Home Drug Guide Dolutegravir Sodium; Rilpivirine Hydrochloride

Drug Guide

Generic Name

Dolutegravir Sodium; Rilpivirine Hydrochloride

Brand Names Juluca

Classification

Therapeutic: Antiretroviral Agent for HIV-1 Infection

Pharmacological: Integrase Strand Transfer Inhibitor (Dolutegravir); Non-Nucleoside Reverse Transcriptase Inhibitor (Rilpivirine)

FDA Approved Indications

Treatment of Virologically Suppressed HIV-1 Infection in Adults

Mechanism of Action

Dolutegravir inhibits HIV integrase enzyme, preventing viral DNA integration into the host genome. Rilpivirine inhibits HIV reverse transcriptase, blocking viral replication.

Dosage and Administration

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

Pediatric: Not approved for pediatric use.

Geriatric: No specific adjustments; use with caution in older adults due to potential comorbidities.

Renal Impairment: No dosage adjustment required.

Hepatic Impairment: Use with caution; no specific dosage adjustment recommended.

Pharmacokinetics

Absorption: Well absorbed orally, with food increasing absorption of rilpivirine.

Distribution: Widely distributed, protein binding high.

Metabolism: Dolutegravir primarily metabolized via glucuronidation; rilpivirine via hepatic CYP3A.

Excretion: Both drugs primarily eliminated via feces.

Half Life: Dolutegravir approximately 14 hours; rilpivirine approximately 45 hours.

Contraindications

Hypersensitivity to any component.
Use with concomitant use of rifampin or other strong CYP3A inducers (rilpivirine).

Precautions

Monitor for HIV resistance; potential interactions affecting efficacy; hepatic impairment; renal impairment. Use in pregnancy only if potential benefit justifies risk.

Adverse Reactions - Common

Insomnia (Common)
Diarrhea (Common)
Headache (Common)

Adverse Reactions - Serious

Allergic reactions including rash, hypersensitivity (Rare)
Depression, neuropsychiatric symptoms (Uncommon)
Liver enzyme elevations or hepatitis (Uncommon)

Drug-Drug Interactions

Antacids containing aluminum or magnesium (reduce absorption of rilpivirine)
Strong CYP3A inducers/inhibitors affecting rilpivirine levels
Rifampin, carbamazepine, phenobarbital

Drug-Food Interactions

High-fat meal can increase rilpivirine absorption

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor HIV viral load and CD4 counts, liver function tests, renal function, adherence.

Diagnoses:

Risk for HIV resistance due to non-adherence
Potential drug interactions

Implementation: Administer once daily with or without food; counsel on adherence; monitor for side effects.

Evaluation: Assess viral suppression, adherence, and side effects periodically.

Patient/Family Teaching

Take medication exactly as prescribed.
Report any signs of allergic reactions or neuropsychiatric symptoms.
Avoid concomitant use of antacids or supplements containing metal ions within 2 hours of dosing.
Maintain regular follow-up appointments.

Special Considerations

Black Box Warnings:

Potential for immune reconstitution syndrome.
Risk of hepatotoxicity.

Genetic Factors: None specified.

Lab Test Interference: May cause false-positive urine tests for cannabinoids and other substances.

Overdose Management

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

Treatment: Supportive care, gastric lavage if recent ingestion, monitor vital signs, consult poison control.

Storage and Handling

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

Stability: Stable under recommended storage conditions, follow expiration date on packaging.