Tenofovir disoproxil/Emtricitabine

Dosing

원내

HIV infection or post-exposure prophylaxis Tenofovir/Emtricitabine 300/200 mg PO q24h

Truvada (TN) 1 tab = Tenofovir disoproxil fumarate 300 mg + Emtricitabine 200 mg

원내

Safety and efficacy in pediatric patients <12y of age or weighing <35 kg have not been established

HIV infection or post-exposure prophylaxis Age ≥12y or BW ≥35 kg: Tenofovir/Emtricitabine 300/200 mg PO q24h

Truvada (TN) 1 tab = Tenofovir disoproxil fumarate 300 mg + Emtricitabine 200 mg

No dose adjustment

CrCl ≥50CrCl 30-49CrCl <30, HDNo dose adjustment1 tab PO q48hAvoid

General Information

Treatment for pre-exposure HIV infection in at risk patients.

Black Box Warning: Not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of emtricitabine/tenofovir disoproxil fumarate have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine/tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Emtricitabine/tenofovir disoproxil fumarate used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate for a PrEP indication following undetected acute HIV-1 infection. Do not initiate for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

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.

Monitor hepatitis B screening at baseline and with modification of ARV treatment.

Perform hepatitis C antibody testing prior to initiation or modification of ARV treatment.

Perform HIV antibody test prior to initiation of therapy and at least every 3 months and upon diagnosis of any sexually transmitted infections for preexposure prophylaxis (PrEP) in adults and adolescents at high risk.

Monitor ALT,AST, and total bilirubin at baseline and with modification of ARV treatment.

Monitor for several months following therapy discontinuation in patients co-infected with hepatitis B virus and HIV-1.

Common

  • Rash

  • Diarrhea

  • Nausea

  • Backache

  • Myalgia

  • Fatigue

  • Dizziness

  • Headache

  • Depression

  • Dream disorder

  • Pneumonia

Serious

  • Lactic acidosis

  • Pancreatitis

  • Hepatomegaly

  • Immune reconstitution syndrome

  • Osteopenia

  • Rhabdomyolysis

  • Renal failure

  • Fanconi syndrome

Avoid concomitant use:

  • Adefovir

  • Lamivudine

  • NSAIDs

  • Nephrotoxic agents

Multiple drug-drug interactions

Antimicrobial class: Antiretroviral agent, Nucleoside Reverse Transcriptase Inhibitor

Pregnancy category: B

Average serum half life: 10 hours (Emtricitabine), 17 hours (Tenofovir disoproxil)

Precautions: Anti-hepatitis B therapy may be warranted especially in patients with advanced liver disease or cirrhosis.

Proximal renal tubulopathy associated with osteomalacia may occur; immediate evaluation of renal function recommended.

Avoid use for pre-exposure prophylaxis when CrCl <60 mL/min.

Discontinue use if lactic acidosis and severe hepatomegaly with steatosis are suspected.

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