What is REBETOL (ribavirin)
“REBETOL” is a form of the antiviral drug ribavirin. It is used in combination with interferon
alfa-2b to treat some patients with chronic hepatitis C infection. It is not known how
REBETOL and interferon alfa-2b work together to fight hepatitis C infection.(see the
REBETRON Combination Therapy or PEG-INTRON Medication Guide).
It is not known if treatment with REBETOL and interferon alfa-2b will cure hepatitis C virus
infections or prevent cirrhosis, liver failure, or liver cancer that can be caused by hepatitis C
virus infections. It is not known if treatment with REBETOL and interferon alfa-2b will prevent
an infected person from infecting another person with the hepatitis C virus.
Who should not take REBETOL Capsules or Oral Solution?
Do not use these medicines if:
âEUR¢ You are a female and you are pregnant or plan to become pregnant at any time during
your treatment with REBETOL or during the 6 months after your treatment has ended.
âEUR¢ You are a male patient with a female sexual partner who is pregnant or plans to
become pregnant at any time while you are being treated with REBETOL or during the
6 months after your treatment has ended. (See ” What is the most important
information I should know about therapy with REBETOL Capsules or Oral Solution?”
and ” What should I avoid while taking REBETOL Capsules or Oral Solution?”)
âEUR¢ You are breast-feeding. REBETOL may pass through your milk and harm your baby.
Talk with your provider about whether you should stop breast-feeding.
âEUR¢ You are allergic to any of the ingredients in REBETOL Capsules or Oral Solution. See
the ingredients listed at the end of this Medication Guide.
Tell your health care provider before starting treatment with REBETOL Capsules or Oral
Solution in combination with interferon alfa-2b if you have any of the following medical
âEUR¢ mental health problems, such as depression or anxiety. REBETOL/interferon alfa-2b
therapy may make them worse. Tell your health care provider if you are being treated
or had treatment in the past for any mental problems, including depression, suicidal
behavior, or a feeling of loss of contact with reality, such as hearing voices or seeing
things that are not there (psychosis). Tell your health care provider if you take any
medicines for these problems.
âEUR¢ high blood pressure, heart problems, or have had a heart attack. REBETOL Capsules
and Oral Solution may worsen heart problems. Patients who have had certain heart
problems should not take REBETOL Capsules or Oral Solution.
âEUR¢ blood disorders, including anemia (low red blood cell count), thalassemia
(Mediterranean anemia), and sickle-cell anemia. REBETOL Capsules and Oral
Solution can reduce the number of red blood cells you have. This may make you feel
dizzy or weak and could worsen any heart problems you might have.
âEUR¢ kidney problems. If your kidneys do not work properly, you may experience worse side
effects from REBETOL therapy and require a lower dose.
âEUR¢ liver problems (other than hepatitis C infection)
âEUR¢ organ transplant, and are taking medicine that keeps your body from rejecting your
transplant (suppresses your immune system).
âEUR¢ thyroid disease. REBETOL/interferon alfa-2b therapy may make your thyroid disease
worse or harder to treat. REBETOL/interferon alfa-2b therapy may be stopped if you
develop thyroid problems that cannot be controlled by medicine.
âEUR¢ lung problems. REBETOL/interferon alfa-2b Therapy can cause breathing problems or
worsen breathing problems you already have.
âEUR¢ alcoholism or drug abuse or addiction
âEUR¢ infection with hepatitis B virus and/or human immunodeficiency virus (the virus that
âEUR¢ diabetes. REBETOL/interferon alfa-2b therapy may make your diabetes worse or
harder to treat.
âEUR¢ past interferon treatment for hepatitis C virus infection that did not work for you.
What are the most common side effects of REBETOL Capsules and Oral Solution?
The most serious possible side effects of REBETOL Capsules and Oral Solution are:
âEUR¢ Harm to unborn children. REBETOL Capsules and Oral Solution may cause birth
defects or death of an unborn child. (For more details, see ” What is the most
important information I should know about REBETOL Capsules or Oral Solution?”)
âEUR¢ Anemia. Anemia is a reduction in the number of red blood cells you have which can be
dangerous, especially if you have heart or breathing problems. Tell your health care
provider right away if you feel tired, have chest pain or shortness of breath. These may
be signs of low red blood cell counts.
Tell your provider right away if you have any of the following symptoms. They may be signs
of a serious side effect:
âEUR¢ trouble breathing
âEUR¢ hives or swelling
âEUR¢ chest pain
âEUR¢ severe stomach or low back pain
âEUR¢ bloody diarrhea or bloody stools (bowel movements). These may appear black and
âEUR¢ other bleeding
The most common side effects of REBETOL Capsules and Oral Solution are:
âEUR¢ feeling tired
âEUR¢ nausea and appetite loss
âEUR¢ rash and itching
This summary does not include all possible side effects of REBETOL therapy. Talk to your
health care provider, if you do not feel well while taking REBETOL. Your health care provider
can give you more information about managing your side effects.