TECOVIRIMAT MONOHYDRATE (TPOXX) Nursing Considerations

What is the generic name?

TECOVIRIMAT MONOHYDRATE

What is the Trade Name for TECOVIRIMAT MONOHYDRATE?

TPOXX

What are the Indications for TECOVIRIMAT MONOHYDRATE?

• 1 INDICATIONS AND USAGE TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 13 kg. ( 1.1 ) Limitations of Use: 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‚Äôs efficacy is not ethical. ( 1.2 ) TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. ( 1.2 ) 1.1 Treatment of Human Smallpox Disease TPOXX ¬Æ is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg. 1.2 Limitations of Use 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‚Äôs 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.

References: https://open.fda.gov/