Loading…
MYLAN-EMTRICITABINE/TENOFOVIR DISOPROXIL is a brand name for Emtricitabine, 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 .................................................................................................. 5 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Mylan-Emtricitabine/Tenofovir Disoproxil is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
Mylan-Emtricitabine/Tenofovir Disoproxil is contraindicated for use as PrEP in individuals with unknown or positive HIV-1 status. WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of Mylan-Emtricitabine/Tenofovir Disoproxil tablets, alone or in combination with other antiretrovirals (see WARNINGS and PRECAUTIONS).
Post-Treatment Exacerbation of Hepatitis B Mylan-Emtricitabine/Tenofovir Disoproxil is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine and tenofovir DF tablets have not been established in patients co-infected with HBV and HIV.
Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV and have discontinued emtricitabine and tenofovir DF tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue Mylan-Emtricitabine/Tenofovir Disoproxil.
If appropriate, initiation of anti-hepatitis B therapy may be warranted (see WARNINGS and PRECAUTIONS). Nephrotoxicity Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia) has been reported with the use of emtricitabine and tenofovir DF tablets during clinical practice (see WARNINGS and PRECAUTIONS).
Risk of Drug Resistance with Use of Mylan-Emtricitabine/Tenofovir Disoproxil for Pre-Exposure Prophylaxis (PrEP) in Undiagnosed Early HIV-1 Infection Mylan-Emtricitabine/Tenofovir Disoproxil used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically (at least every 3 months) during use.
Drug-resistant HIV-1 variants have been identified with the use of emtricitabine and tenofovir DF tablets for a PrEP indication following undetected acute HIV-1 infection. Do not initiate Mylan-Emtricitabine/Tenofovir Disoproxil for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed (see WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Emtricitabine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
Page 6 of 73 General Mylan-Emtricitabine/Tenofovir Disoproxil should be used in the treatment of HIV-1 infected patients only in combination with other antiretroviral agents. Mylan-Emtricitabine/Tenofovir Disoproxil is a fixed-dose combination of emtricitabine and tenofovir DF.
Mylan-Emtricitabine/Tenofovir Disoproxil should not be co-administered with with other products containing tenofovir DF or emtricitabine (ATRIPLA, COMPLERA, DESCOVY, EMTRIVA®, GENVOYA, ODEFSEY, STRIBILD, or VIREAD®, or with medicinal products containing tenofovir alafenamide (DESCOVY®, GENVOYA®, ODEFSEY and VEMLIDY).
Due to similarities between emtricitabine and lamivudine, Mylan- Emtricitabine/Tenofovir Disoproxil should not be co-administered with other drugs containing lamivudine (COMBIVIR®, 3TC®, HEPTOVIR®, KIVEXA®, TRIUMEQ®, or TRIZIVIR®. Mylan-Emtricitabine/Tenofovir Disoproxil should not be administered with adefovir dipivoxil (HEPSERA®).
Clinical studies in HIV-infected patients have demonstrated that certain regimens that only contain three nucleoside reverse transcriptase inhibitors (NRTI) are generally less effective than triple drug regimens containing two NRTIs in combination with either a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor.
In particular, early virological failure and high rates of resistance mutations have been reported. Triple nucleoside regimens should therefore be used with caution. Patients on a therapy utilizing a triple nucleoside-only regimen should be carefully monitored and considered for treatment modification.
Carcinogenesis, Mutagenesis, Impairment of Fertility Emtricitabine:
In long-term oral carcinogenicity studies of emtricitabine, 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 reverse mutation bacterial test (Ames test), 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 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 exposures at the recommended 200 mg daily dose.
Tenofovir DF:
Tenofovir DF did not show any carcinogenic potential in a long-term oral carcinogenicity study in rats. A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumors, considered likely related to high local concentrations in the gastrointestinal tract at the high dose of 600 mg/kg/day.
Liver adenomas were also seen at the Page 7 of 73 high dose in female mice. The mechanism of tumor formation in mice and potential relevance for humans are uncertain. Tenofovir DF was mutagenic in the in vitro mouse lymphoma assay and negative in an in vitro bacterial mutagenicity test (Ames test).
In an in vivo mouse micronucleus assay, tenofovir DF was negative at doses up to 2000 mg/kg when administered orally to male mice. There were no effects on […]