Viekira XR Dosage
Generic name: RITONAVIR 33.33mg, DASABUVIR SODIUM MONOHYDRATE 200mg, PARITAPREVIR DIHYDRATE 50mg, OMBITASVIR HEMINONAHYDRATE 8.33mg
Dosage form: extended release tablets
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Testing Prior to the Initiation of Therapy
- 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 XR [see Warnings and Precautions (5.1)].
- Prior to initiation of VIEKIRA XR, assess for laboratory and clinical evidence of hepatic decompensation [see Warnings and Precautions (5.2 and 5.3)].
Recommended Dosage in Adults
- VIEKIRA XR must be taken with a meal because administration under fasting conditions may result in reduced virologic response and possible development of resistance [see Clinical Pharmacology (12.3)].
- Swallow tablets whole. Splitting, crushing, or chewing tablets may compromise the extended-release performance, efficacy, and/or safety of VIEKIRA XR.
- For optimal release of dasabuvir, alcohol should not be consumed within 4 hours of taking VIEKIRA XR.
VIEKIRA XR is used in combination with ribavirin (RBV) in certain patient populations (see Table 1). When administered with VIEKIRA XR, 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. The starting dosage and on-treatment dosage of RBV can be decreased based on changes in hemoglobin levels and/or creatinine clearance. For ribavirin dosage modifications, refer to the ribavirin prescribing information.
Table 1 shows the recommended VIEKIRA XR treatment regimen and duration based on patient population.
|VIEKIRA XR + ribavirin||12 weeks|
with compensated cirrhosis
|VIEKIRA XR + ribavirin||24 weeks**|
with or without compensated
cirrhosis (Child-Pugh A)
|VIEKIRA XR||12 weeks|
|*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
**VIEKIRA XR administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history [see Clinical Studies (14.3)].
Use in Liver Transplant Recipients
In liver transplant recipients with normal hepatic function and mild fibrosis (Metavir fibrosis score 2 or lower), the recommended duration of VIEKIRA XR with ribavirin is 24 weeks, irrespective of HCV genotype 1 subtype [see Clinical Studies (14.6)]. When VIEKIRA XR is administered with calcineurin inhibitors in liver transplant recipients, dosage adjustment of calcineurin inhibitors is needed [see Drug Interactions (7)].
More about Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir)
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- Drug class: antiviral combinations
Other brands: Viekira Pak