g 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. |
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. 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 contraceptio |
