TEMBEXA® (brincidofovir) is an antiviral medication developed for the treatment of human smallpox disease, a potentially fatal infection caused by the variola virus. It is a nucleotide analog that inhibits viral DNA replication, helping to reduce the severity and progression of the disease. TEMBEXA® is primarily indicated for adults and children (including neonates), and while the drug has been shown to be effective in animal models, its human efficacy has not been definitively proven due to ethical constraints in conducting smallpox challenge studies. It is available as both tablets and oral suspension for patients who have difficulty swallowing pills.

Despite its potential benefits in treating smallpox, TEMBEXA® requires careful monitoring due to its potential to cause liver toxicity and gastrointestinal disturbances. It should be used with caution in individuals of childbearing potential due to risks of embryo-fetal toxicity and male infertility, as shown in animal studies. Given its significant side effect profile, TEMBEXA® is primarily used in the context of emergency preparedness in the event of a smallpox outbreak or bioterrorism attack.