Tepylute FDA Approval History
Last updated by Judith Stewart, BPharm on July 1, 2024.
FDA Approved: Yes (First approved June 25, 2024)
Brand name: Tepylute
Generic name: thiotepa
Dosage form: Injection
Company: Shorla Oncology
Treatment for: Breast Cancer, Ovarian Cancer
Tepylute (thiotepa) is a ready-to-dilute formulation of the approved alkylating agent thiotepa indicated for the treatment of adenocarcinoma of the breast or ovary.
- Thiotepa is a cytotoxic agent related chemically and pharmacologically to nitrogen mustards. As an alkylating agent, thiotepa works by interfering with DNA replication and RNA transcription in cancer cells to cause disruption of nucleic acid function, which leads to cell death.
- Thiotepa was first approved by the U.S. Food and Drug Administration as a treatment for several solid cancers in 1959. Thioplex (thiotepa) lyophilized powder for injection was approved in 1994 and Tepadina (thiotepa) lyophilized powder for injection was approved in 2017. Both of these thiotepa formulations require reconstitution with sterile water for injection.
- Tepylute is supplied as a 15 mg/1.5 mL (10 mg/mL) injection ready for dilution in an appropriate volume of 0.9% Sodium Chloride Injection. It is intended to provide easier preparation and dosing compared to previously approved formulations of thiotepa.
- Tepylute is administered by intravenous infusion.
- The product label for Tepylute carries a Boxed Warning for severe myelosuppression and carcinogenicity. Warnings and precautions associated with Tepylute include cutaneous toxicity, polyethylene glycol 400 toxicity, and fetal harm.
- Common adverse reactions (incidence greater than 10%) include neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria, and rash.
Development timeline for Tepylute
| Date | Article |
|---|---|
| Jun 28, 2024 | Approval FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer |
Further information
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