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VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(二)
evens-Johnson syndrome). (4)
WARNINGS AND PRECAUTIONS
Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. (5.1)
Hepatic Decompensation and Hepatic Failure in Patient with Cirrhosis: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation. (5.2)
ALT Elevations: Discontinue ethinyl estradiol-containing medications prior to starting VIEKIRA XR (alternative contraceptive methods are recommended). Perform hepatic laboratory testing on all patients during the first 4 weeks of treatment. For ALT elevations on VIEKIRA XR, monitor closely and follow recommendations in full prescribing information. (5.3)
Risks Associated With Ribavirin Combination Treatment: If VIEKIRA XR is administered with ribavirin, the warnings and precautions for ribavirin also apply to this combination regimen. (5.4)
Drug Interactions: The concomitant use of VIEKIRA XR and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of VIEKIRA XR. (5.5)
ADVERSE REACTIONS
In subjects receiving the combination of dasabuvir with ombitasvir, paritaprevir, ritonavir with ribavirin, the most commonly reported adverse reactions (greater than 10% of subjects) were fatigue, nausea, pruritus, other skin reactions, insomnia and asthenia. In subjects receiving the combination of dasabuvir with ombitasvir, paritaprevir, ritonavir without ribavirin, the most commonly reported adverse reactions (greater than or equal to 5% of subjects) were nausea, pruritus and insomnia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of VIEKIRA XR can alter the plasma concentrations of some drugs and some drugs may alter the plasma concentrations of VIEKIRA XR. The potential for drug interactions must be considered before and during treatment. Consult the full prescribing information prior to and during treatment for potential drug interactions. (4, 5.5, 7, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to the Initiation of Therapy
2.2 Recommended Dosage in Adults
2.3 Use in Liver Transplant Recipients
2.4 Hepatic Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
5.2 Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
5.3 Increased Risk of ALT Elevations
5.4 Risks Associated With Ribavirin Combination Treatment
5.5 Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions
5.6 Risk of HIV-1 Protease Inhibitor Drug Resistance in HCV/HIV- |
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