Tecovirimat

TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models.

Tecovirimat is an antiviral drug against variola (smallpox) virus.

Pediatric and Adult Patients weighing 40 kg or more (Oral Dosing): 40 kg to less than 120 kg: 600 mg of TPOXX every 12 hours for 14 days 120 kg or more: 600 mg of TPOXX every 8 hours for 14 days Pediatrics and adult patients weighing 13 kg or more and those who cannot swallow capsules (Oral Dosing): TPOXX Capsules can be administered by carefully opening the number of capsule noted below and mixing and administering the entire contents in 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g., apple sauce, yogurt): 13 kg to less than 25 kg: 200 mg (1 Capsule) of TPOXX every 12 hours for 14 days 25 kg to less than 40 kg: 400 mg (2 Capsules) of TPOXX every 12 hours for 14 days 40 kg to less than 120 kg: 600 mg (3 Capsules) of TPOXX every 12 hours for 14 days 120 kg or more: 600 mg (3 capsules) every 8 hours for 14 days Patients weighing 3 kg and above (Intravenous Dosing): 3 kg…

TPOXX Capsules: None. TPOXX Injection: The excipient hydroxypropyl-β-cyclodextrin is eliminated through glomerular filtration. Therefore, TPOXX Injection is contraindicated in patients with severe renal impairment (defined as creatinine clearance below 30 mL/min). TPOXX capsules: None TPOXX injection: TPOXX Injection is contraindicated in patients with severe renal impairment (defined as creatinine clearance below 30 mL/min)

Hypoglycemia: Co-administration with repaglinide may cause hypoglycemia. Monitor blood glucose and monitor for hypoglycemic symptoms during co-administration.

The most common adverse reactions are: TPOXX Capsules (incidence ≥ 2%): headache, nausea, abdominal pain, and vomiting. TPOXX Injection (incidence ≥ 4%): administration site reactions and headache.

Consult the full prescribing information prior to and during treatment for potential drug interactions. Effect of TPOXX on Other Drugs Tecovirimat is a weak inducer of cytochrome P450 (CYP)3A and a weak inhibitor of CYP2C8 and CYP2C19. However, the effects are not expected to be clinically relevant for most substrates of those enzymes based on the magnitude of interactions and the duration of treatment of TPOXX. Table 5 provides a listing of established or significant drug interactions and clinical recommendations for select sensitive substrates. Table 5: Significant Drug Interactions with Effect of TPOXX on Other Drugs a ↓ = decrease, ↑ = increase b These interactions have been studied in healthy adults.

Store capsules in the original bottle at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). Storage and Handling Store TPOXX injection in a refrigerator at 2°C to 8°C (36°F to 46°F) Do not freeze. Short-term (up to 24 hours) storage and handling at an ambient temperature is acceptable. The diluted solution(s) of TPOXX injection with either 0.9% (w/v) sodium chloride (normal saline) or 5% (w/v) dextrose solution should be used within 4 hours of preparation if stored at room temperature or within 24 hours of preparation if stored at 2°C to 8°C.