"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
(Generic versions may still be available.)
The highest documented dose administered is 1875 mg every 8 hours for 4 days in healthy subjects with INCIVEK alone. In that trial, the following common adverse events were reported more frequently with the 1875 mg q8h regimen compared to the 750 mg q8h regimen: nausea, headache, diarrhea, decreased appetite, dysgeusia, and vomiting.
No specific antidote is available for overdose with INCIVEK. Treatment of overdose with INCIVEK consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. In the event of an overdose, it is reasonable to employ the standard supportive measures, such as removing unabsorbed material from the gastrointestinal tract, employing clinical monitoring (including obtaining an electrocardiogram), and instituting supportive therapy if required.
Contraindications to peginterferon alfa and ribavirin also apply to INCIVEK combination treatment.
INCIVEK combination treatment is contraindicated in:
- women who are or may become pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug treatment, the patient should be apprised of the potential hazard to a fetus [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
- men whose female partners are pregnant.
INCIVEK is a strong inhibitor of CYP3A. INCIVEK is contraindicated when combined with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). INCIVEK is contraindicated when combined with drugs that strongly induce CYP3A and thus may lead to lower exposure and loss of efficacy of INCIVEK. Contraindicated drugs are listed below in Table 3 [also see DRUG INTERACTIONS, Table 5 and CLINICAL PHARMACOLOGY, Tables 6 and 7].
Table 3: Drugs that are Contraindicated with INCIVEK
|Drug Class||Drugs within Class that are Contraindicated with INCIVEK||Clinical Comments|
|Alpha 1-adrenoreceptor antagonist||Alfuzosin||Potential for hypotension or cardiac arrhythmia|
|Anticonvulsants||Carbamazepine, phenobarbital, phenytoin||Potential for lower exposure and loss of efficacy of INCIVEK|
|Antimycobacterials||Rifampin||Rifampin significantly reduces telaprevir plasma concentrations.|
|Ergot derivatives||Dihydroergotamine, ergonovine, ergotamine, methylergonovine||Potential for acute ergot toxicity characterized by peripheral vasospasm or ischemia|
|GI motility agent||Cisapride||Potential for cardiac arrhythmias|
|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.|
|HMG-CoA reductase inhibitors||Lovastatin, simvastatin||Potential for myopathy including rhabdomyolysis|
|Neuroleptic||Pimozide||Potential for serious and/or life-threatening adverse reactions such as cardiac arrhythmias|
|PDE5 inhibitor||Sildenafil (Revatio®) or tadalafil (Adcirca®) [for treatment of pulmonary arterial hypertension]a||Potential for PDE5 inhibitor-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope|
|Sedatives/hypnotics||Orally administered midazolamb, triazolam||Prolonged or increased sedation or respiratory depression|
|aSee DRUG INTERACTIONS, Table 5 for co-administration
of sildenafil and tadalafil when dosed for erectile dysfunction.
bSee DRUG INTERACTIONS, Table 5 for parenterally administered midazolam.
Last reviewed on RxList: 11/8/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Incivek Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.