"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 How Should I Take
In this Article
- 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 should I discuss with my healthcare provider before taking telaprevir (Incivek)?
You should not use telaprevir if you are allergic to it.
To make sure you can safely take telaprevir, tell your doctor if you have any of these other conditions:
- hepatitis B or liver problems other than hepatitis C;
- kidney disease (or if you are on dialysis);
- anemia (lack of red blood cells);
- if you have had an organ transplant;
- HIV or AIDS;
- a history of gout; or
- if you have ever used medicine to treat hepatitis in the past and it did not work.
There are many other drugs that can cause serious or life threatening medical problems if you take them together with telaprevir. The following drugs should not be used while you are taking telaprevir:
- alfuzosin (Uroxatral);
- atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync);
- cisapride (Propulsid);
- pimozide (Orap);
- midazolam (Versed) or triazolam (Halcion);
- sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension;
- St. John's wort;
- rifampin (Rifadin, Rifater, Rifamate); or
- ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).
FDA pregnancy category X. Telaprevir is given together with interferon alfa and ribavirin. Although telaprevir is not expected to harm an unborn baby, ribavirin is known to 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. If you are a woman, you may need to have a negative pregnancy test before using these medications and every month during your treatment.
- Use at least 2 non-hormonal forms of birth control while either sexual partner is using telaprevir with interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.
- If you are a woman, do not use telaprevir with interferon alfa and ribavirin if you are pregnant.
- If you are a man, do not use telaprevir with interferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
- Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking telaprevir.
- Tell your doctor right away if a pregnancy occurs while either the mother or the father is using telaprevir with interferon alfa and ribavirin.
It is not known whether telaprevir passes into breast milk or if it could harm a nursing baby. Do not breast-feed a baby while taking telaprevir.
How should I take telaprevir (Incivek)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Do not take telaprevir as your only medication to treat hepatitis C. Telaprevir must be used in combination with peginterferon alfa and ribavirin. Your disease may become resistant to telaprevir if you do not take it in combination with other medicines your doctor has prescribed.
This combination treatment is usually given for 12 to 48 weeks. The usual dose of telaprevir is 2 tablets taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.
Take telaprevir within 30 minutes after eating a meal or snack that contains about 20 grams of fat. Always take telaprevir with food. Examples of snacks that contain about 20 grams of fat include: A bagel and cream cheese, 3 tablespoons of peanut butter, 2 ounces of American or cheddar cheese, 2 ounces of potato chips, a half-cup of nuts or trail mix, or 1 cup of ice cream.
Your total daily dose of 6 tablets is contained in a single blister strip of telaprevir. A package of telaprevir contains 4 cartons of 7 blister strips for a 4-week supply.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.
If you need surgery, tell the surgeon ahead of time that you are using telaprevir. You may need to stop using the medicine for a short time.
Do not stop taking this medication unless your doctor tells you to. If you stop taking telaprevir for any reason, do not start taking it again without your doctor's advice.
Store at room temperature away from moisture and heat.
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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