This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
How to use AVONEX 30 micrograms/0.5 ml SOLUTION FOR INJECTION IN PRE-FILLED PEN
Introduction
Package Leaflet: Information for the User
AVONEX 30 micrograms/0.5 ml solution for injection in pre-filled pen
(interferon beta-1a)
Pre-filled Pen
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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, and you should not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
If you experience any side effects, talk to your doctor or pharmacist, even if they are listed in this leaflet. See section 4.
(Information Notes)
This leaflet is updated from time to time.
Check for updates to this leaflet each time you renew your prescription.
(Information Notes)
If you have any further questions, ask your doctor or pharmacist.
Contents of the Package Leaflet
What is AVONEX and what is it used for
What you need to know before you start using AVONEX
How to use AVONEX PEN
Possible side effects
Storage of AVONEX PEN
Contents of the pack and further information
How to inject yourself using AVONEX PEN
1. What is AVONEX and what is it used for
(Information Notes)
Avonex works best when you use it:
at the same time
once a week
regularly
Do not stop your treatment with Avonex without talking to your doctor first.
What is AVONEX?
Avonex Pen is used to inject Avonex.The active substance of Avonex is a protein called interferon beta-1a.Interferons are natural substances produced by your body to protect you from infections and diseases. The Avonex protein is produced with exactly the same ingredients as the interferon beta present in the human body.
What is AVONEX used for?
Avonex is used to treat multiple sclerosis (MS).Treatment with Avonex may help prevent it from getting worse, although it will not cure MS.
Each patient has specific symptoms of MS.These may include:
Feeling of instability or dizziness, walking problems, muscle stiffness and spasms, fatigue, tingling in the face, arms or legs
Acute or chronic pain, bladder and bowel problems, sexual problems and vision problems
Difficulty thinking and concentrating, depression.
MS also tends to flare up from time to time: this is what is known as a relapse.
Avonex may help reduce the number of relapses you may have and slow down the disabling effects of MS.Your doctor will explain how long you can use Avonex or when to stop treatment.
How does AVONEX work?
Multiple sclerosis is associated with nerve damage (in the brain or spinal cord). In MS, your body's defense system reacts against your own myelin, i.e., the insulation that surrounds nerve fibers. When myelin is damaged, messages between the brain and other parts of the body are disrupted. This is what causes the symptoms of MS. Avonex appears to work by preventing your body's defense system from attacking myelin.
2. What you need to know before you start using AVONEX
(Information Notes)
Avonex and allergic reactions
As Avonex is made from a protein, there is a small chance that an allergic reaction may occur.
Additional information on depression
Do not use Avonex if you have severe depression or have suicidal thoughts. If you have depression, your doctor may still prescribe Avonex, but it is important that you let them know if you have had depression or any other problem that affects your mood.
Do not use AVONEX
if you are allergicto interferon beta or any of the other ingredients of this medicine (listed in section 6);
if you have severe depressionor have suicidal thoughts.
Talk to your doctor immediately in any of these cases.
Warnings and precautions
Talk to your doctor before you start using Avonex if you have or have had in the past:
Depressionor problems that affect your mood
Suicidal thoughts.
You must inform your doctor immediately of any changes in your mood, suicidal thoughts, unusual feelings of sadness, anxiety or hopelessness.
Epilepsyor other uncontrolled seizure disorders
Severe kidney or liver problems
Low white blood cell or platelet counts,which may increase the risk of infection, bleeding or anemia
Heart problemsthat may cause symptoms such as chest pain (angina),especially after any activity; swelling of ankles, difficulty breathing (congestive heart failure)or an irregular heartbeat (arrhythmias).
Irritation at the injection site that can cause skin and tissue damage (injection site necrosis). When you are ready to administer the injection, carefully follow the instructions in section 7 "How to inject AVONEX PEN" at the end of this leaflet. This will reduce the risk of injection site reactions.
Talk to your doctor if you have any of these conditionsor if they get worse while you are using Avonex.
During treatment, blood clots may form in small blood vessels. These clots could affect your kidneys. This can happen after several weeks or several years after starting treatment with Avonex.
Your doctor may want to check your blood pressure, blood (platelet count) and kidney function.
Tell your doctor that you are using Avonex:
If you are going to have a blood test.Avonex may interfere with the results.
(Information Notes)
There may be times when you need to remind other healthcare professionals that you are being treated with Avonex.For example, if you are prescribed other medicines or if you have a blood test, Avonex may interact with other medicines or with the test results.
Pediatric population
Avonex is not recommended for use in children and adolescents as the data on the use of Avonex in this population are limited. Avonex must not be used in children under 10 years of age because it has not been established whether it would work for them and whether it would be safe.
Other medicines and AVONEX
Tell your doctorif you are using, have recently used or might use any other medicines, especially for the treatment of epilepsy or depression. Avonex may affect other medicines or be affected by them. This also includes any medicine obtained without a prescription.
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 using this medicine.
No harmful effects on the baby are expected. Avonex can be used during breastfeeding.
Driving and using machines
If you feel dizzy, do not drive.Avonex can make some people feel dizzy. If this happens to you or if you experience any other side effect that may affect your ability, do not drive or use machines.
Important information about some of the ingredients of Avonex:
This medicine is essentially sodium-free. It contains less than 23 mg (1 mmol) of sodium per weekly dose.
3. How to use AVONEX PEN
(Information Notes)
There is more information on how to inject yourself using Avonex Pen on the back of this leaflet.
Recommended weekly dose
One injection using Avonex Pen, once a week.
Try to use Avonex at the same time on the same day each week.
Self-injection
You can self-inject using Avonex Pen without the help of your doctor if you have been taught how to do it. See the self-injection instructions at the end of this leaflet (see section 7, How to inject yourself using AVONEX PEN).
If you have problemshandling Avonex Pen, ask your doctor for help.
Duration of treatment with AVONEX
Your doctor will tell you how long you should use Avonex. It is important that you use Avonex regularly. Do not make any changes that your doctor has not told you to make.
If you inject more AVONEX than you should
You should administer the injection using only one Avonex Pen, once a week. If you have used more than one Avonex Pen within three days, contact your doctor or pharmacist immediately for advice.
If you miss an injection
If you miss your usual weekly dose,inject a dose as soon as possible. Then wait a week before using Avonex Pen again. Continue with your injection on that day of each week. If you have a preferred day for using Avonex, talk to your doctor to adjust the dose and get back to your preferred day. Do not administer two injections to make up for the missed injection.
4. Possible Adverse Effects
(Informative Notes)
Although the list of possible adverse effects may seem worrisome, it is possible that you will not experience any of them.
Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.
Severe adverse effects: seek medical help.
Severe allergic reactions
If you experience any of the following symptoms:
Swelling of the face, lips, or tongue
Difficulty breathing
Rash.
Call a doctor immediately.Do not use Avonex until you have spoken with a doctor.
Depression
If you experience any symptoms of depression:
Unusual feeling of sadness, anxiety, or hopelessness.
Call a doctor immediately.
Liver problems
If you experience any of the following symptoms:
Yellowing of the skin or the white part of the eyes (jaundice)
Generalized itching
Feeling of discomfort (nausea and vomiting)
Bruises that appear easily on the skin.
Call a doctor immediatelyas they may be manifestations of a possible liver problem.
Adverse effects observed in clinical trials.
(Informative Notes)
Adverse effects observed in clinical trials.
These are adverse effects reported by people during the evaluation of Avonex. The figures are based on the number of people who presented them. They give an idea of the likelihood that you will develop similar adverse effects.
Very common adverse effects(may affect more than 1 in 10 people)
Pseudoflu-like symptoms: headache, muscle pain, chills, or fever: see Pseudoflu-like symptoms, below
Headache.
Common adverse effects(may affect up to 1 in 10 people)
Lack of appetite
Feeling of weakness and fatigue
Difficulty sleeping
Depression
Facial flushing
Nasal discharge
Diarrhea (soft stools)
Feeling of discomfort (nausea or vomiting)
Numbness or tingling of the skin
Rash, skin bruising
Increased sweating, night sweats
Pain in muscles, joints, arms, legs, or neck
Muscle cramps, stiffness in muscles and joints
Pain, bruising, and redness at the injection site
Changes in blood tests. The symptoms you may experience are fatigue, repeated infections, bruising, or bleeding without apparent cause.
Uncommon adverse effects(may affect up to 1 in 100 people)
Hair loss
Changes in menstruation
Burning sensation at the injection site.
Rare adverse effects(may affect up to 1 in 1,000 people)
Difficulty breathing
Kidney problems, including scarring that can reduce kidney function
If you experience any of the following symptoms:
Foamy urine
Fatigue
Swelling, especially of ankles and eyelids, and weight gain.
Inform your doctor as they may be manifestations of a possible kidney problem.
Blood clots in small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome). The symptoms may include an increase in bruising, bleeding, fever, extreme weakness, headache, dizziness, or fainting. Your doctor may find changes in your blood and kidney function.
If you are concerned about any of the effects, talk to your doctor.
Other adverse effects
(Informative Notes)
These effects have been observed in people using Avonex, but we do not know how frequently they occur.
If you feel dizzy, do not drive.
Thyroid dysfunction or excess activity
Nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or hearing things that are not real), confusion, or suicide
Numbness, dizziness, seizures, or epileptic fits, and migraines
Perception of your heartbeat (palpitations), rapid or irregular heartbeat, or heart problems accompanied by the following symptoms: reduced exercise capacity, inability to stay lying down, difficulty breathing, or swelling of ankles
Liver problems, such as those described previously
Urticaria or pseudovesicular rash, itching, worsening of existing psoriasis
Swelling or bleeding at the injection site, tissue destruction (necrosis), or chest pain after an injection
Weight gain or loss
Changes in test results, such as variations in liver function tests
Pulmonary arterial hypertension: a disease in which there is a significant narrowing of the blood vessels in the lungs, causing an increase in pressure in the blood vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension was observed at different times, even several years after starting treatment with interferon beta-containing medications.
If you are concerned about any of the effects, talk to your doctor.
Injection site effects
Fainting sensation:The first injection of Avonex may be administered by your doctor. You may feel dizzy. You may even faint. It is unlikely to happen again.
Immediately after the injection, you may notice tense or very weak muscles,as if you were going to repeat the experience. It is rare. It only occurs when self-injecting, and the effects pass quickly. They can occur at any time after starting treatment with Avonex.
If you notice any skin irritation or other skin problemafter an injection, talk to your doctor.
Pseudoflu-like symptoms
(Informative Notes)
Three simple ways to reduce the impact of pseudoflu-like symptoms:
Administer the injection with Avonex Pen just before bedtime.This way, the effects can pass while you sleep.
Take paracetamol or ibuprofen 30 minutes beforethe injection with Avonex Pen and continue taking it for a day. Talk to your doctor or pharmacist about the appropriate dose.
If you have a fever, drink plenty of waterto stay hydrated.
Some people report that after using Avonex Pen, they feel like they have the flu.
The signs are:
Headache
Muscle pain
Chills or fever.
These symptoms do not actually correspond to the flu
You cannot transmit them to anyone. They are more frequent when using Avonex for the first time. The pseudoflu-like symptoms gradually decrease as more injections are administered.
Children (10 years of age or older) and adolescents
In clinical trials, some adverse effects were reported more frequently in children and adolescents than in adults, e.g., muscle pain, pain in a limb, fatigue, and joint pain.
Reporting adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
In order to improve the traceability of this medicine, your doctor or pharmacist must record the name and batch number of the medicine administered to you in your medical history. You may also want to take note of this information in case you are asked for it in the future.
5. Storage of Avonex Pen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date shown on the label.
Avonex Pen contains a pre-filled syringe of Avonex. Store in the original packaging to
protect it from light.
Store in the refrigerator (between 2°C and 8°C). Do not freeze.
Avonex Pen can also be stored at room temperature (between 15°C and 30°C) for a
maximum of one week.
Do not use Avonex Pen if you observe that:
The pen is broken.
The solution has color and you can see particles floating.
The closure guarantee capsule is broken.
Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.
6. Container Contents and Additional Information
Composition of AVONEX PEN
The active ingredientis: interferon beta-1a 30 micrograms/0.5 ml.
The other componentsare: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polysorbate 20, and water for injectables.
Appearance of AVONEX PEN and Container Contents
Each individual container contains an Avonex Pen, a needle, and a pen protector. Avonex Pen contains a pre-loaded Avonex syringe and should only be used after receiving proper training. Avonex Pen is available in packs of four or twelve, for one month or three months of injection.
Marketing Authorization Holder and Manufacturer
The marketing authorization holder is:
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Avonex is manufactured by:
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1,
DK-3400 Hillerød,
Denmark
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Contact your local representative if you want a version of this leaflet with larger text.
You can request more information about this medicine by contacting the local representative of the marketing authorization holder.
België/Belgique/Belgien
Biogen Belgium NV/SA
Tel: +32 2 2191218
Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176
Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tel: +32 2 2191218
Ceská republika
Biogen (Czech Republic) s.r.o.
Tel: +420 255 706 200
Magyarország
Biogen Hungary Kft.
Tel.: +36 1 899 9883
Danmark
Biogen Denmark A/S
Tlf.: +45 77 41 57 57
Malta
Pharma. MT Ltd.
Tel: +356 21337008
Deutschland
Biogen GmbH
Tel: +49 (0) 89 99 6170
Nederland
Biogen Netherlands B.V.
Tel: +31 20 542 2000
Eesti
Biogen Estonia OÜ
Tel: +372 618 9551
Norge
Biogen Norway AS
Tlf: +47 23 40 01 00
Ελλάδα
Genesis Pharma SA
Τηλ: +30 210 8771500
Österreich
Biogen Austria GmbH
Tel: +43 1 484 46 13
España
Biogen Spain S.L.
Tel: +34 91 310 7110
Polska
Biogen Poland Sp. z o.o.
Tel: +48 22 351 51 00
France
Biogen France SAS
Tél: +33 (0)1 41 37 9595
Portugal
Biogen Portugal
Sociedade Farmacêutica, Unipessoal Lda.
Tel: +351 21 318 8450
Hrvatska
Biogen Pharma d.o.o.
Tel: +385 1 775 73 22
România
Johnson & Johnson Romania S.R.L.
Tel: +40 21 207 18 00
Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799
Slovenija
Biogen Pharma d.o.o.
Tel: +386 1 511 02 90
Ísland
Icepharma hf
Sími: +354 540 8000
Slovenská republika
Biogen Slovakia s.r.o.
Tel: +421 2 323 34008
Italia
Biogen Italia s.r.l.
Tel: +39 02 584 9901
Suomi/Finland
Biogen Finland Oy
Puh/Tel: +358 207 401 200
Κύπρος
Genesis Pharma Cyprus Ltd
Τηλ: +357 22 76 57 15
Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60
Latvija
Biogen Latvia SIA
Tel: +371 68 688 158
Date of last revision of this leaflet:08/2024.
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
This leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.
How to inject using AVONEX PEN
Avonex Pen (single use)
Container contents – Avonex Pen, needle, and Avonex Pen protector
Avonex Pen – prepared for injection
Avonex Pen – after injection (prepared for disposal)
You should have received training on how to use Avonex Pen.
These notes are a reminder. If you have any doubts or problems, consult your doctor or pharmacist.
Where to inject
Use a different injection site each week
The best area is the outer upper thigh. Alternate between the left and right thigh.
Note the injection site each week.
Avonex is injected into a muscle,the best area is the outer upper thighas shown in the diagram above. Injection into the buttocks is not recommended.
Use a different injection site each week.This involves less risk of skin or muscle irritation.
Do not useareas of skin with bruises, pain, or infection, or if there is an open wound.
Preparation
Take an Avonex Pen from the refrigerator
Check that the container contains an Avonex Pen, a needle, and a pen protector.
Do not shake Avonex Pen.
Check the expiration date on the Avonex Pen label.
Do not use it if it is expired.
Let Avonex Pen warm up
Leave it at room temperature for half an hour.
This makes the injection more comfortable than using it directly from the refrigerator.
Tip:Do not use external heat sources such as hot water to warm up Avonex Pen.
Wash your handswith water and soap and dry them.
Prepare alcohol swabs and gauzes(not provided) if you need them.
Find a clean and stable surfaceto place the necessary material for the injection.
Avonex Pen preparation
1 Remove the tamper-evident cap
Make sure the tamper-evident cap is intact and has not been opened.If it appears to have been opened, do not use that Avonex Pen.
Hold Avonex Pen so that the tamper-evident cap faces upwards.
Bend the tamper-evident cap at a right angle to release it.
Do not touch the exposed glass tip.
Tips: Put the pen on the table before starting with step 2.
2 Attach the needle
Avonex Pen is designed to work only with the provided needle
Remove the wrapperfrom the base of the needle protector.
Attach the needle by pressing it onto the glass tip of the pen. Keep the pen upright.
Do not remove the needle protector.
Carefully turn the needle clockwise until it is firmly attached, otherwise, there may be leaks. You may not receive a complete dose if there are leaks.
Tips: The needle protector will automatically release during the next step 3.
3 Extend the injector protector
Hold the pen body firmly with one hand. Point the needle protector away from you and anyone else.
With the other hand and with a quick motion, lift the injector screen (notched area) above the needleuntil the needle is fully covered.
The plastic needle protector will release.
Tips: Do not pressthe blue activation button at the same time.
4 Check that the injector screen is correctly extended
Check that the injector screen is fully extended. A small rectangular area will be visible next to the oval viewing window. It is the safety lock.
5 Check the liquid
Look through the oval viewing window. The liquid should be clear and colorless.
If the solution is cloudy, has color, or contains floating particles, do not use this pen.
Air bubbles are normal.
Using Avonex Pen
1 Clean the injection site
If necessary, use an alcohol swab to clean the skin at the chosen injection site. Let the skin dry.
Tips: The best area is the upper outer thigh.
2 Place Avonex Pen on the skin
Hold the pen body firmly with one hand, forming a right angle with the injection site. Make sure the pen windows are visible.
Tips: Be careful not to press the blue activation button too soon.
Press the pen body firmly against the skin to release the safety lock.
Check that the safety lock is released. The small rectangular window will disappear. Avonex Pen is ready to inject.
Tips: Continue holding the pen firmly against the skin.
Administer the injection
Press the blue activation button with your thumb to start the injection.
You will hear a "click" that indicates the injection process has started. Do not remove the pen from the skin.
Continue holding the pen against the skin and count slowly up to 10 seconds.
After 10 seconds, pull the pen to remove the needle from the injection site.
Press on the injection site for a few seconds. If there is any blood at the site, clean it.
Confirm the injection
administration
Check the circular viewing window.When the full dose has been administered, the window will appear yellow.
Do not reuse Avonex Pen. It is for single use.
5 Disposal
Place the pen protector on a flat and stable surface
Tips: Do not hold the pen protector.You may suffer a needlestick injury.
Insert the needle directly into the pen protector.
Press firmlyuntil you hear a "click" to seal the needle. You may need to use both hands. Once the pen is sealed, there is no risk of injury.
Dispose of the waste properly. Your doctor, nurse, or pharmacist will provide instructions on how to dispose of the used Avonex Pen, for example, in a sharps container.
This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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