Efavirenz, emtricitabine and tenofovir disoproxil fumarate is the generic equivalent of the brand-name drug Efavirenz, emtricitabine and tenofovir disoproxil fumarate. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Efavirenz, emtricitabine and tenofovir disoproxil fumarate through Premier Pharma with same-day fulfillment on in-stock SKUs.
Clinical Identifiers
- RxCUI
- 643066
- Therapeutic Equivalence (TE) Code
ABTherapeutically equivalent — meets FDA bioequivalence requirements
- Pharmacologic Class
- ["Cytochrome P450 2B6 Inducers [MoA]","Cytochrome P450 2C19 Inhibitors [MoA]","Cytochrome P450 2C9 Inhibitors [MoA]","Cytochrome P450 3A Inducers [MoA]","Cytochrome P450 3A4 Inhibitors [MoA]","Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]","Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]","Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]","Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]","Non-Nucleoside Analog [EXT]","Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]","Nucleoside Reverse Transcriptase Inhibitors [MoA]","Nucleoside Reverse Transcriptase Inhibitors [MoA]","Nucleosides [CS]","Nucleosides [CS]"]
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE 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 adu…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions (5.1) ] . Rash [see Warnings and Precautions (5.2) ] . Hepatotoxicity [see Warnings and Precautions (5.3) ] . Psychiatric Symptoms [see Warnings and Precautions (5.5) ] . Nervous System Symptoms [see Warnings and Precautions (5.6) ] . New Onset or Worsening Renal Impairment [see Warni…
Drug Interactions
7 DRUG INTERACTIONS Consult Full Prescribing Information prior to and during treatment for important potential drug interactions. ( 4 , 5.4 , 7 ) HIV-1 protease inhibitors: Coadministration of efavirenz, emtricitabine and tenofovir disoproxil fumarate with either lopinavir/ritonavir or darunavir and ritonavir increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. Coadministration of efavirenz, emtricitabine and tenofovir disoproxil fumarate with either atazanavir or ataz…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Testing: Consult Full Prescribing Information for important testing recommendations prior to initiation and during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets. ( 2.1 ) 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. ( 2.2 ) Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL/min. ( 2…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV Inform patients that severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued FTC or TDF, and may occur with discontinuation of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets . Advise patients not to discontinue efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets without first informing…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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