Avonex

Interferon β-1a.

Avonex Pen is used to inject Avonex. The active ingredient in Avonex is a protein called interferon beta-1a. Interferons are natural substances made in the body to help protect 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.
Excipients/Inactive Ingredients: Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections.

Multiple sclerosis is linked to nerve (brain or spinal cord) damage. In MS, the 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 the body's defence system from attacking the myelin.

Avonex is used to treat Multiple Sclerosis (MS). Treatment with Avonex can help to prevent patient from getting worse, although it will not cure MS.
Everyone has their own set of MS symptoms. These can include: 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.
Avonex can help to reduce the number of relapses and slow down the disabling effects of MS. The doctor will advise for how long Avonex can be used or when to stop.

The 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.
Not for children: Avonex is not to be used in children below the age of 12 years.
Injecting: The patient can self-inject Avonex using the Avonex Pen without the help of the doctor, if he/she has trained to do this. The instructions on how to inject are at the Patient Counselling Informaton Section (see How to inject AVONEX PEN under Patient Counselling Information).
In case of trouble in handling the Avonex Pen, ask the doctor who may be able to help.
How long to use AVONEX: The doctor will advise how long the patient will need to keep using Avonex. It is important to continue using Avonex regularly. Do not make changes unless advised by the doctor.
If the patient misses an injection: If the patient misses the usual weekly dose, inject a dose as soon as possible. Then leave a week before using Avonex Pen again. Continue injecting on this new day every week. If he/she has a preferred day for using Avonex, talk to the doctor about managing the dose, to get back to the preferred day. Do not use two injections to make up for a missed injection.

If the patient injects more than the prescribed: The patient should inject using only one Avonex Pen, once a week. If the patient used more than one Avonex Pen in a three-day period, contact the doctor or pharmacist straight away for advice.

Do not use AVONEX: If the patient is allergic to interferon beta or any of the other ingredients of this medicine (listed in Description).
If the patient has severe depression or thinks about committing suicide.
Talk to a doctor straight away if any of these apply to the patient.

Avonex and allergic reactions: Because Avonex is based on a protein, there is a small chance of an allergic reaction.
More about depression: If the patient has severe depression or thoughts about suicide, do not use Avonex.
In case of depression, the doctor may still prescribe Avonex, but it's important to let the doctor know if the patient had depression or any similar problems affecting moods.

Talk to the doctor before using Avonex if the patient has or had in the past: Depression or problems affecting the moods.
Thoughts about committing suicide.
Changes to the mood, thoughts about suicide, feeling unusually sad, anxious or worthless, should be reported to the doctor immediately.
Epilepsy or other seizure disorders not controlled by medication.
Serious kidney or liver problems.
A low number of white blood cells or platelets, which can cause an increased risk of infection, bleeding or anaemia.
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).
Talk to the doctor in the event of any of these conditions, or if they worsen whilst taking Avonex.
Blood clots in the small blood vessels may occur during treatment. These blood clots could affect the kidneys. This might happen several weeks to several years after starting Avonex.
The doctor may want to check the blood pressure, blood (platelet count) and function of the kidneys.
Thrombotic microangiopathy (TMA): Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products. Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta. Early clinical features include thrombocytopenia, new onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function. Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film. Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended. If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Avonex is recommended.
Nephrotic Syndrome: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products. Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta. Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease. Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Avonex should be considered.
Tell the doctor that the patient is using Avonex: If he/she is having a blood test, Avonex may interfere with the results.
Important information about some of the ingredients of Avonex: This medicine is essentially 'sodium-free'. It contains less than 23 mg (1 mmol) sodium in each weekly dose.
Driving and using machines: If the patient feels dizzy, do not drive. Avonex makes some people feel dizzy. If this happens, or if the patient gets any other side effects that could affect the ability, do not drive or use machines.

If the patient is pregnant, thinks she is pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
No harmful effects on the breastfed newborn/infants are anticipated. Avonex can be used during breast-feeding.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: Get medical help.
Serious allergic reactions: If the patient gets any of these: Swelling of the face, lips or tongue; Difficulty breathing; A rash.
Call a doctor immediately. Do not use any more Avonex until the patient has spoken to a doctor.
Depression: If the patient gets any symptoms of depression: Feeling unusually sad, anxious or worthless.
Call a doctor immediately.
Liver problems: If the patient gets any of these symptoms: Yellowing of the skin or the whites of the eyes (jaundice); Itching all over; Feeling sick, being sick (nausea and vomiting); Easy bruising of the skin.
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 had them. It gives an idea how likely the patient is to get similar side effects.
Very common side effects (may affect more than 1 in 10 people): Flu-like symptoms - headache, muscle aches, chills or a fever: see Flu-like symptoms as follows; Headache.
Common side effects (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 the 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 the patient might notice are tiredness, repeated infection, unexplained bruising or bleeding.
Uncommon side effects (may affect up to 1 in 100 people): Hair loss; Changes to the monthly period; Burning feeling at the site of injection.
Rare side effects (may affect up to 1 in 1,000 people): Difficulty breathing; Kidney problems including scarring that may reduce the kidney function.
If the patient gets some or all of these symptoms: Foamy urine; Fatigue; Swelling, particularly in the ankles and eyelids, and weight gain. Tell the doctor as they may be signs of a possible kidney problem.
Blood clots in the small blood vessels that can affect the kidneys (thrombotic thrombocytopenic purpura or haemolytic uremic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness. The doctor may find changes in the blood and the function of the kidneys.
If any of the effects trouble the patient, talk to the doctor.
Other side effects: These effects have been seen in people using Avonex, but the likelihood of occurrence is not certain.
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 the 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 previously.
Nettle rash or blister-like rash, itching, worsening of psoriasis, if the patient has 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.
If any of the effects trouble the patient, talk to the doctor.
Effects of the injection: Feeling faint: The first injection of Avonex may be given by the doctor. It may make the patient feel faint. He/she may even actually faint. This is unlikely to happen again.
Just after an injection, the muscles may feel tense or very weak - as though having a relapse. This is rare. It only happens when the patient injects and the effects soon pass. They may happen any time after starting on Avonex.
If the patient notices any irritation or skin problems after an injection, talk to the doctor.
Flu-like symptoms: Some people find that after using Avonex Pen, they feel like they have flu. Signs are: Headache, Muscle aches, Chills or a fever.
These symptoms are not really flu. The patient can't pass it on to anyone else. They are more common when he/she first starts using Avonex. As the patient keeps using the injections, the flu-like symptoms gradually decrease.
Three simple ways to help reduce the impact of flu-like symptoms: Use Avonex Pen injection just before bedtime. This may allow the patient to sleep through the effects.
Take paracetamol or ibuprofen half an hour before Avonex Pen injection and continue taking it for up to a day. Speak to the doctor or pharmacist about a suitable dose.
If the patient has a fever, drink plenty of water to keep hydrated.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed. By reporting side effects, it can help provide more information on the safety of this medicine.

Tell the doctor if the patient is using, has 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 medicines without a prescription.

Do not use Avonex Pen if: The pen is broken.
The solution is coloured or particles can be seen floating in it.
The tamper evident cap has been broken.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.

Store in the original package in order to protect from light.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Avonex Pen can be stored at room temperature (between 15°C and 30°C) for up to one week.
Keep this medicine out of the sight and reach of children.

How to inject AVONEX PEN: You should have had training in how to use your Avonex Pen.
These notes are reminders. If there's anything you're not sure about or you have a problem, check with your doctor or pharmacist.
Where to inject: Avonex is injected into a muscle, the best area is the upper, outer thigh muscle. Injection of Avonex into the buttocks is not recommended.
Use a different injection site each week. Alternate the left and right thighs. Keep a note of where you have injected each week. This means less risk of irritation to your skin and muscle.
Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
Getting ready: 1) Take one Avonex Pen out of the refrigerator.
Check if the pack contains one Avonex Pen, one needle and one pen cover.
Do not shake Avonex Pen.
Check the expiry date on the Avonex Pen label. Do not use if it is out-of-date.
2) Leave Avonex Pen to warm up. Leave it at room temperature for half an hour. This makes the injection more comfortable than using straight from the refrigerator.
Tip: Do not use external heat sources such as hot water to warm Avonex Pen.
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.
5) Find a clean, hard surface to lay out the items needed for your injection.
Preparing Avonex Pen: 1) Remove the 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 Avonex Pen.
Hold Avonex Pen so that the cap is pointing up.
Bend the cap at a right angle until it snaps off.
Do not touch the exposed glass tip.
Tip: Place the pen down on the table before beginning step 2.
2) Fit the needle: Avonex Pen has been designed to function only with the supplied needle.
Peel off the foil from the base of the needle cover.
Attach the needle by pressing it onto the glass pen tip. Keep the pen upright.
Do not remove the needle cover.
Gently, turn the needle clockwise until it is firmly attached, otherwise the needle may leak. You may not get the full dose if it leaks.
Tip: The needle cover will come off automatically during step 3, as follows.
3) Extend the injector shield: Hold the body of the pen firmly with one hand. Point the needle cover away from you and anyone else.
Use your other hand, and with one quick motion pull up the injector shield (grooved area) over the needle until the needle is fully covered.
The plastic needle cover will "pop" off.
Tip: Do not press the blue activation button at the same time.
4) Check the injector shield is extended correctly: Check if the injector shield is fully extended. A small rectangular area will be visible next to the oval display window. This is the safety lock.
5) Check the liquid: Look through the oval display window. The liquid should be clear and colourless. If the solution is cloudy, coloured or contains any floating particles, do not use this pen. Air bubble(s) are normal.
Using Avonex Pen: 1) Clean 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.
Tip: The best area is the upper, outer thigh.
2) Place Avonex Pen on the skin: Hold the body of the pen at a right angle to the injection site with one hand. Make sure the windows of the pen are visible.
Tip: Take care not to press the blue activation button too early.
Firmly press the body of the pen down onto the skin to release the safety lock.
Check the safety lock is released. The small rectangular window area will disappear. Avonex Pen is now ready to inject.
Tip: Continue to hold the pen firmly on the skin.
3) Give the injection: Press the blue activation button with your thumb to start the injection. You will hear a "click" indicating the injection process has begun. Do not lift the pen away from your skin.
Continue to hold the pen on your skin and count slowly for a full 10 seconds.
After 10 seconds pull the pen straight out to remove the needle from the injection site.
Apply pressure to the injection site for a few seconds. If there is any blood at the site, wipe it off.
4) Confirm injection delivery: Check the circular display window. The window will now appear yellow when the full dose has been delivered.
Do not re-use the Avonex Pen. It is for a single use only.
5) Disposal: Place the pen cover on a flat, hard surface.
Tip: Do not hold the pen cover. You may get a needle injury.
Insert needle directly into the pen cover.
Firmly press until 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 rubbish properly. Your doctor, nurse or pharmacist should provide you with instructions on how to dispose of your used Avonex Pen, for example into a sharps bin. Always follow your local guidelines.

Vaccines, Antisera & Immunologicals

L03AB07 - interferon beta-1a ; Belongs to the class of interferons. Used as immunostimulants.

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