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INCIVEK(telaprevir)tablet, film coated(五)
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tions, Table 5 for co-administration of sildenafil and tadalafil when dosed for erectile dysfunction.
†
See Drug Interactions, Table 5 for parenterally administered midazolam.
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Alpha 1-adrenoreceptor antagonist |
Alfuzosin |
Potential for hypotension or cardiac arrhythmia |
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Antimycobacterials |
Rifampin |
Rifampin significantly reduces telaprevir plasma concentrations. |
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Ergot derivatives |
Dihydroergotamine, ergonovine, ergotamine, methylergonovine |
Potential for acute ergot toxicity characterized by peripheral vasospasm or ischemia |
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GI Motility Agent |
Cisapride |
Potential for cardiac arrhythmias |
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Herbal products |
St. John's wort (Hypericum perforatum) |
Plasma concentrations of telaprevir can be reduced by concomitant use of the herbal preparation St. John's wort. |
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HMG CoA reductase inhibitors |
Atorvastatin, lovastatin, simvastatin |
Potential for myopathy including rhabdomyolysis |
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Neuroleptic |
Pimozide |
Potential for serious and/or life-threatening adverse reactions such as cardiac arrhythmias secondary to increases in plasma concentrations of antiarrhythmics |
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PDE5 inhibitor |
Sildenafil (Revatio®) or tadalafil (Adcirca®) [for treatment of pulmonary arterial hypertension]* |
Potential for PDE5 inhibitor-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope |
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Sedatives/hypnotics |
Orally administered midazolam†, triazolam |
Prolonged or increased sedation or respiratory depression |
5 WARNINGS AND PRECAUTIONS
5.1Pregnancy: Use with Ribavirin and Peginterferon Alfa
Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Because INCIVEK must be used in combination with peginterferon alfa and ribavirin, the contraindications and warnings applicable to those drugs are applicable to combination therapy. Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during treatment and for 6 months after all treatment has ended. Female patients should have monthly pregnancy tests during treatment and during the 6-month period after stopping treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients as significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin [see Contraindications (4), Use in Specific Populations (8.1), and Patient Counseling Information (17.1)]. Refer also to the prescribing information for ribavirin.
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