served.
Rev. 8/09
B-XXXXXXXXT
U.S. Patent No. 5,935,566 and 6,610,830.
F-277777XXT
MEDICATION GUIDE
INTRON® A
(Interferon alfa-2b, recombinant)
Including appendix with instructions for using INTRON A Solution for Injection
Read this Medication Guide carefully before you start to take INTRON A (In-tron aye) for Injection alone or INTRON A in combination with REBETOL® (REB-eh-tole) (ribavirin, USP) Capsules. Read the Medication Guide each time you refill your prescription because there may be new information. The information in this Medication Guide does not take the place of talking with your healthcare provider.
If you are taking INTRON A and REBETOL combination therapy, also read the Medication Guide for REBETOL (ribavirin, USP) Capsules.
What is the most important information I should know about INTRON® A?
INTRON A is a treatment for some people who have hairy cell leukemia, malignant melanoma, follicular lymphoma, AIDS-related Kaposi's sarcoma, chronic hepatitis B, chronic hepatitis C, and condylomata acuminata. If you have chronic hepatitis C, your healthcare provider may prescribe INTRON A in combination with REBETOL®. INTRON A used by itself or with REBETOL can help you, but can also have serious side effects and may cause death in rare cases. Before starting treatment, you should talk to your healthcare provider about the possible benefits and possible side effects of INTRON A alone or in combination with REBETOL, to decide if this treatment is right for you. While taking INTRON A alone or in combination with REBETOL, you need to see a healthcare provider regularly for medical examinations and lab tests to make sure the treatment is working and to check for side effects.
You should call your healthcare provider immediately if you develop any of these conditions while taking INTRON A:
You become pregnant or if you are a male and your female partner becomes pregnant
New or worsening mental health problems such as thoughts about hurting or killing yourself or others
Decreased vision
Trouble breathing or chest pain
Severe stomach or lower back pain
Bloody diarrhea or bloody bowel movements
High fever
Easy bruising or bleeding
The most serious possible side effects of INTRON A include:
RISK TO PREGNANCY. Combination INTRON A and REBETOL therapy can cause death, serious birth defects or other harm to your unborn child. If you are pregnant, you or your male partner must not take INTRON A and REBETOL combination therapy. You must not become pregnant while either you or your partner are taking the combination of INTRON A and REBETOL and for 6 months after you stop taking the combination. If you are a woman of childbearing age you must have negative pregnancy tests immediately before starting treatment, during treatment and for 6 months after you have stopped treatment. You should use two forms of birth control during and for 6 months after you have stopped treatment. If you are a man taking INTRON A/REBETOL combination therapy, one of the two forms of birth control should be a condom. You must use birth control even if you believe that you are not fertile or that your fertility is low. You should talk to your healthcare provider about birth control for you and your partner. If you or your partner becomes pregnant while either of you is being treated or within 6 months of stopping treatment, tell your healthcare provider right away. There is a Ribavirin Pregnancy Registry that col