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DESCOVY 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: Treatment of HIV-1 Infection DESCOVY is indicated in combination with other antiretrovirals (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg. HIV-1 Pre-Exposure…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Prior to or when initiating DESCOVY, and during use of DESCOVY, assess serum creatinine, estimated creatinine clearance (CrCl), urine glucose, and urine protein in all individuals as clinically appropriate. In individuals with chronic kidney disease, also assess serum phosphorus.
2 Drug-Food Interactions). HIV-1 PrEP DESCOVY is not recommended in individuals at risk of HIV-1 from receptive vaginal sex because the efficacy in this population has not been established. Serious Warnings and Precautions Post-treatment Exacerbation of Hepatitis B Virus DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of DESCOVY have not been established in individuals infected with HBV.
Discontinuation of DESCOVY therapy in individuals infected with HBV may be associated with severe acute exacerbations of hepatitis due to the emtricitabine (FTC) or tenofovir alafenamide (TAF) components of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals infected with HBV who discontinue DESCOVY.
1 Special Populations). Risk of Drug Resistance with Use of DESCOVY for HIV-1 PrEP in Undiagnosed Early HIV-1 Infection DESCOVY used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use.
Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. 1 Special Populations). 5 Missed Dose and 7 WARNINGS AND PRECAUTIONS); and screen all individuals for HIV-1 infection immediately prior to initiating DESCOVY for HIV-1 PrEP and at least once every 3 months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections (STIs) (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment Treatment of HIV-1 Infection The choice of dose of DESCOVY depends on the other antiretroviral agents being coadministered: the 200/10 mg dose is recommended when DESCOVY is used in combination with an HIV-1 protease inhibitor that is administered with either ritonavir or COBI.
e. non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, maraviroc). This dose should not be used in combination with an HIV-1 protease inhibitor that is administered with either ritonavir or COBI. Table 1 includes dosing recommendations based upon clinical data from third agents evaluated with DESCOVY in Study GS-US-311-1089 or drug interactions studies.
and 14 CLINICAL TRIALS).
Pediatrics (weighing < 25 kg):
Safety and efficacy of DESCOVY for the treatment of HIV-1 infection in children weighing < 25 kg have not been established. HIV-1 PrEP Pediatrics (weighing ≥ 35 kg):The safety and efficacy of DESCOVY for HIV-1 PrEP in at-risk adolescents weighing ≥ 35 kg (excluding individuals at risk from receptive vaginal sex) is supported by data from an adequate and well-controlled trial of DESCOVY for HIV-1 PrEP in adults together with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TAF, with EVG+COBI, in HIV-1 infected adults and pediatric subjects (see 8 ADVERSE REACTIONS, 10 CLINICAL PHARMACOLOGY and 14 CLINICAL TRIALS).
Pediatrics (weighing < 35 kg):
Safety and efficacy of DESCOVY for HIV-1 PrEP in children weighing < 35 kg have not been established. 2 Geriatrics (≥ 65 years of age) Geriatrics (≥ 65 years of age): No differences in safety or efficacy have been observed between elderly patients and those < 65 years of age (see 10 CLINICAL PHARMACOLOGY).
DESCOVY (emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Product Monograph Page 5 of 68 2 CONTRAINDICATIONS DESCOVY is contraindicated in patients with known hypersensitivity to any of the components of the product.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph. DESCOVY for PrEP is contraindicated in individuals with unknown or positive HIV-1 status. 1 Dosing Considerations Prior to or when initiating DESCOVY, and during use of DESCOVY, assess serum creatinine, estimated creatinine clearance (CrCl), urine glucose, and urine protein in all individuals as clinically appropriate.
); and screen all individuals for HIV-1 infection immediately prior to initiating DESCOVY for HIV-1 PrEP and at least once every 3 months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections (STIs) (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment Treatment of HIV-1 Infection The choice of dose of DESCOVY depends on the other antiretroviral agents being coadministered: the 200/10 mg dose is recommended when DESCOVY is used in combination with an HIV-1 protease inhibitor that is administered with either ritonavir or COBI.
e. non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, maraviroc). This dose should not be used in combination with an HIV-1 protease inhibitor that is administered with either ritonavir or COBI. Table 1 includes dosing recommendations based upon clinical data from third agents evaluated with DESCOVY in Study GS-US-311-1089 or drug interactions studies.
Table 1. Dose of DESCOVY according to third agent in the HIV treatment regimen Dose of DESCOVY Third agent in HIV treatment regimen DESCOVY 200/10 mg once daily Atazanavir with ritonavir or COBIa Darunavir with ritonavir or COBIa Lopinavir with ritonavir DESCOVY 200/25 mg once daily Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir a.
Atazanavir w ith COBI and darunavir w ith COBI w ere not evaluated in Study GS-US-311-1089 (see DRUG INTERACTIONS). For specific dosing recommendations for coadministered antiretroviral agents, refer to their respective Product Monograph.
HIV-1 PrEP The recommended DESCOVY dosage in HIV-1 uninfected adults (excluding individuals at risk from receptive vaginal sex) is 200/25 mg once daily with or without food. DESCOVY (emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Product Monograph Page 7 of 68 Geriatrics (≥ 65 years of age) No dose adjustment is required for elderly patients.
DESCOVY is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph. DESCOVY for PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
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Table 1. Dose of DESCOVY according to third agent in the HIV treatment regimen Dose of DESCOVY Third agent in HIV treatment regimen DESCOVY 200/10 mg once daily Atazanavir with ritonavir or COBIa Darunavir with ritonavir or COBIa Lopinavir with ritonavir DESCOVY 200/25 mg once daily Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir a.
Atazanavir w ith COBI and darunavir w ith COBI w ere not evaluated in Study GS-US-311-1089 (see DRUG INTERACTIONS). For specific dosing recommendations for coadministered antiretroviral agents, refer to their respective Product Monograph.
HIV-1 PrEP The recommended DESCOVY dosage in HIV-1 uninfected adults (excluding individuals at risk from receptive vaginal sex) is 200/25 mg once daily with or without food. DESCOVY (emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Product Monograph Page 7 of 68 Geriatrics (≥ 65 years of age) No dose adjustment is required for elderly patients.
No differences in safety or efficacy have been observed between elderly patients and those < 65 years of age.
Renal Impairment Adults with Renal Impairment:
No dose adjustment of DESCOVY is required in adult individuals with estimated CrCl ≥ 30 mL per minute or in adult individuals with end stage renal disease (ESRD) (estimated CrCl < 15 mL/minute) on chronic hemodialysis. On days of hemodialysis, administer the daily dose of DESCOVY after completion of hemodialysis treatment.
DESCOVY is not recommended in individuals with severe renal impairment (estimated CrCl ≥ 15 and < 30 mL/minute), or with ESRD (estimated CrCl < 15 mL/minute) who are not on chronic hemodialysis, as the safety of DESCOVY has not been established in these populations.
Pediatrics with Renal Impairment:
DESCOVY is not recommended in pediatric individuals with renal impairment as no data are available in this population. Hepatic Impairment No dose adjustment of DESCOVY is required in individuals with hepatic impairment. (see 10 CLINICAL PHARMACOLOGY).
4 Administration DESCOVY is one tablet (containing 200 mg of FTC and 10 mg of TAF or 200 mg of FTC and 25 mg of TAF) taken orally once daily with or without food. 5 Missed Dose If an individual misses a dose of DESCOVY within 18 hours of the time it is usually taken, the individual should take DESCOVY with or without food as soon as possible, and then take the next dose of DESCOVY at the regularly scheduled time.
If […]
In individuals with chronic kidney disease, also assess serum phosphorus. 2 Drug-Food Interactions). HIV-1 PrEP DESCOVY is not recommended in individuals at risk of HIV-1 from receptive vaginal sex because the efficacy in this population has not been established.
Serious Warnings and Precautions Post-treatment Exacerbation of Hepatitis B Virus DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of DESCOVY have not been established in individuals infected with HBV.
Discontinuation of DESCOVY therapy in individuals infected with HBV may be associated with severe acute exacerbations of hepatitis due to the emtricitabine (FTC) or tenofovir alafenamide (TAF) components of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals infected with HBV who discontinue DESCOVY.
1 Special Populations). Risk of Drug Resistance with Use of DESCOVY for HIV-1 PrEP in Undiagnosed Early HIV-1 Infection DESCOVY used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use.
Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. 1 Special Populations). 5 Missed Dose and 7 WARNINGS AND PRECAUTIONS); and screen all individuals for HIV-1 infection immediately prior to initiating DESCOVY for HIV-1 PrEP and at least once every 3 months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections (STIs) (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment Treatment of HIV-1 Infection The choice of dose of DESCOVY depends on the other antiretroviral agents being coadministered: the 200/10 mg dose is recommended when DESCOVY is used in combination with an HIV-1 protease inhibitor that is administered with either ritonavir or COBI.
e. non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, maraviroc). This dose should not be used in combination with an HIV-1 protease inhibitor that is administered with either ritonavir or COBI. Table 1 includes dosing recommendations based upon clinical data from third agents evaluated with DESCOVY in Study GS-US-311-1089 or drug interactions studies.
Table 1. Dose of DESCOVY according to third agent in the HIV treatment regimen Dose of DESCOVY Third agent in HIV treatment regimen DESCOVY 200/10 mg once daily Atazanavir with ritonavir or COBIa Darunavir with ritonavir or COBIa Lopinavir with ritonavir DESCOVY 200/25 mg once daily Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir a.
Atazanavir w ith COBI and darunavir w ith COBI w ere not evaluated in Study GS-US-311-1089 (see DRUG INTERACTIONS). For specific dosing recommendations for coadministered antiretroviral agents, refer to their respective Product Monograph.
HIV-1 PrEP The recommended DESCOVY dosage in HIV-1 uninfected adults (excluding individuals at risk from receptive vaginal sex) is 200/25 mg once daily with or without food. DESCOVY (emtricitabine/tenofovir […]
No differences in safety or efficacy have been observed between elderly patients and those < 65 years of age.
Renal Impairment Adults with Renal Impairment:
No dose adjustment of DESCOVY is required in adult individuals with estimated CrCl ≥ 30 mL per minute or in adult individuals with end stage renal disease (ESRD) (estimated CrCl < 15 mL/minute) on chronic hemodialysis. On days of hemodialysis, administer the daily dose of DESCOVY after completion of hemodialysis treatment.
DESCOVY is not recommended in individuals with severe renal impairment (estimated CrCl ≥ 15 and < 30 mL/minute), or with ESRD (estimated CrCl < 15 mL/minute) who are not on chronic hemodialysis, as the safety of DESCOVY has not been established in these populations.
Pediatrics with Renal Impairment:
DESCOVY is not recommended in pediatric individuals with renal impairment as no data are available in this population. Hepatic Impairment No dose adjustment of DESCOVY is required in individuals with hepatic impairment. (see 10 CLINICAL PHARMACOLOGY).
4 Administration DESCOVY is one tablet (containing 200 mg of FTC and 10 mg of TAF or 200 mg of FTC and 25 mg of TAF) taken orally once daily with or without food. 5 Missed Dose If an individual misses a dose of DESCOVY within 18 hours of the time it is usually taken, the individual should take DESCOVY with or without food as soon as possible, and then take the next dose of DESCOVY at the regularly scheduled time.
If an individual misses a dose of DESCOVY by more than 18 hours, the individual should not take the missed dose, but resume the usual dosing schedule. Uninfected individuals who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses (see 7 WARNINGS AND PRECAUTIONS).
5 OVERDOSAGE If overdose occurs the individual must be monitored for evidence of toxicity. Treatment of overdose with DESCOVY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the individual.
Emtricitabine DESCOVY (emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Product Monograph Page 8 of 68 Limited clinical experience is available at doses higher than the therapeutic dose of FTC. In one clinical pharmacology study, single doses of FTC 1200 mg (6 times the dose in DESCOVY) were administered to 11 subjects.
No severe adverse reactions were reported. The effects of higher doses are not known. 5 hours of FTC dosing. It is not known whether FTC can be removed by peritoneal dialysis. Tenofovir Alafenamide Limited clinical experience is available at doses higher than the therapeutic dose of TAF.
A single supratherapeutic dose of 125 mg TAF was administered to 48 healthy subjects. No serious adverse reactions were reported. The effects of higher doses are unknown. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2. 0 mg tenofovir alafenamide hemifumarate) croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The grey tablets are film-coated with a coating material containing iron oxide black, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
The blue tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. DESCOVY is available as rectangular-shaped, film-coated tablets containing 200 mg of FTC and […]