonstrated in clinical trials
Side effects have been demonstrated in clinical trials . These side effects have been reported when Avonex was tested. The figures are based on how many people stated that they had the side effects . It gives an indication of how great the risk is that you will have similar side effects .|
Very common side effect is (can occur in more than 1 in 10)
- Flu-like symptoms – headache, muscle aches, chills or fever: see Flu-like symptoms, below
Common side effects are (may affect up to 1 in 10)
- Loss of appetite
- Feeling weak and tired
- Difficulty sleeping
- Runny nose
- Diarrhea ( loose in the stomach )
- Nausea ( nausea or vomiting )
- Numbness or tingling in the skin
- Skin rash, bruising
- Increased sweating, night sweats
- Pain in muscles, joints, arms, legs, or neck
- Muscle cramps, stiffness in joints and muscles
- Pain, bruising, and redness at the injection site
- Changes in blood tests. Symptoms that you may notice are fatigue, repeated infections, unexplained bruising, or bleeding.
Less common side effects are (may affect up to 1 in 100)
- hair loss
- Altered menstrual bleeding
- Burning at the injection site.
Rare side effects are (may affect up to 1 in 1000 patients)
- Breathing difficulties
- Kidney problems including scarring that can impair kidney function if you get any or all of these symptoms:
- Frothy urine
- Swelling, especially in the ankles and eyelids, as well as weight gain.
Tell your doctor as they may be a sign of a possible kidney problem.
Blood clots in the small blood vessels, which can affect the kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome ). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness, or fainting. Your doctor may notice changes in your blood and kidney function.
Talk to your doctor if you experience any side effects.
Other side effects are
The following side effects have been reported in people using Avonex but the risk of getting them is unknown.|
If you feel dizzy, do not drive.
- Less or more active thyroid than normal
- Nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or hearing things that do not exist), confusion or suicide
- Numbness, dizziness, seizures, and migraines
- Awareness of heartbeats ( palpitations s ), rapid or irregular heartbeat, or heart problems with the following symptoms: reduced ability to exercise, inability to lie flat in the bed, shortness of breath, or swollen ankles
- Liver problems as described above
- Hives or bladder-like rash, itching, worsening of any psoriasis
- Swelling or bleeding at the injection site or chest pain after injection
- Weight loss or gain
- Changed test results, eg changed liver function values.
- Pulmonary arterial hypertension: A disease with severe narrowing of the blood vessels of the lungs that leads to high blood pressure in the blood vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at various times during treatment, even up to several years after initiating interferon- beta treatment.
Talk to your doctor if you experience any side effects.
Effects of injection a
- Feeling tired: You get your first Avonex injection from your doctor. You may then feel dull and you may faint. This is unlikely to happen again.
- Just after injection, the muscles may feel tense or very weak – as if you are having a relapse. These symptoms rarely occur. They only occur when you inject and the effects then quickly disappear. This can happen at any time after you start treatment with Avonex.
- If you notice any irritation or skin problem after an injection, talk to your doctor.
|Three simple ways to relieve flu-like symptoms:Use the Avonex Pen just before bedtime. Then you can sleep through the symptoms.Take paracetamol or ibuprofen half an hour before using Avonex Pen and continue to take it for up to a day. Ask your doctor or pharmacist what dose is appropriate.Drink plenty of water if you get a fever so that you do not become dehydrated.|
Some people feel like they have the flu after using Avonex Pen. The symptoms are as follows:
- Muscle aches
- Chills or fever
These symptoms are not signs of the flu.
You can not infect anyone else. Symptoms are more common at the beginning of Avonex treatment. When you continue with the injections, the flu-like symptoms gradually decrease.
To facilitate the traceability of this medicine, your doctor or pharmacist should document the product name and batch number in your patient record. Note these details in case you are asked about this information in the future.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store AVONEX PEN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label.
The Avonex Pen contains a pre-filled syringe of Avonex. Store in the original package. Sensitive to light.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Avonex Pen can also be stored at room temperature (between 15 ° C and 30 ° C) for up to one week.
Do not use Avonex Pen if you see:
- that the pen is broken
- that the solution is colored or contains particles
- that the tamper-proof protective hat has been broken.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
The active substance is: Interferon-beta 1a 30 micrograms / 0.5 ml
The other ingredients are Sodium acetate trihydrate; concentrated acetic acid, arginine hydrochloride, polysorbate, and water for injections.
What the medicine looks like and the contents of the pack
Each individual pack contains an Avonex Pen, a needle, and a pen cap. Avonex Pen contains a pre-filled syringe of Avonex and should only be used after adequate training. Avonex Pen comes in packs of four or twelve for one or three months of injections you.
Marketing Authorization Holder and Manufacturer
The marketing authorization holder is:
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
Avonex is manufactured by:
Biogen Denmark Manufacturing ApS,
Biogen Allé 1,
If you contact your local representative, you can get this leaflet with larger text.
Belgium / Belgique / BelgienBiogen Belgium NV / SA(+32 2 2191218
|LithuaniaUAB “JOHNSON & JOHNSON”(+370 5 278 68 88|
BulgariaTP WATERMARMA(+359 2 962 12 00
|Luxembourg / LuxemburgBiogen Belgium NV / SA(+32 2 2191218|
Czech RepublicBiogen (Czech Republic) sro(+420 255 706 200
|HungaryBiogen Hungary Kft.(+36 1 899 9883|
DenmarkBiogen Denmark A / S(+45 77 41 57 57
|MaltaPharma. MT Ltd ..(+356 21337008|
GermanyBiogen GmbH(+49 (0) 89 99 6170
|The NetherlandsBiogen Netherlands BV(+31 20 542 2000|
EestiUAB “JOHNSON & JOHNSON” Eesti subsidiary(+372 617 7410
|NorwayBiogen Norway AS(+47 23 40 01 00|
GreeceGenesis Pharma SA(+30 210 8771500
|AustriaBiogen Austria GmbH(+43 1 484 46 13|
|SpainBiogen Spain SL(+34 91 310 7110||PolandBiogen Poland Sp. z oo(+48 22 351 51 00|
|FranceBiogen France SAS(+33 (0) 1 41 37 9595||PortugalBiogen PortugalPharmaceutical Society, Unipessoal Lda.(+351 21 318 8450|
|CroatiaMedis Adria doo(+385 1 230 34 46||RomaniaJohnson & Johnson Romania SRL(+40 21 207 18 00|
|IrelandBiogen Idec (Ireland) Ltd.(+353 (0) 1 463 7799||SloveniaBiogen Pharma doo(+386 1 511 02 90|
|IcelandIcepharma hf(+354 540 8000||Slovak RepublicBiogen Slovakia sro(+421 2 323 34008|
|ItalyBiogen Italia srl(+39 02 584 9901||Finland / FinlandBiogen Finland Oy(+358 207 401 200|
|ΚύπροςGenesis Pharma Cyprus Ltd(+3572 2 769946|
|LatviaUAB “JOHNSON & JOHNSON” subsidiary Latvijā(+371 678 93561||United KingdomBiogen Idec Limited(+44 (0) 1628 50 1000|