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APO-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.
Recommended Dose Treatment of HIV-1 Infection The dose of APO-EMTRICITABINE-TENOFOVIR is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food. Pre-exposure Prophylaxis of HIV-1 Infection The dose of APO-EMTRICITABINE-TENOFOVIR is one tablet (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.
Special Populations Dose Adjustment for Renal Impairment Treatment of HIV-1 Infection Significantly increased drug exposures occurred when emtricitabine or tenofovir disoproxil fumarate were administered to patients with moderate to severe renal impairment (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency).
Therefore, the dosing interval of APO-EMTRICITABINE- TENOFOVIR should be adjusted in HIV-1 infected adult patients with baseline creatinine clearance 30 to 49 mL/min using the recommendations in Table 13. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis.
The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in moderate to severe renal impairment, therefore, clinical response to treatment and renal function should be closely monitored in these patients.
No dose adjustment of APO-EMTRICITABINE-TENOFOVIR tablets is necessary with mild renal impairment patients (creatinine clearance 50 to 80 mL/min). Routine monitoring of calculated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed for patients with mild renal impairment (creatinine clearance 50 to 80 mL/min).
(see WARNINGS AND PRECAUTIONS). Page 34 of 64 Table 13 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min)1 50 30–49 <30 (Including Patients Requiring Hemodialysis) Recommended Dosing Interval Every 24 hours Every 48 hours APO-EMTRICITABINE- TENOFOVIR should not be administered.
1. Calculated using ideal (lean) body weight. Pre-exposure Prophylaxis of HIV-1 Infection Do not use APO-EMTRICITABINE-TENOFOVIR for PrEP in HIV-1 uninfected individuals with creatinine clearance below 60 mL/min (see WARNINGS AND PRECAUTIONS).
). In treatment-experienced patients, the use of APO-EMTRICITABINE- TENOFOVIR should be guided by laboratory testing and treatment history (see VIROLOGY). Pre-Exposure Prophylaxis (PrEP) of HIV-1 Infection APO-EMTRICITABINE-TENOFOVIR is indicated in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
When considering APO-EMTRICITABINE-TENOFOVIR for PrEP, the following factors may help to identify individuals at high risk: has partner(s) known to be HIV-1 infected, or engages in sexual activity within a high prevalence area or social network and one or more of the following: o inconsistent or no condom use o diagnosis of sexually transmitted infections o exchange of sex for commodities (such as money, food, shelter, or drugs) o use of illicit drugs or alcohol dependence o incarceration o partner(s) of unknown HIV-1 status with any of the factors listed above When prescribing APO-EMTRICITABINE-TENOFOVIR for PrEP, healthcare providers must: prescribe APO-EMTRICITABINE-TENOFOVIR as part of a comprehensive prevention strategy because APO-EMTRICITABINE-TENOFOVIR is not always effective in preventing the acquisition of HIV-1 infection (see WARNINGS AND PRECAUTIONS); counsel all uninfected individuals to strictly adhere to the recommended APO- EMTRICITABINE-TENOFOVIR dosing schedule because the effectiveness of APO- EMTRICITABINE-TENOFOVIR in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials (see WARNINGS AND PRECAUTIONS); confirm a negative HIV-1 test immediately prior to initiating APO- EMTRICITABINE-TENOFOVIR for a PrEP indication.
If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by Health Canada as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection (see WARNINGS AND PRECAUTIONS); and screen for HIV-1 infection at least once every 3 months while taking APO- EMTRICITABINE-TENOFOVIR for PrEP.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No dose adjustment of APO-EMTRICITABINE-TENOFOVIR tablets is necessary with mild renal impairment patients (creatinine clearance 50 to 80 mL/min). Routine monitoring of calculated creatinine clearance, serum phosphorus, urine glucose and urine protein should be performed in all individuals with mild renal impairment.
If a decrease in calculated creatinine clearance is observed in uninfected individuals while using APO- EMTRICITABINE-TENOFOVIR for PrEP, evaluate potential causes and re- assess potential risks and benefits of continued use (see WARNINGS AND PRECAUTIONS).
Hepatic Impairment No dose adjustment is required in patients with hepatic impairment (see WARNINGS AND PRECAUTIONS). Geriatrics (>65 years of age) Clinical studies of emtricitabine or tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.
In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Missed Dose If a patient misses a dose within 12 hours of the regularly scheduled time, but then remembers it that same day, the patient should take the missed dose with food as soon as possible and resume their normal dosing schedule.
If a patient misses a dose of APO- EMTRICITABINE-TENOFOVIR by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule. The patient should not take more than 1 dose of APO-EMTRICITABINE- TENOFOVIR in a day, and should not take 2 doses of APO-EMTRICITABINE- TENOFOVIR at the same time to make up for missing a dose.
Page 35 of 64 Uninfected individuals who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses (see WARNINGS AND PRECAUTIONS). OVERDOSAGE For management of a suspected drug overdose, please contact your regional Poison Control Centre.
If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
Emtricitabine:
Limited clinical experience is available at doses higher than the therapeutic dose of emtricitabine. In one clinical pharmacology study single doses of emtricitabine 1200 mg were administered to 11 patients. No severe adverse reactions were reported.
The effects of higher doses are not known. 5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min); however, a single treatment does not significantly affect emtricitabine Cmax or AUC.
It is not known whether emtricitabine can be removed by peritoneal dialysis.
Tenofovir disoproxil fumarate:
Limited clinical experience at doses higher than the therapeutic dose of tenofovir disoproxil fumarate 300 mg is available. In one study, 600 mg tenofovir disoproxil fumarate was administered to 8 patients orally for 28 days. No severe adverse reactions were reported.
The effects of higher doses are not known. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir disoproxil fumarate, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action APO-EMTRICITABINE-TENOFOVIR is a […]
This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see CLINICAL TRIALS). com/ca/en/. Geriatrics (>65 years of age) Clinical studies of emtricitabine or tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Pediatrics (<18 years of age) Safety and effectiveness in pediatric patients have not been established. CONTRAINDICATIONS APO-EMTRICITABINE-TENOFOVIR 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. APO-EMTRICITABINE-TENOFOVIR 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 APO-EMTRICITABINE- TENOFOVIR, alone or in combination with other antiretrovirals (see WARNINGS AND PRECAUTIONS).
Post-Treatment Exacerbation of Hepatitis B APO-EMTRICITABINE-TENOFOVIR is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine and tenofovir disoproxil fumarate 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 disoproxil fumarate. 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 APO- 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/tenofovir disoproxil fumarate during clinical practice (see WARNINGS AND PRECAUTIONS).
Risk of Drug Resistance with Use of APO-EMTRICITABINE-TENOFOVIR for Pre-Exposure Prophylaxis (PrEP) in Undiagnosed Early HIV-1 Infection Page 6 of 64 APO-EMTRICITABINE-TENOVOFIR 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/tenofovir disoproxil fumarate for a PrEP indication following undetected acute HIV-1 infection. Do not initiate APO- EMTRICITABINE-TENOFOVIR for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed (see WARNINGS AND PRECAUTIONS).
General APO-EMTRICITABINE-TENOFOVIR should be used in the treatment of HIV-1 infected patients only in combination with other antiretroviral agents. APO-EMTRICITABINE-TENOFOVIR is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.
APO-EMTRICITABINE- TENOFOVIR should not be coadministered with other products containing tenofovir disoproxil fumarate or emtricitabine EMTRIVA (emtricitabine), VIREAD (tenofovir disoproxil fumarate), ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate), COMPLERA (emtricitabine/rilpivirine/tenofovir […]