Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients—both during treatment and for 6 months after the completion of all treatment. INCIVEK combination treatment should not be started unless a female patient has a negative pregnancy test immediately prior to initiation of treatment. Pregnancy testing should occur monthly during INCIVEK combination treatment and for 6 months after all treatment has ended [see Contraindications (4) and Patient Counseling Information (17.1)]. Pregnancy testing in non-pregnant female partners is recommended before INCIVEK combination therapy, every month during INCIVEK combination therapy, and for 6 months after ribavirin therapy has ended.
Hormonal contraceptives may be continued but may not be reliable during INCIVEK dosing and for up to two weeks following cessation of INCIVEK [see Drug Interactions (7)]. During this time, female patients of childbearing potential should use 2 effective non-hormonal methods of contraception. Examples may include barrier methods or IUDs [see also Warnings and Precautions (5.1) and Patient Counseling Information (17.1)]. Refer also to the prescribing information for ribavirin.
Two weeks after completion of INCIVEK treatment, hormonal contraceptives are again appropriate as one of the 2 required effective methods of birth control; however, specific prescribing information recommendations should be followed for the contraceptives. Refer also to the prescribing information for ribavirin.
8.3 Nursing Mothers
It is not known whether telaprevir is excreted in human breast milk. When administered to lactating rats, levels of telaprevir were higher in milk compared to those observed in plasma. Rat offspring exposed to telaprevir in utero showed no effects on body weight at birth. However, when fed via milk from telaprevir-treated dams, body weight gain of pups was lower than pups fed milk from control dams. After weaning, rat pup body weight gain was similar in offspring from telaprevir-treated and control dams. Because of the potential for adverse reactions in nursing infants, nursing must be discontinued prior to initiation of treatment. See also the prescribing information for ribavirin.
8.4 Pediatric Use
The safety, efficacy and pharmacokinetic profile of INCIVEK in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of INCIVEK did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, caution should be exercised in the administration and monitoring of INCIVEK in geriatric patients reflecting the greater frequency of decreased hepatic function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)].
8.6 Hepatic Impairment
INCIVEK is not recommended for use in patients with moderate or severe hepatic impairment (Child-Pugh B or C, score greater than or equal to 7) because no pharmacokinetic or safety data are available regarding the use of INCIVEK in HCV-infected patients with moderate or severe hepatic impairment, and appropriate doses have not been established [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3)]. No dose adjustment of INCIVEK is necessary for patients with mild hepatic impairment (Child-Pug
