Important Safety Information
Serious Side Effects
INCIVEK combination treatment may cause serious side effects, including:
Skin rash and serious skin reactions. Skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become serious, require treatment in a hospital, and may lead to death.
Call your healthcare provider right away if you develop any skin changes or itching during treatment with INCIVEK. Your healthcare provider will decide if your skin changes or any of the following symptoms may be a sign of a serious skin reaction: skin rash with or without itching, fever, swelling of your face, blisters or skin lesions, mouth sores or ulcers, or red or inflamed eyes, like “pink eye” (conjunctivitis). Your healthcare provider will decide if you need treatment for your skin rash or if you need to stop taking INCIVEK or any of your other medicines. Never stop taking INCIVEK combination treatment without talking with your healthcare provider first.
Low red blood cell count (anemia) that can be severe. Tell your healthcare provider if you have any of these symptoms of anemia: dizziness, shortness of breath, tiredness, or weakness.
Your healthcare provider will do blood tests regularly to check your red blood cell count during treatment. If your anemia is severe, your healthcare provider may tell you to stop taking INCIVEK. If this happens, do not start taking it again.
Birth defects or death of an unborn baby. INCIVEK combined with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you or your sexual partner is pregnant or plan to become pregnant, do not take these medicines. You or your partner should not become pregnant while taking INCIVEK with peginterferon alfa and ribavirin and for 6 months after treatment is over.
If you are a female who can become pregnant, or if you are a female whose male partner takes these medicines:
- You must have a negative pregnancy test before starting treatment, every month during treatment, and for 6 months after your treatment ends.
- You must use 2 effective methods of birth control during treatment and for 6 months after all treatment has ended. These 2 forms of birth control should not contain hormones, as these may not work during treatment with INCIVEK. Talk to your healthcare provider about the forms of birth control you should use during this time.
Two weeks after stopping INCIVEK, you can use a hormonal form of birth control as one of your two forms of birth control.
- If you or your partner becomes pregnant during treatment or within 6 months after stopping these medicines, tell your healthcare provider right away. Contact the Ribavirin Pregnancy Registry right away by calling 1-800-593-2214. The Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while pregnant.
Who should not take INCIVEK?
- Do not take INCIVEK if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
Do not take INCIVEK if you are taking certain medicines as there could be serious side effects. If these drugs are taken together, this can cause you to have too much or not enough INCIVEK or your other medicines in your body. It can also cause side effects that can be serious or life-threatening.
- These medicines include: alfuzosin hydrochloride (Uroxatral®), carbamazepine (Carbatrol®, Equetro®, Tegretol®), cisapride (Propulsid®), ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, Migranal®), ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes), methylergonovine maleate (Ergotrate®, Methergine®), lovastatin (Advicor®, Altoprev®, Mevacor®), midazolam when taken by mouth, phenobarbital, phenytoin (Dilantin®, Phenytek®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®), sildenafil citrate (Revatio®) or tadalafil (Adcirca®) for the lung problem pulmonary artery hypertension (PAH), simvastatin (Zocor®, Vytorin®, Simcor®), St. John’s wort (Hypericum perforatum) or products containing St. John’s wort, or triazolam (Halcion®).
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INCIVEK and other medicines can affect each other. Your healthcare provider may need to change the amount of medicines you take.
What should I tell my healthcare provider before taking INCIVEK?
Tell your healthcare provider if you:
- have certain blood problems such as low red blood cell count (anemia)
- have liver problems other than hepatitis C infection
- have hepatitis B, HIV infection, or any problems with your immune system
- have a history of gout or high uric acid levels in your blood
- have had an organ transplant
- plan to have surgery
- have any other medical condition
- are breastfeeding
How should I take INCIVEK?
Do not take INCIVEK alone to treat chronic hepatitis C infection. It must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
Take INCIVEK exactly as your healthcare provider tells you. Do not stop taking INCIVEK unless your healthcare provider tells you to. If your healthcare provider tells you to stop, you should not start taking it again, even if the reason for stopping goes away. If you take too much INCIVEK, call your healthcare provider or local Poison Control Center, or go to the nearest emergency room right away.
Common Side Effects of INCIVEK Combination Treatment
The most common side effects include itching, nausea, diarrhea, vomiting, anal or rectal problems (including hemorrhoids, discomfort or burning around or near the anus, itching around or near the anus), taste changes, and tiredness. Tell your healthcare provider about any side effect that bothers you or doesn’t go away.
These are not all the possible side effects of INCIVEK. For more information, ask your healthcare provider or pharmacist.
Please see full Prescribing Information for INCIVEK, including Boxed Warning, and read the Medication Guide.
Please see full Prescribing Information and read the Medication Guides for peginterferon alfa and ribavirin.
This site is intended for U.S. audiences only. All other audiences please click here.