Incivo
telaprevir
telaprevir
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What INCIVO is and what it is used for
What you need to know before you take INCIVO
How to take INCIVO
Possible side effects
How to store INCIVO
Medicinal product no longer authorised
Contents of the pack and other information
INCIVO acts against the virus that causes hepatitis C infection and is used to treat chronic hepatitis C infection in adult patients (aged 18–65 years) in combination with peginterferon alfa and ribavirin. INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors’. The NS3-4A protease inhibitor reduces the amount of hepatitis C virus in your body. INCIVO must not be taken alone and must be taken in combination with peginterferon alfa and ribavirin to be sure your treatment works. INCIVO can be used for patients with chronic hepatitis C infection who have never been treated before or can be used in patients with chronic hepatitis C infection who have been treated previously with an interferon-based regimen.
See the package leaflets for peginterferon alfa and ribavirin for a list of their contraindications (e.g. pregnancy precautions for men and women) since INCIVO must be used in combination with peginterferon alfa and ribavirin. Ask your doctor if you are unsure about any contraindications mentioned in the package leaflets.
Medicine (name of the active substance) | Purpose of the medicine |
alfuzosin | to treat symptoms of an enlarged prostate (alpha-1-adrenoreceptor antagonists) |
amiodarone, bepridil, quinidine, other Class Ia or III antiarrhythmics | to treat certain heart disorders such as irregular heart beat (antiarrhythmics) |
astemizole, terfenadine | to treat allergy symptoms (antihistamines) |
rifampicin | to treat some infections like tuberculosis (antimycobacterial) |
dihydroergotamine, ergonovine, ergotamine, methylergonovine | to treat migraine and headaches (ergot derivatives) |
cisapride | to treat some stomach conditions (gastrointestinal motility agents) |
St John’s wort (Hypericum perforatum) | an herbal product to relieve anxiety |
atorvastatin, lovastatin, simvastatin | to lower cholesterol levels (HMG CoA reductase inhibitors) |
pimozide | to treat psychiatric conditions (neuroleptics) |
sildenafil, tadalafil | Sildenafil or tadalafil must not be used to treat a heart and lung disorder called pulmonary arterial hypertension. There are other uses for sildenafil and tadalafil. Please see section ‘Other medicines and INCIVO’. |
quetiapine | to treat schizophrenia, bipolar disorder and major depressive disorder |
midazolam (taken by mouth), triazolam (taken by mouth) | to help you sleep and/or relieve anxiety (sedatives/hypnotics) |
carbamazepine, phenobarbital, phenytoin | to treat epileptic seizures (anticonvulsants) |
Medicinal product no longer authorised
If you are taking any of the above, ask your doctor about switching to another medicine.
Talk to your doctor or pharmacist before taking INCIVO.
INCIVO must be taken in combination with peginterferon alfa and ribavirin. It is therefore very important that you read the package leaflets that are provided with these medicines, too. If you have any questions about your medicines, please ask your doctor or pharmacist.
Make sure that you check the following points and tell your doctor treating your hepatitis C virus (HCV) if any of these apply to you.
Skin rash
Patients taking INCIVO may develop a skin rash. There may be itching with the rash. Usually the rash is mild or moderate, but the rash may be, or may become, severe and/or
life-threatening. You should contact your doctor immediately if you develop a rash or have a
rash that gets worse. INCIVO must not be restarted if discontinued by your doctor. You must carefully read the information under Rash in section 4 Possible Side Effects.
Anaemia (decrease in your red blood cells)
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.
Heart problems
Tell your doctor if you have heart failure, irregular heartbeat, slow heart rate, an abnormality shown in your heart tracing (ECG) called ’long QT syndrome’, or a family history of a heart condition called ’congenital QT syndrome’.
Your doctor may request additional monitoring during your INCIVO treatment.
Liver problems
Tell your doctor if you have had other problems with your liver such as liver failure. Signs might be yellowing of the skin or eyes (jaundice), swelling of the stomach (ascites) or legs due to fluid, and bleeding from swollen veins (varices) in the gullet (oesophagus). Your doctor may evaluate how severe your liver disease is before deciding if you can take INCIVO.
Infections
Tell your doctor if you have an hepatitis B infection so that your doctor can decide if INCIVO is right for you.
Organ transplant
Medicinal product no longer authorised
Tell your doctor if you have had or are going to have a liver or other organ transplant as INCIVO might not be right for you in this situation.
Blood tests
Your doctor will do blood tests before starting treatment and regularly during your treatment:
to see how much virus is in your blood and to determine if you have the type of virus (genotype 1) that can be treated with INCIVO. Decisions related to your treatment may be made based on the results of these tests. Your doctor will monitor your early response to treatment and how much virus is in your blood. If your treatment is not working, your doctor may stop your medicines. If your doctor stops INCIVO, it should not be restarted.
to check if you have anaemia (decrease in your red blood cells).
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 (a gland in your neck that controls your metabolism) levels, liver and kidney tests.
INCIVO has only been used in a limited number of patients of 65 years or older. If you belong to this age group, please discuss the use of INCIVO with your doctor.
INCIVO is not for use in children or adolescents, because it has not been sufficiently studied in patients under 18 years of age.
INCIVO may affect other medicines or other medicines may affect INCIVO. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you take any of the following medicines:
Medicine (name of the active substance) | Purpose of the medicine |
flecainide, propafenone | to treat certain heart disorders such as irregular heart beat (antiarrhythmics) |
alfentanil, fentanyl | to treat pain (analgesics) or used during surgery to induce sleep |
digoxin, intravenous lidocaine | to treat certain heart disorders such as abnormal heart beat (antiarrhythmics) |
clarithromycin, erythromycin, telithromycin, troleandomycin | to treat bacterial infections (antibacterials) |
warfarin, dabigatran | to prevent blood clots (anticoagulants) |
escitalopram, trazodone | to treat mood disorders (antidepressants) |
metformin | to treat diabetes (antidiabetics) |
domperidone | to treat vomiting and nausea (antiemetics) |
itraconazole, ketoconazole, posaconazole, voriconazole | to treat fungal infections (antifungals) |
colchicine | to treat inflammatory arthritis (anti-gout agents) |
rifabutin | to treat certain infections (antimycobacterials) |
alprazolam, midazolam through injection | to help you sleep and/or relieve anxiety (benzodiazepines) |
zolpidem | to help you sleep and/or relieve anxiety (non-benzodiazepine sedatives) |
amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil | to decrease blood pressure (calcium channel blockers) |
maraviroc | to treat HIV infections (CCR5 antagonist) |
budesonide, inhaled/nasal fluticasone, dexamethasone if taken by mouth or through injection | to treat asthma or to treat inflammatory and autoimmune conditions (corticosteroids) |
bosentan | to treat a heart and lung disorder called pulmonary arterial hypertension (endothelin receptor antagonist) |
atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir | to treat HIV infections (HIV-protease inhibitors) |
abacavir, efavirenz, tenofovir disoproxil fumarate, zidovudine | to treat HIV infections (reverse transcriptase inhibitors) |
fluvastatin, pitavastatin, pravastatin, rosuvastatin | to lower cholesterol levels (HMG CoA reductase inhibitors) |
all types of hormonal contraceptives (‘the pill’) | hormonal contraceptives |
oestrogen-based medicines | hormone replacement therapy |
cyclosporine, sirolimus, tacrolimus | to lower your immune system (immunosuppressants), medicines used in some rheumatic diseases or to avoid problems with organ transplants |
salmeterol | to improve breathing for asthma (inhaled beta agonists) |
repaglinide | to treat type II diabetes (blood glucose lowering medicine) |
methadone | for the treatment of opioid (narcotic) dependence |
sildenafil, tadalafil, vardenafil | to treat erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension (PDE-5 inhibitors) |
Medicinal product no longer authorised
INCIVO must always be taken together with food. The food is important to get the right levels of medicine in your body.
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 or your female partner become pregnant during INCIVO treatment or the months that follow, you must contact your doctor immediately (see section ’Pregnancy precautions for men and women’ below).
If you are breast-feeding, you must stop breast-feeding before starting to take INCIVO. It is not known whether telaprevir, the active ingredient in INCIVO, is found in human breast milk.
Ask your doctor or pharmacist for advice before taking any medicine. Pregnancyprecautionsformenandwomen
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. Any birth control method can fail, and, therefore, you and your partner must use at least two effective birth control methods during INCIVO therapy and afterwards. Following the end of the INCIVO treatment, please see the ribavirin package leaflet regarding continued contraception requirements.
Femalepatientsofchildbearingageandtheirmalepartners
A hormonal contraceptive (‘the pill’) may not be reliable during the treatment with INCIVO. Therefore, you and your partner must use two other birth control methods during the time you are taking INCIVO and for 2 months after stopping this medicine.
Medicinal product no longer authorised
You must read the package leaflets for peginterferon alfa and ribavirin for additional information.
Some patients may experience fainting or problems with vision during INCIVO treatment. Do not drive or operate machines if you feel faint or have problems with your vision while taking INCIVO. See also the package leaflets for peginterferon alfa and ribavirin.
This medicine contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet. Tell your doctor if you have to take care of your salt intake and follow a low sodium diet.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide on the appropriate dose regimen for you. The recommended dose regimen is:
If you have both hepatitis C virus infection and human immunodeficiency virus infection, and are taking efavirenz, the recommended dose regimen is 3 tablets of INCIVO every 8 hours with food.
You must always take INCIVO with food as this is important to get the right levels of medicine in your body. You must not reduce your dose of INCIVO. Swallow the tablets whole. Do not chew,
break, or dissolve the tablets before you swallow them. Tell your health care provider if you have problems swallowing whole tablets.
Since INCIVO treatment always needs to be used together with peginterferon alfa and ribavirin, please also check the package leaflets for the dosage instructions of these medicines. If you need help, ask your doctor or pharmacist.
Take INCIVO with peginterferon alfa and ribavirin for 12 weeks. The total duration of treatment of peginterferon alfa and ribavirin varies from 24 to 48 weeks depending on treatment response and whether you have been treated before. Your doctor will measure blood levels of your virus at weeks 4 and 12 to determine your treatment duration. The recommended total duration of treatment for patients who have received a liver transplant is 48 weeks. Please check with your doctor and follow the recommended duration of treatment.
If your doctor stops INCIVO because of side effects or because your treatment is not working, INCIVO should not be restarted.
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.
Medicinal product no longer authorised
Contact your doctor or pharmacist immediately to ask for advice.
In case of overdose you may experience nausea, headache, diarrhoea, decreased appetite, abnormal taste and vomiting.
IfyouaretakingINCIVOtwicedaily(morningandevening)
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.
IfyouaretakingINCIVOevery8hours
If you notice the missed dose within 4 hours, you must take two tablets immediately. Always take the tablets with food. If you notice the missed dose after 4 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.
Unless your doctor tells you to stop, continue taking INCIVO in order to ensure that your medicine continues to work against the virus. INCIVO must not be restarted if discontinued by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients taking INCIVO frequently get an itchy skin rash. Usually the rash is mild or moderate, but the rash may be, or may become, severe and/or life-threatening. Rarely patients may have other symptoms with the rash that may be a sign of a severe skin reaction.
if your rash worsens, OR
if you develop other symptoms with a rash such as:
fever
tiredness
swelling of the face
swelling of lymph glands, OR
if you have a wide-spread rash with peeling skin which may be accompanied by fever, flu-like symptoms, painful skin blisters, and blisters in the mouth, eyes, and/or genitals.
Your doctor should check your rash to determine how to manage it. Your doctor may stop your treatment. INCIVO must not be restarted if discontinued by your doctor.
tiredness, weakness, shortness of breath, light-headedness, and/or feeling of heart racing. These may be symptoms of anaemia (decrease in your red blood cells);
fainting;
painful inflammation of the joints most commonly in the foot (gout);
problems with your eyesight;
Medicinal product no longer authorised
bleeding from the anus;
swelling of the face.
The frequency rate of the side effects associated with INCIVO is given below. Very common side effects (affects more than 1 in 10 people):
low red blood cell count (anaemia);
nausea, diarrhoea, vomiting;
swollen veins in the rectum or anus (haemorrhoids), pain in the anus or rectum;
skin rash and itching of the skin.
Common side effects (affects less than 1 in 10 people):
fungal infection in the mouth;
low blood platelet count, decrease in lymphocytes (a type of white blood cell), decrease in thyroid gland activity, increase in uric acid in your blood, decrease in potassium in your blood, increase in bilirubin in your blood;
change in taste;
fainting;
itching around or near the anus, bleeding around or near the anus or rectum, a small tear in the skin that lines the anus that may cause pain and/or bleeding during bowel movements;
red, cracked, dry, scaly skin (eczema), rash with red, cracked, dry, scaly skin (exfoliative rash);
swelling of the face, swelling of the arms and/or legs (oedema);
abnormal product taste.
Uncommon side effects (affects less than 1 in 100 people):
increase in creatinine in your blood;
painful inflammation of the joints most commonly in the foot (gout);
damage to back of the eye (retina);
inflammation of the anus and rectum;
inflamed pancreas
severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS);
hives (urticaria)
dehydration. Signs and symptoms of dehydration include increased thirst, dry mouth, decreased urine frequency or volume, and dark coloured urine. It is important to stay hydrated with fluids during INCIVO combination treatment.
Rare side effects (affects less than 1 in 1,000 people):
a wide-spread 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).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in AppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
See also the package leaflets for peginterferon alfa and ribavirin for side effects reported for these products.
Keep this medicine out of the sight and reach of children.
Medicinal product no longer authorised
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
INCIVO tablets should be stored in the original bottle. Keep the bottle tightly closed in order to protect from moisture. Each bottle contains one pouch or two pouches of desiccant to keep the tablets dry. Do not remove this desiccant from the bottle. Do not eat the desiccant.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is telaprevir. Each tablet of INCIVO contains 375 mg of telaprevir. The other ingredients are:
Tablet core
hypromellose acetate succinate, calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulphate, croscarmellose sodium, sodium stearyl fumarate
Tablet film-coat
polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172)
Film-coated tablet. Yellow caplet-shaped tablets of approximately 20 mm in length, marked with ‘T375’ on one side.
INCIVO is available in packs containing one bottle or 4 bottles per carton. Each bottle contains one pouch or two pouches to keep the tablets dry (desiccant).
Not all pack-sizes may be marketed.
B-2340 Beerse Belgium
04100 Borgo San Michele, Latina, Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
B-2340 Beerse
Tel/Tél: +32 14 64 94 11
UAB „Johnson & Johnson“ Geležinio Vilko g. 18A
LT-08104 Vilnius
Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД ж.к. Младост 4
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Бизнес Парк София, сграда 4 София 1766
Тел.: +359 2 489 94 00
B-2340 Beerse Belgique/Belgien Tél/Tel: +32 14 64 94 11
CZ-150 00 Praha 5 - Smíchov
Tel: +420 227 012 227
H-Budapest, 1123
Tel: +36 1 884 2858
Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
AM MANGION LTD.
Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000
Tel: +356 2397 6000
Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss
Tel: +49 2137 955-955
Janssen-Cilag B.V.
Dr. Paul Janssenweg 150 NL-5026 RH Tilburg Tel: +31 13 583 73 73
Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Lõõtsa 2
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Janssen-Cilag AS Postboks 144
NO-1325-Lysaker Tlf: +47 24 12 65 00
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GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH Vorgartenstraße 206B
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Tel: +43 1 610 300
Janssen-Cilag, S.A.
Paseo de las Doce Estrellas, 5-7 E-28042 Madrid
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PL-02-135 Warszawa Tel: +48 22 237 60 00
Janssen-Cilag
1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03
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PT-2734-503 Barcarena Tel: +351 21 43 68 835
Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h
10010 Zagreb
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Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA
Tel: +40 21 207 1800
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Janssen-Cilag Ltd.
50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom
Tel: +44 1 494 567 444
Johnson & Johnson d.o.o. Šmartinska cesta 53
SI-1000 Ljubljana
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Janssen-Cilag AB c/o Vistor hf. Hörgatúni 2
IS-210 Garðabær Sími: +354 535 7000
Tel: +421 232 408 400
Janssen-Cilag SpA Via M.Buonarroti, 23
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Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā Mūkusalas iela 101
Rīga, LV-1004
Tel: +371 678 93561
Janssen-Cilag Ltd.
50-100 Holmers Farm Way High Wycombe
Buckinghamshire HP12 4EG - UK Tel: +44 1 494 567 444
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