Brincidofovir

Dosing Considerations • TEMBEXA should be avoided in pregnant women or in individuals of childbearing potential who think they might be pregnant. 1 Pregnancy]. 1 Pregnancy]. ” TEMBEXA (brincidofovir) Product Monograph Page 5 of 26 TEMBEXA, as clinically appropriate.

• Advise women of childbearing potential to avoid becoming pregnant and to use effective contraception during treatment with TEMBEXA and for at least 2 months after the last dose [see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential; Contraception].

• Advise male patients of reproductive potential with female partners of childbearing potential to use condoms during treatment with TEMBEXA and for at least 4 months after the last dose [see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential; Contraception].

• TEMBEXA efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models [see 7 WARNINGS AND PRECAUTIONS, Immune]. • Animal studies have indicated that co-administration of TEMBEXA at the same time as the live smallpox vaccine (vaccinia virus) may reduce the immune response to the vaccine.

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 ) Limitations of Use: • TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease.

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.

2 ) • TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. 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.

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 )] .