Drug Guide
Brincidofovir
Classification
Therapeutic: Antiviral
Pharmacological: Nucleoside analog antiviral agent
FDA Approved Indications
- Treatment of smallpox (vaccinia virus daniello strain) in adults and pediatric patients 2 years of age and older
Mechanism of Action
Brincidofovir inhibits viral DNA polymerase, leading to chain termination and suppression of viral DNA synthesis. It is a lipid conjugate of cidofovir, facilitating improved cellular uptake and reduced nephrotoxicity.
Dosage and Administration
Adult: Initial dose of 200 mg orally once every week; treatment duration varies based on clinical response and CDC guidance.
Pediatric: Dosing based on weight and age, as determined by CDC guidance; typically, 4 mg/kg once weekly, with adjustments as needed.
Geriatric: No specific dosage adjustment required; however, monitor for hepatic function and overall health status.
Renal Impairment: Use caution; dose adjustments may be necessary due to limited data.
Hepatic Impairment: No specific dosage adjustment recommended, but monitor liver function.
Pharmacokinetics
Absorption: Orally absorbed with bioavailability increased via lipid conjugation.
Distribution: Extensively distributed into tissues, especially infected cells.
Metabolism: Metabolized intracellularly to active cidofovir diphosphate.
Excretion: Eliminated primarily via feces and urine.
Half Life: Approximately 17 hours
Contraindications
- Hypersensitivity to brincidofovir or any component of the formulation
Precautions
- Monitor liver function due to potential hepatotoxicity
- Use with caution in immunocompromised patients
- Potential for gastrointestinal adverse effects
Adverse Reactions - Common
- Gastrointestinal symptoms (nausea, diarrhea) (Common)
- Elevated liver enzymes (Common)
Adverse Reactions - Serious
- Hepatotoxicity (Uncommon)
- Myelosuppression (Uncommon)
- Hypersensitivity reactions (Rare)
Drug-Drug Interactions
- Potential increased risk of hepatotoxicity with other hepatotoxic agents
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor hepatic function tests, renal function, and for gastrointestinal symptoms.
Diagnoses:
- Risk for hepatotoxicity
- Risk for dehydration due to gastrointestinal effects
Implementation: Administer as prescribed, monitor labs regularly, educate patient on side effects.
Evaluation: Assess clinical response and adverse effects; adjust therapy if necessary.
Patient/Family Teaching
- Take medication exactly as prescribed and maintain scheduled doses.
- Report any symptoms of liver trouble, severe diarrhea, or allergic reactions.
- Attend regular laboratory monitoring appointments.
- Inform healthcare provider of all ongoing medications.
Special Considerations
Black Box Warnings:
- Potential for hepatotoxicity and depletion of tissue antioxidant defenses.
Genetic Factors: Limited data; no specific genetic considerations identified.
Lab Test Interference: None reported.
Overdose Management
Signs/Symptoms: Severe gastrointestinal symptoms, hepatotoxicity, or allergic reactions.
Treatment: Supportive care, discontinue medication, monitor organ functions, and provide symptomatic treatment as needed.
Storage and Handling
Storage: Store at room temperature, away from moisture and light.
Stability: Stable for the duration specified in the package insert.