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These Highlights Do Not Include All the Information Needed to Use DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR ALAFENAMIDE TABLETS Saely and Effectiv

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These Highlights Do Not Include All the Information Needed to Use DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR ALAFENAMIDE TABLETS Saely and Effectiv These highlights do not include all the information needed to use DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR ALAFENAMIDE TABLETS saely and effectiv... DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE- dolutegravir, lamivudine and tenofovir alafenamide tablet, film coated Mylan Laboratories Limited ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION • Coadministration with dofetilide. (4) These highlights do not include all the information needed to use DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR WARNINGS AND PRECAUTIONS ALAFENAMIDE TABLETS saely and effectively. See full • prescribing information for DOLUTEGRAVIR, LAMIVUDINE Hypersensitivity reactions characterized by rash, constitutional and TENOFOVIR ALAFENAMIDE TABLETS. findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue dolutegravir, lamivudine DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR and tenofovir alafenamide tablets and other suspect agents ALAFENAMIDE tablets, for oral use immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life- Initial U.S. Approval: threatening reaction. (5.2) • Hepatotoxicity has been reported in patients receiving WARNING: POSTTREATMENT EXACERBATIONS OF dolutegravir-containing regimens. Patients with underlying HEPATITIS B hepatitis B or C may be at increased risk for worsening or development of transaminase elevations. Monitoring for See full prescribing information for complete boxed warning. hepatotoxicity is recommended. (5.3) Severe acute exacerbations of hepatitis B virus (HBV) have • Embryo-fetal toxicity may occur when used at the time of been reported in HBV-infected patients who have conception and in early pregnancy. Avoid use of dolutegravir, discontinued products containing lamivudine (3TC) and/or lamivudine and tenofovir alafenamide tablets at the time of tenofovir disoproxil fumarate (TDF) and may occur with conception through the first trimester of pregnancy due to the risk discontinuation of dolutegravir, lamivudine and tenofovir of neural tube defects. Advise adolescents and adults of alafenamide tablets. Monitor hepatic function closely in childbearing potential to use effective contraception. (2.1, 5.4, HBV-infected patients who discontinue dolutegravir, 8.1, 8.3) lamivudine and tenofovir alafenamide tablets. If appropriate, • New onset or worsening renal impairment: Assess creatinine initiation of anti-HBV therapy may be warranted. (5.1) clearance, urine glucose, and urine protein in all patients before INDICATIONS AND USAGE initiating dolutegravir, lamivudine and tenofovir alafenamide Dolutegravir, lamivudine and tenofovir alafenamide tablets, a tablets therapy and monitor during therapy. Monitor serum combination of dolutegravir (integrase strand transfer inhibitor phosphorus in patients with chronic kidney disease. (5.6) [INSTI]), lamivudine, and tenofovir alafenamide (both nucleoside • Immune reconstitution syndrome: Observed in HIV-infected reverse transcriptase inhibitors), is indicated as a complete regimen for patients. May necessitate further evaluation and treatment (5.7) the treatment of HIV-1 infection in adults and pediatric patients • Lactic acidosis and severe hepatomegaly with steatosis: weighing at least 40 kg. (1) Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced Limitations of Use: hepatotoxicity. (5.8) • Pancreatitis: Use with caution in pediatric patients with a history • Dolutegravir, lamivudine and tenofovir alafenamide tablets alone of pancreatitis or other significant risk factors for pancreatitis. is not recommended in patients with resistance-associated Discontinue treatment as clinically appropriate. (5.9) integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir in ADVERSE REACTIONS dolutegravir, lamivudine and tenofovir alafenamide tablets is insufficient in these subpopulations. See the dolutegravir • The most common adverse reactions (in those receiving the prescribing information. (1) components of dolutegravir, lamivudine and tenofovir alafenamide) are nausea, insomnia, fatigue, headache, diarrhea, DOSAGE AND ADMINISTRATION and depression. (6.1) • Pregnancy Testing: Perform pregnancy testing before initiation of To report SUSPECTED ADVERSE REACTIONS, contact Mylan dolutegravir, lamivudine and tenofovir alafenamide tablets in at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at adolescents and adults of childbearing potential. (2.1, 5.4) 1-800-FDA-1088 or www.fda.gov/medwatch. • Testing: Prior to or when initiating dolutegravir, lamivudine and DRUG INTERACTIONS tenofovir alafenamide tablets, test for HBV infection. Prior to Coadministration of dolutegravir, lamivudine and tenofovir initiation and during use of dolutegravir, lamivudine and alafenamide tablets with other drugs can alter the concentration of other tenofovir alafenamide tablets, on a clinically appropriate drugs and other drugs may alter the concentrations of dolutegravir, schedule, assess serum creatinine, estimated creatinine clearance, lamivudine and tenofovir alafenamide tablets. The potential drug-drug urine glucose, and urine protein in all patients. In patients with interactions must be considered prior to and during therapy. (4, 7, 12.3) 54b23133-e188-4520-974f-6fdb870113e5.xml[1/14/2020 12:07:19 PM] These highlights do not include all the information needed to use DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR ALAFENAMIDE TABLETS saely and effectiv... chronic kidney disease, also assess serum phosphorous. (2.1) USE IN SPECIFIC POPULATIONS • Recommended dose in adults and pediatric patients weighing at least 40 kg: One tablet daily. May be taken with or without food. • Pregnancy: Avoid use of dolutegravir, lamivudine and tenofovir (2.2) alafenamide tablets at the time of conception through the first • Because dolutegravir, lamivudine and tenofovir alafenamide trimester due to the risk of neural tube defects. (2.1, 5.4, 8.1) tablets is a fixed-dose product and cannot be dose adjusted, • Lactation: Breastfeeding is not recommended due to the potential dolutegravir, lamivudine and tenofovir alafenamide tablets is not for HIV-1 transmission. (8.2) recommended in patients requiring dosage adjustment, patients • Females and males of reproductive potential: Pregnancy testing with creatinine clearance less than 50 mL per minute, or patients and contraception are recommended in adolescents and adults of with end-stage renal disease requiring hemodialysis. (2.3) childbearing potential. (8.3) • DOSAGE FORMS AND STRENGTHS Pediatrics: Not recommended for patients weighing less than 40 Tablet: 50 mg of dolutegravir, 300 mg of lamivudine, and 25 mg of kg. (8.4) tenofovir alafenamide (3) • Dolutegravir, lamivudine and tenofovir alafenamide tablets is not CONTRAINDICATIONS recommended in patients with creatinine clearance less than 50 mL per min or patients with end-stage renal disease requiring • Previous hypersensitivity reaction to dolutegravir, lamivudine, or hemodialysis. (8.6) tenofovir alafenamide. (4) See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling. Revised: 9/2019 FULL PRESCRIBING INFORMATION: 7.5 Drugs Affecting Renal Function with TAF CONTENTS* 8 USE IN SPECIFIC POPULATIONS WARNING: POSTTREATMENT 8.1 Pregnancy EXACERBATIONS OF HEPATITIS B 8.2 Lactation 1 INDICATIONS AND USAGE 8.3 Females and Males of Reproductive Potential 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 2.1 Testing Prior to Initiation and During Treatment 8.5 Geriatric Use with Dolutegravir, Lamivudine and Tenofovir 8.6 Renal Impairment Alafenamide Tablets 8.7 Hepatic Impairment 2.2 Recommended Dosage 10 OVERDOSAGE 2.3 Not Recommended Due to Lack of Dosage 11 DESCRIPTION Adjustment 12 CLINICAL PHARMACOLOGY 3 DOSAGE FORMS AND STRENGTHS 12.1 Mechanism of Action 4 CONTRAINDICATIONS 12.2 Pharmacodynamics 5 WARNINGS AND PRECAUTIONS 12.3 Pharmacokinetics 5.1 Severe Acute Exacerbation of Hepatitis B in 12.4 Microbiology Patients with HBV Infection 13 NONCLINICAL TOXICOLOGY 5.2 Hypersensitivity Reactions 13.1 Carcinogenesis, Mutagenesis, Impairment of 5.3 Hepatotoxicity Fertility 5.4 Embryo-Fetal Toxicity 13.2 Animal Toxicology and/or Pharmacology 5.5 Risk of Adverse Reactions or Loss of Virologic 14 CLINICAL STUDIES Response Due to Drug Interactions 14.1 Adult Subjects 5.6 New Onset or Worsening Renal Impairment 14.2 Pediatric Subjects 5.7 Immune Reconstitution Syndrome 16 HOW SUPPLIED/STORAGE AND HANDLING 5.8 Lactic Acidosis and Severe Hepatomegaly with 17 PATIENT COUNSELING INFORMATION Steatosis * Sections or subsections omitted from the full prescribing 5.9 Pancreatitis information are not listed. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Effect of Dolutegravir, 3TC, or TAF on the 54b23133-e188-4520-974f-6fdb870113e5.xml[1/14/2020 12:07:19 PM] These highlights do not include all the information needed to use DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR ALAFENAMIDE TABLETS saely and effectiv... Pharmacokinetics of Other Agents 7.2 Effect of Other Agents on the Pharmacokinetics of Dolutegravir, 3TC, or TAF 7.3 Significant Drug Interactions for Dolutegravir, 3TC, or TAF 7.4 Drugs without Clinically Significant Interactions with Dolutegravir or TAF FULL PRESCRIBING INFORMATION WARNING: POSTTREATMENT EXACERBATIONS OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued products
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