"The US Food and Drug Administration (FDA) has okayed expanded use of the combination antiviral drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) in patients with genotype 4, 5, and 6 chronic hepatitis C virus (HCV) infection and in p"...
Daily doses of 3600 mg have been taken by healthy volunteers for 5 days without untoward symptomatic effects.
There is no specific antidote for overdose with VICTRELIS. Treatment of overdosage with VICTRELIS should consist of general supportive measures, including monitoring of vital signs, and observation of the patient's clinical status.
Contraindications to peginterferon alfa and ribavirin also apply to VICTRELIS combination treatment. Refer to the respective prescribing information for a list of the contraindications for peginterferon alfa and ribavirin.
VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in:
- Pregnant women and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with ribavirin [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
- Patients with a history of a hypersensitivity reaction to boceprevir [see WARNINGS AND PRECAUTIONS].
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, is contraindicated [see DRUG INTERACTIONS].
Coadministration with potent CYP3A4/5 inducers, where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy, including those in Table 2, is contraindicated [see DRUG INTERACTIONS].
Table 2 : Drugs that are contraindicated with
|Drug Class||Drugs Within Class that are Contraindicated With VICTRELIS||Clinical Comments|
|Alpha 1-Adrenoreceptor antagonists||Alfuzosin, doxazosin, silodosin, tamsulosin||Potential for alpha 1-adrenoreceptor antagonist-associated adverse events, such as hypotension and priapism|
|Anticonvulsants||Carbamazepine, phenobarbital, phenytoin||May lead to loss of virologic response to VICTRELIS|
|Antimycobacterial Agents||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||Drospirenone||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
† See DRUG INTERACTIONS, Table 5 for parenterally administered midazolam.
Last reviewed on RxList: 8/11/2014
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