Testing Prior to Initiation and During Treatment with SYMFI LO

Prior to initiation of SYMFI LO, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)].

It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating SYMFI LO and during therapy in all patients as clinically appropriate [see Warnings and Precautions (5.4)].

Monitor hepatic function prior to and during treatment with SYMFI LO [see Warnings and Precautions (5.9)].

Recommended Dosage for Adult and Pediatric Patients Weighing at Least 35 kg

SYMFI LO is a three-drug fixed-dose combination product containing 400 mg of efavirenz (EFV), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF). The recommended dosage of SYMFI LO in HIV-1-infected adults and pediatric patients weighing at least 35 kg is one tablet taken orally once daily. SYMFI LO tablets should be taken on an empty stomach, preferably at bedtime. Dosing at bedtime may improve the tolerability of nervous system symptoms [see Warnings and Precautions (5.6) and Adverse Reactions (6.1)].

Not Recommended in Renal Impairment

Because SYMFI LO is a fixed-dose combination tablet and cannot be dose adjusted, it is not recommended for patients with impaired renal function (creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis [see Use in Specific Populations (8.6)].

Not Recommended in Moderate to Severe Hepatic Impairment

SYMFI LO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) [see Warnings and Precautions (5.9) and Use in Specific Populations (8.7)].