Finished product reference
Emtricitabine / Tenofovir Disoproxil Fumarate / Efavirenz
Tablet · Oral · 200 mg/300 mg/600 mg
- List code
- 51351
- Pharmacologic class
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor · Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), which are components of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets.
What it is and how it works
Mechanism of Action Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is a fixed-dose combination of antiviral drugs EFV, FTC, and TDF .
Mechanism class: Non-Nucleoside Reverse Transcriptase Inhibitors · Cytochrome P450 3A Inducers · Cytochrome P450 2B6 Inducers
Indications
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
Dosage and administration (summary)
• Testing: Consult Full Prescribing Information for important testing recommendations prior to initiation and during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets. • Recommended dosage in adults and pediatric patients weighing at least 40 kg: One tablet once daily taken orally on an empty stomach, preferably at bedtime. • Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL/min. • Hepatic impairment: Not recommended in patients with moderate to severe hepatic impairment. • Dosage adjustment with rifampin coadministration: An additional 200 mg/day of efavirenz is recommended for patients weighing 50 kg or more.
Contraindications
• Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets .
Warnings and precautions
• Rash: Discontinue if severe rash develops. ( 5.2 , 6.1 ) • Hepatotoxicity: Monitor liver function tests before and during treatment in patients with underlying hepatic disease, including hepatitis B or C coinfection, marked transaminase elevations, or who are taking medications associated with liver toxicity. Among reported cases of hepatic failure, a few occurred in patients with no pre-existing hepatic disease.
Pregnancy
Pregnancy Antiretroviral Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and tenofovir disoproxil fumarate during pregnancy.
Storage and supply
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets 600 mg/200 mg/300 mg are white to off-white colored, capsule shaped, film-coated tablets debossed with ‘H’ on one side and ‘128’ on the other side. Each bottle contains 30 tablets (NDC 31722-736-30) and silica gel desiccant, and is closed with a child-resistant closure.
Source: Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate (Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate) — US FDA prescribing information, 2022-07-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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