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VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(三)
1 Co-infected Patients
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Potential for VIEKIRA XR to Affect Other Drugs
7.2 Potential for Other Drugs to Affect One or More Components of VIEKIRA XR
7.3 Established and Other Potential Drug Interactions
7.4 Drugs without Clinically Significant Interactions with VIEKIRA XR
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Description of Clinical Trials
14.2 Clinical Trial Results in Adults with Chronic HCV Genotype 1a and 1b Infection without Cirrhosis
14.3 Clinical Trial Results in Adults with Chronic HCV Genotype 1a and 1b Infection and Compensated Cirrhosis
14.4 Effect of Ribavirin Dose Reductions on SVR12
14.5 Clinical Trial of Selected Liver Transplant Recipients (CORAL-I)
14.6 Clinical Trial in Subjects with HCV/HIV-1 Co-infection (TURQUOISE-I)
14.7 Durability of Response
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
VIEKIRA XR is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2) and Clinical Studies (14)]:
genotype 1b infection without cirrhosis or with compensated cirrhosis
genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
2 DOSAGE AND ADMINISTRATION
2.1 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)].
2.2 Recommended Dosage in Adults
VIEKIRA XR is a 4-drug fixed-dose combination, extended-release tablet containing 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir.
The recommended dosage of VIEKIRA XR is three tablets taken orally once daily.
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 dosa |
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