en and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with ribavirin [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
•Coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events, including those in Table 2 [see also Drug Interactions (7)].
•Coadministration with potent CYP3A4/5 inducers, where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy, including those in Table 2 [see also Drug Interactions (7)].
Table 2 Drugs that are contraindicated with VICTRELIS Drug Class Drugs Within Class that are Contraindicated With VICTRELIS Clinical Comments
Alpha 1-Adrenoreceptor antagonist Alfuzosin Increased alfuzosin concentrations can result in hypotension.
Anticonvulsants Carbamazepine, phenobarbital, phenytoin May lead to loss of virologic response to VICTRELIS
Antimycobacterial Rifampin May lead to loss of virologic response to VICTRELIS.
Ergot Derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine Potential for acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI Motility Agent Cisapride Potential for cardiac arrhythmias.
Herbal Products St. John's Wort (hypericum perforatum) May lead to loss of virologic response to VICTRELIS.
HMG-CoA Reductase Inhibitors Lovastatin, simvastatin Potential for myopathy, including rhabdomyolysis.
Oral Contraceptives Drosperinone Potential for hyperkalemia.
PDE5 enzyme Inhibitor REVATIO® (sildenafil) or ADCIRCA® (tadalafil) when used for the treatment of pulmonary arterial hypertension* Potential for PDE5 inhibitor-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope.
Neuroleptic Pimozide Potential for cardiac arrhythmias.
Sedative/Hypnotics Triazolam; orally administered midazolam† Prolonged or increased sedation or respiratory depression.
*See Drug Interactions, Table 5 for coadministration of sildenafil and tadalafil when dosed for erectile dysfunction.
†See Drug Interactions, Table 5 for parenterally administered midazolam.
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy (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. Women of childbearing potential and men must use at least two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS. Two alternative effective methods of contraception, including intrauterine devices and barrier methods, should be used in women during treatment with VICTRELIS and concomitant ribavirin.
5.2 Anemia (Use with Ribavirin and Peginterferon Alfa)
Anemia has been reported with peginterferon alfa and ribavirin therapy. T |
