VIEKIRA PAK- dasabuvir and ombitasvir and paritaprevir and ritonavir
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VIEKIRA PAK. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals 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 [see Warnings and Precautions (5.1)].
- genotype 1b without cirrhosis or with compensated cirrhosis
- genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
- Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VIEKIRA PAK [see Warnings and Precautions (5.1)].
- Prior to initiation of VIEKIRA PAK, assess for laboratory and clinical evidence of hepatic decompensation [see Warnings and Precautions (5.2 and 5.3)].
The recommended oral dosage of VIEKIRA PAK is two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening). Take VIEKIRA PAK with a meal without regard to fat or calorie content [see Clinical Pharmacology (12.3)].
VIEKIRA PAK is used in combination with ribavirin (RBV) in certain patient populations (see Table 1). When administered with VIEKIRA PAK, the recommended dosage of RBV is based on weight: 1000 mg/day for subjects <75 kg and 1200 mg/day for those ≥75 kg, divided and administered twice-daily with food. For ribavirin dosage modifications, refer to the ribavirin prescribing information.
Table 1 shows the recommended VIEKIRA PAK treatment regimen and duration based on patient population.
|Genotype 1a, without cirrhosis||VIEKIRA PAK + ribavirin||12 weeks|
|Genotype 1a, with compensated cirrhosis (Child-Pugh A)||VIEKIRA PAK + ribavirin||24 weeks**|
|Genotype 1b, with or without compensated cirrhosis (Child-Pugh A)||VIEKIRA PAK||12 weeks|
|*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.**VIEKIRA PAK administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history [see Clinical Studies (14.3)].|
In liver transplant recipients with normal hepatic function and mild fibrosis (Metavir fibrosis score 2 or lower), the recommended duration of VIEKIRA PAK with ribavirin is 24 weeks, irrespective of HCV genotype 1 subtype [see Clinical Studies (14.6)]. When VIEKIRA PAK is administered with calcineurin inhibitors in liver transplant recipients, dosage adjustment of calcineurin inhibitors is needed [see Drug Interactions (7)].
VIEKIRA PAK is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) [see Contraindications (4), Warnings and Precautions (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
- Ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “AV1” on one side.
- Dasabuvir 250 mg tablets are beige-colored, film-coated, oval-shaped, debossed with “AV2” on one side. Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir.
- If VIEKIRA PAK is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.
- VIEKIRA PAK is contraindicated:
- In patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
- With drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events [see Drug Interactions (7) and Clinical Pharmacology (12.3)]:
- Alpha1-adrenoreceptor antagonist: alfuzosin HCL
- Anti-anginal: ranolazine
- Antiarrhythmic: dronedarone
- Anti-gout: colchicine in patients with renal and/or hepatic impairment
- Antipsychotic: lurasidone, pimozide
- Ergot derivatives: ergotamine, dihydroergotamine, methylergonovine
- Ethinyl estradiol-containing products such as combined oral contraceptives
- GI Motility Agent: cisapride
- HMG-CoA Reductase Inhibitors: atorvastatin, lovastatin, simvastatin
- Immunosuppressants: everolimus, sirolimus, tacrolimus
- Microsomal triglyceride transfer protein inhibitor: lomitapide
- Non-nucleoside reverse transcriptase inhibitor: efavirenz
- Phosphodiesterase-5(PDE5) inhibitor: sildenafil when dosed as Revatio for the treatment of pulmonary arterial hypertension (PAH)
- Sedatives/hypnotics: triazolam, orally administered midazolam
- With drugs that are moderate or strong inducers of CYP3A and strong inducers of CYP2C8 and may lead to reduced efficacy of VIEKIRA PAK [see Drug Interactions (7) and Clinical Pharmacology (12.3)]:
- Anticonvulsants: carbamazepine, phenytoin, phenobarbital
- Androgen receptor inhibitor: apalutamide
- Antimycobacterial: rifampin
- Herbal Product: St. John’s Wort (Hypericum perforatum)
- With drugs that are strong inhibitors of CYP2C8 and may increase dasabuvir plasma concentrations and the risk of QT prolongation [see Drug Interactions (7) and Clinical Pharmacology (12.3)]:
- Antihyperlipidemic agent: gemfibrozil
- In patients with known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome).
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