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GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(三十二)
proved patient labeling (Patient Information).
Drug Interactions
GENVOYA may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or non-prescription medication or herbal products including St. John's wort [see CONTRAINDICATIONS (4) and DRUG INTERACTIONS (7)].
Post-treatment Acute Exacerbation of Hepatitis B in Patients with HBV Co-Infection
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine and/or TDF, and may likewise occur with discontinuation of GENVOYA [see WARNINGS AND PRECAUTIONS (5.1)]. Advise the patient to not discontinue GENVOYA without first informing their healthcare provider.
Immune Reconstitution Syndrome
Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see WARNINGS AND PRECAUTIONS (5.3)].
Renal Impairment
Advise patients to avoid taking GENVOYA with concurrent or recent use of nephrotoxic agents. Renal impairment including cases of acute renal failure has been reported in association with the use of tenofovir prodrugs [see WARNINGS AND PRECAUTIONS (5.4)].
Lactic Acidosis and Severe Hepatomegaly
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to GENVOYA. Advise patients that they should stop GENVOYA if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see WARNINGS AND PRECAUTIONS (5.5)].
Missed Dosage
Inform patients that it is important to take GENVOYA on a regular dosing schedule with food and to avoid missing doses as it can result in development of resistance [see DOSAGE AND ADMINISTRATION (2.2)].
Pregnancy Registry
Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to GENVOYA [see USE IN SPECIFIC POPULATIONS (8.1)].
Lactation
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see USE IN SPECIFIC POPULATIONS (8.2)].
SPL UNCLASSIFIED SECTION
Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404
PATIENT PACKAGE INSERT
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 04/2017
Patient Information
GENVOYA® (jen-VOY-uh)
(elvitegravir, cobicistat, emtricitabine,
and tenofovir alafenamide)
tablets
Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with GENVOYA. For more information, see the section "WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING GENVOYA?"
Read this Patient Information before you start taking GENVOYA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about GENVOYA?
GENVOYA can cause serious side effects, including:
1.Worsening of Hepatitis B infection. GENVOYA is not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B v |
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