Tecovirimat

Kathryn Dzintars, Pharm.D., BCPS, Edina Avdic, Pharm.D.
Tecovirimat is a topic covered in the Johns Hopkins ABX Guide.

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INDICATIONS

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.

NON-FDA APPROVED USES

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INDICATIONS

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.

NON-FDA APPROVED USES

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Last updated: August 25, 2022