It is not known if VICTRELIS is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
VICTRELIS® (boceprevir) plus peg/riba may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines.
- Females and males must use 2 effective forms of birth control during treatment and for 6 months after treatment with VICTRELIS plus peg/riba combination therapy. Hormonal forms of birth control such as implants, injections, vaginal rings, and some birth control pills may not work during treatment with VICTRELIS. The use of certain types of birth control pills may be acceptable. Talk to your health care provider about forms of birth control that may be used during this time.
- Females must have a pregnancy test before starting treatment with VICTRELIS plus peg/riba combination therapy, every month while being treated, and every month for 6 months after all treatment is over.
- If you or your female sexual partner becomes pregnant while taking VICTRELIS plus peg/riba combination therapy or within 6 months after you stop taking these medicines, tell your health care provider right away. You or your health care provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
Before and while you take VICTRELIS, tell your health care provider if you have blood problems like low red blood cell count (anemia), a certain type of low white blood cell count (neutropenia) or combination of low platelet, red, and white blood cell counts (pancytopenia), have liver failure, have liver problems other than hepatitis C infection, have had a liver or other organ transplant, plan to have surgery, have any other medical condition, or are breastfeeding. It is not known if VICTRELIS passes into breast milk. You and your health care provider should decide if you will take VICTRELIS or breastfeed. You should not do both.
VICTRELIS may cause serious side effects, including serious allergic reactions and blood problems.
- Serious allergic reactions may become severe, requiring treatment in a hospital. If you experience itching, hives, swelling of the face, eyes, lips, tongue, or throat or have trouble breathing or swallowing, you should tell your health care provider immediately.
- VICTRELIS can affect your bone marrow and cause low red blood cell, low white blood cell, and low platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get anemia, infections, or bleed easily.
The most common side effects of VICTRELIS® (boceprevir) with combination therapy include: tiredness, nausea, headache, and change in taste. Tell your health care provider about any side effect that bothers you or that does not go away. There may be other side effects of VICTRELIS. For more information, ask your health care provider.
Do not take VICTRELIS if you have had an allergic reaction to VICTRELIS. Do not take VICTRELIS if you take certain medicines. VICTRELIS and other medicines may affect each other. This can cause you to have too much or not enough VICTRELIS or your other medicines in your body, affecting the way VICTRELIS and your other medicines work, or causing side effects that can be serious or life threatening.
Tell your health care provider about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start taking a new medicine without telling your health care provider. For a listing of medicines that you should not take with VICTRELIS, please see the accompanying Medication Guide.
It is not known if treatment with VICTRELIS will prevent you from infecting another person with the hepatitis C virus during your treatment. Talk with your health care provider about ways to prevent spreading the hepatitis C virus.
Do not take VICTRELIS if you take a medicine that contains:
alfuzosin hydrochloride (UROXATRAL®) • anti-seizure medicines: carbamazepine (CARBATROL®, EPITOL®, EQUETRO®, TEGRETOL®, TEGRETOL® XR, TERIL™); phenobarbital; phenytoin (DILANTIN®) • cisapride (PROPULSID®) • drospirenone-containing birth control medicines, including: YAZ®, YASMIN®, ZARAH®, OCELLA®, GIANVI®, BEYAZ®, ANGELIQ®, LORYNA®, SYEDA®, SAFYRAL® • doxazosin (CARDURA®, CARDURA® XL) • ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, MIGRANAL®); ergonovine and methylergonovine (ERGOTRATE®, METHERGINE®); ergotamine tartrate (CAFERGOT®, MIGERGOT®, ERGOMAR®, ERGOSTAT, MEDIHALER ERGOTAMINE, WIGRAINE, WIGRETTES) • lovastatin (ADVICOR®, ALTOPREV®, MEVACOR®) • midazolam when taken by mouth • pimozide (ORAP®) • rifampin (RIFADIN®, RIFAMATE®, RIFATER®, RIMACTANE) • sildenafil (REVATIO®), when used for treating lung problems • silodosin (RAPAFLO®) •simvastatin (SIMCOR®, VYTORIN®, JUVISYNC®, ZOCOR®) • St. John’s wort (Hypericum perforatum) or products containing St. John’s wort • tadalafil (ADCIRCA®), when used for treating lung problems • tamsulosin (FLOMAX ®, JALYN®) • triazolam (HALCION®).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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