Spectrum Of Activity
HIV infection, chronic hepatitis B 300 mg PO q24h
Safety and efficacy in pediatric patients <2y of age or <35 kg with HIV infection and <12y of age or <35 kg with chronic hepatitis B have not been established
Age 2-12y: 8 mg/kg PO q24h (max 300 mg)
Age >12y and BW ≥35 kg: 300 mg PO q24h
Chronic hepatitis B
- Age >12y and BW ≥35 kg: 300 mg PO q24h
No dose adjustment
CrCl ≥50CrCl 30-49CrCl 10-29CrCl <10HDNo dose adjustment300 mg PO q48h300 mg PO q72-96hNo data300 mg PO q1w (after hemodialysis session)
Treatment of HIV infection. Chronic hepatitis B virus infection.
Black Box Warning: Severe acute exacerbations of hepatitis B virus have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Screen for HIV-1 prior to initiation.
Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients prior to initiation and during use.
Monitor viral load prior to initiation or modification of treatment.
Monitor CD4 cell counts prior to initiation or with modification of ARV treatment and every 3-6 months; thereafter during at least the first 2 years of treatment
Screen for hepatitis B at baseline and with modification of ARV treatment.
Test for hepatitis C antibody prior to initiation or modification of ARV treatment.
Monitor ALT,AST, and total bilirubin at baseline and with modification of ARV treatment.
Hepatomegaly (with steatosis)
Immune reconstitution syndrome
Acute renal failure
Tubular necrosis (acute)
Antimicrobial class: Antiretroviral agent, Nucleotide reverse transcriptase inhibitor
Average serum half life: 17 hours
Precautions: Coinfection with HIV-1 and HBV increased risk of HIV-resistance; use only with appropriate antiretroviral combination regimen.
Monitoring recommended in patients with renal impairment. Dose adjustment and monitoring recommended in moderate to severe renal impairment (CrCl <50 mL/min).
Proximal renal tubulopathy associated with osteomalacia may occur; immediate evaluation of renal function recommended.
Suspend treatment if lactic acidosis or hepatotoxicity are suspected.