Advertisement
Advertisement

Pegatron Clearclick

A combination therapy containing PEG-Intron® CLEARCLICK® (Peginterferon alfa-2b) and REBETOL® (Ribavirin)
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Pegatron Clearclick. It does not contain all the information that is known about Pegatron Clearclick. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What PEGATRON Combination Therapy is used for?

PEGATRON Combination Therapy is used for the treatment of chronic hepatitis C (a viral infection of the liver) in patients (18 years or older) who have compensated liver disease and who either have not previously received, or have failed, interferon alfa treatment (pegylated or nonpegylated). This includes patients who are co-infected with stable Human Immunodeficiency Virus (HIV).
PEGATRON combination therapy is also used for the treatment of chronic hepatitis C in children and adolescents with a body weight of 27 kg or more, who have compensated liver disease and who have not previously received interferon treatment.
PEGATRON Combination Therapy consists of two products, an injection called PEG-Intron and capsules called Rebetol.
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 modify the response of the body's immune system to help fight infections and severe diseases.
Rebetol capsules contain an antiviral agent called ribavirin.
REBETOL capsules are not effective when used alone to treat chronic hepatitis C and must only be used in combination with PEG-Intron injections.
The combination of Rebetol capsules and PEG-Intron injections make the treatment of hepatitis C more effective.

Before you use PEGATRON Combination Therapy

When you must not use it:

Do not use PEGATRON Combination Therapy if you are allergic to:
peginterferon alfa-2b
any alpha interferon
ribavirin
any of the ingredients listed at the end of this leaflet (for PEG-Intron and REBETOL).
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.
PEGATRON Combination Therapy is not suitable for patients with certain other past or present serious illness.
Do not use PEGATRON Combination Therapy if you have or have had severe nervous or mental problems, such as severe depression or thoughts of suicide.
Some people get depressed when taking pegylated interferon alfa alone or in combination treatment with ribavirin. Be sure to seek emergency care if you notice that you are becoming depressed, have suicidal thoughts, thoughts of harming others or there are any changes in your behaviour.
Do not use PEGATRON Combination Therapy 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 PEGATRON Combination Therapy.
It is very important that you or your partner avoid becoming pregnant during treatment and for 6 months after treatment. This is because Rebetol capsules can affect the sperm as well as the unborn child.
Do not use PEGATRON Combination Therapy if you are breastfeeding.
Do not use PEGATRON Combination Therapy if you have any of these medical conditions:
serious heart problems during the last six months or any previous serious heart condition
blood disorders including anaemia (low number of red blood cells), thalassaemia (Mediterranean anaemia), sickle-cell anaemia
serious kidney problems
serious liver problems other than chronic hepatitis C
autoimmune hepatitis or any other problem with your immune system
thyroid disease that is not well controlled with medicines.
epilepsy and/or compromised CNS function
Do not use PEGATRON Combination Therapy if you are presently taking or have been treated recently with medications that suppress the immune system.
This includes body organ transplant recipients.
Do not use PEGATRON Combination Therapy if you have any of the following hereditary disorders:
Galactose intolerance (the body is unable to absorb galactose)
Lapp lactase deficiency (the body is unable to digest milk and milk products)
Glucose-galactose malabsorption (the small intestine's is unable to transport and absorb glucose and galactose).
Do not attempt to inject yourself unless you are sure you understand the procedure and requirements for self-injection.
Do not use PEGATRON Combination Therapy after the expiry date (EXP) printed on the packs has passed.
If you use it after the expiry date has passed, it may not work as well.
Do not use PEGATRON Combination Therapy if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start using PEGATRON Combination Therapy, talk to your doctor.

Before you start to use it

If you are or your partner is a woman of childbearing age, you or your partner must have a negative pregnancy test before treatment with PEGATRON Combination Therapy starts. You or your partner must also have a negative pregnancy test each month during treatment and for the 6 months after treatment is stopped.
Two effective forms of contraception must be used one by each partner, male and female, during treatment with PEGATRON Combination Therapy and for the 6 months after treatment is completed.
REBETOL can cause harm to the unborn child if a pregnant woman takes REBETOL herself during pregnancy or has unprotected sex (sex without using a condom) with a man who is taking REBETOL. REBETOL can damage the sperm and the embryo (unborn child).
Do not use PEGATRON Combination Therapy if you are breastfeeding.
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.
Your doctor may request liver and kidney function tests before starting your treatment, especially if you are older than 65 years or if you have problems with your liver and/or 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.
For children and adolescents being treated with PEGATRON Combination Therapy, your doctor will monitor the function of your thyroid gland regularly.
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, irregular or very fast heartbeat, heart disease, or you have ever had a heart attack or other heart problems
hypertriglyceridaemia (or high triglycerides levels in the blood)
a history of diabetes or lung disease
blood clotting disorder
psoriasis
sarcoidosis
kidney problems
liver problems (besides hepatitis C)
thyroid disease
eye problems
gout
organ transplant
HIV positive
severe nervous or mental problems, such as severe depression or thoughts of suicide
substance use disorder.
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 REBETOL capsules 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.

Use in Children

Weight loss and slowed growth are common in children and adolescents during treatment with PEGATRON Combination Therapy. Catch-up weight gain and some catch-up in growth happen after treatment stops, but some children may not reach the height that they were expected to have before treatment. Your doctor will consider whether the benefits of taking PEGATRON Combination Therapy outweigh the risks of these side effects.
PEGATRON Combination Therapy is not recommended for use in children under 3 years of age.
The ability of younger children to swallow the REBETOL capsule should be carefully assessed.

How to use PEGATRON Combination Therapy

Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
Routine blood tests will help your doctor to monitor your response to treatment.
Do not exceed the recommended dosage.

REBETOL CAPSULES

How much to take

Adults
Your doctor has determined the dose of Rebetol capsules based on your weight. For patients weighing:
less than 65 kg: the usual dose is 2 capsules in the morning and 2 capsules in the evening.
65 kg to 80 kg: the usual dose is 2 capsules in the morning and 3 capsules in the evening.
81 kg to 105 kg: the usual dose is 3 capsules in the morning and 3 capsules in the evening.
more than 105 kg: the usual dose is 3 capsules in the morning and 4 capsules in the evening.
Your doctor may adjust your dose during therapy according to your response.
In some cases, your doctor may reduce the REBETOL dosage to one capsule in the morning and 2 capsules in the evening.
Children and Adolescents
The ability of younger children to swallow the REBETOL capsule should be carefully assessed.
Your doctor has determined the dose of REBETOL based on your weight. For patients weighing:
27 kg to 35 kg: the usual dose is 1 capsule in the morning and one capsule in the evening.
36 kg to 49 kg: the usual dose is 1 capsule in the morning and 2 capsules in the evening.
50 kg to 65 kg: the usual dose is 2 capsules in the morning and 2 capsules in the evening.
More than 65 kg: see the dose instructions for adults (above).

How to take the capsules

Do not open, break or crush REBETOL capsules. Rebetol capsules should be taken with food.
Swallow the capsules whole with water.

PEG-INTRON INJECTIONS

How much PEG-Intron to inject

Adults
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 1.5 mcg/kg once a week.
Children and Adolescents
Your doctor has determined your dose of PEG-Intron based on your height and weight and according to your needs. The usual dose of PEG-Intron is 60 mcg per square metre once a week.

How to prepare and administer the injection

PEG-Intron Powder for Injection is available as a CLEARCLICK injection device
The CLEARCLICK 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 the 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 that 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 and use it immediately.
Inject PEG-Intron once each week on the same day.
If you are injecting this medicine yourself, inject it at bedtime.
Interferons may cause unusual tiredness (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 PEGATRON Combination Therapy

Adults
Treatment should be for at least 12 weeks and for up to 1 year depending on your response.
For HCV/HIV co-infected patients, the recommended duration of treatment is 48 weeks.
Children and Adolescents
Treatment should be for at least 24 weeks and for up to 48 weeks.
Do not stop using this medicine without first checking with your doctor.
Your doctor will determine when your treatment should be stopped.
If you become pregnant while using PEGATRON Combination Therapy, you should immediately stop the treatment and tell your doctor. If your partner becomes pregnant while you are using PEGATRON Combination Therapy, ask your partner to tell her doctor immediately.

If you forget to use PEGATRON Combination Therapy

If you miss a dose of REBETOL capsules take the missed dose as soon as possible during the same day. If an entire day has gone by, check with your doctor. Do not double the next dose to make up for the dose that you missed.
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 dose that you missed.
If you are not sure what to do, ask your doctor.
If you have trouble remembering when to take your medicine, ask your doctor or pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor or the 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 PEGATRON Combination Therapy. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using PEGATRON Combination Therapy

Things you must do

Use PEGATRON Combination Therapy 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 PEGATRON Combination Therapy.
If you become pregnant while using PEGATRON Combination Therapy, you should immediately stop the treatment and tell your doctor.
If your partner becomes pregnant while you are using PEGATRON Combination Therapy, ask your partner to tell her doctor immediately.
Tell your doctor immediately if you become depressed, have suicidal or homicidal feelings while you are using PEGATRON Combination Therapy.
Some people get depressed when taking pegylated interferon alfa alone or in combination treatment with ribavirin. Be sure to seek emergency care if you notice that you are becoming depressed, have suicidal thoughts, thoughts of harming others or there are any changes in your behaviour.
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 PEGATRON Combination Therapy.
Make sure you brush your teeth twice daily and have regular dental checks while you are using PEGATRON combination therapy. 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 PEGATRON Combination Therapy.
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 from this therapy, do not drive or use machinery.
PEGATRON Combination Therapy may cause dizziness and drowsiness in some people.
Do not use PEGATRON Combination Therapy to treat any other complaints.
Do not give this therapy 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

PEGATRON Combination Therapy can cause a temporary lowering of the number of cells/ platelets in your blood.

Check with your doctor immediately

Tell your doctor immediately if:
you notice any signs of anaemia, such as tiredness, being short of breath, and looking pale.
you think you are getting a cold or chest infection. While using PEGATRON Combination Therapy, you may temporarily have a greater risk of getting an infection.
you notice unusual bleeding or bruising. Your blood may temporarily take a longer time to clot.
Tell your doctor immediately if you become depressed, have suicidal or homicidal feelings while you are using PEGATRON Combination Therapy.
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.
Your doctor may want you to drink extra fluids.
This will help prevent low blood pressure while you are on PEGATRON Combination Therapy.
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 PEGATRON Combination Therapy.
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 PEGATRON Combination Therapy, 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 signs of a serious allergic reaction.
Check with your doctor immediately if any of the following side effects occurs:
signs of anaemia such as tiredness, being short of breath and looking pale
signs of liver decomposition such as a swollen abdomen, swelling of the legs, bruising, vomiting blood and difficulty in staying awake or alert
lower back or side pain, painful difficult or frequent urination
severe stomach pain
severe nosebleed
unusual bruising or bleeding (signs of bleeding include blood in stool or urine, or black or tar-like stools)
fever or chills beginning after a few weeks of treatment
persistent cough or shortness of breath
problems with eyesight or hearing
seizures
depression, aggressive behaviour, suicidal or homicidal feelings (thoughts about threatening the life of others)
confusion, trouble sleeping, thinking or concentrating
chest pain, or fast or irregular heartbeat
numbness or tingling sensation
inability to control facial muscle movement
muscle weakness
signs of anxiety such as difficulty breathing, dizziness, light headedness, sweating, trembling and faintness.
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-like symptoms such as headache, fatigue, fever and chills
weakness, sleepiness
flushing, increased sweating feeling faint or dizziness
shaky hands
increased or decreased sensitivity to touch
dry or teary eyes
sore mouth or tongue, mouth ulcers, dry mouth or lips or taste change, burning sensation on tongue, tooth problem
bleeding gums
thirst
weight loss, loss of appetite
stomach pain, indigestion or constipation, bloating
nausea (feeling sick), vomiting or diarrhoea/intestinal gas
muscular ache and pain or joint pain
swelling of joints
pain on right side around your ribs
gout
tense muscles
migraine
nervousness, mood swings, anxiety, agitation irritability
hair loss/change in hair texture, itching, rash or dry or redness of the skin
skin sensitive to sunlight
jaundice ( yellow skin)
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
eye or ear pain/infection
lack of interest in sex/inability to perform, erectile problem
sore throat, cough, runny or stuffy nose
swollen glands
viral or fungal infection
menstrual problems or period pain
mouth thrush
back pain, limb pain
bone pain, pain around the breast bone, sometimes spreading to the neck and shoulders, sometimes fever.
These side effects may go away as your body adjusts to the medication. If they continue or are severe, tell your doctor.
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 PEGATRON Combination Therapy, 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 the list of possible side effects.
You may not experience any of them.

After using PEGATRON Combination Therapy

Storage

Store PEGATRON Combination Therapy in the refrigerator (2°C to 8°C). Do not freeze.
You may remove the REBETOL capsules from the PEGATRON Combination Therapy carton and store them at room temperature (below 25°C).
PEG-Intron CLEARCLICK injections are for single use only and must be stored in the refrigerator at 2°C to 8°C (do not freeze).
After preparation of PEG-Intron powder with sterile Water for Injections in the CLEARCLICK injector, use the reconstituted solution immediately. If it is not possible to use the reconstituted solution immediately, store it in the refrigerator 2°C to 8°C for not more than 24 hours.
Use the injector once only and discard any solution left over.
Do not store the REBETOL capsules in the bathroom or near a sink. Do not leave it in the car or on windowsills.
Heat and dampness can destroy some medicines.
Keep the two drugs where children cannot reach them.
A locked cupboard at least 1.5 metres above the ground is a good place to store the REBETOL capsules.
Keep the REBETOL capsules and the PEG-Intron CLEARCLICK injector in their individual packs until it is time to use them.
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 CLEARCLICK injectors and needles safely in a sharps container.

Product description

What it looks like

Rebetol capsules are available as 200 mg ribavirin.
The capsules are opaque white in colour with blue markings of '200 mg' and a stripe on one half of the capsule, and the 'S-P' logo and a stripe on the other half.
The capsules are packaged in blister packs.
PEG-Intron Powder for Injection is available as a CLEARCLICK injection device.
The CLEARCLICK 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 prepared/reconstituted solution should be clear, colourless and free of particles.
PEG-Intron is available in five strengths of peginterferon alfa-2b: 50 mcg, 80 mcg, 100 mcg, 120 mcg and 150 mcg. Each strength of PEG-Intron CLEARCLICK Injector has a different colour coded dosing button (at the end of the pen):
50 mcg: Red dosing button
80 mcg: Dark green dosing button
100 mcg: Light blue dosing button
120 mcg: Pink dosing button
150 mcg: Rust dosing button

Ingredients

Each Rebetol capsule contains:
ribavirin 200 mg
microcrystalline cellulose
lactose
croscarmellose sodium
magnesium stearate
The REBETOL capsule shell contains:
gelatin
titanium dioxide
sodium lauryl sulfate
silicon dioxide
TekPrint SB-6018 Blue Ink PI (2653).
The PEG-Intron Powder for Injection in the CLEARCLICK injector contains:
peginterferon alfa-2b
dibasic sodium phosphate
monobasic sodium phosphate
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 Numbers
PEGATRON Combination Therapy (PEG-Intron CLEARCLICK Injector + Rebetol Capsule):
PEG-Intron 50 mcg + REBETOL AUST R 204806
PEG-Intron 80 mcg + REBETOL AUST R 204807
PEG-Intron 100 mcg + REBETOL AUST R 204808
PEG-Intron 120 mcg + REBETOL AUST R 204809
PEG-Intron 150 mcg + REBETOL AUST R 204810

Date of Preparation

May 2016
S-CCDS-MK4031-ALL-082014