Fresenius Kabi Announces U.S. Availability of Cancer Therapeutic Thiotepa

Expanding access to affordable oncology medicines

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today it has introduced Thiotepa for Injection, USP, in the United States. Thiotepa, a generic equivalent to Tepadina^®, is the newest addition to the company’s injectable oncology portfolio – the most comprehensive in the industry.

Fresenius Kabi Thiotepa for Injection, USP is available immediately in 100 mg single-dose vials. It has multiple indications, including for the treatment of patients with adenocarcinoma of the breast or ovary.

“We are pleased to add Thiotepa for Injection, USP to our portfolio of generic oncology medicines,” said John Ducker, president and CEO of Fresenius Kabi USA. “As a company whose purpose is ‘caring for life,’ we remain committed to supporting patients and their care teams by expanding access to affordable cancer treatment options.”

INDICATIONS AND USAGE

Thiotepa for injection is an alkylating drug indicated:

• For treatment of adenocarcinoma of the breast or ovary.
• For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
• For treatment of superficial papillary carcinoma of the urinary bladder.

IMPORTANT SAFETY INFORMATION

WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY See full prescribing information for complete boxed warning May cause severe marrow suppression or ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Potentially carcinogenic in humans.

Thiotepa for Injection is contraindicated in patients with a hypersensitivity to the active substance and with concomitant use with live or attenuated vaccines.

Cutaneous toxicity: Cleanse skin at least twice daily through 48 hours after the last dose of thiotepa.

Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy.

The most common adverse reactions (incidence greater than 10%) were neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800‐551‐7176, option 5, or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.com.

Lactation: Breastfeeding is not recommended.

Moderate or severe renal impairment: Monitor patients more frequently for toxicity.

Moderate or severe hepatic impairment: Monitor patients more frequently for toxicity.

This Important Safety Information does not include all the information needed to use Thiotepa for Injection safely and effectively. Please see full prescribing information for Thiotepa for Injection at www.fresenius-kabi.com/us.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.

*Tepadina^® is a registered trademark of Amneal/Adienne.