Brincidofovir Dosage

Usual Adult Dose for Smallpox

Patients weighing 48 kg or above:
200 mg as two 100 mg tablets or 20 mL oral suspension, once weekly for 2 doses (on Days 1 and 8)

Patients weighing less than 48 kg:
4 mg/kg oral suspension once weekly for two doses (on Days 1 and 8)

Duration of therapy: 2 weeks

Comments: Perform hepatic laboratory testing in all patients, and pregnancy testing (in female patients of childbearing potential) before treatment initiation.

Use: Treatment of adults with human smallpox disease

Usual Pediatric Dose for Smallpox

Pediatric patients weighing less than 10 kg:
6 mg/kg oral suspension once weekly for 2 doses (on Days 1 and 8)

Pediatric patients weighing 10 kg to less than 48 kg:
4 mg/kg oral suspension once weekly for 2 doses (on Days 1 and 8)

Pediatric patients weighing 48 kg or above:
200 mg (two 100 mg tablets or 20 mL oral suspension) once weekly for 2 doses (on Days 1 and 8)

Duration of therapy: 2 weeks

Comments: Perform hepatic laboratory testing in all patients, and pregnancy testing (in female patients of childbearing potential) before treatment initiation.

Use: Treatment of children with human smallpox disease

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

US BOXED WARNING:
Increased Risk for Mortality When Used for Longer Duration
An increased incidence of mortality was seen in subjects treated with this drug compared to placebo in a 24-week clinical trial when this drug was evaluated in another disease

CONTRAINDICATIONS: None

This drug is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of this drug in smallpox infected adults and pediatric patients, including neonates, is based solely on efficacy studies in animal models of orthopoxvirus disease.

Efficacy may be reduced in immunocompromised patients.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:

Tablets should be swallowed whole, do not crush or break.
Tablets can be taken on an empty stomach or with a low-fat meal.
Oral suspension should be taken on an empty stomach. Shake well before taking.
Use an appropriate dosing syringe to measure the suspension prescribed dose and discard any left medication after completing the 2 prescribed doses.
Avoid direct contact with broken or crushed tablets or with the oral suspension.
If there is contact with skin or mucous membranes, wash thoroughly with water and soap. If contact is with eyes, rinse with abundant water.
Oral suspension can be administered by enteral tube (in patients that cannot swallow). See manufacturer prescribing information for instructions.

Storage requirements:

Tablets and oral suspension: Store at 20C to 25C (68F to 77F); with excursions permitted from 15C to 30C (59F to 86F)

Monitoring:

Liver function tests should be monitored before and during treatment.
Monitor patients for gastrointestinal adverse events such as diarrhea and dehydration, provide supportive care and if needed do not administer the second dose.

Patient advice: