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
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.
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
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
Contact:
Phone: (847) 550-2300
Toll Free: (888) 391-6300
Email: communications.USA@fresenius-kabi.com
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