Source: FDA, National Drug Code (US) Revision Year: 2018
TPOXX is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg.
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 [see Clinical Studies (14)].
TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models.
The recommended dosage of TPOXX in adults and pediatric patients weighing at least 40 kg is 600 mg (three 200 mg capsules) taken twice daily orally for 14 days. TPOXX should be taken within 30 minutes after a full meal of moderate or high fat [see Clinical Pharmacology (12.3)].
The recommended dosage for pediatric patients is based on weight starting at 13 kg as shown in Table 1. The dose should be given twice daily orally for 14 days and should be taken within 30 minutes after a full meal of moderate or high fat [see Clinical Pharmacology (12.3)].
TPOXX capsules can be administered by carefully opening the capsule and mixing the entire contents in 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g., apple sauce, yogurt). The entire mixture should be administered within 30 minutes of its preparation.
Table 1. Recommended Pediatric and Adult Dosage and Preparation Instructions:
| Body Weight | Dosage | Number of Capsules | Drug-Food Preparation |
|---|---|---|---|
| 13 kg to less than 25 kg | 200 mg twice daily | Contents of 1 Capsule twice daily | Mix 1 capsule of TPOXX with 30 mL of liquid or soft food. Administer the whole mixture. |
| 25 kg to less than 40 kg | 400 mg twice daily | Contents of 2 Capsules twice daily | Mix 2 capsules of TPOXX with 30 mL of liquid or soft food. Administer the whole mixture. |
| 40 kg and above | 600 mg twice daily | Contents of 3 Capsules twice daily | Mix 3 capsules of TPOXX with 30 mL of liquid or soft food. Administer the whole mixture. |
There is no clinical experience with overdosage of TPOXX. In case of overdosage, monitor patients for any signs or symptoms of adverse effects. Hemodialysis will not significantly remove TPOXX in overdosed patients.
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) [See USP Controlled Room Temperature].
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