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Outline
What is the generic name?
RIBAVIRIN
What is the Trade Name for RIBAVIRIN?
REBETOL
What are the Indications for RIBAVIRIN?
- 1 INDICATIONS AND USAGE REBETOL is a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. ( 1.1 ) Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. 1.1 Chronic Hepatitis C (CHC) REBETOL ® (ribavirin) in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease [see Warnings and Precautions (5.9 , 5.10) , and Use in Specific Populations (8.4) ]. The following points should be considered when initiating REBETOL combination therapy with PegIntron ® or INTRON A ® : Combination therapy with REBETOL/PegIntron is preferred over REBETOL/INTRON A as this combination provides substantially better response rates [see Clinical Studies (14) ]. Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see Clinical Studies (14) ]. No safety and efficacy data are available for treatment duration lasting longer than one year.
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References: https://open.fda.gov/
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