Loading…
BIKTARVY is a brand name for Bictegravir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg with no known substitution associated with resistance to bictegravir or tenofovir. 1.1 Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations BIKTARVY is a three-drug fixed dose combination product containing 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF. Testing Prior to or when initiating BIKTARVY, test for hepatitis B virus infection. Prior to or when initiating BIKTARVY, and during treatment with BIKTARVY, assess serum creatinine, estimated glomerular filtration rate (eGFR), urine glucose, and urine protein in all patients as clinically appropriate.
In patients with chronic kidney disease, also assess serum phosphorus. 2 Recommended Dose and Dosage Adjustment Adults and Pediatric Patients weighing ≥ 25 kg The recommended dose of BIKTARVY is one tablet taken orally once daily with or without food.
Pediatrics (weighing < 25 kg) BIKTARVY is not indicated for use in pediatric patients weighing < 25 kg Geriatrics (≥ 65 years of age) No dose adjustment of BIKTARVY 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 No dose adjustment of BIKTARVY is required in adult patients with eGFR ≥ 30 mL/minute or in adult patients with end stage renal disease (ESRD; eGFR < 15 mL/minute) who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of BIKTARVY after completion of hemodialysis treatment.
BIKTARVY is not recommended in patients with eGFR ≥ 15 and < 30 mL per minute, or < 15 mL/minute who are not receiving chronic hemodialysis, as the safety of BIKTARVY has not been established in these populations. Serious Warnings and Precautions • Post-treatment Exacerbation of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing FTC and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY.
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 BIKTARVY. 1 Special Populations). Product Monograph Page 6 of 60 BIKTARVY (bictegravir*/emtricitabine/tenofovir alafenamide**) tablets *as bictegravir sodium **as tenofovir alafenamide hemifumarate No data are available to make dose recommendations in pediatric patients with renal impairment.
and 14 CLINICAL TRIALS). Safety and efficacy of BIKTARVY in children weighing < 25 kg have not been established. 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 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS).
2 CONTRAINDICATIONS BIKTARVY is contraindicated in patients who are hypersensitive to bictegravir (BIC), emtricitabine (FTC), tenofovir alafenamide (TAF) or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Coadministration of BIKTARVY is contraindicated with: • dofetilide* due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events (see
1 Special Populations). Product Monograph Page 6 of 60 BIKTARVY (bictegravir*/emtricitabine/tenofovir alafenamide**) tablets *as bictegravir sodium **as tenofovir alafenamide hemifumarate No data are available to make dose recommendations in pediatric patients with renal impairment.
Hepatic Impairment BIKTARVY is not recommended in patients with severe hepatic impairment (Child -Pugh Class C) because it has not been studied in these patients. No dose adjustment of BIKTARVY is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions).
3 Administration The recommended dose of BIKTARVY is one tablet taken orally once daily with or without food in adults and pediatric patients weighing ≥ 25 kg. 4 Missed Dose If a patient misses a dose of BIKTARVY within 18 hours of the time it is usually taken, the patient should take BIKTARVY as soon as possible, and then take the next dose of BIKTARVY at the regularly scheduled time.
If a patient misses a dose of BIKTARVY by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. 5 OVERDOSAGE No data are available on overdose of BIKTARVY in patients. If overdose occurs, the patient must be monitored for evidence of toxicity.
Treatment of overdose with BIKTARVY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. There is no specific antidote for overdose with BIKTARVY. As BIC is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis.
5 hours of FTC dosing. It is not known whether FTC can be removed by peritoneal dialysis. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
BIKTARVY is contraindicated in patients who are hypersensitive to bictegravir (BIC), emtricitabine (FTC), tenofovir alafenamide (TAF) or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Coadministration of BIKTARVY is contraindicated with: • dofetilide* due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events (see 9 DRUG INTERACTIONS). • rifampin due to decreased BIC plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to BIKTARVY (see 9 DRUG INTERACTIONS).
• St. John’s wort due to the effect of St. John’s wort on the BIC component of BIKTARVY. This may result in loss of therapeutic effect and development of resistance (see 9 DRUG INTERACTIONS). *Product not marketed in Canada Product Monograph Page 5 of 60 BIKTARVY (bictegravir*/emtricitabine/tenofovir alafenamide**) tablets *as bictegravir sodium **as tenofovir alafenamide hemifumarate
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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.
Hepatic Impairment BIKTARVY is not recommended in patients with severe hepatic impairment (Child -Pugh Class C) because it has not been studied in these patients. No dose adjustment of BIKTARVY is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions).
3 Administration The recommended dose of BIKTARVY is one tablet taken orally once daily with or without food in adults and pediatric patients weighing ≥ 25 kg. 4 Missed Dose If a patient misses a dose of BIKTARVY within 18 hours of the time it is usually taken, the patient should take BIKTARVY as soon as possible, and then take the next dose of BIKTARVY at the regularly scheduled time.
If a patient misses a dose of BIKTARVY by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Product Monograph Page 7 of 60 BIKTARVY (bictegravir*/emtricitabine/tenofovir alafenamide**) tablets *as bictegravir sodium **as tenofovir alafenamide hemifumarate 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 Dosage Forms, Strengths, Composition and Packaging BIKTARVY tablets are purplish brown, capsule-shaped, film-coated, and debossed with “GSI” on one side and “9883” on the other side.
BIKTARVY tablets are packaged in white, high density polyethylene (HDPE) bottles and enclosed with a polypropylene continuous thread child resistant cap, lined with an induction activated aluminum foil liner. Each bottle contains 7 or 30 tablets, silica ge l desiccant, and polyester coil.
BIKTARVY tablets are also packaged in blister packaging which consists of a clear laminated blister film sealed to an aluminum lidding material. Each individual blister cavity contains a tablet and a die-cut desiccant film (Activ-Film™), which is heat staked to the lidding material.
Each blister card is fitted between 2 paperboard cards, which are sealed together. There are 4 blister cards containing 7 tablets and 1 card containing 2 tablets placed inside a paperboard carton for a total of 30 tablets per pack. 0 mg of tenof ovir alaf enamide hemif umarate).
Croscarmellose Sodium, Iron Oxide Black, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium-Dioxide Product Monograph Page 8 of 60 BIKTARVY (bictegravir*/emtricitabine/tenofovir alafenamide**) tablets *as bictegravir sodium **as tenofovir alafenamide hemifumarate 7 WARNINGS AND PRECAUTIONS Please see the 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General BIKTARVY should not be coadministered with any other antiretroviral products including products containing BIC, FTC, or TAF (COMPLERA®, DESCOVY®, EMTRIVA®, GENVOYA®, ODEFSEY®, Symtuza™, STRIBILD®, TRUVADA®, VEMLIDY®); or with products containing lamivudine or tenofovir disoproxil fumarate (3TC®, Combivir®, COMPLERA, Delstrigo®, Dovato®, Heptovir®, Kivexa®, STRIBILD, Triumeq®, Trizivir®, TRUVADA, VIREAD®).
BIKTARVY should not be administered with adefovir dipivoxil (HEPSERA®). The safety and efficacy of BIKTARVY have not been established in patients who have failed treatment with an antiretroviral therapy regimen and are currently not virologically suppressed.
Driving and Operating Machinery No studies on the effects of BIKTARVY on the ability to drive and use machines have been performed. Endocrine and Metabolism Serum Lipids and Blood Glucose Serum lipid and blood glucose levels may increase during antiretroviral therapy (ART).
Disease control and life style changes may also be contributing factors. Consideration should be given to the measurement of serum lipids and blood glucose. Lipid disord ers and blood glucose elevations should be managed as clinically appropriate.
Hepatic/Biliary/Pancreatic Lactic acidosis and severe hepatomegaly with steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogs, including FTC, a component of BIKTARVY, and TDF, another prodrug of tenofovir, alone or in combination with other antiretrovirals.
Treatment with BIKTARVY should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Hepatic Impairment […]