Brincidofovir
Nucleosides and Nucleotides Excl. Reverse Transcriptase Inhibitors
Sold as TEMBEXA
- Drug class
- Nucleosides and Nucleotides Excl. Reverse Transcriptase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 2
- Products on record
- 3
- FDA reports (12 mo)
- 11
Overview
Plain-language summary, compiled from the cited regulatory records
Brincidofovir is a nucleoside and nucleotide analog DNA polymerase inhibitor [1]. It is approved for the treatment of human smallpox disease in adult and pediatric patients, including neonates [1].
Brincidofovir is marketed under the brand name Tembexa [1]. This medication is specifically indicated for smallpox disease and is not approved for treating other conditions [1]. The effectiveness of brincidofovir for treating smallpox has not been determined in humans through adequate and well-controlled field trials [1].
In the past 12 months, there have been 11 adverse event reports associated with brincidofovir [2]. The most frequently reported adverse events include acute graft versus host disease in the intestine, liver, and skin, as well as cytomegalovirus infection and reports of the drug being ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 2 | March 16, 2026 |
| US United States | FDA | 1 | July 23, 2025 |
CACanada· Health Canada
2 products
How to take
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.
USUnited States· FDA
1 product
Uses
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 )] .
Sources & citations
- [1]Health Canada (DPD) · 02543842 · revised March 16, 2026
- [2]FDA DailyMed · 0784838e-00bd-4b… · revised July 23, 2025 [PDF]
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.