Peginterferon alfa-2b (rbe)
Consumer Medicine Information
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 who have compensated liver disease and who have not previously received interferon therapy.
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.
Some of the symptoms of an allergic reaction may include:
- hives, itching or skin rash
- swelling of the face, lips or tongue which may lead to difficulty in swallowing
- shortness of breath, wheezing, difficulty in breathing or a tight feeling in your chest.
You must mention any past or present serious illness to your doctor. PEG-Intron is not suitable for patients with certain other past or present serious illness.
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 liver problems (other than hepatitis C)
- serious kidney problems and are taking a medicine containing the ingredient ribavirin.
Do not use PEG-Intron if you have or have had severe nervous or mental problems, such as severe depression or thoughts of suicide.
Do not use PEG-Intron if you are pregnant or planning to become pregnant. PEG-Intron is not recommended for use during pregnancy. Ask your doctor about the risks and benefits involved.
Do not use PEG-Intron in combination with ribavirin if you are or your partner is pregnant or planning to become pregnant. This applies to both female patients and to partners of male patients using PEG-Intron in combination with ribavirin. It is very important that you or your partner avoid becoming pregnant during treatment and for 6 months after treatment. This is because ribavirin can affect the sperm as well as the unborn child.
Do not use PEG-Intron if you are breastfeeding.
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 the packaging is torn or shows signs of tampering.
Do not use PEG-Intron after the expiry date (EXP) printed on the pack has passed. If you use it after the expiry date it may have no effect, 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.
Your doctor may ask you to have an eye examination before starting treatment.
You must tell your doctor if you have allergies to:
- any other medicines
- any other substance, such as food, dyes or preservatives.
You must tell your doctor if you have or have had any medical conditions, especially the following:
- 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
- substance use disorder
- eye problems
- organ transplant
- HIV positive
You must tell your doctor if you have or have had serious nervous or mental problems, such as severe depression, thoughts of suicide or any other psychiatric disorder.
Do not use PEG-Intron if you are pregnant or planning to become pregnant. PEG-Intron is not recommended for use during pregnancy. Ask your doctor about the risks and benefits involved.
Do not use PEG-Intron if you are breastfeeding.
Use in children
PEG-Intron is not recommended for use in patients under 18 years old.
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.
Tell your doctor if you are taking antiviral medications for HIV infection (e.g. didanosine, abacavir) as co administration with PEG-Intron and ribavirin is not recommended and will need to be monitored.
Tell your doctor if you are taking theophylline for asthma, as you may need to take different amounts of your medicine.
Tell your doctor if you are taking shosaikoto, a Chinese herbal medicine. Lung problems such as shortness of breath and pneumonia have been reported more frequently if shosaikoto is taken with a form of interferon.
How to use PEG-Intron
How much to inject
Follow all directions given to you by your doctor carefully.
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 1.0 mcg/kg once a week.
The dose may vary from one patient to another. Your doctor may recommend a different dose, or may change your dose during treatment, depending on your condition.
Do not exceed the recommended dosage.
How to prepare and administer the injection
PEG-Intron Powder for Injection is available as a Redipen injection device.
The Redipen injection device is a plastic injection pen containing the PEG-Intron powder and the solvent (Water for Injections) in separate compartments of a two-chamber cartridge.
The PEG-Intron powder for injection is dissolved in sterile Water for Injection before it can be used.
The prepared/reconstituted solution should be clear, colourless and free of particles.
PEG-Intron is for subcutaneous use. This means that it is injected into fatty tissue just under the skin.
If you are injecting this medicine yourself, your doctor or nurse will teach you how to prepare and give the injection under the skin.
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
Prepare the dose just before you intend to inject it and use it immediately.
Inject PEG-Intron once each week on the same day. Injecting it at the same time of day each week will help you get into a routine and remember when to give the injection.
If you are injecting this medicine yourself, inject it at bedtime. Interferons may cause unusual tiredness and flu-like symptoms and is best used before going to bed.
When self injecting, ensure that the injection site is varied each time the injection is administered.
How long to use it
Treatment should be for at least 6 months and for up to 1 year depending on your response.
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 what to do, check with your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your doctor or pharmacist for some hints.
You use too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (in Australia call 13 11 26; in New Zealand call 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much PEG-Intron. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
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, which 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.
Tell your doctor immediately if you become depressed, have suicidal or homicidal feelings 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.
Your doctor may want you to drink extra fluids. This will help prevent low blood pressure while you are on PEG-Intron.
Make sure you brush your teeth twice daily and have regular dental checks while you are using PEG-Intron. If you experience vomiting, rinse your mouth thoroughly afterwards.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using PEG-Intron.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are using this medicine.
Things you must not do
If you become drowsy or confused from this medicine, do not drive or use machinery. PEG-Intron may cause dizziness, drowsiness and confusion in some people.
Do not use PEG-Intron to treat any other complaints.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not switch to any other brands of interferon as your response to other interferons may be different.
Do not let yourself run out of medicine over weekends or holiday periods.
Things to be careful of
PEG-Intron can cause a temporary lowering of the number of cells/platelets in your blood.
Check with your doctor immediately
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).
Check with your doctor if you notice any of the following:
- jaundice (skin and eyes turning yellow)
- dark-brown coloured urine
- right-sided abdominal pain
- fever
- severe fatigue (tiredness).
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
- that you are looking unusually pale.
If you are also taking antiviral medications for HIV infection, and suddenly develop unexplained/ abnormal sensation of shortness of breath, consult your doctor immediately. Stop using medications until you have checked with your doctor.
The shortness of breath sensation may be due to a condition known as “lactic acidosis” (high acid levels in the blood). This condition has been reported with some HIV (antiviral) medications.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using PEG-Intron. All medicines 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.
Stop using PEG-Intron, tell your doctor immediately or go to Accident and Emergency at your nearest hospital, if you suddenly get an itchy rash, swelling of the face, lips or tongue, start wheezing or have trouble breathing or feel faint. These could be the signs of a serious allergic reaction.
Check with your doctor immediately if any of the following side effects occur:
- chest pain, or fast or irregular heartbeat
- seizures
- numbness or tingling sensation
- signs of liver decompensation such as a swollen abdomen, swelling of the legs, bruising, vomiting blood and difficulty in staying awake or alert
- aggressive behaviour, depression, suicidal or homicidal feelings
- confusion, trouble sleeping, thinking or concentrating
- jaundice
- 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
- painful, difficult or frequent urination
- severe stomach pain
- problems with eyesight or hearing
- signs of anaemia such as tiredness, being short of breath and looking pale
- severe nosebleed
- unusual bruising or bleeding (signs of bleeding include blood in the stool or urine, or black or tar-like stools)
- inability to control facial muscle movement
- muscle weakness
- fungal infection
The above list includes serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following and they worry you:
- injection site irritation, inflammation or pain
- flu symptoms including muscle aches or pain, fever, chills and headache
- weakness, tiredness, sleepiness or dizziness
- problems with your thyroid function which may appear as facial puffiness, swelling around the eyes, intolerance to cold or weight loss, increased appetite and difficulty sleeping
- nausea (feeling sick), vomiting or diarrhoea/intestinal gas
- stomach pain, indigestion or constipation
- nervousness, mood swings, anxiety, agitation, irritability
- eye or ear pain/infection
- loss of appetite, weight loss
- pain in joints; stiffness and swelling of joints
- lack of interest in sex/inability to perform
- increased sweating, flushing
- hair loss/change in hair texture
- itching, dry skin, rash
- migraine headache
- muscle cramps
- sore mouth or tongue, dry mouth or taste change
- viral or fungal infection
- increased or decreased sensitivity to touch
- shaky hands
- muscular ache and tense muscles
- sore throat, cough, runny or stuffy nose
- menstrual problems or period pain
Other side effects not listed above may also occur in some patients.
Tell your doctor if you notice anything that is making you feel unwell.
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
Store PEG-Intron in the refrigerator (2°C to 8°C). Do not freeze.
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 the injector once only and discard any solution left over.
Do not store PEG-Intron in the bathroom or near a sink. Do not leave it in the car or on windowsills. Only store PEG-Intron in the refrigerator. Heat and dampness can destroy some medicines.
Keep the medicine were children cannot reach it.
Keep PEG-Intron in its individual pack until it is time to use it. If you take your medicine out of the pack it will not keep as well.
Disposal
Return any unused medicine to your pharmacist.
Dispose of the PEG-Intron Redipen injectors and needles safely in a sharps container.
Product description
What it looks like
PEG-Intron is available as a Redipen injection device.
The Redipen injection device is a plastic injection pen containing the PEG-Intron powder and the solvent (Water for Injections) in separate compartments of a two-chamber cartridge.
PEG-Intron Powder for Injection is a white to off-white powder. The prepared/reconstituted solution should be clear, colourless and free of particles.
PEG-Intron Redipen Injectors are available in five strengths of peginterferon alfa-2b: 50 mcg, 80 mcg, 100 mcg, 120 mcg and 150 mcg.
Ingredients
The PEG-Intron Powder for Injection in the Redipen injector contains:
Active Ingredient
Peginterferon alfa-2b
Inactive Ingredients
- sodium phosphate dibasic (anhydrous)
- sodium phosphate monobasic (dihydrate)
- sucrose (sugar)
- polysorbate 80
Supplier
Merck Sharp & Dohme (Australia) Pty Limited
Level 1 Building A
26 Talavera Road
Macquarie Park NSW 2113
AUSTRALIA
Australian Registration Number
PEG-Intron Redipen Injectors:
- 50 mcg: AUST R 92005
- 80 mcg: AUST R 92006
- 100 mcg: AUST R 92007
- 120 mcg: AUST R 92008
- 150 mcg: AUST R 92009
Date of Preparation
October 2014
Published by MIMS June 2015