Home Drug Guide Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate

Drug Guide

Generic Name

Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate

Brand Names Biktarvy

Classification

Therapeutic: Antiretroviral agent for HIV-1 infection

Pharmacological: Combination of integrase inhibitor, nucleoside reverse transcriptase inhibitor, and nucleotide reverse transcriptase inhibitor

FDA Approved Indications

Treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg

Mechanism of Action

Bictegravir inhibits HIV integrase enzyme, preventing viral DNA integration into host DNA. Emtricitabine and tenofovir alafenamide are reverse transcriptase inhibitors that block HIV replication by terminating DNA synthesis.

Dosage and Administration

Adult: One tablet once daily, with or without food.

Pediatric: Dosage based on weight; consult specific guidelines.

Geriatric: No specific adjustment, but caution advised due to comorbidities.

Renal Impairment: Adjust or avoid in severe impairment; consult guidelines.

Hepatic Impairment: Use with caution; no dose adjustment recommended in mild to moderate impairment.

Pharmacokinetics

Absorption: Rapidly absorbed after oral administration.

Distribution: Wide distribution; extensive tissue penetration.

Metabolism: Minimal hepatic metabolism; primarily via esterase enzymes.

Excretion: Renal and fecal routes.

Half Life: Approximately 12 hours for component drugs.

Contraindications

Hypersensitivity to components.

Precautions

Monitor renal function and bone mineral density; use caution in hepatic impairment.

Adverse Reactions - Common

Nausea (Occasional)
Diarrhea (Less common)
Headache (Common)

Adverse Reactions - Serious

Lactic acidosis (Rare)
Hepatotoxicity (Rare)
New or worsening renal impairment (Uncommon)

Drug-Drug Interactions

Metformin (risk of lactic acidosis), certain polyvalent cations (reduce absorption)

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor renal function, liver function, and bone mineral density periodically.

Diagnoses:

Risk for renal impairment
Impaired medication adherence

Implementation: Administer once daily, counsel on adherence.

Evaluation: Assess virologic response and adverse effects regularly.

Patient/Family Teaching

Take medication at the same time each day.
Report any signs of lactic acidosis, liver problems, or worsening kidney function.
Use caution with concomitant nephrotoxic drugs.

Special Considerations

Black Box Warnings:

Lactic acidosis and severe hepatomegaly with steatosis.

Genetic Factors: None specific.

Lab Test Interference: May slightly affect renal function tests.

Overdose Management

Signs/Symptoms: Nausea, vomiting, dizziness, diarrhea.

Treatment: Supportive care; no specific antidote.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable for the shelf life indicated by the manufacturer.