le taking VICTRELIS. Therefore, two alternative effective methods of contraception, including intrauterine devices and barrier methods, should be used in women during treatment with VICTRELIS and concomitant ribavirin [see Warnings and Precautions (5.1)].
In case of exposure during pregnancy, a Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Pregnancy Category B: VICTRELIS
VICTRELIS must not be used as a monotherapy [see Indications and Usage (1)]. There are no adequate and well-controlled studies with VICTRELIS in pregnant women.
No effects on fetal development have been observed in rats and rabbits at boceprevir AUC exposures approximately 11.8- and 2.0-fold higher, respectively, than those in humans at the recommended dose of 800 mg three times daily [see Nonclinical Toxicology (13.1)].
8.3 Nursing Mothers
It is not known whether VICTRELIS is excreted into human breast milk. Levels of boceprevir and/or metabolites in the milk of lactating rats were slightly higher than levels observed in maternal blood. Peak blood concentrations of boceprevir and/or metabolites in nursing pups were less than 1% of those of maternal blood concentrations. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with VICTRELIS, taking into account the importance of the therapy to the mother.
8.4 Pediatric Use
The safety, efficacy, and pharmacokinetic profile of VICTRELIS in pediatric patients have not been studied.
8.5 Geriatric Use
Clinical studies of VICTRELIS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration and monitoring of VICTRELIS in geriatric patients due to the greater frequency of decreased hepatic function, concomitant diseases and other drug therapy [see Clinical Pharmacology (12.3)].
8.6 Renal Impairment
No dosage adjustment of VICTRELIS is required for patients with any degree of renal impairment [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
No dose adjustment of VICTRELIS is required for patients with mild, moderate or severe hepatic impairment [see Clinical Pharmacology (12.3)]. Safety and efficacy of VICTRELIS have not been studied in patients with decompensated cirrhosis. See Package Inserts for peginterferon alfa for contraindication in hepatic decompensation.
8.8 Human Immunodeficiency Virus (HIV) Co-Infection
The safety and efficacy of VICTRELIS alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection have not been established in patients co-infected with HIV and HCV.
8.9 Hepatitis B Virus (HBV) Co-Infection
The safety and efficacy of VICTRELIS alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection in patients co-infected with HBV and HCV have not been studied.
8.10 Organ Transplantation
The safety and efficacy of VICTRELIS alone or in combination with peginterferon alfa and ribavirin for the treatment of ch |
