Home Drug Guide Daclatasvir Dihydrochloride

Drug Guide

Generic Name

Daclatasvir Dihydrochloride

Brand Names Daklinza

Classification

Therapeutic: Antiviral (HCV NS5A replication complex inhibitor)

Pharmacological: NS5A replication complex inhibitor

FDA Approved Indications

Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection

Mechanism of Action

Daclatasvir inhibits HCV NS5A protein, which plays a crucial role in viral RNA replication and virion assembly, thereby preventing viral replication.

Dosage and Administration

Adult: 60 mg once daily, with or without food.

Pediatric: Not approved for use in individuals under 18 years.

Geriatric: No specific dosage adjustment recommended, but monitor for tolerability.

Renal Impairment: No adjustment needed for mild to moderate impairment; limited data on severe impairment.

Hepatic Impairment: Use with caution; no dose adjustment for mild impairment, contraindicated in severe impairment.

Pharmacokinetics

Absorption: Rapidly absorbed, peak plasma levels in about 2 hours.

Distribution: Wide tissue distribution, plasma protein binding approximately 99%.

Metabolism: Primarily metabolized in the liver via CYP3A4/5, with some contribution from CYP2C8.

Excretion: Excreted mainly in feces (~90%) and urine (~6%).

Half Life: Approximately 12-15 hours.

Contraindications

Concurrent use with strong CYP3A inducers (e.g., rifampin, carbamazepine).
Hypersensitivity to daclatasvir or any component of the formulation.

Precautions

Use with caution in patients with hepatic impairment.
Monitor for drug interactions, especially with medications affecting CYP3A4.

Adverse Reactions - Common

Headache (Common)
Fatigue (Common)
Nausea (Common)

Adverse Reactions - Serious

Bradycardia (when used with amiodarone) (Serious but infrequent)
Elevated liver enzymes (Serious)

Drug-Drug Interactions

Strong CYP3A inducers or inhibitors (e.g., rifampin, ketoconazole, clarithromycin)

Drug-Food Interactions

Grapefruit and grapefruit juice may increase plasma levels of daclatasvir.

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor liver function tests, assess for signs of hepatitis or liver failure.

Diagnoses:

Risk for infection due to hepatic impairment.
Knowledge deficit related to medication use.

Implementation: Administer as prescribed, monitor for adverse reactions, and educate patient about adherence and potential side effects.

Evaluation: Assess viral load reduction and liver function tests to evaluate treatment efficacy.

Patient/Family Teaching

Take medication exactly as prescribed, without missing doses.
Report symptoms such as fatigue, jaundice, or severe nausea.
Avoid grapefruit or grapefruit juice during therapy.
Attend all follow-up appointments for monitoring.

Special Considerations

Black Box Warnings:

There are no black box warnings for daclatasvir.

Genetic Factors: None specific.

Lab Test Interference: None known.

Overdose Management

Signs/Symptoms: N/A - overdose data limited; monitor for adverse effects.

Treatment: Supportive care, discontinue medication, and provide symptomatic treatment as needed.

Storage and Handling

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

Stability: Stable under recommended storage conditions, protected from moisture and light.