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TECHNIVIE
Viral infections
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Drug Name:

TECHNIVIE Rx

Generic Name and Formulations:
Ombitasvir 12.5mg, paritaprevir 75mg, ritonavir 50mg; tabs.

Company:
AbbVie

Therapeutic Use:

Indications for TECHNIVIE:

In combination with ribavirin for chronic HCV genotype 4 infection without cirrhosis or with compensated cirrhosis.

Adult:

Test for HBV infection, hepatic decompensation prior to initiation. Take with a meal. ≥18yrs: 2 tabs once daily in the AM for 12 weeks with ribavirin. Treatment-naive without cirrhosis (with ribavirin intolerance): may consider administering without ribavirin for 12 weeks.

Children:

<18yrs: not established.

Contraindications:

Moderate-to-severe hepatic impairment. Concomitant alfuzosin, colchicine (in renal and/or hepatic impairment), ranolazine, dronedarone, carbamazepine, phenytoin, phenobarbital, rifampin, lurasidone, pimozide, ergots, ethinyl estradiol, cisapride, St. John’s wort, atorvastatin, lovastatin, simvastatin, everolimus, sirolimus, tacrolimus, efavirenz, sildenafil (as Revatio), triazolam, oral midazolam. When coadministered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy Cat.X).

Warnings/Precautions:

Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Risk of hepatic decompensation and hepatic failure in patients with cirrhosis; monitor for signs/symptoms and discontinue if occurs. Monitor hepatic function prior to initiation, during the first 4 weeks, and as clinically indicated thereafter. Consider discontinuing if ALT persistently >10XULN. Discontinue if ALT elevation is accompanied with liver inflammation or increasing direct bilirubin, alkaline phosphatase, or INR. HCV/HIV-1 co-infected: give suppressive antiretroviral regimen. Dialysis: not studied. Pregnancy. Use progestin-only contraception or non-hormonal methods during therapy. Nursing mothers.

Interactions:

See Contraindications. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. Increased risk of ALT elevations esp. in females using ethinyl estradiol-containing drugs; discontinue prior to starting; may resume 2 weeks after Technivie completion. May potentiate substrates of CYP3A, P-gp, BCRP, OATP1B1, or OATP1B3. Potentiated by strong CYP3A inhibitors or P-gp, BCRP, OATP1B1, or OATP1B3 inhibitors. Potentiates ARBs (eg, valsartan, losartan, candesartan), CCBs (eg, amlodipine, nifedipine, diltiazem, verapamil); reduce dose of these (amlodipine by at least 50%) and monitor; consider alternatives if adverse effects occur. Potentiates ketoconazole (limit max 200mg/day), pravastatin (max 40mg/day), cyclosporine (reduce to 1/5 of current dose and monitor renal function), hydrocodone (reduce dose by 50% and monitor). Concomitant voriconazole, atazanavir, atazanavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol, metformin (in renal or hepatic impairment): not recommended. Concomitant quetiapine: consider alternative anti-HCV therapy; if necessary, reduce quetiapine to 1/6 of current dose and monitor. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant darunavir 800mg (without ritonavir): can be co-administered with Technivie. Antagonizes carisoprodol, cyclobenzaprine, diazepam; increase dose if needed. May antagonize omeprazole; consider increasing omeprazole dose: max 40mg/day. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor digoxin levels; decrease digoxin dose by 30–50%. Monitor with furosemide, buprenorphine/naloxone, alprazolam.

Pharmacological Class:

HCV NS5A inhibitor + HCV NS3/4A protease inhibitor + CYP3A inhibitor.

Adverse Reactions:

Asthenia, fatigue, nausea, insomnia, headache, musculoskeletal pain, pruritus, skin reactions, mood disorders, dizziness, dyspnea; ALT and bilirubin elevations.

Note:

For ribavirin specific dosing and safety information, refer to the full prescribing information.

Generic Availability:

NO

How Supplied:

Monthly carton—4 x 7 daily dose packs

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