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Victrelis

"The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver"...

Victrelis

Victrelis Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking boceprevir (Victrelis)?

You should not use boceprevir if you are allergic to it.

To make sure you can safely take boceprevir, tell your doctor if you have hepatitis B or cirrhosis of the liver.

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FDA pregnancy category X. Boceprevir is given together with interferon alfa and ribavirin. Although boceprevir 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 boceprevir 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 boceprevir with interferon alfa and ribavirin if you are pregnant.
  • If you are a man, do not use boceprevir 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 boceprevir.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using boceprevir with interferon alfa and ribavirin.

It is not known whether boceprevir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using boceprevir.

How should I take boceprevir (Victrelis)?

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 boceprevir as your only medication to treat hepatitis C. Boceprevir must be used in combination with peginterferon alfa and ribavirin. Your disease may become resistant to boceprevir if you do not take it in combination with other medicines your doctor has prescribed.

Take boceprevir with food. The usual dose of boceprevir is 4 capsules taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.

Your total daily dose of 12 capsules is contained in a single bottle of boceprevir. A carton of boceprevir contains 28 bottles 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.

Store boceprevir capsules in the refrigerator, do not freeze. Throw away any unused capsules after the expiration date on the label has passed.

You may also store the capsules at room temperature for up to 3 months. Protect the capsules from heat.

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Additional Victrelis Information

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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