Facts About REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) Injection

Q: What are REBETRON Combination Therapy and REBETOL®?

A:
REBETRON Combination Therapy is the name of a specific combination therapy that uses two medications – INTRON® A and REBETOL®. REBETRON Combination Therapy is only available by prescription from a doctor.

REBETOL® is the brand name for ribavirin – an antiviral medicine from a class of drugs called nucleoside analogues. REBETOL® is thought to prevent the ability of viruses to multiply. REBETOL® comes in capsules, usually taken twice a day. Your recommended dose will depend on your body weight.


Q: Why did my doctor prescribe REBETRON Combination Therapy for me?

A:
Most likely, your doctor has prescribed REBETRON Combination Therapy because you have been diagnosed with chronic hepatitis C or because you have relapsed after treatment with interferon alone. In clinical studies, more patients responded to REBETRON Combination Therapy than to therapy with interferon alone. Nearly half of relapsed patients who were re-treated using this combination therapy showed decreased levels of the hepatitis C virus in the blood.


Q: How do I take REBETRON Combination Therapy?

A:
With REBETRON Combination Therapy, patients usually take REBETOL capsules twice every day along with injections of INTRON® A 3 times per week. It’s called "combination therapy" because the two medications are used together, compared to "monotherapy," where one medication is used.


Q: How long will I have to stay on REBETRON Combination Therapy?

A:
The usual length of treatment is 6 months in patients who have relapsed. Previously untreated patients are treated for either 24 or 48 weeks, which is decided by their doctors.


Q: Are there hepatitis C patients who shouldn’t receive REBETRON Combination Therapy?

A:
Yes. Pregnant women can’t receive this therapy. If you or your partner become pregnant, your use of REBETOL capsules could cause serious birth defects and harm (including death) to your unborn child.

  • If you or your partner are pregnant, you should not receive REBETRON Combination Therapy.

  • Pregnancy should not be planned while you or your partner are on therapy or for 6 months after therapy.

  • If you or your partner become pregnant while on therapy or during the 6 months after stopping therapy, immediately report your pregnancy to your doctor.

  • Both male and female patients must use 2 effective forms of contraception during treatment and for the 6 months after treatment is completed.

  • If you are a woman of childbearing age, you must have a negative pregnancy test immediately before treatment, as well as a negative pregnancy test each month during treatment and for 6 months after stopping therapy. Because REBETOL capsules could cause serious birth defects and harm (including death) to your unborn child, both you and your partner must use effective contraception (two reliable methods) during therapy and for 6 months after stopping therapy. You must use effective contraception even if you believe that you are infertile or your fertility has been reduced. You should discuss with your doctor how you or your partner can prevent getting pregnant.

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