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MINT-EMTRICITABINE/TENOFOVIR 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.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Adverse Reactions from Clinical Trials Experience in HIV-1 Infected Subjects Emtricitabine and tenofovir DF tablets: Four hundred and forty-seven HIV-1 infected patients have received combination therapy with emtricitabine or tenofovir DF with either a non- nucleoside reverse transcriptase inhibitor or protease inhibitor for 48 weeks in ongoing clinical studies.
Study 934 - Treatment Emergent Adverse Events:
Assessment of adverse reactions is based on data from Study 934 in which 511 antiretroviral-naïve patients received either emtricitabine + tenofovir DF administered in combination with efavirenz (N=257) or Combivir (lamivudine/zidovudine) administered in combination with efavirenz (N=254).
Adverse events observed in this study were generally consistent with those seen in other studies in treatment experienced or treatment-naïve patients (Table 1). MINT-EMTRICITABINE/TENOFOVIR Page 16 of 66 Table 1. Selected Treatment-Emergent Adverse Events (Grades 2–4) Reported in 3% in Any Treatment Group in Study 934 (0–48 Weeks) Emtricitabine +Tenofovir disoproxil fumarate + EFV AZT/3TC+EFV N=257 N=254 Blood and Lymphatic System Disorders Anemia 1% 5% Gastrointestinal Disorder Diarrhea Nausea Vomiting 7% 8% 1% 4% 6% 4% General Disorders and Administration Site Condition Fatigue 7% 6% Infections and Infestations Sinusitis Upper respiratory tract infections Nasopharyngitis 4% 3% 3% 2% 3% 1% Nervous System Disorders Somnolence Headache Dizziness 3% 5% 8% 2% 4% 7% Psychiatric Disorders Depression Insomnia Abnormal dreams 4% 4% 4% 7% 5% 3% Skin and Subcutaneous Tissue Disorders Rash 5% 4% Patients who received treatment up to 144 weeks in Study 934 reported adverse events similar in nature and severity to those reported in the first 48 weeks.
Through 48 weeks, 7 patients in the emtricitabine + tenofovir DF group and 5 patients in the lamivudine/zidovudine group experienced a new CDC Class C event (10 and 6 patients, respectively, through 144 weeks). Renal safety assessed by laboratory abnormalities was similar in the two groups and no patient discontinued study drug due to renal events.
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 DF, a component of MINT-EMTRICITABINE/ TENOFOVIR, alone or in combination with other antiretrovirals (see WARNINGS AND PRECAUTIONS).
Post-Treatment Exacerbation of Hepatitis B MINT-EMTRICITABINE/TENOFOVIR is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine and tenofovir DF 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. 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 MINT-EMTRICITABINE/TENOFOVIR.
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 during clinical practice (see WARNINGS AND PRECAUTIONS).
Risk of Drug Resistance with Use of MINT-EMTRICITABINE/TENOFOVIR for Pre-Exposure Prophylaxis (PrEP) in Undiagnosed Early HIV-1 Infection MINT-EMTRICITABINE/TENOFOVIR 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 for a PrEP indication following undetected acute HIV-1 infection. Do not initiate MINT-EMTRICITABINE/ TENOFOVIR 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.
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MINT-EMTRICITABINE/TENOFOVIR Page 17 of 66 At Weeks 48 and 144, total limb fat (as measured by dual-energy x-ray absorptiometry) was significantly less in a subgroup of patients in the lamivudine/zidovudine group compared to the tenofovir/emtricitabine subgroup (see Table 2).
Table 2. 001 for the comparison between arms Laboratory Abnormalities: Laboratory Abnormalities observed in this study were generally consistent with those seen in other studies (Table 3). Table 3. 0 mg/dL) 0% 3% Hyperglycemia (250 mg/dl) 1% 1% Hematuria (75 RBC/HPF) 2% 2% Neutrophil (750/mm3) 3% 4% Fasting Triglycerides (750 mg/dL) 4% 2% Laboratory abnormalities in patients who received treatment up to 144 weeks in Study 934 were consistent with those observed in the first 48 weeks of treatment.
In addition to the events described above for Study 934, other adverse events that occurred in at least 3-5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials include: anorexia, anxiety, arthralgia, asthenia, increased cough, depressive disorders, dyspepsia, fever, flatulence, myalgia, pain, abdominal pain, back pain, chest pain, paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy), pneumonia, rhinitis and rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash and allergic reaction), sweating and weight loss.
Skin discoloration has been reported with higher frequency among emtricitabine treated patients. Skin discoloration mainly manifested by hyperpigmentation on the palms and/or soles was generally mild and asymptomatic and of little clinical significance.
The mechanism is unknown. 0 x ULN), and urine glucose (3+) occurred in up to 3% of patients treated with emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials. For more information, please consult the emtricitabine and tenofovir DF Product Monographs.
In Study 903 through 144 weeks, decreases from baseline in bone mineral density (BMD) were seen at the lumbar spine and hip in both arms of the study. At Week 144, there was a significantly greater mean percentage decrease from baseline in BMD at the lumbar spine in patients in the tenofovir DF group compared with patients in the stavudine group (see Table […]
General MINT-EMTRICITABINE/TENOFOVIR should be used in the treatment of HIV-1 infected patients only in combination with other antiretroviral agents. MINT-EMTRICITABINE/TENOFOVIR is a fixed-dose combination of emtricitabine and tenofovir DF.
MINT-EMTRICITABINE/TENOFOVIR should not be coadministered 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, MINT-EMTRICITABINE/TENOFOVIR should not be coadministered with other drugs containing lamivudine (Combivir®, 3TC®, Heptovir®, Kivexa®, Triumeq®, or Trizivir®). MINT-EMTRICITABINE/TENOFOVIR should not be administered with adefovir dipivoxil (HEPSERA).
MINT-EMTRICITABINE/TENOFOVIR Page 7 of 66 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 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 fertility, mating performance or early embryonic development when tenofovir DF was administered at 600 mg/kg/day to male rats for 28 days prior to mating and to female rats for 15 days prior to mating through day seven of gestation.
There was, however, an alteration of the estrous cycle in female rats. A dose of 600 mg/kg/day is equivalent to 19 times the human dose based on body surface area comparisons. Drug Interactions Use with Certain HCV Regimens Tenofovir exposure is increased when MINT-EMTRICITABINE/TENOFOVIR is coadministered with HARVONI® (ledipasvir/sofosbuvir), EPCLUSA® […]