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Revisions to HCV drug label address adverse events, monitoring recommendations
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The FDA recently announced revisions to product labeling for Incivek, a protease inhibitor used in conjunction with ribavirin and peginterferon alfa to treat genotype 1 chronic hepatitis C.
Revisions to labeling for the telaprevir equivalent (Incivek, Vertex Pharmaceuticals) include the alteration of a warning for contraindications with the neuroleptic drug pimozide, which now indicates “potential for serious and/or life-threatening adverse reactions such as cardiac arrhythmias” but removes previous mention of “arrhythmias secondary to increases in the plasma concentrations of antiarrhythmics.” A warning also has been added regarding the potential for anemia, with clinicians advised to monitor patients’ hemoglobin prior to prescription and at least at weeks 2, 4, 8 and 12 during treatment.
Other revisions also announced included:
- An RT-PCR assay to monitor HCV-RNA levels with quantification of 25 IU/mL or less and a detection limit of 10 IU/mL to 15 IU/mL is recommended.
- Desipramine has been removed from a list of established and potentially significant drug interactions.
- No dose adjustment is needed for Incivek when administered with raltegravir or buprenorphine, following results from a drug-drug interaction trial.
The drug is intended for treatment-naive patients or those who have been unresponsive to previous interferon-based therapy.