VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(三十五)
iew the Medication Guide for ribavirin [see Warnings and Precautions (5.3)].
Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of hepatitis B virus infection [see Warnings and Precautions (5.1)].
Risk of ALT Elevations or Hepatic Decompensation and Failure
Inform patients to watch for early warning signs of liver inflammation or failure, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice, onset of confusion, abdominal swelling, and discolored feces, and to consult their health care professional without delay if such symptoms occur [see Warnings and Precautions (5.2 and 5.3) and Adverse Reactions (6)].
Pregnancy
Advise patients taking VIEKIRA XR with ribavirin to avoid pregnancy during treatment and within 6 months of stopping ribavirin. Inform patients to notify their health care provider immediately in the event of a pregnancy [see Use in Specific Populations (8.1)].
Drug Interactions
Inform patients that VIEKIRA XR may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription, non-prescription medication or herbal products [see Contraindications (4), Warnings and Precautions (5.5) and Drug Interactions (7)].
Inform patients that contraceptives containing ethinyl estradiol are contraindicated with VIEKIRA XR [see Contraindications (4) and Warnings and Precautions (5.3)].
Administration
Advise patients to take VIEKIRA XR every day at the regularly scheduled time and that VIEKIRA XR must be taken with a meal because taking it under fasting conditions may result in reduced virologic response and possible development of resistance. Inform patients to swallow tablets whole and not to consume alcohol within 4 hours of taking VIEKIRA XR [see Dosage and Administration (2.2)].
Inform patients that it is important not to miss or skip doses and to take VIEKIRA XR for the duration that is recommended by the healthcare provider.
Manufactured by AbbVie Inc., North Chicago, IL 60064.
VIEKIRA XR and NORVIR are trademarks of AbbVie Inc. All other brands listed are trademarks of their respective owners and are not trademarks of AbbVie Inc. The makers of these brands are not affiliated with and do not endorse AbbVie Inc. or its products.
© 2017 AbbVie Inc. All rights reserved.
03-B505
MEDICATION GUIDE
MEDICATION GUIDE
VIEKIRA XR (vee-KEE-rah-XR)
(dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets
for oral use
Important: When taking VIEKIRA XR in combination with ribavirin, you should also read the Medication Guide that comes with ribavirin.
What is the most important information I should know about VIEKIRA XR?
VIEKIRA XR can cause serious side effects, including,
Hepatitis B virus reactivation: Before starting treatment with VIEKIRA XR, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with VIEKIRA XR. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare |
