Telaprevir drug interactions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Drug Interactions
Potential for INCIVEK to Affect Other Drugs
INCIVEK is a strong inhibitor of CYP3A. Co-administration of INCIVEK with drugs that are primarily metabolized by CYP3A may result in increased plasma concentrations of such drugs, which could increase adverse reactions (see Table 5). INCIVEK is also an inhibitor of P-gp, OATP1B1, and OATP2B1. Co-administration of INCIVEK with drugs that are substrates for P-gp, OATP1B1, and OATP2B1 transport may result in increased plasma concentrations of such drugs, which could increase adverse reactions (see Table 5). If dose adjustments of concomitant medications are made during INCIVEK treatment, they should be re-adjusted after administration of INCIVEK is completed.
Potential for Other Drugs to Affect INCIVEK
INCIVEK is a substrate of CYP3A and P-gp; therefore, drugs that induce CYP3A and/or P-gp may decrease INCIVEK plasma concentrations and reduce the therapeutic effect of INCIVEK. Co-administration of INCIVEK with drugs that inhibit CYP3A and/or P-gp may increase INCIVEK plasma concentrations.
Established and Other Potentially Significant Drug Interactions
Table 5 provides effect on concentration of INCIVEK or concomitant drug with INCIVEK. These recommendations are based on either drug interaction trials (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy. Most drug interaction studies have been performed with a dose of 750 mg q8h of INCIVEK. The 1125 mg twice-daily regimen provides similar total daily exposures of telaprevir; thus drug interactions are expected to be similar between the two regimens when evaluated after multiple doses [see Clinical Pharmacology (12.3)].
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In addition to the drugs included in Table 5, the interaction between INCIVEK and the following drugs was evaluated in clinical trials and no dose adjustment is needed for any drug [see Clinical Pharmacology (12.3)]: esomeprazole, raltegravir, or buprenorphine.[1]
References
- ↑ "INCIVEK (TELAPREVIR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED]". Retrieved 8 January 2014.
Adapted from the FDA Package Insert.