Children: <18 years: not established.
Contraindication(s): Severe hepatic impairment. Concomitant alfuzosin, carbamazepine, phenytoin, phenobarbital, gemfibrozil, rifampin, ergot derivatives, ethinyl estradiol-containing products, St. John’s Wort, lovastatin, simvastatin, pimozide, efavirenz, sildenafil (as Revatio), triazolam, oral midazolam. When coadministered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy Category X).
Warnings/precautions: Monitor hepatic function prior to initiation, during the first 4 weeks, and thereafter. Consider discontinuing if ALT persistently >10 × ULN. Discontinue if ALT elevation is accompanied with liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR. HCV/HIV-1 co-infected: give suppressive antiretroviral regimen. Dialysis: not studied. Moderate hepatic impairment: not recommended. Pregnancy (Category B). Use progestin-only contraception or non-hormonal methods, if necessary. Nursing mothers.
Interaction(s): See Contraindications. Discontinue ethinyl estradiol-containing products prior to starting; may resume 2 weeks after therapy completion. May potentiate substrates of CYP3A, UGT1A1, BCRP, OATP1B1, or OATP1B3. Potentiated by strong CYP3A inhibitors or CYP2C8, P-gp, BCRP, OATP1B1, or OATP1B3 inhibitors. Potentiates ketoconazole (limit max 200mg/day), pravastatin (max 40mg/day), rosuvastatin (max 10mg/day), cyclosporine (reduce to 1/5 of current dose and monitor renal function). Concomitant calcineurin inhibitors (in liver transplant): adjust dose of these. Concomitant tacrolimus (use reduced dose): do not administer on same day as initiating Viekira Pak; monitor tacrolimus levels and renal function. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant voriconazole, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol: not recommended. May decrease exposure to omeprazole; consider increasing omeprazole dose: max 40mg/day. Concomitant atazanavir 300mg (without ritonavir): give only in the AM. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor with amlodipine, furosemide, buprenorphine/naloxone, alprazolam.
Adverse reaction(s): Fatigue, nausea, pruritus, other skin reactions, insomnia, asthenia.
Notes: For ribavirin specific dosing and safety information, refer to the respective prescribing information.
How supplied: Monthly carton—4 × 7 daily dose packs n
For more information, call (800) 633-9110 or visit www.Viekira.com