Telaprevir contraindications
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Contraindications
Contraindications to peginterferon alfa and ribavirin also apply to INCIVEK combination treatment.
INCIVEK combination treatment is contraindicated in:
- women who are or may become pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug treatment, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.3) andUse in Specific Populations (8.1)].
- men whose female partners are pregnant.
INCIVEK is a strong inhibitor of CYP3A. INCIVEK is contraindicated when combined with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). INCIVEK is contraindicated when combined with drugs that strongly induce CYP3A and thus may lead to lower exposure and loss of efficacy of INCIVEK. Contraindicated drugs are listed below in Table 3 [also seeDrug Interactions (7), Table 5 and Clinical Pharmacology (12.3), Tables 6 and 7].
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References
- ↑ "INCIVEK (TELAPREVIR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED]". Retrieved 8 January 2014.
Adapted from the FDA Package Insert.