Introducing the first antiviral to be approved for the treatment of smallpox in all age groups, including infants, and for patients who have difficulty swallowing.
TEMBEXA® (brincidofovir) is an oral antiviral approved by the U.S. Food and Drug Administration (FDA) in tablet and oral suspension formulations for the treatment of smallpox disease in adult and pediatric patients.
This is not an offer for sale. TEMBEXA is not available commercially.
IMPORTANT SAFETY INFORMATION Including BOXED WARNING
WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION
An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease.
WARNINGS AND PRECAUTIONS
Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment.
Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur. Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA.
Coadministration with Related Products: TEMBEXA should not be co-administered with intravenous cidofovir.
Carcinogenicity: TEMBEXA is considered a potential human carcinogen. Do not crush or divide TEMBEXA tablets and avoid direct contact with broken or crushed tablets or oral suspension.
Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA may irreversibly impair fertility in individuals of reproductive potential.
Common adverse reactions (adverse events assessed as causally related by the investigator in ≥ 2% of subjects) experienced in the first 2 weeks of dosing with TEMBEXA were diarrhea, nausea, vomiting and abdominal pain.
USE IN SPECIFIC POPULATIONS
Based on findings from animal reproduction studies, TEMBEXA may cause fetal harm when administered to pregnant individuals. Pregnancy testing should be performed before initiation of TEMBEXA in individuals of childbearing potential to inform risk. An alternative therapy should be used to treat smallpox during pregnancy, if feasible.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088
REV 09/2021 24CH0605