Biktarvy

Biktarvy

Manufacturer:

Gilead

Distributor:

DCH Auriga

Marketer:

DCH Auriga
Concise Prescribing Info
Contents
Bictegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg
Indications/Uses
Adults infected w/ HIV-1 w/o present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split.
Contraindications
Hypersensitivity. Co-administration w/ rifampicin & St. John's wort (Hypericum perforatum).
Special Precautions
Patients w/ chronic hepatitis B or C treated w/ antiretroviral therapy; co-infected w/ HIV-1 & HBV/HCV. Closely monitor patients co-infected w/ HIV & HBV who discontinued Biktarvy for at least several mth after stopping treatment. Patients w/ significant underlying liver disorders. Monitor patients w/ preexisting liver dysfunction including those w/ chronic active hepatitis. Consider interruption or discontinuation of treatment if liver disease worsens. Wt gain & increase of blood lipid & glucose levels may occur. Mitochondrial dysfunction following exposure in utero. Immune reactivation syndrome. Closely observe patients for opportunistic infections. Osteonecrosis. Nephrotoxicity. Concomitant use w/ Mg- or Al-containing antacids or Fe supplements. Not recommended to co-administer w/ atazanavir, boceprevir, carbamazepine, ciclosporin (IV or oral), oxcarbazepine, phenobarb, phenytoin, rifabutin, rifapentine or sucralfate, & other antiretrovirals. May affect ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Depression, abnormal dreams; headache, dizziness; diarrhoea, nausea; fatigue.
Drug Interactions
Do not co-administer w/ drugs containing tenofovir, alafenamide, tenofovir disoproxil, lamivudine or adefovir dipivoxil. Bictegravir: Decreased plasma conc w/ St. John's wort or, rifampicin. Increased plasma conc w/ drugs that potently inhibit CYP3A & UGT1A1 eg, atazanavir. Concomitant use w/ drug known to inhibit P-gp &/or BCRP eg, macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir). Emtricitabine: Increased conc w/ drugs eliminated by active tubular secretion & decreased renal function. Tenofovir alafenamide: Decreased absorption w/ drugs that induce P-gp activity (eg, rifabutin, carbamazepine, phenobarb). Increased absorption & plasma conc w/ drugs that inhibit P-gp & BCRP.
MIMS Class
Antivirals
ATC Classification
J05AR20 - emtricitabine, tenofovir alafenamide and bictegravir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Biktarvy FC tab
Packing/Price
30's
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