Tembexa
brincidofovir
Manufacturer: Emergent BioDefense Operations Lansing LLC
Black Box Warning (Boxed Warning)
A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.
FDA-Approved Indications (2)
Treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates
TEMBEXA is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates.
Population: adult and pediatric patients, including neonates
Indications & Usage
1 INDICATIONS AND USAGE TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. ( 1.1 ) Limitations of Use: • TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. ( 1.2 ) • The effectiveness of TEMBEXA 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’s efficacy is not ethical. ( 1.2 ) • TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. ( 1.2 ) 1.1 Treatment of Human Smallpox Disease TEMBEXA ® is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. 1.2 Limitations of Use TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease [see Warnings and Precautions ( 5.1 , 5.2 )] . The effectiveness of TEMBEXA for the 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 [see Clinical Studies ( 14 )] . TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.
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