ombitasvir/paritaprevir/ritonavir & dasabuvir (Rx)

Brand and Other Names:Viekira Pak
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Viekira Pak

  • Contains ombitasvir, paritaprevir, and ritonavir as a fixed-dose combination tablet copackaged with a dasabuvir tablet
  • ombitasvir/paritaprevir/ritonavir
    • coformulated tablet: 12.5mg/75mg/50mg
  • dasabuvir
    • tablet: 250mg

Viekira XR

  • Coformulated tablet containing ombitasvir, paritaprevir, ritonavir and dasabuvir as a fixed-dose combination tablet
  • May 24, 2018: Manufacturer announced Viekira XR is to be discontinued; it is estimated to be available until January 2019
  • ombitasvir/paritaprevir/ritonavir/dasabuvir
    • coformulated tablet: 8.33mg/50mg/33.33mg/200mg

Chronic Hepatitis C

Indicated for chronic hepatitis C virus (HCV) genotype 1 infection, including patients with compensated cirrhosis; may be used for patients with HCV/HIV-1 coinfection

Viekira: 2 tablets (ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg) PO qDay, PLUS dasabuvir 250 PO BID with a meal

Viekira XR: 3 tablets (~ombitasvir 25 mg, paritaprevir 150 mg, ~ritonavir 100 mg, dasabuvir 600 mg) PO qDay with a meal

Used in combination with ribavirin in certain patient populations

Use with ribavirin, regimen by genotype, duration

  • Used in combination with ribavirin in certain patient populations
  • When administered with Viekira Pak or Viekira XR, ribavirin dose is based on weight: 1000 mg for patients ≤75 kg and 1200 mg/day for those >75 kg, divide daily dose BID and administered with food
  • Treatment regimen and duration according to genotype
    • Genotype 1a, without cirrhosis: Viekira Pak or Viekira XR plus ribavirin for 12 weeks
    • Genotype 1a, with compensated cirrhosis (Child-Pugh A): Viekira Pak or Viekira XR plus ribavirin for 24 weeks*
    • Genotype 1b, with or without compensated cirrhosis: Viekira Pak or Viekira XR for 12 weeks
    • Note: Follow the genotype 1a dosing if genotype 1 subtype is unknown or with mixed genotype 1 infection
    • Use in liver transplant recipients: With normal hepatic function and mild fibrosis (Metavir fibrosis score ≤2), the recommended duration of Viekira Pak or Viekira XR with ribavirin is 24 weeks, irrespective of HCV genotype 1 subtype
    • *Viekira Pak or Viekira XR administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history

Dosage Modifications

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment required
  • Moderate to severe hepatic impairment (Child-Pugh B and C): Contraindicated

Renal impairment

  • Mild, moderate, or severe: No dosage adjustment required
  • Dialysis: Not studied
  • For patients who require ribavirin, refer to the ribavirin prescribing information for information regarding use with renal impairment

Dosing Considerations

Monitor liver function tests before initiating and during therapy

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HCV direct acting antivirals (DDAs)

<18 years: Safety and efficacy not established

Hepatitis C (Orphan)

Orphan designation for treatment of pediatric patients with hepatitis C virus infection (aged birth through 16 yr)

Sponsor

  • Abbvie, Inc; 1 North Waukegan Road; North Chicago, IL 60064
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Interactions

Interaction Checker

and ombitasvir/paritaprevir/ritonavir & dasabuvir

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            Contraindicated (41)

            • abiraterone

              abiraterone will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by decreasing metabolism. Contraindicated. Strong CYP2C8 inhibitors are shown to increase dasabuvir plasma concentrations (~10-fold), and therefore increase risk of QT prolongation

            • alfuzosin

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of alfuzosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Increased risk for hypotensio

            • bosentan

              bosentan will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • carbamazepine

              carbamazepine will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

              carbamazepine will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • clopidogrel

              clopidogrel will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by decreasing metabolism. Contraindicated. Strong CYP2C8 inhibitors are shown to increase dasabuvir plasma concentrations (~10-fold), and therefore increase risk of QT prolongation

            • dabrafenib

              dabrafenib will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • dexamethasone

              dexamethasone will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • dihydroergotamine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of dihydroergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Acute ergot toxicity characterized by vasospasm and tissue ischemia has been associated with coadministration of ritonavir

            • efavirenz

              ombitasvir/paritaprevir/ritonavir & dasabuvir, efavirenz. unspecified interaction mechanism. Contraindicated. Coadministration of avirenz-based regimens with Viekira Pak was poorly tolerated and resulted in liver enzyme elevations.

              efavirenz will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • elagolix

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of elagolix by Other (see comment). Contraindicated. OATP1B1/1B3 inhibition

            • enzalutamide

              enzalutamide will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • ergotamine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of ergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Acute ergot toxicity characterized by vasospasm and tissue ischemia has been associated with coadministration of ritonavir

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • ethinylestradiol

              ombitasvir/paritaprevir/ritonavir & dasabuvir, ethinylestradiol. unspecified interaction mechanism. Contraindicated. Potential for increased ALT; contraceptive failure may occur when coadministered with protease inhibitors (ritonavir).

              ethinylestradiol, ombitasvir/paritaprevir/ritonavir & dasabuvir. Either increases toxicity of the other by unspecified interaction mechanism. Contraindicated. ALT elevations >5 x ULN (including some >20 x ULN) observed in clinical trials when ethinyl estradiol was coadministered with ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Discontinue ethinyl estradiol-containing medications before initiating ombitasvir/paritaprevir/ritonavir, and/or dasabuvir. Restart ethinyl estradiol containing medication ~2 weeks after hepatitis C combination drug regimen completed.

            • etravirine

              etravirine will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • fosphenytoin

              fosphenytoin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

              fosphenytoin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • gemfibrozil

              gemfibrozil will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by decreasing metabolism. Contraindicated. Strong CYP2C8 inhibitors are shown to increase dasabuvir plasma concentrations (~10-fold), and therefore increase risk of QT prolongation

            • ibrutinib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of ibrutinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • idelalisib

              idelalisib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

              levonorgestrel oral/ethinylestradiol/ferrous bisglycinate, ombitasvir/paritaprevir/ritonavir & dasabuvir. unknown mechanism. Contraindicated. ALT elevations >5x ULN (including some >20x ULN) observed in clinical trials when ethinyl estradiol was coadministered with ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Discontinue ethinyl estradiol-containing medications before initiating ombitasvir/paritaprevir/ritonavir, and/or dasabuvir. Restart ethinyl estradiol containing medication ~2 weeks after hepatitis C combination drug regimen completed.

            • lovastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of lovastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Increased risk of myopathy, including rhabdomyolysis

            • methylergonovine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of methylergonovine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Acute ergot toxicity characterized by vasospasm and tissue ischemia has been associated with coadministration of ritonavir

            • midazolam

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of midazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration with benzodiazepines that are extensively metabolized by CYP3A4 may cause large increases in the concentration of these benzodiazepines, possibly leading to serious and/or life -hreatening events (eg, prolonged or increased sedation or respiratory depression); applies to repeat dosing with PO midazolam

            • mitotane

              mitotane will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • nafcillin

              nafcillin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • nevirapine

              nevirapine will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • pentobarbital

              pentobarbital will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • phenobarbital

              phenobarbital will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

              phenobarbital will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • phenytoin

              phenytoin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

              phenytoin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • pimozide

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of pimozide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Potential for cardiac arrhythmias

            • primidone

              primidone will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

              primidone will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • rifabutin

              rifabutin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • rifampin

              rifampin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

              rifampin will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • rifapentine

              rifapentine will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

              rifapentine will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • secobarbital

              secobarbital will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing metabolism. Contraindicated. Strong CYP2C8 inducers may reduce dasabuvir levels, and therefore decreased efficacy of Viekira Pak

            • silodosin

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of silodosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Increased risk for hypotensio

            • simvastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of simvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Increased risk of myopathy, including rhabdomyolysis

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of simvastatin by Other (see comment). Contraindicated. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • St John's Wort

              St John's Wort will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Strong CYP3A4 inducers may reduce partiaprevir and ritonavir levels, and therefore decreased efficacy of Viekira Pak

            • tamsulosin

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of tamsulosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Increased risk for hypotensio

            • triazolam

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of triazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration with benzodiazepines that are extensively metabolized by CYP3A4 may cause large increases in the concentration of these benzodiazepines, possibly leading to serious and/or life -hreatening events (eg, prolonged or increased sedation or respiratory depression)

            Serious - Use Alternative (48)

            • abametapir

              abametapir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • amobarbital

              amobarbital will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • apalutamide

              apalutamide will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • atorvastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of atorvastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • chloramphenicol

              chloramphenicol will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • cobicistat

              cobicistat will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • colchicine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of colchicine by Other (see comment). Avoid or Use Alternate Drug. Colchicine is a P-gp and CYP3A4 substrate. Avoid use with drugs that are both P-gp and strong CYP3A4 inhibitors. If coadministration is necessary, decrease colchicine dose or frequency as recommended in prescribing information. Use of any colchicine product in conjunction with strong CYP3A4 inhibitors is contraindicated in patients with renal or hepatic impairment.

            • conivaptan

              conivaptan will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • copanlisib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of copanlisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If concomitant use with strong CYP3A inhibitors cannot be avoided, reduce copanlisib dose to 45 mg.

            • darunavir

              ombitasvir/paritaprevir/ritonavir & dasabuvir will decrease the level or effect of darunavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of Viekira Pak with darunavir/ritonavir is not recommended

              darunavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • edoxaban

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • eluxadoline

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases levels of eluxadoline by decreasing metabolism. Avoid or Use Alternate Drug. Decrease eluxadoline dose to 75 mg PO BID if coadministered with OATP1B1 inhibitors. .

            • encorafenib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of encorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If concomitant use of a strong CYP3A4 inhibitor is unavoidable, reduce encorafenib dose to one-third of the dose (eg, reduce from 450 mg/day to 150 mg/day). After discontinuing the inhibitor for 3-5 elimination half-lives, resume previous encorafenib dose.

            • fexinidazole

              fexinidazole will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fluticasone furoate

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of fluticasone furoate by unspecified interaction mechanism. Avoid or Use Alternate Drug. Coadministration may reduce serum cortisol concentrations; alternative corticosteroids should be considered, particularly for long term use

            • fluticasone inhaled

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of fluticasone inhaled by unspecified interaction mechanism. Avoid or Use Alternate Drug. Coadministration may reduce serum cortisol concentrations; alternative corticosteroids should be considered, particularly for long term use

            • fluticasone intranasal

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of fluticasone intranasal by unspecified interaction mechanism. Avoid or Use Alternate Drug. Coadministration may reduce serum cortisol concentrations; alternative corticosteroids should be considered, particularly for long term use.

            • infigratinib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • irinotecan

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of irinotecan by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • irinotecan liposomal

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • itraconazole

              itraconazole will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ivosidenib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of ivosidenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of strong CYP3A4 inhibitors with ivosidenib or replace with alternate therapies. If coadministration of a strong CYP3A4 inhibitor is unavoidable, reduce ivosidenib dose to 250 mg qDay. If the strong inhibitor is discontinued, increase ivosidenib dose (after at least 5 half-lives of the strong CYP3A4 inhibitor) to the recommended dose of 500 mg qDay. Monitor for increased risk of QTc interval prolongation.

              ivosidenib will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • ketoconazole

              ketoconazole will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lasmiditan

              lasmiditan increases levels of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • lopinavir

              lopinavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Increased levels of paritaprevir; coadministration of Viekira Pak with lopinavir/ritonavir is not recommended

            • lorlatinib

              lorlatinib will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mifepristone

              mifepristone will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nefazodone

              nefazodone will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • neratinib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of neratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of neratinib with strong/moderate CYP3A4 inhibitors.

            • palbociclib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of palbociclib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of palbociclib with strong CYP3A inhibitors. If unable to avoid, reduce palbociclib dose to 75 mg/day.

            • posaconazole

              posaconazole will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • quetiapine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of quetiapine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternative anti-HCV therapy to avoid increases in quetiapine exposures; if coadministration necessary, reduce quetiapine dose to 1/6th of current dose and monitor for quetiapine associated adverse reactions; refer to quetiapine prescribing information for recommendations on adverse reaction monitoring

            • revefenacin

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases levels of revefenacin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 and OATP1B3 transport inhibitors may increase systemic exposure of revefenacin's active metabolite. Coadministration not recommended.

            • rilpivirine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of rilpivirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of Viekira Pak with rilpivirine once daily is not recommended due to potential for QT interval prolongation with higher concentrations of rilpivirine

            • rimegepant

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of rimegepant by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • ritonavir

              ritonavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rosuvastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug.

            • salmeterol

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of salmeterol by decreasing metabolism. Avoid or Use Alternate Drug. Concurrent administration of Viekira Pak and salmeterol is not recommended; coadministration may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia

            • saquinavir

              saquinavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • secobarbital

              secobarbital will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • sildenafil

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If used concomitantly, monitor for toxicities. Patients receiving indinavir with ritonavir should receive not more than 25 mg of sildenafil for treatment of erectile dysfunction in a 48-hour period, and patients receiving other protease inhibitors should use a lower initial sildenafil dose of 25 mg. Patient taking sildenafil for PAH with ritonavir is not recommended.

            • sotorasib

              sotorasib will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

            • tepotinib

              tepotinib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

            • tipranavir

              tipranavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • tucatinib

              tucatinib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • voriconazole

              ombitasvir/paritaprevir/ritonavir & dasabuvir will decrease the level or effect of voriconazole by unspecified interaction mechanism. Avoid or Use Alternate Drug. Not recommended unless an assessment of the benefit-to-risk ratio justifies the use of voriconazole

              voriconazole will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • voxelotor

              voxelotor will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (67)

            • alprazolam

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of alprazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing alprazolam dose based on clinical response

            • amiodarone

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of amiodarone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • amlodipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Decrease dose of calcium channel blocker; dose of amlodipine should be decreased by at least 50%; clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. if such events occur, consider further dose reduction of calcium channel blocker or switching to alternative to calcium channel blocker

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of amlodipine by altering metabolism. Modify Therapy/Monitor Closely. Decrease dose of calcium channel blocker; dose of amlodipine should be decreased by at least 50%; clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. if such events occur, consider further dose reduction of calcium channel blocker or switching to alternative to calcium channel blocker

            • apalutamide

              apalutamide will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces OATP1B1 and may decrease systemic exposure of drugs that are OATP1B1 substrates.

            • atazanavir

              atazanavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increased levels of paritaprevir when coadministered with atazanavir/ritonavir; give atazanavir 300 mg (without ritonavir) in the morning when coadministered with Viekira Pak

            • benzhydrocodone/acetaminophen

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases effects of benzhydrocodone/acetaminophen by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Reduce dose of hydrocodone by 50% and monitor patients for respiratory depression and sedation at frequent intervals; upon completion of therapy, adjust hydrocodone dose and monitor for signs of opioid withdrawal.

            • berotralstat

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases levels of berotralstat by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Reduced berotralstat dose to 110 mg/day when coadministered with P-gp inhibitors.

              berotralstat will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • betrixaban

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.

            • brexpiprazole

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of brexpiprazole by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Administer half of the usual brexpiprazole dose when coadministered with strong CYP2D6 inhibitors. If also administered with a strong/moderate CYP3A4 inhibitor, administer a quarter of brexpiprazole dose. NOTE: In MDD clinical trials, brexpiprazole dosage was not adjusted for strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine); thus, CYP considerations are already factored into general dosing recommendations and brexpiprazole may be administered without dosage adjustment in patients with MDD.

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of brexpiprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Administer half of the usual brexpiprazole dose when coadministered with strong CYP3A4 inhibitors. If also administered with a strong/moderate CYP2D6 inhibitor, administer a quarter of brexpiprazole dose.

            • buprenorphine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of buprenorphine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increases levels of buprenorphine and active metabolite norbuprenorphine; no dose adjustment of buprenorphine is required, but closely monitor for sedation and cognitive effects

            • buprenorphine buccal

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of buprenorphine buccal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increases levels of buprenorphine and active metabolite norbuprenorphine; no dose adjustment of buprenorphine is required, but closely monitor for sedation and cognitive effects

            • candesartan

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of candesartan by unspecified interaction mechanism. Use Caution/Monitor. Decrease dose of angiotensin receptor blockers and monitor patients for signs and symptoms of hypotension and/or worsening renal function; if such events occur, consider further dose reduction of angiotensin receptor blocker or switching to alternative to angiotensin receptor blocker

            • cannabidiol

              cannabidiol will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C8 activity. Consider reducing the dose when concomitantly using CYP2C8 substrates.

            • carisoprodol

              ombitasvir/paritaprevir/ritonavir & dasabuvir decreases effects of carisoprodol by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Increase dose if clinically indicated.

            • cenobamate

              cenobamate will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • clevidipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of clevidipine by altering metabolism. Modify Therapy/Monitor Closely. May decrease calcium channel blocker dose if necessary

            • cyclobenzaprine

              ombitasvir/paritaprevir/ritonavir & dasabuvir decreases effects of cyclobenzaprine by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Increase dose if clinically indicated .

            • cyclosporine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of cyclosporine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. When initiating therapy with Viekira Pak, reduce cyclosporine dose to 1/5th of the patient?s current cyclosporine dose; measure cyclosporine blood concentrations to determine subsequent dose modifications; upon completion of Viekira Pak, the appropriate time to resume pre-Viekira Pak dose of cyclosporine should be guided by assessment of cyclosporine blood concentrations; also monitor renal function and cyclosporine-related side effects when coadministered

            • darolutamide

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of darolutamide by Other (see comment). Modify Therapy/Monitor Closely. Darolutamide is a P-gp and CYP3A4 substrate. Closely monitor for increased adverse reactions and modify dose of darolutamide as needed when coadministered with drugs that are both P-gp and strong or moderate CYP3A4 inhibitors.

            • diazepam

              ombitasvir/paritaprevir/ritonavir & dasabuvir decreases effects of diazepam by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Increase dose if clinically indicated.

            • diltiazem

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of diltiazem by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • disopyramide

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of disopyramide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • duvelisib

              duvelisib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of duvelisib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • fedratinib

              fedratinib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • felodipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of felodipine by altering metabolism. Modify Therapy/Monitor Closely. May decrease calcium channel blocker dose if necessary

            • flecainide

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of flecainide by decreasing metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • fluvastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of fluvastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathyoy.

            • fostamatinib

              fostamatinib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.

            • fostemsavir

              fostemsavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits OATP1B1/3 transporter. If possible, avoid coadministration or modify dose of OATP1B1/3 substrates coadministered with fostemsavir.

            • furosemide

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of furosemide by unspecified interaction mechanism. Use Caution/Monitor. Adjust furosemide dose according to individual response

            • glecaprevir/pibrentasvir

              glecaprevir/pibrentasvir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by Other (see comment). Use Caution/Monitor. Coadministration with glecaprevir/pibrentasvir may increase plasma concentration of drugs that are substrates of OATP1B1 or OATP1B3

            • ifosfamide

              ombitasvir/paritaprevir/ritonavir & dasabuvir will decrease the level or effect of ifosfamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of CYP3A4 inhibitors may decrease the metabolism of ifosfamide to its active alkylating metabolites and decrease the efficacy of ifosfamide.

            • indinavir

              indinavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • isradipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of isradipine by altering metabolism. Modify Therapy/Monitor Closely. May decrease calcium channel blocker dose if necessary

            • istradefylline

              istradefylline will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic enzyme CYP2E1 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              istradefylline will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

            • ketoconazole

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of ketoconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Maximum daily dose of ketoconazole should be limited to 200 mg/day

            • letermovir

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases levels of letermovir by decreasing metabolism. Use Caution/Monitor. Coadminstration of letermovir, an OATP1B1/3 substrate, with OATP1B1/3 inhibitors may increase letermovir plasma concentrations.

            • lidocaine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of lidocaine by decreasing metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • lonafarnib

              lonafarnib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

            • losartan

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of losartan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Decrease dose of angiotensin receptor blockers and monitor patients for signs and symptoms of hypotension and/or worsening renal function; if such events occur, consider further dose reduction of angiotensin receptor blocker or switching to alternative to angiotensin receptor blocker

            • metformin

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of metformin by unspecified interaction mechanism. Use Caution/Monitor. Monitor for signs of onset of lactic acidosis such as respiratory distress, somnolence, and non-specific abdominal distress or worsening renal function; concomitant metformin use in patients with renal insufficiency or hepatic impairment not recommended.

            • mexiletine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of mexiletine by decreasing metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • mometasone, intranasal

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of mometasone, intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nelfinavir

              nelfinavir will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nicardipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of nicardipine by altering metabolism. Modify Therapy/Monitor Closely. May decrease calcium channel blocker dose if necessary

            • nifedipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of nifedipine by altering metabolism. Modify Therapy/Monitor Closely. Decrease dose of calcium channel blocker; clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. if such events occur, consider further dose reduction of calcium channel blocker or switching to alternative to calcium channel blocker

            • nimodipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of nimodipine by altering metabolism. Modify Therapy/Monitor Closely. May decrease calcium channel blocker dose if necessary

            • nisoldipine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of nisoldipine by altering metabolism. Modify Therapy/Monitor Closely. May decrease calcium channel blocker dose if necessary

            • omeprazole

              ombitasvir/paritaprevir/ritonavir & dasabuvir will decrease the level or effect of omeprazole by unspecified interaction mechanism. Use Caution/Monitor. Monitor for decreased omeprazole efficacy; consider increasing omeprazole dose in patients whose symptoms are not well controlled (not to exceed 40 mg/day)

            • pitavastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of pitavastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • pravastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of pravastatin by decreasing hepatic clearance. Modify Therapy/Monitor Closely. Maximum daily dose of pravastatin should be limited to 40 mg/day

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of pravastatin by Other (see comment). Use Caution/Monitor. Comment: OATP1B1 inhibitors may increase risk of myopathy.

            • propafenone

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of propafenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • quinidine

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of quinidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • ribociclib

              ribociclib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • rosuvastatin

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of rosuvastatin by decreasing hepatic clearance. Modify Therapy/Monitor Closely. Maximum daily dose of rosuvastatin should be limited to 10 mg/day

            • rucaparib

              rucaparib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • sarecycline

              sarecycline will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

            • stiripentol

              stiripentol, ombitasvir/paritaprevir/ritonavir & dasabuvir. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              stiripentol will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a CYP2C8 inhibitor. Consider dosage reduction for CYP2C8 substrates if adverse effects are experienced when coadministered.

              stiripentol will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

            • tacrolimus

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of tacrolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. When initiating therapy with Viekira Pak, the dose of tacrolimus needs to be reduced; do not administer tacrolimus on the day Viekira Pak is initiated; beginning the day after Viekira Pak is initiated, reinitiate tacrolimus at a reduced dose based on tacrolimus blood concentrations; typical tacrolimus dosing is 0.5 mg q7days; measure tacrolimus blood concentrations and adjust dose or dosing frequency to determine subsequent dose modifications; upon completion of Viekira Pak, the appropriate time to resume pre-Viekira Pak dose of tacrolimus should be guided by assessment of blood concentrations

            • talazoparib

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

            • tazemetostat

              tazemetostat will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • tucatinib

              tucatinib will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • valsartan

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of valsartan by Other (see comment). Use Caution/Monitor. May inhibit organic anion transporter polypeptides; decrease dose of angiotensin receptor blockers and monitor patients for signs and symptoms of hypotension and/or worsening renal function; if such events occur, consider further dose reduction of angiotensin receptor blocker or switching to alternative to angiotensin receptor blocker

            • verapamil

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of verapamil by altering metabolism. Modify Therapy/Monitor Closely. Decrease dose of calcium channel blocker; clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. if such events occur, consider further dose reduction of calcium channel blocker or switching to alternative to calcium channel blocker m channel blocker dose if necessary

            • warfarin

              ombitasvir/paritaprevir/ritonavir & dasabuvir increases toxicity of warfarin by anticoagulation. Use Caution/Monitor. Fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment; frequent monitoring of INR values recommended during treatment and post-treatment follow-up.

            Minor (2)

            • valsartan

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of valsartan by decreasing elimination. Minor/Significance Unknown. May inhibit hepatic efflux transporter MRP2; decrease dose of angiotensin receptor blockers and monitor patients for signs and symptoms of hypotension and/or worsening renal function; if such events occur, consider further dose reduction of angiotensin receptor blocker or switching to alternative to angiotensin receptor blocker

            • voclosporin

              voclosporin will increase the level or effect of ombitasvir/paritaprevir/ritonavir & dasabuvir by Other (see comment). Minor/Significance Unknown. Information suggests voclosporin (an OATP1B1 inhibitor) may increase in the concentration of OATP1B1 substrates is possible. Monitor for adverse reactions of OATP1B1 substrates when coadministered with voclosporin.

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            Adverse Effects

            >10%

            Data listed below are from 2 placebo-controlled trials (SAPHHIRE-I and –II); treatment included ribavirin

            Fatigue (34%)

            Nausea (22%)

            Pruritus (18%)

            Skin reactions (16%)

            Insomnia (14%)

            Asthenia (14%)

            Postmarketing reports

            Immune system disorders: Anaphylactic reactions and other hypersensitivity reactions (including angioedema)

            Hepatic decompensation

            Hepatic failure

            Erythema multiforme

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            Warnings

            Black Box Warnings

            Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HCV direct acting antivirals (DDAs)

            HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with DDAs and were not receiving HBV antiviral therapy

            Some cases have resulted in fulminant hepatitis, hepatic failure, and death

            Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up

            Initiate appropriate patient management for HBV infection as clinically indicated

            Contraindications

            Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV DDAs, and who were not receiving HBV antiviral therapy; HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level (see Black Box Warnings and Dosing Considerations)

            If administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen; refer to the ribavirin prescribing information

            Severe hepatic impairment (Child-Pugh B and C) due to risk for toxicity

            Patients with known hypersensitivity (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to ritonavir

            Coadministered drugs that are contraindicated

            • Drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events
            • Moderate or strong inducers of CYP3A and strong inducers of CYP2C8 that may lead to reduced efficacy of therapy
            • Drugs that are strong inhibitors of CYP2C8 and may increase dasabuvir plasma concentrations and the risk of QT prolongation
            • Contraindicated drugs and potential toxicity
              • Alpha1-adrenoreceptor antagonist (alfuzosin): Potential for hypotension
              • Anticonvulsants (carbamazepine, phenytoin, phenobarbital): Decreased exposure of ombitasvir, paritaprevir, ritonavir, and dasabuvir, leading to a potential loss of therapeutic activity
              • Antihyperlipidemic (gemfibrozil): Increase in dasabuvir exposures by 10-fold, which may increase the risk of QT prolongation
              • Antimycobacterial (rifampin): Decreased exposure of ombitasvir, paritaprevir, ritonavir, and dasabuvir, leading to a potential loss of therapeutic activity
              • Ergot derivatives (ergotamine, dihydroergotamine, ergonovine, methylergonovine): Acute ergot toxicity characterized by vasospasm and tissue ischemia has been associated with coadministration of ritonavir and ergonovine, ergotamine, dihydroergotamine, or methylergonovine
              • Ethinyl estradiol: Potential for increased ALT
              • HMG-CoA reductase inhibitors (lovastatin, simvastatin): Increased risk of myopathy, including rhabdomyolysis
              • Neuroleptics (pimozide): Potential for cardiac arrhythmias
              • NNRTIs (efavirenz): Coadministration of efavirenz-based regimens with paritaprevir, ritonavir plus dasabuvir was poorly tolerated and resulted in liver enzyme elevations
              • PDE5 inhibitors (sildenafil [Revatio for treatment of PAH]): There is increased potential for sildenafil-associated adverse events (eg, visual disturbances, hypotension, priapism, and syncope)
              • Sedatives/hypnotics (triazolam, oral midazolam): Extensively metabolized by CYP3A4; coadministration may cause large increases in the concentration of these benzodiazepines, possibly leading to serious and/or life -hreatening events (eg, prolonged or increased sedation or respiratory depression)
              • Ranolazine and lurasidone: Potential for serious and/or life-threatening reactions
              • Dronedarone and cisapride: Potential for serious and/or life-threatening reactions such as cardiac arrhythmias
              • Lurasidone: Potential for serious and/or life-threatening reactions
              • Microsomal triglyceride transfer protein inhibitor: Lomitapide
              • Androgen receptor inhibitor: Apalutamide

            Cautions

            Increased ALT to >5 xULN occurred in ~1% of patients within the first 4 weeks of treatment; significantly more frequent in females taking ethinyl estradiol-containing medications (also see Contraindications)

            If ALT found to be elevated above baseline levels, repeat and monitor closely; instruct patients to consult their health care professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces; consider discontinuing therapy if ALT levels remain persistently greater than 10 times the ULN; discontinue therapy if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing direct bilirubin, alkaline phosphatase, or INR

            Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, reported mostly in patients with advanced cirrhosis; discontinue treatment in patients who develop evidence of hepatic decompensation

            If coadministered with ribavirin, the warnings and precautions for ribavirin, in particular the contraindication during pregnancy, apply to this combination regimen

            Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy; test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti- HBc before initiating HCV treatment with this drug; in patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment and during post-treatment follow-up; initiate appropriate patient management for HBV infection as clinically indicated

            Patients with cirrhosis

            • Monitor for clinical signs and symptoms of hepatic decompensation, including ascites, hepatic encephalopathy, variceal hemorrhage
            • Hepatic laboratory testing including direct bilirubin levels should be performed at baseline and during first 4 weeks of starting treatment and as clinically indicated
            • Discontinue therapy in patients who develop evidence of hepatic decompensation

            Use in HCV/HIV-1 coinfection

            • Viekira Pak with ribavirin was assessed in 63 subjects with HCV/HIV-1 coinfection who were on stable antiretroviral therapy
            • The most common adverse events occurring in at least 10% of patients were fatigue (48%), insomnia (19%), nausea (17%), headache (16%), pruritus (13%), cough (11%), irritability (10%), and ocular icterus (10%)
            • Elevations in total bilirubin greater than 2 x ULN (mostly indirect) occurred in 34 (54%) individuals

            Use in Liver transplant recipients

            • Safety assessed in 34 post-liver transplantation recipients with recurrent HCV infection
            • Adverse events occurring in >20% of patients included fatigue (50%), headache (44%), cough (32%), diarrhea (26%), insomnia (26%), asthenia (24%), nausea (24%), muscle spasms (21%), and rash (21%)
            • Ten patients (29%) had at least one post-baseline hemoglobin value of <10 g/dL

            Drug interaction overview

            • Concomitant use with certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of Viekira Pak and possible development of resistance, or clinically significant adverse reactions from greater exposures of concomitant drugs or components of Viekira Pak
            • Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact the safe and effective use of concomitant medications; for example, altered blood glucose control resulting in serious symptomatic hypoglycemia reported in diabetic patients in postmarketing case reports and published epidemiological studies; management of hypoglycemia in these cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment
            • Frequent monitoring of relevant laboratory parameters (e.g. International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as CYP P450 substrates with a narrow therapeutic index (eg, certain immunosuppressants) is recommended to ensure safe and effective use; dose adjustments of concomitant medications may be necessary
            • Also see Contraindications and the Drug Interaction Checker
            • Potential for Viekira Pak to affect other drugs
              • Coadministration with drugs that are substrates of CYP3A, UGT1A1, BCRP, OATP1B1, or OATP1B3 may result in increased plasma concentrations of such drugs (dose adjustment may be required)
              • UGT1A1 inhibitors: ombitasvir, paritaprevir, and dasabuvir
              • CYP3A4 inhibitor: ritonavir
              • OATP1B1 and OATP1B3 inhibitor: paritaprevir
              • BCRP inhibitors: paritaprevir, ritonavir, and dasabuvir
            • Potential for other drugs to affect Viekira Pak
              • Inhibition of CYP3A, CYP2C8, P-gp, BCRP, OATP1B1, or OATP1B3 may increase the plasma concentrations of the various components of Viekira Pak, although there is no dose adjustment for Viekira Pak
              • Primarily metabolized by CYP3A enzymes: paritaprevir and ritonavir; coadministration with strong CYP3A inhibitors may increase paritaprevir and ritonavir concentrations
              • Primarily metabolized by CYP2C8: dasabuvir; coadministration with strong CYP2C8 inhibitors may increase dasabuvir concentrations
              • Metabolized via amide hydrolysis (CYP enzymes play a minor role): ombitasvir
              • Substrates of P-gp: ombitasvir, paritaprevir, dasabuvir, and ritonavir
              • Substrates of BCRP: ombitasvir, paritaprevir, and dasabuvir
              • Substrates of OATP1B1 and OATP1B3: paritaprevir
            • Drugs without clinically significant interactions
              • No dose adjustments are recommended when Viekira Pak is coadministered with the following medications: digoxin, duloxetine, emtricitabine/tenofovir disoproxil fumarate, escitalopram, methadone, progestin-only contraceptives, raltegravir, warfarin, and zolpidem
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            Pregnancy & Lactation

            Pregnancy Category: B; however, contraindicated if administered with ribavirin in pregnant women and men whose partners are pregnant

            There is an Antiretroviral Pregnancy Registry that monitors pregnancy outcomes in women who are HCV/HIV-1 coinfected and taking concomitant antiretrovirals; physicians are encouraged to register patients by calling 1-800-258-4263

            Lactation: Unknown if distributed in human breast milk

            If administered with ribavirin: Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or to delay or discontinue treatment

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Ombitasvir: Inhibits HCV NS5A protein, which is required for viral replication

            Paritaprevir: NS3/4A serine protease inhibitor; NS3/4A protease is needed for proteolytic cleavage of the HCV-encoded polyprotein into mature forms

            Ritonavir: Protease inhibitor that is used as a 'boosting agent' to increase paritaprevir serum levels

            Dasabuvir: Nonnucleoside NS5B RNA-dependent polymerase inhibitor; its inhibition, in turn, suppresses viral replication

            Absorption

            Peak plasma time: 4-5 hr

            Steady-state achieved: ~12 days

            Bioavailability: 70% (dasabuvir)

            AUC

            • Ombitasvir: 1000 ng•hr/mL
            • Paritaprevir: 2220 ng•hr/mL
            • Ritonavir: 6180 ng•hr/mL
            • Dasabuvir: 3240 ng•hr/mL

            Peak plasma concentration

            • Ombitasvir: 68 ng/mL
            • Paritaprevir: 262 ng/mL
            • Ritonavir: 682 ng/mL
            • Dasabuvir: 667 ng/mL

            Distribution

            Protein bound

            • Ombitasvir: 99.9%
            • Paritaprevir: 98.6%
            • Ritonavir: 99%
            • Dasabuvir: >99.5%

            Vd

            • Ombitasvir: 50.1 L
            • Paritaprevir: 16.7 L
            • Ritonavir: 21.5 L
            • Dasabuvir: 396 L

            Metabolism

            Ombitasvir: Predominantly metabolized by amide hydrolysis followed by oxidative metabolism

            Paritaprevir: Predominantly metabolized by CYP3A4 and to a lesser extent by CYP3A5

            Ritonavir: Predominantly metabolized by CYP3A and to a lesser extent by CYP2D6

            Dasabuvir: Predominantly metabolized by CYP2C8 and to a lesser extent by CYP3A

            Elimination

            Half-life

            • Ombitasvir: 21-25 hr
            • Paritaprevir: 5.5 hr
            • Ritonavir: 4 hr
            • Dasabuvir: 5.5-6 hr

            Excretion

            • Ombitasvir: 90.2% feces; 1.91% urine
            • Paritaprevir: 88% feces; 8.8% urine
            • Ritonavir: 86.4% feces; 11.3% urine
            • Dasabuvir: 94.4% feces; 2% urine
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            Administration

            Oral Administration

            Viekira Pak or Viekira XR: Take with a meal without regard to fat or calorie content; if administered under fasting conditions, may result in reduced virologic response and possible development of resistance

            Prior to initiation, assess for laboratory and clinical evidence of hepatic

            Viekira XR

            • Swallow tablets whole; splitting, crushing, or chewing tablets may compromise the extended-release performance, efficacy, and/or safety
            • For optimal release of dasabuvir, alcohol should not be consumed within 4 hr of taking Viekira XR
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Viekira Pak oral
            -
            12.5 mg-75 mg -50 mg/250 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            ombitasvir-paritaprevir-ritonavir-dasabuvir oral

            OMBITASVIR/PARITAPREVIR/RITONAVIR/DASABUVIR - ORAL

            (om-BIT-as-vir/PAR-i-TA-pre-vir/ri-TOE-na-vir/da-SA-bue-vir)

            COMMON BRAND NAME(S): Viekira Pak

            WARNING: Although this product helps many people with hepatitis C, it may rarely cause serious liver problems. Also, people who have another liver problem called hepatitis B may get worse. Before starting this product, tell your doctor if you have ever had hepatitis B. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.

            USES: This product contains 2 different tablets. One tablet contains 3 medications ("multi-drug"): ombitasvir, paritaprevir, and ritonavir. The other tablet contains dasabuvir.This product is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Ombitasvir, paritaprevir, and dasabuvir work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Ritonavir is used to increase ("boost") the levels of paritaprevir. This helps paritaprevir work better. This product may also be used with a certain other medication (ribavirin). Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this product and each time you get a refill. Follow the instructions very closely since this product contains tablets with different drugs. If you have any questions, ask your doctor or pharmacist.Take this product by mouth with meals as directed by your doctor. Take the multi-drug tablets and dasabuvir once every morning. Then take dasabuvir once every evening.This product works best when the amount of drug in your body is kept at a constant level. Take this product at evenly spaced intervals. To help you remember, take it at the same time(s) each day. Do not skip any doses.Continue to take this product for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

            SIDE EFFECTS: See also Warning section.Tiredness, weakness, nausea, mild itching, or difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this product has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.This product can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to any of the drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this product, tell your doctor or pharmacist your medical history, especially of: other liver problems (such as hepatitis B), HIV infection, diabetes.If you have diabetes, your blood sugar may be lower with hepatitis C treatment. This can increase your risk of low blood sugar, so your doctor may adjust your diabetes treatment plan. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.This product, in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for 6 months after stopping treatment (see also Drug Interactions section). If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.It is unknown if this product passes into breast milk. Breast-feeding while using this product, in combination with ribavirin, is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: efavirenz, ethinyl estradiol-containing products (such as combined birth control pills, patch or ring).If you are using hormonal birth control containing a certain type of estrogen (ethinyl estradiol), it must be stopped before starting treatment with this product. Use other reliable forms of birth control during treatment with this product and for 2 weeks after stopping treatment. Ethinyl estradiol-containing birth control may be restarted after that time. Talk to your doctor for more details.This product can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, silodosin), certain benzodiazepines (midazolam, triazolam), cisapride, colchicine, ergot alkaloids (such as dihydroergotamine, ergotamine), certain heart drugs (dronedarone, ranolazine), lurasidone, pimozide, rilpivirine, salmeterol, certain drugs used to treat erectile dysfunction-ED or pulmonary hypertension (avanafil, sildenafil), certain "statin" cholesterol drugs (atorvastatin, lovastatin, simvastatin), certain drugs that weaken the immune system (such as everolimus, sirolimus, tacrolimus, temsirolimus), among others.Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), apalutamide, clopidogrel, cobicistat, elagolix, gemfibrozil, mitotane, rifampin, St. John's wort, thioridazine, among others.Do not take this product with other products that contain ritonavir.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this product with others.Lab tests (such as liver function, tests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments.If you are using this product with ribavirin, it is recommended that female patients or female partners of male patients take a pregnancy test before starting treatment. A pregnancy test should also be taken every month while using this product and for 6 months after treatment ends to make sure no pregnancy occurs.

            MISSED DOSE: If you miss a dose, take it with a meal as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.