Thiotepa: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Thiotepa appears in the FDA drug-label database. Marketed as Thiotepa.

Drug class

Alkylating Drug (FDA established pharmacologic class)

Mechanism of action

Alkylating Activity (as stated on the FDA label)

Boxed warning

The FDA label for Thiotepa carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Thiotepa for injection is an alkylating drug indicated: • For treatment of adenocarcinoma of the breast or ovary. ( 1.2 ) • For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. ( 1.3 ) • For treatment of superficial papillary carcinoma of the urinary bladder. ( 1.4 ) 1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. 1.3 Malignant Effusions Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 1.4 Superficial Papillary Carcinoma of the Urinary Bladder Thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection. However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.

FDA label via openFDA