Johns Hopkins ABX Guide
Tecovirimat
Tecovirimat is a topic covered in the Johns Hopkins ABX Guide.
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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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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: August 25, 2022
Citation
Dzintars, Kathryn, and Edina Avdic. "Tecovirimat." Johns Hopkins ABX Guide, The Johns Hopkins University, 2022. Johns Hopkins Guides, www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat.
Dzintars K, Avdic E. Tecovirimat. Johns Hopkins ABX Guide. The Johns Hopkins University; 2022. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat. Accessed March 26, 2023.
Dzintars, K., & Avdic, E. (2022). Tecovirimat. In Johns Hopkins ABX Guide. The Johns Hopkins University. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat
Dzintars K, Avdic E. Tecovirimat [Internet]. In: Johns Hopkins ABX Guide. The Johns Hopkins University; 2022. [cited 2023 March 26]. Available from: https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat.
* Article titles in AMA citation format should be in sentence-case
TY - ELEC
T1 - Tecovirimat
ID - 540718
A1 - Dzintars,Kathryn,Pharm.D., BCPS
AU - Avdic,Edina,Pharm.D.
Y1 - 2022/08/25/
BT - Johns Hopkins ABX Guide
UR - https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540718/all/Tecovirimat
PB - The Johns Hopkins University
DB - Johns Hopkins Guides
DP - Unbound Medicine
ER -
