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GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(二)
dverse reactions or loss of virologic response due to drug interactions: The concomitant use of GENVOYA and other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of GENVOYA and possible development of resistance; and possible clinically significant adverse reactions from greater exposures of concomitant drugs. (5.2)
Immune reconstitution syndrome: May necessitate further eva luation and treatment. (5.3)
New onset or worsening renal impairment: Assessment of serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein is recommended before initiating GENVOYA therapy and during therapy as clinically appropriate. (5.4)
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.5)
ADVERSE REACTIONS
Most common adverse reaction (incidence greater than or equal to 10%, all grades) is nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
GENVOYA should not be administered with other antiretroviral medications for treatment of HIV-1 infection. (7.1)
GENVOYA can alter the concentration of drugs metabolized by CYP3A or CYP2D6. Drugs that induce CYP3A can alter the concentrations of one or more components of GENVOYA. Consult the full prescribing information prior to and during treatment for potential drug-drug interactions. (4, 7.2, 7.3, 12.3)
USE IN SPECIFIC POPULATIONS
Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. (8.2)
Pediatrics: Not recommended for patients less than 12 years of age or weighing less than 35 kg. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to Initiation and During Treatment with GENVOYA
2.2 Recommended Dosage
2.3 Not Recommended in Patients with Severe Renal Impairment
2.4 Not Recommended in Patients with Severe Hepatic Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV
5.2 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions
5.3 Immune Reconstitution Syndrome
5.4 New Onset or Worsening Renal Impairment
5.5 Lactic Acidosis/Severe Hepatomegaly with Steatosis
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Not Recommended with Other Antiretroviral Medications
7.2 Potential for GENVOYA to Affect Other Drugs
7.3 Potential for Other Drugs to Affect One or More Components of GENVOYA
7.4 Drugs Affecting Renal Function
7.5 Established and Other Potentially Significant Interactions
7.6 Drugs without Clinically Significant Interactions with GENVOYA
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
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