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BIKTARVY (Bictegravir, Emtricitabine, and Tenofovir

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BIKTARVY (Bictegravir, Emtricitabine, and Tenofovir HIGHLIGHTS OF PRESCRIBING INFORMATION or below 15 mL per minute who have no antiretroviral treatment These highlights do not include all the information needed to use history. (2.3) BIKTARVY safely and effectively. See full prescribing information • Hepatic impairment: BIKTARVY is not recommended in patients for BIKTARVY. with severe hepatic impairment. (2.4) BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) ----------------------DOSAGE FORMS AND STRENGTHS--------------------- tablets, for oral use Tablets: 50 mg of bictegravir (equivalent to 52.5 mg of bictegravir Initial U.S. Approval: 2018 sodium), 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate). (3) WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B -------------------------------CONTRAINDICATIONS------------------------------- See full prescribing information for complete boxed warning. BIKTARVY is contraindicated to be co-administered with: • dofetilide. (4) Severe acute exacerbations of hepatitis B have been • rifampin. (4) reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing -----------------------WARNINGS AND PRECAUTIONS------------------------ emtricitabine (FTC) and/or tenofovir disoproxil fumarate • Immune reconstitution syndrome: May necessitate further evaluation (TDF), and may occur with discontinuation of BIKTARVY. and treatment. (5.3) Closely monitor hepatic function in these patients. If • New onset or worsening renal impairment: Assess serum creatinine, appropriate, anti-hepatitis B therapy may be warranted. estimated creatinine clearance, urine glucose and urine protein (5.1) when initiating BIKTARVY and during therapy as clinically appropriate in all patients. Also assess serum phosphorus in ----------------------------RECENT MAJOR CHANGES-------------------------- patients with chronic kidney disease. (5.4) Dosage and Administration (2.2, 2.3) 02/2021 • Lactic acidosis/severe hepatomegaly with steatosis: Discontinue Warnings and Precautions, New Onset or Worsening Renal treatment in patients who develop symptoms or laboratory findings Impairment (5.4) 03/2021 suggestive of lactic acidosis or pronounced hepatotoxicity. (5.5) ----------------------------INDICATIONS AND USAGE---------------------------- -------------------------------ADVERSE REACTIONS------------------------------ BIKTARVY is a three-drug combination of bictegravir (BIC), a human Most common adverse reactions (incidence greater than or equal to immunodeficiency virus type 1 (HIV-1) integrase strand transfer 5%, all grades) are diarrhea, nausea, and headache. (6.1) inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors To report SUSPECTED ADVERSE REACTIONS, contact Gilead (NRTIs), and is indicated as a complete regimen for the treatment of Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or HIV-1 infection in adults and pediatric patients weighing at least 25 kg www.fda.gov/medwatch. who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 -------------------------------DRUG INTERACTIONS------------------------------- RNA less than 50 copies per mL) on a stable antiretroviral regimen • Because BIKTARVY is a complete regimen, coadministration with with no history of treatment failure and no known substitutions other antiretroviral medications for the treatment of HIV-1 infection is associated with resistance to the individual components of BIKTARVY. not recommended. (7.1) (1) • Consult the Full Prescribing Information prior to and during treatment for important drug interactions. (4, 5.2, 7, 12.3) ------------------------DOSAGE AND ADMINISTRATION----------------------- • Testing: Prior to or when initiating BIKTARVY test for hepatitis B ------------------------USE IN SPECIFIC POPULATIONS----------------------- virus infection. Prior to or when initiating BIKTARVY, and during • Lactation: Women infected with HIV should be instructed not to treatment, assess serum creatinine, estimated creatinine clearance, breastfeed due to the potential for HIV transmission. (8.2) urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess • Pediatrics: Not recommended for patients weighing less than 25 kg. serum phosphorus. (2.1) (8.4) • Recommended dosage: One tablet taken once daily with or without food in patients weighing at least 25 kg. (2.2) See 17 for PATIENT COUNSELING INFORMATION and • Renal impairment: BIKTARVY is not recommended in patients with FDA-approved patient labeling. estimated creatinine clearance of 15 to below 30 mL per minute, or below 15 mL per minute who are not receiving chronic hemodialysis, Revised: 09/2021 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 When Initiating and During Treatment with BIKTARVY 8.6 Renal Impairment 2.2 Recommended Dosage 8.7 Hepatic Impairment 2.3 Not Recommended in Patients with Severe Renal Impairment 10 OVERDOSAGE 2.4 Not Recommended in Patients with Severe Hepatic Impairment 11 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics 5.1 Severe Acute Exacerbation of Hepatitis B in Patients 12.3 Pharmacokinetics Coinfected with HIV-1 and HBV 12.4 Microbiology 5.2 Risk of Adverse Reactions or Loss of Virologic Response Due 13 NONCLINICAL TOXICOLOGY to Drug Interactions 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.3 Immune Reconstitution Syndrome 13.2 Animal Toxicology and/or Pharmacology 5.4 New Onset or Worsening Renal Impairment 14 CLINICAL STUDIES 5.5 Lactic Acidosis/Severe Hepatomegaly with Steatosis 14.1 Description of Clinical Trials 6 ADVERSE REACTIONS 14.2 Clinical Trial Results in HIV-1 Subjects with No Antiretroviral 6.1 Clinical Trials Experience Treatment History 6.2 Postmarketing Experience 14.3 Clinical Trial Results in HIV-1 Virologically-Suppressed 7 DRUG INTERACTIONS Subjects Who Switched to BIKTARVY 7.1 Other Antiretroviral Medications 14.4 Clinical Trial Results in HIV-1 Infected Pediatric Subjects 7.2 Potential for BIKTARVY to Affect Other Drugs Between the Ages of 6 to Less than 18 Years 7.3 Potential Effect of Other Drugs on One or More Components of 16 HOW SUPPLIED/STORAGE AND HANDLING BIKTARVY 17 PATIENT COUNSELING INFORMATION 7.4 Drugs Affecting Renal Function *Sections or subsections omitted from the full prescribing information 7.5 Established and Potentially Significant Drug Interactions are not listed. 7.6 Drugs without Clinically Significant Interactions with BIKTARVY Gilead Sciences 2 FULL PRESCRIBING INFORMATION WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B 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 BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)]. 1 INDICATIONS AND USAGE BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY. 2 DOSAGE AND ADMINISTRATION 2.1 Testing When Initiating and During Treatment with BIKTARVY Prior to or when initiating BIKTARVY, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)]. Prior to or when initiating BIKTARVY, and during treatment with BIKTARVY, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.4)]. 2.2 Recommended Dosage BIKTARVY is a three-drug fixed dose combination product containing 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of BIKTARVY is one tablet taken orally once daily with or without food in: • adults and pediatric patients weighing at least 25 kg and estimated creatinine clearance greater than or equal to 30 mL per minute; or Gilead Sciences 3 • virologically-suppressed adults with estimated creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of BIKTARVY after completion of hemodialysis treatment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 2.3 Not Recommended in Patients with Severe Renal Impairment BIKTARVY is not recommended in patients with:
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