telaprevir
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about Incivo. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
If you have any concerns about using Incivo, ask your doctor or pharmacist. Your doctor and pharmacist have more information.
Keep this information handy. You can refer to it later if you have any questions.
Please also refer to Consumer Medicine Information documents of other medicines your doctor may have prescribed for use in combination with Incivo. Ask your doctor or pharmacist if you have any questions.
What Incivo is used for
Incivo belongs to a group of medicines called ‘NS3-4A protease inhibitors’. It is an inhibitor of the HCV NS3 4A protease, an enzyme that is essential for hepatitis C virus replication.
Incivo is part of a treatment for chronic hepatitis C. It must be taken in combination with peginterferon alfa and ribavirin. This combination of medicines is used to treat adult patients (aged 18-65).
Your doctor, however, may prescribe this medicine for another use.
Ask your doctor if you have any questions about why it has been prescribed to you.
Before you take it
When you must not use it
Do not use Incivo if you know you are allergic to any of its ingredients listed at the end of this leaflet. Signs of allergy include skin rash, itching, shortness of breath, and/or swollen face.
Do not use it after the expiry date printed on the pack. If you use it after the expiry date has passed, it may not work as well.
Do not use it if the packaging is torn or shows signs of being tampered with.
Do not use it to treat any other complaints unless your doctor says it is safe to do so.
Do not combine Incivo with any of the following medicines:
If you are taking any of these, ask your doctor about switching to another medicine.
- alfuzosin, a medicine to treat symptoms of an enlarged prostate.
- medicines used to treat certain heart disorders such as abnormal heart beat.
- astemizole, terfenadine. These medicines are used to treat allergy symptoms.
- rifampicin, a medicine used to treat some infections like tuberculosis.
- medicines containing dihydroergotamine, ergonovine, ergotamine or methylergonovine. These are used to treat migraine and headaches.
- cisapride, a medicine used to treat some stomach conditions.
- St John’s wort, an herbal product used to relieve anxiety.
- lovastatin, simvastatin. These medicines are used to lower cholesterol levels.
- pimozide, a medicine used to treat psychiatric conditions.
- sildenafil, tadalafil, a medicine used to treat a heart and lung disorder called pulmonary arterial hypertension.
- midazolam, triazolam. These medicines help you sleep and/or relieve anxiety.
- carbamazepine, phenobarbital, phenytoin. These medicines are used to treat epilepsy.
- quetiapine, a medicine used to treat mental disorders.
Before you start to use it
Incivo should be used with caution in some patients.
Tell your doctor if you have or have ever had:
- heart failure, irregular heartbeat, slow heart rate, an abnormality of heart tracing (ECG) called “long QT syndrome”, or a family history of a heart condition called “congenital QT syndrome”.
- problems with your liver.
Signs might be yellowing of the skin (jaundice), fluid accumulation in the stomach, and bleeding of the oesophagus. Your doctor may evaluate how severe your liver disease is before deciding if you can take Incivo. - HIV-infection or hepatitis B/hepatitis C infection.
- if you are taking a medicinal product because of an organ transplant.
Tell your doctor if:
you or your female partner are pregnant or are planning to become pregnant.
Pregnancy and breast-feeding
If you are pregnant, you must not take Incivo. Incivo must be used in combination with peginterferon alfa and ribavirin. Ribavirin can damage your unborn baby. It is therefore absolutely essential that you take all precautions not to get pregnant during this therapy.If you are pregnant, you must not take Incivo. Incivo must be used in combination with peginterferon alfa and ribavirin. Ribavirin can damage your unborn baby. It is therefore absolutely essential that you take all precautions not to get pregnant during this therapy.
If you are a woman who is breast-feeding, you must stop breast-feeding before starting to take Incivo.
Ask your doctor or pharmacist for advice before taking any medicine. If you or your female partner become pregnant during Incivo treatment or the months that follow, contact your doctor immediately.
Pregnancy precautions
Since Incivo must be used in combination with ribavirin and ribavirin can be very damaging to an unborn baby, both female and male patients must take special precautions in order to prevent pregnancy if there is any possibility for pregnancy to occur. Any birth control method can fail, and, therefore, you and your partner must use at least two effective birth control methods during this therapy and afterwards.
- Female patients of childbearing age:
You and your partner must each use an effective contraceptive during treatment and for 4 months after stopping all treatment.
You must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after the complete treatment is stopped. An oestrogen-based hormonal contraceptive (‘the pill’) is not reliable during the treatment with Incivo. Therefore, you and your partner must use two barrier birth control methods during the time you are taking Incivo and for 2 months after stopping Incivo. Possible barrier birth control methods are a female condom with a spermicidal jelly, a male condom with a spermicidal jelly, a diaphragm with spermicidal jelly, male condom or a cervical cap. These options must be discussed with your doctor.
A combination of a male condom and a female condom is not suitable: these might tear. - Male patients
You must use condoms during the time you are taking Incivo and for 7 months after stopping all treatment. Your female partner must also use an effective contraceptive for this period. Your female partner will need to be tested for pregnancy each month during treatment and for the 7 months after all treatment has stopped. If your female partner is pregnant, it is still important that you use a condom to ensure that your partner and the baby are not exposed to ribavirin.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
INCIVO might interact with other medicines.
Tell your doctor if you are taking:
- digoxin, lidocaine. These medicines are used to treat certain heart disorders such as abnormal heart beat.
- clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin. These medicines are used to treat infections.
- warfarin, a medicine used to prevent blood clots.
- escitalopram, trazodone. These medicines are used to treat mood disorders.
- domperidone, a medicine used to treat vomiting and nausea.
- itraconazole, ketoconazole, posaconazole, voriconazole. These medicines are used to treat fungal infections.
- colchicine, a medicine used to treat inflammatory arthritis.
- alprazolam, parenterally administered midazolam, zolpidem. These medicines are used to help you sleep and/or relieve anxiety.
- amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil. These medicines are used to help decrease blood pressure.
- budesonide, inhaled/nasal fluticasone, dexamethasone if taken by mouth or through injection. These medicines are used to treat asthma or to treat inflammatory and autoimmune conditions.
- bosentan, a medicine used to treat a heart and lung disorder called pulmonary arterial hypertension.
- atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir, efavirenz, etravirine, rilpivirine, raltegravir tenofovir disoproxil fumarate. These medicines are used to treat HIV infections.
- atorvastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin. medicines used to lower cholesterol levels.
- hormonal contraceptives.
- hormone replacement therapy.
- cyclosporine, sirolimus, tacrolimus. These medicines are used to support your immune system.
- salmeterol, a medicine used to improve breathing.
- repaglinide, a medicine used to treat diabetes.
- methadone, buprenorphine, a medicine used to combat pain or for treatment of opioid dependence.
- sildenafil, tadalafil, vardenafil. These medicines are used to treat erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension.
- fentanyl, alfentanil. These medicines are used to treat pain.
How to take it
Your doctor will decide the dose of Incivo suitable for you alongside your treatment with pegylated-interferon-alfa and ribavirin. The usual Incivo dose is three tablets taken twice daily with food. Swallow the tablets whole with water. Do not chew, break, or dissolve the tablets before you swallow them. Tell your doctor or pharmacist if you have problems swallowing whole tablets.
Check the package leaflets for the dosage instructions of peginterferon alfa and ribavirin. If you need help, ask your doctor or pharmacist.
Take Incivo with peginterferon alfa and ribavirin for 12 weeks. After that, you will be taking peginterferon alfa and ribavirin for another 12 or 36 weeks.
Removing the child resistant cap
The plastic bottle comes with a child resistant cap and should be opened as follows:
- Push the plastic screw cap down while turning it counter clockwise.
- Remove the unscrewed cap.
Follow your doctor’s instructions carefully and do not change or stop the required dosage without consulting your doctor first.
Incivo cannot be recommended for use in children with chronic hepatitis C under 18 years at the present time as there is little experience with the product in this group.
If you forget to take it
- If you notice the missed dose within 6 hours, you must take three tablets immediately. Always take the tablets with food. If you notice the missed dose after 6 hours, then skip the intake and take the next doses as usual.
- Do not take a double dose to make up for a forgotten dose.
- Please refer to Consumer Medicine Information documents of other missed medicines your doctor may have prescribed for use in combination with Incivo. Ask your doctor or pharmacist if you have any questions.
If you have problems remembering when to take your medicine, ask your pharmacist for some hints.
Overdose
If you think you or anybody else has taken too much Incivo, contact your doctor, pharmacist or the Poisons Information Centre who will advise you what to do.
You can contact the Poisons Information Centre by dialling:
- Australia: 13 11 26
- New Zealand: 0800 POISON or 0800 764 766
You may need urgent medical attention.
While you are using it
Things you must do
Follow your doctor’s instructions carefully. Do not miss or stop the treatment without consulting your doctor first. Your doctor will be happy to discuss any questions you may have with your treatment.
Your doctor will perform blood tests regularly to check for changes in some values of your blood cells or chemistry. These can be seen in the results from blood tests. Your doctor will explain these to you. Examples are: blood count levels, thyroid levels, liver enzymes, and kidney function.
Your doctor will also be performing blood tests to monitor your early response to treatment. If your response to treatment is not adequate, your doctor may stop your treatment.
Tell your doctor if you pregnant or are planning to become pregnant.
Tell your doctor if you experience tiredness, weakness, shortness of breath, light-headedness, and/or the feeling of the heart racing. These may be symptoms of anaemia (decrease in your red blood cells). Your doctor will check your blood regularly for low blood count during your HCV treatment.
Tell your doctor immediately if you develop a new rash or have a rash that gets worse. Your doctor should check your rash to determine how to manage it. Patients taking Incivo may develop a skin rash. There may be itching (pruritis) with the rash. Usually the rash is mild or moderate, but the rash may be, or may become, severe.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Incivo.
Things you must not do
Do not miss any appointments with the doctor.
Do not stop using Incivo without talking to your doctor first.
Do not stop taking Incivo unless your doctor tells you to. If you think there is a reason to stop taking Incivo, talk to your doctor before doing so.
Things to be careful of
Ask your doctor or pharmacist before taking any other medicines. These include herbal treatments and those bought in a pharmacy or supermarket.
Side Effects
All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
All medicines can have side effects. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Incivo. It helps most people with chronic hepatitis C, but it may have unwanted side effects in a few people.
Tell your doctor if you notice any of the following and they worry you:
- skin rash or itching skin
- eczema (red, cracked, dry, scaly skin)
- nausea (feeling sick)
- diarrhoea
- easy bruising
- haemorrhoids
These are mild side effects of Incivo but may require medical attention.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:
- signs of anaemia
Signs such as tiredness, shortness of breath when exercising, headaches, dizziness or looking pale. - widespread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome)
These may be serious side effects of Incivo. You may need urgent medical attention.
Serious side effects are uncommon.
Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some consumers.
Do not hesitate to report any other side effects to your doctor or pharmacist.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using it
Storage
Keep the tablets in its original container in a dry place where the temperature stays below 25°C.
Do not store it or any medicines in the bathroom or near a sink. Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Do not use it beyond the expiry date (month and year) printed on the pack. Medicines cannot be stored indefinitely, even if stored properly.
Product Description
What it looks like
Yellow caplet-shaped tablets of approximately 20 mm in length, marked with ‘T375’ on one side.
Incivo is available in a plastic bottle containing 42 film-coated tablets and a pouch to keep the tablets dry.
Ingredients
The active ingredient in Incivo is telaprevir.
The inactive ingredients are
- hypromellose acetate succinate,
- sodium lauryl sulfate,
- calcium hydrogen phosphate anhydrous,
- croscarmellose sodium, cellulose – microcrystalline,
- silicon dioxide,
- sodium stearyl fumarate,
- polyvinyl alcohol,
- macrogol 3350,
- talc – purified,
- titanium dioxide and
- iron oxide yellow.
Sponsor
Janssen-Cilag Pty Ltd
1-5 Khartoum Road,
Macquarie Park NSW 2113
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
Registration Numbers
375 mg film-coated tablets – AUST R 180138
This leaflet was prepared in September 2014.
Published by MIMS May 2015