Classes
DEA Class; Rx
Common Brand Names; Truvada
- HIV, ART Combos
Description
Combination product of a nucleotide and a nucleoside reverse transcriptase inhibitor
Used in combination with other antiretroviral agents for the treatment of HIV infection, and in combination with safe sex practices for HIV pre-exposure prophylaxis in adults and adolescents without HIV weighing more than 35 kg
Black Box warning for severe, acute exacerbations of hepatitis B virus (HBV) in patients with HBV who have discontinued emtricitabine; tenofovir disoproxil fumarate
Indications
Indicated in combination with other antiretroviral (ART) agents in adults and adolescents weighing at least 35 kg
Indicated in combination with safer sex practices to reduce risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing ≥35 kg
Treatment of Hepatitis B / HIV-1 Coinfection (Off-label)
Contraindications
Hypersensitivity
Do not use as PrEP in HIV-infected individuals or individuals with unknown HIV status
Use as monotherapy in HIV-infected patients
Adverse Effects
- Diarrhea
- Nausea
- Fatigue
- Headache
- Dizziness
- Depression
- Insomnia
- Abnormal dreams
- Rash
- Diarrhea (9%)
- Nausea (9%)
- Fatigue (9%)
- Depression (9%)
- Sinusitis (8%)
- URI infections (8%)
- Dizziness (8%)
- Rash event (7%)
- Headache (6%)
- Nasopharyngitis (5%)
- Insomnia (5%)
- Vomiting (2%)
Warnings
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues, including emtricitabine and tenofovir; suspend dosing in those who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
Do not coadminister with other drugs containing emtricitabine or tenofovir
Severe exacerbation of hepatitis B may occur upon discontinuation (see Black Box Warning)
Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis); autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) have also been reported
Pregnancy and Lactation
Data on the use during pregnancy from observational studies have shown no increased risk of major birth defects
Emtricitabine and tenofovir have been shown to be present in human breast milk
Maximum Dosage
200 mg/day emtricitabine and 300 mg/day tenofovir DF PO is FDA-approved maximum; however, intermittent doses of 400 mg/day emtricitabine and 600 mg/day tenofovir DF PO have been used off-label for HIV pre-exposure prophylaxis.
200 mg/day emtricitabine and 300 mg/day tenofovir DF PO is FDA-approved maximum; however, intermittent doses of 400 mg/day emtricitabine and 600 mg/day tenofovir DF PO have been used off-label for HIV pre-exposure prophylaxis.
weight 35 kg or more: 200 mg/day emtricitabine and 300 mg/day tenofovir DF PO.
weight 28 to 34 kg: 167 mg/day emtricitabine and 250 mg/day tenofovir DF PO.
weight 35 kg or more: 200 mg/day emtricitabine and 300 mg/day tenofovir DF PO.
weight 28 to 34 kg: 167 mg/day emtricitabine and 250 mg/day tenofovir DF PO.
weight 22 to 27 kg: 133 mg/day emtricitabine and 200 mg/day tenofovir DF PO.
weight 17 to 21 kg: 100 mg/day emtricitabine and 150 mg/day tenofovir DF PO.
weight less than 17 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Emtricitabine/tenofovir disoproxil fumarate
tablet
- 200mg/300mg
