428 0 obj <>stream HIV-1–negative status must be confirmed immediately prior to initiation. Do not initiate DESCOVY for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

b) Blister pack: (i) 250µm white rigid PVC. *魅�����n��~8�Nu�'� ��La�퇻2�����tO���~��"�z?ȵp|����>X��A��~���AMt�\����ႾPCn�L���.��7,�i;7! Population pharmacokinetics analysis of HIV-infected subjects in Phase 2 and Phase 3 trials of FTC+TAF and EVG+COBI showed that age did not have a clinically relevant effect on exposures of TAF up to 75 years of age Exposures of FTC and TAF achieved in 23 pediatric subjects between the ages of 6 to less than 12 years and weighing at least 25 kg (55 lbs) who received FTC+TAF with EVG+COBI were higher (20% to 80% for AUC) than exposures achieved in adults following the administration of this dosage regimen; however, the increase was not considered clinically significant (Table 9) Based on population pharmacokinetic analyses, there are no clinically meaningful differences based on race or gender.The pharmacokinetics of FTC+TAF combined with EVG+COBI in HIV-1 infected subjects with renal impairment (eGFR 30 to 69 mL per minute by Cockcroft-Gault method), and in HIV-1 infected subjects with ESRD (eGFR less than 15 mL per minute by Cockcroft-Gault method) receiving chronic hemodialysis were evaluated in subsets of virologically-suppressed subjects in open-label trials.
Hepatic function should be monitored closely in these individuals. In a study of virally suppressed subjects with baseline estimated creatinine clearance between 30 and 69 mL per minute treated with FTC+TAF with EVG+COBI for a median duration of 43 weeks, FTC+TAF with EVG+COBI was permanently discontinued due to worsening renal function in two of 80 (3%) subjects with a baseline estimated creatinine clearance between 30 and 50 mL per minute Individuals taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including non-steroidal anti-inflammatory drugs are at increased risk of developing renal-related adverse reactions.Prior to or when initiating DESCOVY, and during treatment with DESCOVY on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. For both DESCOVY and TRUVADA, efficacy was therefore strongly correlated to adherence to daily dosing.DESCOVY 200 mg/25 mg tablets are blue, rectangular-shaped, and film-coated with "GSI" debossed on one side and "225" on the other side.Each bottle contains 30 tablets (NDC 61958-2002-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure.Each blister pack contains 30 tablets (NDC 61958-2002-2).Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Advise the patient to read the FDA-approved patient labeling (Medication Guide).Advise HIV-1 uninfected individuals about the following Inform individuals that severe acute exacerbations of hepatitis B have been reported in patients who are infected with HBV and have discontinued products containing FTC and/or TDF and may likewise occur with discontinuation of DESCOVY Advise HIV-1 infected patients to inform their healthcare provider immediately of any symptoms of infection. �Q A�"�\�d.

The safety and efficacy of FTC+TAF with EVG+COBI in these pediatric subjects was similar to that of HIV-1 infected adults on this regimen Use of DESCOVY in pediatric patients weighing at least 25 kg is supported by adequate and well controlled studies of FTC+TAF with EVG+COBI in adults and by an open-label trial in virologically-suppressed pediatric subjects between the ages of 6 to less than 12 years weighing at least 25 kg, in which subjects were switched from their antiretroviral regimen to FTC+TAF with EVG+COBI (N=23; cohort 2).

WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTIONWARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTIONSevere acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who 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 individuals who are infected with HBV and discontinue DESCOVY. The indication does not include use of DESCOVY in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated. HBV-uninfected individuals should be offered vaccination.Immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including FTC, a component of DESCOVY.

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