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These highlights do not include all the information needed to use TPOXX ®safely and effectively. See full prescribing information for TPOXX. TPOXX (tecovirimat) capsules, for oral use TPOXX (tecovirimat) injection for intravenous use Initial U.S. Approval: 2018
Medication labelWhy this: Advisory · dailymed-prescription
TPOXX ®is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 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.
- generic_name
- tecovirimat monohydrate
- product_names
- tecovirimat monohydrate
- ndc
- 50072-200, 50072-010, 50072-010-30, 50072-010-01, 50072-200-42
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en