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MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE is a brand name for Efavirenz, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ....................................................................................................................3 CONTRAINDICATIONS ........................................................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs including VIREAD, a component of efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets, alone or in combination with other antiretrovirals (see WARNINGS AND PRECAUTIONS: Hepatic/Biliary/Pancreatic).
Mylan-Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Mylan-Efavirenz/ Emtricitabine/Tenofovir Disoproxil Fumarate have not been established in patients coinfected with HBV and HIV.
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV after the discontinuation of EMTRIVA® or VIREAD®, two of the components of efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets.
In some patients infected with HBV and treated with EMTRIVA, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Hepatic function should be closely monitored with both clinical and laboratory follow-up for at least several months in patients who discontinue efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets and are coinfected with HIV and HBV.
If appropriate, initiation of anti-hepatitis B therapy may be warranted (see WARNINGS AND PRECAUTIONS: Special Populations). Renal failure, renal insufficiency, elevated creatinine, hypophosphatemia, and Fanconi syndrome have been reported with the use of TDF during clinical practice (see WARNINGS AND PRECAUTIONS).
General Mylan-Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate should not be administered with the following related drugs including COMPLERA® (FTC/rilpivirine/TDF), EMTRIVA® (FTC), TRUVADA® (FTC/TDF), STRIBILD® (elvitegravir/cobicistat/FTC/TDF) and VIREAD® (TDF).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Efavirenz in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Due to similarities between FTC and lamivudine, Mylan-Efavirenz/Emtricitabine/ Tenofovir Disoproxil Fumarate should not be administered with drugs containing lamivudine including Combivir® (lamivudine/zidovudine), 3TC® (lamivudine), Heptovir® (lamivudine), Kivexa® (abacavir/lamivudine), Triumeq® (dolutegravir/abacavir/lamivudine) and Trizivir® (abacavir/lamivudine/zidovudine).
Mylan-Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate should not be administered concurrently with drugs containing tenofovir alafenamide (TAF) including DESCOVY® (FTC/TAF) or GENVOYA® (elvitegravir / cobicistat / FTC / TAF), ODEFSEY® (FTC/rilpivirine/TAF), or VEMLIDY® (TAF).
Mylan-Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate should not be administered with HEPSERA® (adefovir dipivoxil). , with rifampin) (see DRUG INTERACTIONS). Page 6 of 75 Clinical trial data of patients who were switched to efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets from a prior PI-containing regimen suggest that they may have lower response rates than patients who remain on their baseline regimens (see CLINICAL TRIALS section).
Therefore, patients who are switched to efavirenz/emtricitabine/tenofovir disoproxil fumarate tablets from a prior PI-containing regimen should be monitored for both treatment-emergent adverse events and rises in viral load.
Carcinogenesis, Mutagenesis, Impairment of Fertility Efavirenz:
Oral carcinogenicity studies in mice and rats were carried out with EFV. Mice were dosed with 0, 25, 75, 150, or 300 mg/kg/day for 2 years. Incidences of hepatocellular adenomas and carcinomas and pulmonary alveolar/bronchiolar adenomas at all doses were increased above background in females.
No increases in tumor incidence above background were seen in males. 7-fold that in humans receiving the 600-mg/day dose. Rats were administered EFV at doses of 0, 25, 50, or 100 mg/kg/day for 2 years; no increases in tumor incidence above background were observed.
The exposure in rats was lower than that in humans. The mechanism of the carcinogenic potential is unknown. However, in genetic toxicology assays, EFV showed no evidence of mutagenic or clastogenic activity in a battery of in vitro and in vivo studies.
These included bacterial mutation assays in S. typhimurium and E. coli, mammalian mutation assays in Chinese hamster ovary cells, chromosome aberration assays in human peripheral blood lymphocytes or Chinese hamster ovary cells, and an in vivo mouse bone marrow micronucleus assay.
Given the lack of genotoxic activity of EFV, the relevance to humans of neoplasms in EFV-treated mice is not known. Efavirenz did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats. The reproductive performance of offspring born to female rats given EFV was not affected.
As a result of the rapid clearance of EFV in rats, systemic drug exposures achieved in these studies were equivalent to or below those achieved in humans given therapeutic doses of EFV.
Emtricitabine:
In long-term oral carcinogenicity studies of FTC, no drug-related increase in tumor incidence was found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/kg/day (31 times the human systemic exposure at the therapeutic dose).
Emtricitabine was not genotoxic in the in vitro reverse mutation bacterial test (Ames test), or in vivo mouse lymphoma or mouse micronucleus assays. Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended Page 7 of 75 200 mg daily dose.
Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60-fold higher than human […]