Finished product reference
Efavirenz / Lamivudine / Tenofovir Disoproxil Fumarate
Tablet · Oral · 400 mg/300 mg/300 mg
- List code
- 53194
- Pharmacologic class
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor · Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor · Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine or tenofovir disoproxil fumarate, two components of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
What it is and how it works
Mechanism of Action Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are a fixed-dose combination of antiviral drugs EFV, 3TC, and TDF with antiviral activity against HIV-1 .
Mechanism class: Non-Nucleoside Reverse Transcriptase Inhibitors · Cytochrome P450 3A Inducers · Cytochrome P450 2B6 Inducers
Indications
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
Dosage and administration (summary)
Testing: Prior to initiation and during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, patients should be tested for hepatitis B virus infection, and estimated creatinine clearance, urine glucose, and urine protein should be obtained. Recommended dose: One tablet taken orally once daily on an empty stomach, preferably at bedtime. Renal Impairment: Not recommended in patients with CrCL less than 50 mL/min or patients with end-stage renal disease requiring hemodialysis. Hepatic Impairment: Not recommended for patients with moderate or severe hepatic impairment. Use caution in patients with mild hepatic impairment.
Contraindications
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are contraindicated: in patients with a previous hypersensitivity reaction (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components contained in the formulation . when coadministered with elbasvir and grazoprevir .
Warnings and precautions
Lactic Acidosis/Severe Hepatomegaly with Steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. New Onset or Worsening Renal Impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering efavirenz, lamivudine and tenofovir disoproxil fumarate tablets with concurrent or recent use of nephrotoxic drugs. Serious Psychiatric Symptoms: Immediate medical evaluation is recommended for serious psychiatric symptoms such as severe depression or suicidal ideation.
Pregnancy
Pregnancy Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
Storage and supply
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets 600 mg/300 mg/300 mg are white colored, capsule shaped, biconvex, film coated tablets, debossed with ‘L65’ on one side and plain on the other side.
Source: Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate (Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate) — US FDA prescribing information, 2023-11-15, 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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