Loading…
GENVOYA is a brand name for Elvitegravir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: GENVOYA (150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabine/10 mg tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg and with no known mutations associated with resistance to the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations GENVOYA is one tablet (containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide) taken orally once daily with food. Testing Prior to Initiation and During Treatment with GENVOYA Prior to or when initiating GENVOYA, test patients for hepatitis B virus infection.
Prior to or when initiating GENVOYA, and during treatment with GENVOYA, assess serum creatinine, estimated creatinine clearance (CrCl), urine glucose and urine protein in all patients on a clinically appropriate schedule. In patients with chronic kidney disease, also asses s serum phosphorus (see 7 WARNINGS AND PRECAUTIONS, Renal).
2 Recommended Dose and Dosage Adjustment Adults and Pediatric Patients weighing ≥ 25 kg The recommended dose of GENVOYA is one tablet daily. Pediatrics (weighing < 25 kg) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for use in pediatrics weighing < 25 kg.
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 adult patients < 65 years of age. Renal Impairment No dose adjustment of GENVOYA is required in adult patients with estimated CrCl ≥ 30 mL/minute or in adult patients with end stage renal disease (estimated CrCl < 15 mL/minute) on chronic hemodialysis.
On days of hemodialysis, administer GENVOYA after completion of hemodialysis treatment. GENVOYA is not recommended in patients with estimated CrCl ≥ 15 and < 30 mL/minute, or < 15 mL/minute who are not on chronic hemodialysis, as the safety of GENVOYA has not been established in these populations.
No data are available to make dose recommendations in pediatric patients with renal impairment. Hepatic Impairment No dose adjustment of GENVOYA is required in patients with mild (Child -Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
GENVOYA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, GENVOYA is not recommended for use in patients with severe hepatic impairment (see 10 CLINICAL PHARMACOLOGY). 4 Administration GENVOYA is one tablet (containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide) taken orally once daily with food.
and 14 CLINICAL TRIALS).
Pediatrics (weighing < 25 kg):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for use in pediatrics weighing < 25 kg. 2 Geriatrics Geriatrics (≥ 65 years of age): No differences in safety or efficacy have been observed between elderly patients and adult patients < 65 years of age (see 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS GENVOYA 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.
Coadministration with the following drugs listed in Table 1 is contraindicated due to the potential for serious and/or life-threatening events or loss of virologic response and possible resistance to GENVOYA. 4 Drug-Drug Interactions.
Table 1. Drugs That Are Contraindicated with GENVOYA Drug Class Drugs within class that are contraindicated with GENVOYA Clinical Comment Alpha 1- adrenoreceptor antagonists alfuzosin Potential for increased alfuzosin concentrations, which can result in hypotension.
Anticonvulsants carbamazepine, phenobarbital, phenytoin Carbamazepine, phenobarbital, and phenytoin are potent inducers of CYP450 metabolism and may cause significant decrease in the plasma concentration of elvitegravir, cobicistat and tenofovir alafenamide.
This may result in loss of therapeutic effect to GENVOYA. Product Monograph Page 5 of 87 GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Drug Class Drugs within class that are contraindicated with GENVOYA Clinical Comment Antihistamines astemizole*, terfenadine* Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
, Renal). 2 Recommended Dose and Dosage Adjustment Adults and Pediatric Patients weighing ≥ 25 kg The recommended dose of GENVOYA is one tablet daily. Pediatrics (weighing < 25 kg) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for use in pediatrics weighing < 25 kg.
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 adult patients < 65 years of age. Renal Impairment No dose adjustment of GENVOYA is required in adult patients with estimated CrCl ≥ 30 mL/minute or in adult patients with end stage renal disease (estimated CrCl < 15 mL/minute) on chronic hemodialysis.
On days of hemodialysis, administer GENVOYA after completion of hemodialysis treatment. GENVOYA is not recommended in patients with estimated CrCl ≥ 15 and < 30 mL/minute, or < 15 mL/minute who are not on chronic hemodialysis, as the safety of GENVOYA has not been established in these populations.
No data are available to make dose recommendations in pediatric patients with renal impairment. Hepatic Impairment No dose adjustment of GENVOYA is required in patients with mild (Child -Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
GENVOYA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, GENVOYA is not recommended for use in patients with severe hepatic impairment (see 10 CLINICAL PHARMACOLOGY). 4 Administration GENVOYA is one tablet (containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide) taken orally once daily with food.
5 Missed Dose If a patient misses a dose of GENVOYA within 18 hours of the time it is usually taken, the patient should take GENVOYA with food as soon as possible, and then take the next dose of GENVOYA at the regularly scheduled time.
GENVOYA 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. Coadministration with the following drugs listed in Table 1 is contraindicated due to the potential for serious and/or life-threatening events or loss of virologic response and possible resistance to GENVOYA.
4 Drug-Drug Interactions. Table 1. Drugs That Are Contraindicated with GENVOYA Drug Class Drugs within class that are contraindicated with GENVOYA Clinical Comment Alpha 1- adrenoreceptor antagonists alfuzosin Potential for increased alfuzosin concentrations, which can result in hypotension.
Anticonvulsants carbamazepine, phenobarbital, phenytoin Carbamazepine, phenobarbital, and phenytoin are potent inducers of CYP450 metabolism and may cause significant decrease in the plasma concentration of elvitegravir, cobicistat and tenofovir alafenamide.
This may result in loss of therapeutic effect to GENVOYA. Product Monograph Page 5 of 87 GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Drug Class Drugs within class that are contraindicated with GENVOYA Clinical Comment Antihistamines astemizole*, terfenadine* Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Antimycobacterials rifampin Rifampin is a potent inducer of CYP450 metabolism and may cause significant decrease in the plasma concentration of elvitegravir, cobicistat and tenofovir alafenamide. This may result in loss of therapeutic effect to GENVOYA.
Benzodiazepines orally administered midazolam*, triazolam Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with GENVOYA may cause large increases in the concentration of these benzodiazepines.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Elvitegravir 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.
5 Missed Dose If a patient misses a dose of GENVOYA within 18 hours of the time it is usually taken, the patient should take GENVOYA with food as soon as possible, and then take the next dose of GENVOYA at the regularly scheduled time.
If a patient misses a dose of GENVOYA by more than 18 hours, the patient should not take the missed dose, but resume the usual dosing schedule. Product Monograph Page 8 of 87 GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate
Antimycobacterials rifampin Rifampin is a potent inducer of CYP450 metabolism and may cause significant decrease in the plasma concentration of elvitegravir, cobicistat and tenofovir alafenamide. This may result in loss of therapeutic effect to GENVOYA.
Benzodiazepines orally administered midazolam*, triazolam Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with GENVOYA may cause large increases in the concentration of these benzodiazepines.
The potential exists for serious and/or life-threatening events such as prolonged or increased sedation or respiratory depression. Beta 2-adrenoceptor agonist salmeterol Coadministration of salmeterol with GENVOYA may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Direct oral anticoagulants apixaban, rivaroxaban Apixaban and rivaroxaban are primarily metabolized by CYP3A4 and transported by P-gp. Coadministration with GENVOYA may result in increased plasma concentrations of apixaban or rivaroxaban, which may lead to an increased bleeding risk.
Ergot derivatives dihydroergotamine, ergonovine, ergotamine, methylergonovine* Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI motility agents cisapride* Potential for serious and/or life-threatening events such as cardiac arrhythmias. Herbal products St. John’s Wort (Hypericum perforatum) Coadministration of products containing St. John’s Wort and GENVOYA may result in reduced plasma concentrations of elvitegravir, cobicistat and tenofovir alafenamide.
This may result in loss of therapeutic effect and development of resistance. HMG-CoA reductase inhibitors lovastatin, simvastatin Potential for serious reactions such as myopathy, including rhabdomyolysis. Microsomal triglyceride transfer protein inhibitor lomitapide Potential for increased lomitapide concentrations which may result in markedly increased transaminases.
Product Monograph Page 6 of 87 GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Drug Class Drugs within class that are contraindicated with GENVOYA Clinical Comment Neuroleptics lurasidone pimozide Potential for serious and/or life-threatening reactions.
Potential for serious and/or life-threatening events such as cardiac arrhythmias. PDE-5 inhibitors sildenafil† A safe and effective dose in combination with GENVOYA has not been established for sildenafil (REVATIO®) when used for the treatment of pulmonary arterial hypertension.
There is increased potential for sildenafil- associated adverse events (which include visual disturbances, hypotension, priapism, and syncope). *Not marketed in Canada. †For the treatment of pulmonary arterial hypertension. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Post-treatment Exacerbation of Hepatitis B GENVOYA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of GENVOYA have not been established in patients coinfected with HIV-1 and HBV.
Discontinuation of GENVOYA therapy in patients coinfected with HIV-1 and HBV may be associated with severe acute exacerbations of hepatitis due to the emtricitabine or tenofovir alafenamide components of GENVOYA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue GENVOYA.
1 Special Populations). 1 Dosing Considerations GENVOYA is one tablet (containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide) taken orally once daily with food. Testing Prior to Initiation and During Treatment with GENVOYA Prior to or when initiating GENVOYA, test patients for hepatitis B virus […]
If a patient misses a dose of GENVOYA by more than 18 hours, the patient should not take the missed dose, but resume the usual dosing schedule. Product Monograph Page 8 of 87 GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate 5 OVERDOSAGE If overdose occurs the patient must be monitored for evidence of toxicity.
Treatment of overdose with GENVOYA consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Elvitegravir Limited clinical experience is available at doses higher than the therapeutic dose of elvitegravir in GENVOYA.
In one study, boosted elvitegravir equivalent to 2 times the therapeutic dose of 150 mg once daily for 10 days was administered to 42 healthy subjects. No severe adverse reactions were reported. The effects of higher doses are not known.
As elvitegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis. Cobicistat Limited clinical experience is available at doses higher than the therapeutic dose of cobicistat in GENVOYA.
7 times the dose in GENVOYA) was administered to a total of 60 healthy subjects. No severe adverse reactions were reported. The effects of higher doses are not known. As cobicistat is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis.
Emtricitabine Limited clinical experience is available at doses higher than the therapeutic dose of emtricitabine in GENVOYA. In one clinical pharmacology study, single doses of emtricitabine 1200 mg (6 times the dose in GENVOYA) were administered to 11 subjects.
No severe adverse reactions were reported. The effects of higher doses are not known. 5 hours of emtricitabine dosing. It is not known whether emtricitabine can be removed by peritoneal dialysis. Tenofovir alafenamide Limited clinical experience is available at doses higher than the therapeutic dose of tenofovir alafenamide in GENVOYA.
A single supratherapeutic dose of 125 mg tenofovir alafenamide 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%.
For management of a suspected drug overdose, contact your regional poison control centre. Product Monograph Page 9 of 87 GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2.
2 mg tenofovir alafenamide hemifumarate) Croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and sodium lauryl sulfate. The tablets are coated with a coating material containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, indigo carmine aluminum lake, and iron oxide yellow.
GENVOYA is available as green capsule-shaped, film-coated tablets, debossed with ‘GSI’ on one side of the tablet and ‘510’ on the other side of the tablet. Each bottle contains 30 tablets and a silica gel desiccant and closed with a child-resistant closure.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General GENVOYA is a fixed dose combination of elvitegravir, […]
The potential exists for serious and/or life-threatening events such as prolonged or increased sedation or respiratory depression. Beta 2-adrenoceptor agonist salmeterol Coadministration of salmeterol with GENVOYA may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Direct oral anticoagulants apixaban, rivaroxaban Apixaban and rivaroxaban are primarily metabolized by CYP3A4 and transported by P-gp. Coadministration with GENVOYA may result in increased plasma concentrations of apixaban or rivaroxaban, which may lead to an increased bleeding risk.
Ergot derivatives dihydroergotamine, ergonovine, ergotamine, methylergonovine* Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI motility agents cisapride* Potential for serious and/or life-threatening events such as cardiac arrhythmias. Herbal products St. John’s Wort (Hypericum perforatum) Coadministration of products containing St. John’s Wort and GENVOYA may result in reduced plasma concentrations of elvitegravir, cobicistat and tenofovir alafenamide.
This may result in loss of therapeutic effect and development of resistance. HMG-CoA reductase inhibitors lovastatin, simvastatin Potential for serious reactions such as myopathy, including rhabdomyolysis. Microsomal triglyceride transfer protein inhibitor lomitapide Potential for increased lomitapide concentrations which may result in markedly increased transaminases.
Product Monograph Page 6 of 87 GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide*) tablets *as tenofovir alafenamide hemifumarate Drug Class Drugs within class that are contraindicated with GENVOYA Clinical Comment Neuroleptics lurasidone pimozide Potential for serious and/or life-threatening reactions.
Potential for serious and/or life-threatening events such as cardiac arrhythmias. PDE-5 inhibitors sildenafil† A safe and effective dose in combination with GENVOYA has not been established for sildenafil (REVATIO®) when used for the treatment of pulmonary arterial hypertension.
There is increased potential for sildenafil- associated adverse events (which include visual disturbances, hypotension, priapism, and syncope). *Not marketed in Canada. †For the treatment of pulmonary arterial hypertension.