Johns Hopkins ABX Guide
Tecovirimat
INDICATIONS
FDA
FDA
- Indicated for treating human smallpox disease in adults and pediatric patients weighing at least 13 kg.
- Limitations of use:
- The effectiveness of tecovirimat 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.
- The U.S. approved the drug based on the FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models.
- Efficacy may be reduced in immunocompromised patients based on animal models.
- The effectiveness of tecovirimat 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.
- Limitations of use:
NON-FDA APPROVED USES
NON-FDA APPROVED USES
- Available under an expanded-access (EA-IND) protocol Treatment Information for Healthcare Professionals | Monkeypox | Poxvirus | CDC and the National Drug Stockpile
- CDC and FDA have streamlined the process by reducing the paperwork and data collection (Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC).
- The effectiveness of tecovirimat for treating monkeypox disease has not been determined in humans because of the disease’s rarity and sporadic occurrence before 2022, so adequate and well-controlled field trials have not been feasible.
- Efficacy may be reduced in immunocompromised patients based on animal models.
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Last updated: March 16, 2025
Citation
Dzintars, Kathryn. "Tecovirimat." Johns Hopkins ABX Guide, The Johns Hopkins University, 2025. Pediatrics Central, peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat.
Dzintars K. Tecovirimat. Johns Hopkins ABX Guide. The Johns Hopkins University; 2025. https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat. Accessed April 7, 2025.
Dzintars, K. (2025). Tecovirimat. In Johns Hopkins ABX Guide. The Johns Hopkins University. https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat
Dzintars K. Tecovirimat [Internet]. In: Johns Hopkins ABX Guide. The Johns Hopkins University; 2025. [cited 2025 April 07]. Available from: https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat.
* Article titles in AMA citation format should be in sentence-case
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PB - The Johns Hopkins University
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