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Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate) Initiating Treatment with ATRIPLA and Periodically During Tablets, for Oral Use Treatment

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Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate) Initiating Treatment with ATRIPLA and Periodically During Tablets, for Oral Use Treatment HIGHLIGHTS OF PRESCRIBING INFORMATION New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine These highlights do not include all the information needed to use clearance before initiating treatment with ATRIPLA. In patients at ATRIPLA safely and effectively. See full prescribing information risk for renal dysfunction, assess estimated creatinine clearance, for ATRIPLA. serum phosphorus, urine glucose and urine protein before ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) initiating treatment with ATRIPLA and periodically during tablets, for oral use treatment. Avoid administering ATRIPLA with concurrent or recent use of nephrotoxic drugs. (5.7) Initial U.S. Approval: 2006 Pregnancy: Fetal harm may occur when administered to a WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH pregnant woman during the first trimester. Women should be STEATOSIS and POST TREATMENT EXACERBATION OF apprised of the potential harm to the fetus. A pregnancy registry HEPATITIS B is available. (5.8, 8.1) See full prescribing information for complete boxed warning. Rash: Discontinue if severe rash develops. (5.9, 6.1) Lactic acidosis and severe hepatomegaly with steatosis, Hepatotoxicity: Monitor liver function tests before and during including fatal cases, have been reported with the use of treatment in patients with underlying hepatic disease, including nucleoside analogs, including tenofovir disoproxil hepatitis B or C coinfection, marked transaminase elevations, or fumarate, a component of ATRIPLA. (5.1) who are taking medications associated with liver toxicity. Among reported cases of hepatic failure, a few occurred in patients with ATRIPLA is not approved for the treatment of chronic no pre-existing hepatic disease. (5.10, 6.3, 8.6) hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients Decreases in bone mineral density (BMD): Consider assessment coinfected with HBV and HIV-1 who have discontinued of BMD in patients with a history of pathological fracture or other EMTRIVA or VIREAD, two of the components of ATRIPLA. risk factors for osteoporosis or bone loss. (5.11) Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy Convulsions: Use caution in patients with a history of seizures. may be warranted. (5.2) (5.12) Immune reconstitution syndrome: May necessitate further ---------------------------RECENT MAJOR CHANGES--------------------------- evaluation and treatment. (5.13) Contraindications (4.2) 01/2015 Warnings and Precautions, Rash (5.9) 01/2015 Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy. (5.14) -------------------------------INDICATIONS AND USAGE------------------------- ATRIPLA, a combination of 2 nucleoside analog HIV-1 reverse Coadministration with other products: Do not use with drugs transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse containing emtricitabine or tenofovir disoproxil fumarate including transcriptase inhibitor, is indicated for use alone as a complete COMPLERA, EMTRIVA, STRIBILD, TRUVADA, or VIREAD; or regimen or in combination with other antiretroviral agents for the with drugs containing lamivudine. SUSTIVA (efavirenz) should treatment of HIV-1 infection in adults and pediatric patients 12 years of not be coadministered with ATRIPLA unless required for dose- age and older. (1) adjustment when coadministered with rifampin. (5.4) Do not administer in combination with HEPSERA. (5.2) ---------------------------DOSAGE AND ADMINISTRATION-------------------- --------------------------------ADVERSE REACTIONS----------------------------- Recommended dose in adults and pediatric patients (12 years of age and older and weighing at least 40 kg): One tablet once daily Most common adverse reactions (incidence greater than or equal to taken orally on an empty stomach, preferably at bedtime. (2) 10%) observed in an active-controlled clinical trial of efavirenz, emtricitabine, and tenofovir DF are diarrhea, nausea, fatigue, Dose in renal impairment: Should not be administered in patients headache, dizziness, depression, insomnia, abnormal dreams, and with estimated creatinine clearance below 50 mL/min. (2) rash. (6) With rifampin coadministration, an additional 200 mg/day of To report SUSPECTED ADVERSE REACTIONS, contact Gilead efavirenz is recommended for patients weighing 50 kg or more. Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or (2) www.fda.gov/medwatch --------------------------DOSAGE FORMS AND STRENGTHS----------------- ---------------------------------DRUG INTERACTIONS---------------------------- Tablet containing 600 mg of efavirenz, 200 mg of emtricitabine and Efavirenz: Coadministration of efavirenz can alter the 300 mg of tenofovir disoproxil fumarate. (3) concentrations of other drugs and other drugs may alter the concentrations of efavirenz. The potential for drug-drug ---------------------------------CONTRAINDICATIONS----------------------------- interactions must be considered before and during therapy. (4.2, Previously demonstrated hypersensitivity (e.g., Stevens-Johnson 7.1, 12.3) syndrome, erythema multiforme, or toxic skin eruptions) to Didanosine: Tenofovir disoproxil fumarate increases didanosine efavirenz, a component of ATRIPLA. (4.1) concentrations. Use with caution and monitor for evidence of Coadministration with voriconazole due to a significant drug didanosine toxicity (e.g., pancreatitis, neuropathy) when interaction with efavirenz, a component of ATRIPLA, that may coadministered. Consider dose reductions or discontinuations of decrease the therapeutic effectiveness of voriconazole and didanosine if warranted. (7.2) increase the risk of efavirenz-associated side effects. (4.2) HIV-1 protease inhibitors: Coadministration of ATRIPLA with ---------------------------WARNINGS AND PRECAUTIONS-------------------- either lopinavir/ritonavir or darunavir and ritonavir increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. Serious psychiatric symptoms: Immediate medical evaluation is Coadministration of ATRIPLA with either atazanavir or atazanavir recommended. (5.5, 6.1) and ritonavir is not recommended. (7.3) Nervous system symptoms (NSS): NSS are frequent, usually --------------------------USE IN SPECIFIC POPULATIONS------------------ begin 1-2 days after initiating therapy and resolve in 2-4 weeks. Dosing at bedtime may improve tolerability. NSS are not Pregnancy: Women should avoid pregnancy while receiving predictive of onset of psychiatric symptoms. (2, 5.6) ATRIPLA and for 12 weeks after discontinuation. (5.8) Bristol-Myers Squibb and Gilead Sciences, LLC 1 Reference ID: 3846716 Nursing mothers: Women infected with HIV should be instructed not to breastfeed. (8.3) Hepatic impairment: ATRIPLA is not recommended for patients with moderate or severe hepatic impairment. Use caution in patients with mild hepatic impairment. (5.10, 8.6) Pediatrics: The incidence of rash was higher than in adults. (5.9, 6.1) See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling. Revised: 11/2015 Bristol-Myers Squibb and Gilead Sciences, LLC 2 Reference ID: 3846716 6.3 Postmarketing Experience FULL PRESCRIBING INFORMATION: CONTENTS* 7 DRUG INTERACTIONS WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY 7.1 Efavirenz WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B 7.2 Emtricitabine and Tenofovir Disoproxil Fumarate 1 INDICATIONS AND USAGE 7.3 Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate 2 DOSAGE AND ADMINISTRATION 7.4 Efavirenz Assay Interference 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 8 USE IN SPECIFIC POPULATIONS 4.1 Hypersensitivity 8.1 Pregnancy 4.2 Contraindicated Drugs 8.3 Nursing Mothers 5 WARNINGS AND PRECAUTIONS 8.4 Pediatric Use 5.1 Lactic Acidosis/Severe Hepatomegaly with Steatosis 8.5 Geriatric Use 5.2 Patients Coinfected with HIV-1 and HBV 8.6 Hepatic Impairment 5.3 Drug Interactions 8.7 Renal Impairment 5.4 Coadministration with Related Products 10 OVERDOSAGE 5.5 Psychiatric Symptoms 11 DESCRIPTION 5.6 Nervous System Symptoms 12 CLINICAL PHARMACOLOGY 5.7 New Onset or Worsening Renal Impairment 12.1 Mechanism of Action 5.8 Reproductive Risk Potential 12.3 Pharmacokinetics 5.9 Rash 12.4 Microbiology 5.10 Hepatotoxicity 13 NONCLINICAL TOXICOLOGY 5.11 Bone Effects of Tenofovir DF 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.12 Convulsions 13.2 Animal Toxicology and/or Pharmacology 5.13 Immune Reconstitution Syndrome 14 CLINICAL STUDIES 5.14 Fat Redistribution 16 HOW SUPPLIED/STORAGE AND HANDLING 6 ADVERSE REACTIONS 17 PATIENT COUNSELING INFORMATION 6.1 Adverse Reactions from Clinical Trials Experience * Sections or subsections omitted from the full prescribing information 6.2 Laboratory Abnormalities are not listed Bristol-Myers Squibb and Gilead Sciences, LLC 3 Reference ID: 3846716 FULL PRESCRIBING INFORMATION WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of ATRIPLA, in combination with other antiretrovirals [See Warnings and Precautions (5.1)]. ATRIPLA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of ATRIPLA have not been
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