Tecovirimat

Kathryn Dzintars, Pharm.D., BCPS, Edina Avdic, Pharm.D.

INDICATIONS

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.

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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