Consumer Medicine Information
PEG-Intron®
Peginterferon Alfa-2b (rbe)
What is in this leaflet
This leaflet answers some common questions about PEG-Intron. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using PEG-Intron against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may want to read it again.
What PEG-Intron is used for
PEG-Intron is used to treat chronic hepatitis C (a viral infection of the liver) in patients 18 years of age or older.
The active ingredient in PEG-Intron is peginterferon alfa-2b. Peginterferon alfa-2b belongs to a group of medicines called interferons.
Interferons are a family of naturally occurring small protein molecules. They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Interferons modify the response of the body's immune system to help fight infections and severe diseases.
Before you use PEG-Intron
When you must not use it:
Do not use PEG-Intron if you are allergic to:
- peginterferon alfa-2b
- any interferon
- any of the ingredients listed at the end of this leaflet.
Do not use PEG-Intron if you have any of these medical conditions:
- autoimmune hepatitis or any other problem with your immune system
- severe depression or any other severe nervous or mental disorder
- thyroid disease that is not well controlled with medicines
- serious kidney problems
- serious liver problem (other than hepatitis C).
Do not attempt to inject yourself unless you are sure you understand the procedure and requirements for self-injection.
Do not use PEG-Intron if you are pregnant or breastfeeding.
If you are a woman of childbearing age make sure you do not become pregnant while using PEG-Intron. Ask your doctor about the risks and benefits involved.
Do not use PEG-Intron if packaging is torn or shows signs of tampering.
Do not use PEG-Intron after the expiry date printed on the pack.
If you use it after the expiry date it may have no effect at all, or worse, an unexpected effect.
If you are not sure whether you should start using PEG-Intron, talk to your doctor.
Before you start to use it
Your doctor may request kidney function tests before starting your treatment, especially if you are older than 65 years or if you have problems with your kidneys.
Your doctor may also request tests of your heart function before starting treatment, especially if you have problems with your heart.
If you are diabetic or have high blood pressure, your doctor may ask you to have an eye examination before starting treatment.
You must tell your doctor if:
- you are allergic to:
- any other medicines or any food, dyes or preservatives
- you have or have had any of these medical conditions:
- congestive heart failure, heart disease, heart attack, irregular or very fast heartbeat or other heart problems
- hypertriglyceridaemia (or high triglycerides levels in the blood)
- liver problems (besides hepatitis C)
- kidney problems recent fever
- lung or thyroid disease
- psoriasis
- sarcoidosis
- depression or any other nervous or mental disorders
- eye problems
- gout
- organ transplant
- HIV positive
- you are pregnant or planning to become pregnant.
You should not use PEG-Intron if you are pregnant or planning to become pregnant without discussing this with your doctor. Your doctor will discuss the risks and benefits involved. - you are breastfeeding.
Your doctor will discuss the risks and benefits of breastfeeding while being treated with PEG-Intron.
Use in Children
PEG-Intron is not recommended for use in patients under 18 years old. There is no experience with the use of PEG-Intron in children.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Be sure to tell your doctor if you are taking theophylline for asthma, as you may need to take different amounts of your medicine.
How to use PEG-Intron
How much to inject
Your doctor has determined your dose of PEG-Intron based on your weight and according to your needs. The usual dose of PEG-Intron is 0.5 or 1 microgram (µg)/kg once a week. Your doctor may change your dose during treatment.
Do not exceed the recommended dosage.
How to prepare and administer the injection
In the REDIPEN presentation, PEG-Intron powder for injection is dissolved in sterile Water for Injections before it can be used.
PEG-Intron is for subcutaneous use. This means that it is injected into fatty tissue just under the skin.
Your doctor or nurse will teach you how to prepare and give the injection under the skin if you are injecting this medicine yourself.
A brief outline of the preparation and injection procedure for self-injection is described below. More detailed instructions will be provided by your doctor or nurse. Your doctor or nurse will instruct and assist you in learning the procedure and technique of how to self-inject PEG-Intron.
There is a patient instruction sheet inside the box which describes how to prepare the injection and self- inject.
Do not attempt to inject yourself until you understand the procedure and requirement of self-injection.
When to inject
Inject PEG-Intron once each week on the same day.
If you are injecting this medicine yourself, use it at bedtime as interferons may cause tiredness and flu-like symptoms. Injecting it at the same time of day each week will help you get into a routine and remember when to give the injection.
Prepare the dose just before you intend to inject it and use it immediately.
How long to use it
Treatment should be for at least 6 months and possibly for 1 year depending on your response. Most patients are treated for one year.
Do not stop using this medicine without first checking with your doctor.
Your doctor will determine when your treatment should be stopped.
If you forget to use it
If you missed a dose of PEG-Intron injection,
- take the missed dose as soon as possible during the same day or on the next day, and continue your treatment as usual.
- If several days have gone by, check with your doctor.
Do not double the next dose to make up for the injection that you missed.
If you are not sure if you should inject your missed dose, check with your doctor or pharmacist.
You use too much (overdose)
Telephone your doctor or Poisons Information Centre (Phone Australia 13 11 26 or New Zealand 0800 764 766) for advice as soon as possible, if you think you or anyone else may have taken too much PEG-Intron. Do this even if there are no signs of discomfort or poisoning.
Keep telephone numbers for these places handy.
While you are using PEG-Intron
Things you must do
Use PEG-Intron exactly as your doctor has prescribed.
Tell your doctor immediately if you have an allergic reaction.
Symptoms of an allergic reaction may include:
- hives, itching or skin rash
- swelling of the face, lips or tongue. This may lead to difficulty in swallowing.
- shortness of breath, wheezing, difficulty in breathing or a tight feeling in your chest.
Tell all doctors, dentists and pharmacists who are treating you that you are using PEG-Intron.
Tell your doctor immediately if you become pregnant while you are using PEG-Intron.
Keep all your doctor's appointments so that your progress can be checked. Your doctor will carry out blood tests to monitor your response to treatment.
Your doctor may ask you to have regular eye checks during treatment, especially if you are diabetic or have high blood pressure.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are on PEG-Intron.
Things you must not do
If you become drowsy or confused from this medicine, do not drive a car or use machinery.
PEG-Intron may cause dizziness, drowsiness and confusion in some people.
Do not use it to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not let yourself run out of medicine over weekends or holiday periods.
Things to be careful of
Check with your doctor if you think you are developing symptoms associated with a cold or other respiratory infection.
While receiving PEG-Intron, you may have a greater risk of getting an infection. Your doctor may do blood tests to check that you have an acceptable number of white blood cells (cells that fight infection).
Check with your doctor immediately if you notice unusual bleeding or bruising.
Your blood may temporarily take a longer time to clot. Your doctor may do blood tests to check that you have an acceptable number of platelets (blood clotting cells).
Your doctor may want you to drink extra fluids. This will help prevent low blood pressure while you are on PEG-Intron.
Tell your doctor if you notice:
- any changes in your eyes or eyesight even if there is no pain or discomfort
- signs of psoriasis for the first time or worsening of the disease
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using PEG-Intron.
Like all medicines, PEG-Intron can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist any questions you may have.
Check with your doctor immediately if any of the following side effects occur:
- an allergic reaction (such as hives, wheezing or difficulty in breathing)
- chest pain, or fast or irregular heartbeat
- seizures
- confusion, aggressive behaviour, depression or suicidal feelings
- numbness or tingling sensation
- fever or chills beginning after a few weeks of treatment
- persistent cough or shortness of breath or difficulty breathing
- pain in your side or lower back
- problems with your eyesight or hearing
- you are looking unusually pale
- * severe nosebleed
- unusual bruising or bleeding (signs of bleeding include blood in the stool or urine, or black or tar-like stools)
You may need urgent medical attention.
Tell your doctor if you notice any of the following and they worry you:
- Irritation, redness or swelling at the site of injection
- flu symptoms including muscle aches or pain, fever, chills and headache
Your doctor may tell you to take paracetamol to help control these symptoms. - weakness, tiredness, sleepiness or dizziness
- feeling sick, vomiting or diarrhoea
- stomach pain, indigestion or constipation
- irritability
- feeling anxious or nervous, trouble sleeping, lack of concentrating
- loss of appetite, weight loss
- pain in joints
- increased sweating, flushing
- hair loss
- itching, dry skin, rash
- dry mouth
- changes in taste.
- mood swings
- viral infection
- weakness
- menstrual problems or period pain
Other side effects not listed above may also occur in some patients.
If you notice any other side effects, check with your doctor.
Check with your doctor as soon as possible if you have any problems while using PEG-Intron even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using PEG-Intron
Storage
Keep PEG-Intron where children cannot reach it.
Before use:
Store PEG-Intron in the refrigerator (2° to 8°C). Do not freeze. Do not leave it in the car.
After preparation of PEG-Intron powder with sterile Water for Injections in the Redipen Injector, use the reconstituted solution immediately or within 24 hours when stored in the refrigerator (2°C to 8°C).
As the solution contains no preservative, it should be used as soon as possible after preparation.
Use once only and discard any solution left over.
Disposal
Return any unused medicine to your pharmacist.
Dispose used needles, safely in a sharps container.
Product description
What it looks like
PEG-Intron Powder for Injection is a white to off-white powder. The powder is soluble in water. The prepared solution should be clear and colourless.
PEG-Intron is available asRedipen Injector - a plastic injection pen containing the PEG-Intron powder and the solvent (Water for Injections) in separate compartments of a two-chamber cartridge.
Ingredients
Active ingredient:
Peginterferon alfa-2b
Inactive ingredients:
- sodium phosphate dibasic (anhydrous)
- sodium phosphate monobasic (dihydrate)
- sucrose (sugar)
- polysorbate 80
PEG-Intron Redipen Injectors are available in five strengths of peginterferon alfa-2b: 50 µg, 80 µg, 100 µg, 120 µg and 150 µg.
Supplier
In Australia:
Schering-Plough Pty Limited
11 Gibbon Road
Baulkham Hills NSW 2153
AUSTRALIA
In New Zealand:
Schering-Plough
33 Whakatiki Street
Upper Hutt
Wellington
NEW ZEALAND
Australian Registration Number
PEG-Intron Redipen Injectors:
50 µg : AUST R 92005
80 µg : AUST R 92006
100 µg : AUST R 92007
120 µg : AUST R 92008
150 µg : AUST R 92009
Date of Preparation
1st February 2007
© Schering-Plough Pty Limited