TPOXX Capsule Ref.[10236] Active ingredients: Tecovirimat

Source: FDA, National Drug Code (US)  Revision Year: 2018 

1. Indications and Usage

1.1 Treatment of Human Smallpox Disease

TPOXX is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg.

1.2 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 [see Clinical Studies (14)].

TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models.

2. Dosage and Administration

2.1 Dosage for Adults and Pediatric Patients Weighing at Least 40 kg

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)].

2.2 Dosage for Pediatric Patients

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)].

2.3 Preparation for Administration to Pediatrics and Those Who Cannot Swallow Capsules

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 WeightDosageNumber of CapsulesDrug-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.

10. Overdosage

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.

16.2. Storage and Handling

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].

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.