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Emtricitabine and Tenofovir Alafenamide

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Emtricitabine and Tenofovir Alafenamide HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------DOSAGE AND ADMINISTRATION----------------------­ These highlights do not include all the information needed to use • Testing: Prior to initiation of DESCOVY, patients should be tested for DESCOVY safely and effectively. See full prescribing information hepatitis B virus infection, and estimated creatinine clearance, urine for DESCOVY. glucose and urine protein should be obtained. (2.1) • ® Recommended dosage: One tablet taken once daily with or without DESCOVY (emtricitabine and tenofovir alafenamide) tablets, for food in patients with body weight at least 25 kg and a creatinine oral use clearance greater than or equal to 30 mL per minute. (2.2) Initial U.S. Approval: 2015 • Renal impairment: DESCOVY is not recommended in patients with WARNING: POST TREATMENT ACUTE EXACERBATION OF estimated creatinine clearance below 30 mL per minute. (2.3) HEPATITIS B ----------------------DOSAGE FORMS AND STRENGTHS--------------------­ See full prescribing information for complete boxed warning. Tablets: 200 mg of FTC and 25 mg of TAF (3) • DESCOVY is not approved for the treatment of chronic -------------------------------CONTRAINDICATIONS------------------------------­ hepatitis B virus (HBV) infection. Severe acute None. exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have -----------------------WARNINGS AND PRECAUTIONS-----------------------­ discontinued products containing emtricitabine (FTC) • Immune reconstitution syndrome: May necessitate further evaluation and/or tenofovir disoproxil fumarate (TDF), and may occur and treatment.(5.2) with discontinuation of DESCOVY. Hepatic function should • New onset or worsening renal impairment: Assess creatinine be monitored closely in these patients. If appropriate, clearance, urine glucose, and urine protein in all patients before initiation of anti-hepatitis B therapy may be warranted. (5.1) initiating DESCOVY therapy and monitor during therapy. Monitor serum phosphorus in patients with chronic kidney disease. (5.3) ----------------------------RECENT MAJOR CHANGES-------------------------­ • Indications and Usage (1) 09/2017 Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings Dosage and Administration, Recommended Dosage (2.2) 09/2017 suggestive of lactic acidosis or pronounced hepatotoxicity. (5.4) Warnings and Precautions, Bone Loss and Mineralization Defects [removed] 09/2017 -------------------------------ADVERSE REACTIONS-----------------------------­ Boxed Warning, Lactic Acidosis/Severe Hepatomegaly with Steatosis Most common adverse reaction (incidence greater than or equal to 10%, [removed] 04/2017 all grades) is nausea. (6.1) Warnings and Precautions, Lactic Acidosis/Severe Hepatomegaly with Steatosis (5.4) 04/2017 To report SUSPECTED ADVERSE REACTIONS, contact Gilead Warnings and Precautions, Fat Redistribution [removed] 04/2017 Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ----------------------------INDICATIONS AND USAGE---------------------------­ DESCOVY is a two-drug combination of emtricitabine (FTC) and -------------------------------DRUG INTERACTIONS------------------------------­ tenofovir alafenamide (TAF), both HIV nucleoside analog reverse Consult the Full Prescribing Information prior to and during treatment for transcriptase inhibitors (NRTIs), and is indicated: potential drug interactions. (7, 12.3) • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least ------------------------USE IN SPECIFIC POPULATIONS----------------------­ 35kg. • Lactation: Women infected with HIV should be instructed not to • in combination with other antiretroviral agents other than protease breastfeed, due to the potential for HIV transmission. (8.2) inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 • Pediatrics: Not recommended for patients weighing less than 25 kg. infection in pediatric patients weighing at least 25 kg and less than (8.4) 35 kg. (1) Limitations of Use: DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) See 17 for PATIENT COUNSELING INFORMATION and to reduce the risk of sexually acquired HIV-1 in adults at high risk. FDA-approved patient labeling. Revised: 09/2017 Reference ID: 4160389 Gilead Sciences 1 FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS WARNING: POST TREATMENT ACUTE EXACERBATION OF 8.1 Pregnancy HEPATITIS B 8.2 Lactation 1 INDICATIONS AND USAGE 8.4 Pediatric Use 2 DOSAGE AND ADMINISTRATION 8.5 Geriatric Use 2.1 Testing Prior to Initiation of DESCOVY 8.6 Renal Impairment 2.2 Recommended Dosage 8.7 Hepatic Impairment 2.3 Not Recommended in Patients with Severe Renal Impairment 10 OVERDOSAGE 3 DOSAGE FORMS AND STRENGTHS 11 DESCRIPTION 4 CONTRAINDICATIONS 12 CLINICAL PHARMACOLOGY 5 WARNINGS AND PRECAUTIONS 12.1 Mechanism of Action 5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected 12.2 Pharmacodynamics with HIV-1 and HBV 12.3 Pharmacokinetics 5.2 Immune Reconstitution Syndrome 12.4 Microbiology 5.3 New Onset or Worsening Renal Impairment 13 NONCLINICAL TOXICOLOGY 5.4 Lactic Acidosis/Severe Hepatomegaly with Steatosis 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 6 ADVERSE REACTIONS 13.2 Animal Toxicology and/or Pharmacology 6.1 Clinical Trials Experience 14 CLINICAL STUDIES 7 DRUG INTERACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 7.1 Potential for Other Drugs to Affect One or More Components of 17 PATIENT COUNSELING INFORMATION DESCOVY *Sections or subsections omitted from the full prescribing information 7.2 Drugs Affecting Renal Function are not listed. 7.3 Established and Other Potentially Significant Interactions 7.4 Drugs without Clinically Significant Interactions with DESCOVY Gilead Sciences 2 Reference ID: 4160389 FULL PRESCRIBING INFORMATION WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of DESCOVY have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue DESCOVY. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)]. 1 INDICATIONS AND USAGE DESCOVY is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. DESCOVY is also indicated, in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg. Limitations of Use: DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. 2 DOSAGE AND ADMINISTRATION 2.1 Testing Prior to Initiation of DESCOVY Prior to initiation of DESCOVY, patients should be tested for hepatitis B virus infection [see Warnings and Precautions (5.1)]. Estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating DESCOVY therapy and should be monitored during therapy in all patients [see Warnings and Precautions (5.3)]. 2.2 Recommended Dosage DESCOVY is a two-drug fixed dose combination product containing 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of DESCOVY is one tablet taken orally once daily with or without food in adults and pediatric patients with body weight at least 25 kg and creatinine Gilead Sciences 3 Reference ID: 4160389 clearance greater than or equal to 30 mL per minute [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. For specific dosing recommendations for coadministered third agents, refer to their respective prescribing information [see Drug Interactions (7)]. The safety and effectiveness of DESCOVY coadminstered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in pediatric subjects weighing less than 35 kg. 2.3 Not Recommended in Patients with Severe Renal Impairment DESCOVY is not recommended in patients with estimated creatinine clearance below 30 mL per minute [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)]. 3 DOSAGE FORMS AND STRENGTHS Each DESCOVY tablet contains 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF) (equivalent to 28 mg of tenofovir alafenamide fumarate). The tablets are blue, rectangular-shaped, film-coated, debossed with “GSI” on one side and “225” on the other side. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV Patients with HIV-1 should be tested for the presence of chronic hepatitis B virus (HBV) before initiating antiretroviral therapy [see Dosage and Administration (2.1)]. DESCOVY is not approved
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