"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
(Generic versions may still be available.)
Incivek Patient Information Including Side Effects
Brand Names: Incivek
Generic Name: telaprevir (Pronunciation: tel A pre vir)
- What is telaprevir (Incivek)?
- What are the possible side effects of telaprevir (Incivek)?
- What is the most important information I should know about telaprevir (Incivek)?
- What should I discuss with my healthcare provider before taking telaprevir (Incivek)?
- How should I take telaprevir (Incivek)?
- What happens if I miss a dose (Incivek)?
- What happens if I overdose (Incivek)?
- What should I avoid while taking telaprevir (Incivek)?
- What other drugs will affect telaprevir (Incivek)?
- Where can I get more information?
What is telaprevir (Incivek)?
Telaprevir is an antiviral medication that prevents certain virus cells from multiplying in your body. Telaprevir is used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) to treat hepatitis C in adults.
Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.
Telaprevir is usually given to people who have never been treated for hepatitis C, or after interferon and ribavirin have been tried without successful treatment of symptoms.
Telaprevir may also be used for purposes not listed in this medication guide.
What are the possible side effects of telaprevir (Incivek)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- tired feeling;
- nausea, vomiting, diarrhea, altered sense of taste;
- rectal itching, burning, or discomfort; or
- mild skin rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Incivek (telaprevir film-coated tablets) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about telaprevir (Incivek)?
Do not take telaprevir as your only medication to treat hepatitis C. Telaprevir must be used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab).
Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.
Telaprevir is given together with interferon alfa and ribavirin. Ribavirin can cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. Use at least 2 effective forms of birth control while either sexual partner is using interferon alfa and ribavirin, and for at least 6 months after treatment ends.
Telaprevir may cause a severe skin reaction. Call your doctor right away if you have a fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
The following drugs should not be used while you are taking telaprevir: alfuzosin (Uroxatral), cisapride (Propulsid), pimozide (Orap), atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin, Juvisync), midazolam (Versed), triazolam (Halcion), sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension, St. John's wort, rifampin (Rifadin, Rifater, Rifamate), ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).
There are many other drugs that can interact with telaprevir. Tell your doctor about all medications you use.
Additional Incivek Information
- Incivek Drug Interactions Center: telaprevir oral
- Incivek Side Effects Center
- Incivek FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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