Nurses Compass
Drug Guide
Boceprevir
Classification
Therapeutic: Antiviral agent for hepatitis C virus (HCV) infection
Pharmacological: HCV NS3/4A protease inhibitor
FDA Approved Indications
- Treatment of chronic hepatitis C genotype 1 infection in combination with peginterferon and ribavirin
Mechanism of Action
Boceprevir inhibits the HCV NS3/4A protease, an enzyme crucial for viral replication, thereby reducing viral load.
Dosage and Administration
Adult: 200 mg three times daily in combination with peginterferon alfa and ribavirin for up to 48 weeks.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustments recommended, consider hepatic function.
Renal Impairment: No specific dose adjustment recommended, use with caution.
Hepatic Impairment: Use with caution; avoid in decompensated liver disease.
Pharmacokinetics
Absorption: Well absorbed with food.
Distribution: Bound approximately 75% to plasma proteins.
Metabolism: Primarily via hepatic CYP3A4 enzyme.
Excretion: Metabolites eliminated in feces and urine.
Half Life: 3-4 hours.
Contraindications
- Hypersensitivity to boceprevir or any component of the formulation.
- Use with drugs highly dependent on CYP3A4 for clearance and with narrow therapeutic index.
Precautions
- Use in patients with hepatic impairment, especially decompensated cirrhosis.
- Monitor hematologic status due to potential anemia and neutropenia.
Adverse Reactions - Common
- Anemia (Very common)
- Neutropenia (Common)
- Fatigue (Common)
- Headache (Common)
Adverse Reactions - Serious
- Sudden vision loss (rare) (Serious)
- Allergic reactions including rash, itching, swelling (Rare)
- Elevations in liver enzymes (Common)
Drug-Drug Interactions
- Component of multi-drug regimens metabolized by CYP3A4, e.g., certain statins, antiarrhythmics.
- Use caution with drugs that are CYP3A4 substrates, inhibitors, or inducers.
Drug-Food Interactions
- No specific interactions reported.
Drug-Herb Interactions
- Potential interactions with herbal products affecting CYP3A4, such as St. John's Wort.
Nursing Implications
Assessment: Baseline hepatic function and hemoglobin levels.
Diagnoses:
- Risk for bleeding (due to anemia), Risk for infection (neutropenia).
Implementation: Monitor CBC, liver enzymes, and HCV RNA levels regularly. Ensure adherence to dosing schedule.
Evaluation: Assess viral load response and monitor for adverse effects.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report signs of anemia, rash, or allergic reactions immediately.
- Avoid alcohol and hepatotoxic drugs.
- Attend all follow-up and lab appointments.
Special Considerations
Black Box Warnings:
- Potential to cause hepatitis exacerbation upon discontinuation.
- Use with caution in patients with hepatic decompensation.
Genetic Factors: Not specifically indicated.
Lab Test Interference: May affect liver function tests.
Overdose Management
Signs/Symptoms: N/A specific symptoms; may include severity of adverse effects.
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 under recommended storage conditions.