Home Drug Guide Doravirine

Drug Guide

Generic Name

Doravirine

Brand Names Pifeltro

Classification

Therapeutic: Antiretroviral agent, HIV-1 reverse transcriptase inhibitor

Pharmacological: Non-nucleoside reverse transcriptase inhibitor (NNRTI)

FDA Approved Indications

Treatment of human immunodeficiency virus type 1 (HIV-1) infection

Mechanism of Action

Doravirine binds directly to reverse transcriptase at an allosteric site, causing a conformational change that inhibits its enzymatic activity, thereby blocking HIV replication.

Dosage and Administration

Adult: 600 mg once daily, with or without food

Pediatric: Not established; not approved for pediatric use

Geriatric: No specific dosage adjustment; use with caution in older adults

Renal Impairment: No dosage adjustment necessary

Hepatic Impairment: Use with caution; no specific dosage recommendation available

Pharmacokinetics

Absorption: Rapidly absorbed; peak plasma concentrations in approximately 2 hours

Distribution: Widely distributed; plasma protein binding ~74%

Metabolism: Primarily metabolized by CYP3A4 and UGT1A1 enzyme pathways

Excretion: Primarily fecal (about 69%), minimal renal excretion

Half Life: Asymptomatic half-life approximately 13 hours

Contraindications

Hypersensitivity to doravirine or any component of the formulation

Precautions

Use with caution in patients with hepatic impairment; potential for resistance in cases of prior NNRTI failure; co-administration with potent CYP3A4 inducers may decrease effectiveness

Adverse Reactions - Common

Nausea (Less than 10%)
Headache (Less than 10%)
Diarrhea (Less than 10%)
Fatigue (Less than 10%)

Adverse Reactions - Serious

Hypersensitivity reactions including rash, hepatotoxicity, and hypersensitivity (Rare)

Drug-Drug Interactions

CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase doravirine levels
CYP3A4 inducers (e.g., rifampin, carbamazepine) may decrease efficacy

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of hypersensitivity, liver function abnormalities, adherence counseling

Diagnoses:

Risk for infection due to immunosuppression

Implementation: Take as prescribed; counsel on adherence and potential drug interactions

Evaluation: Assess viral load and CD4 counts periodically to evaluate efficacy

Patient/Family Teaching

Take medication exactly as prescribed
Report symptoms of allergic reactions, liver problems
Maintain regular medical follow-up
Inform healthcare provider of all medications and supplements used

Special Considerations

Black Box Warnings:

None at this time

Genetic Factors: No specific genetic testing recommended

Lab Test Interference: May affect liver function tests, lipid panel, and viral load testing

Overdose Management

Signs/Symptoms: Nausea, vomiting, dizziness, hypotension

Treatment: Supportive care; no specific antidote; contact poison control center

Storage and Handling

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

Stability: Stable at room temperature; keep in original container, protected from moisture and light