Home Drug Guide Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate

Drug Guide

Generic Name

Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate

Brand Names Complera

Classification

Therapeutic: Antiretroviral combination for HIV infection

Pharmacological: Nucleoside reverse transcriptase inhibitors (Emtricitabine and Tenofovir) and Non-nucleoside reverse transcriptase inhibitor (Rilpivirine)

FDA Approved Indications

Treatment of HIV-1 infection in adults with viral load suppression

Mechanism of Action

This combination inhibits HIV replication through multiple mechanisms: Emtricitabine and Tenofovir are nucleoside reverse transcriptase inhibitors that block viral DNA synthesis, while Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that binds directly to reverse transcriptase enzyme, inhibiting its activity.

Dosage and Administration

Adult: One tablet once daily with food

Pediatric: Not approved for pediatric use

Geriatric: Adjust based on renal function and tolerability

Renal Impairment: Use with caution; dosage adjustments may be necessary

Hepatic Impairment: Use with caution; no specific adjustment recommended

Pharmacokinetics

Absorption: Well absorbed with food

Distribution: Wide tissue distribution, including lymphoid tissue

Metabolism: Metabolized minimally; primarily via cytochrome P450 pathways for rilpivirine

Excretion: Renal and fecal routes

Half Life: Emtricitabine: ~10 hours; Rilpivirine: ~45 hours; Tenofovir: ~17 hours

Contraindications

Hypersensitivity to any components

Precautions

Renal impairment, hepatic impairment, history of depression or suicidality, concomitant use with drugs affecting renal proximal tubule

Adverse Reactions - Common

Nausea (Common)
Headache (Common)
Insomnia (Common)

Adverse Reactions - Serious

Lactic acidosis (Serious but rare)
Osteomalacia or decreased bone mineral density (Serious but rare)
Depression or mood changes (Serious)

Drug-Drug Interactions

Use caution with drugs that reduce gastric acidity (e.g., PPIs, H2 antagonists)
Interactions with other antivirals, drugs causing renal toxicity

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor renal function, liver function, HIV viral load, and CD4 count

Diagnoses:

Risk for ineffective protection related to nonadherence

Implementation: Ensure adherence, counsel on side effects, monitor labs as indicated

Evaluation: Assess viral suppression and side effects regularly

Patient/Family Teaching

Take medication with food to enhance absorption
Do not skip doses
Report any side effects or adverse reactions promptly

Special Considerations

Black Box Warnings:

Posttreatment HIV-1 viral rebound and resistance may occur if therapy is discontinued

Genetic Factors: None specified

Lab Test Interference: May increase serum creatinine without affecting actual renal function

Overdose Management

Signs/Symptoms: Nausea, vomiting, dizziness, possible signs of lactic acidosis or renal failure

Treatment: Supportive care, consider hemodialysis for Tenofovir overdose, manage symptoms

Storage and Handling

Storage: Store at room temperature (15–30°C), away from moisture and light

Stability: Stable under normal conditions for the shelf life indicated