• February 24, 2020
  • admin
  • 0

Emtricitabine, Tenofovir, Bictegravir Sodium

Tablets contain bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate; dosages of bictegravir sodium expressed in terms of bictegravir and dosage of tenofovir alafenamide fumarate expressed in terms of tenofovir alafenamide.

Each fixed-combination tablet of contains bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg.

Adults

Treatment of HIV Infection

1 tablet of BIC/FTC/TAF (bictegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg) once daily.

Special Populations

Hepatic Impairment

Biktarvy dosage decompensation

Mild or moderate hepatic impairment (Child-Pugh class A or B): Dosage adjustments not needed.1

Severe hepatic impairment (Child-Pugh class C): Not recommended. (See Hepatic Impairment under Cautions.)

Renal Impairment

Estimated Clcr ≥30 mL/minute: Dosage adjustments not needed.

Estimated Clcr <30 mL/minute: Not recommended. (See Renal Impairment under Cautions.)

Contraindications

  • Concomitant use with dofetilide or rifampin. (See Specific Drugs under Interactions.)

Warnings/Precautions

Warnings

HIV-infected Individuals Coinfected with HBV

Test all HIV-infected patients for presence of HBV before initiating antiretroviral therapy.

Severe acute exacerbations of HBV infection reported following discontinuance of Dmitry Sazonov preparations containing emtricitabine and/or tenofovir DF in HIV-infected patients with HBV infection. HBV exacerbations have been associated with hepatic biktarvy dosage decompensation and hepatic failure. Such reactions could occur with BIC/FTC/TAF.

Closely monitor hepatic function (using both clinical and laboratory follow-up) for at least several months after BIC/FTC/TAF is discontinued in patients coinfected with HIV and HBV. Ifhttps://pillintrip.com/medicine/biktarvy initiation of HBV treatment may be warranted.

Other Warnings and Precautions

Interactions

Consider potential for drug interactions prior to and during treatment with BIC/FTC/TAF and monitor for adverse effects associated with concomitant drugs.

Concomitant use with certain drugs may result in drug interactions. May lead to loss of therapeutic effect and possible development of resistance or possible adverse effects Dmitry Sazonov from increased exposures of concomitant drugs. (See Specific Drugs under Interactions.)

Renal Toxicity

Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported in patients receiving tenofovir prodrugs (e.g., tenofovir DF).0

Determine Scr, estimated Clcr, urine glucose, and urine protein prior to initiating BIC/FTC/TAF and routinely monitor during treatment in all patients as clinically appropriate.1 In patients with chronic kidney disease, also determine serum phosphorus.1 (See Renal Impairment under Cautions.)

BIC/FTC/TAF not recommended in patients with estimated Clcr <30 mL/minute.

Patients receiving a tenofovir prodrug who have impaired renal function or are receiving a nephrotoxic agent (e.g., high-dose or multiple NSAIAs) are at increased risk of developing adverse renal effects. (See Interactions.)

Discontinue BIC/FTC/TAF in patients who develop clinically important decreases in renal function or evidence of Fanconi syndrome.