Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
THIOTEPA (UNII: 905Z5W3GKH) (THIOTEPA - UNII:905Z5W3GKH)
ADIENNE SA
THIOTEPA
THIOTEPA 15 mg
PRESCRIPTION DRUG
New Drug Application
TEPADINA- THIOTEPA INJECTION, POWDER, FOR SOLUTION ADIENNE SA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TEPADINA® SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TEPADINA®. TEPADINA® (THIOTEPA) FOR INJECTION, FOR INTRAVENOUS, INTRACAVITARY, OR INTRAVESICAL USE. INITIAL U.S. APPROVAL: 1959 WARNING: SEVERE MYELOSUPPRESSION, CARCINOGENICITY TEPADINA MAY CAUSE SEVERE MARROW SUPPRESSION, AND HIGH DOSES MAY CAUSE MARROW ABLATION WITH RESULTING INFECTION OR BLEEDING. MONITOR HEMATOLOGIC LABORATORY PARAMETERS. HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION (HSCT) IS REQUIRED TO PREVENT POTENTIALLY FATAL COMPLICATIONS OF THE PROLONGED MYELOSUPPRESSION AFTER HIGH DOSES OF TEPADINA [SEE _WARNINGS AND PRECAUTIONS (5.1)_] TEPADINA SHOULD BE CONSIDERED POTENTIALLY CARCINOGENIC IN HUMANS [SEE _WARNINGS AND PRECAUTIONS_ _(5.7)_] INDICATIONS AND USAGE TEPADINA (thiotepa) is an alkylating drug indicated: (1) To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1, 14) 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) DOSAGE AND ADMINISTRATION The recommended dose of TEPADINA for class 3 beta-thalassemia is two administrations of 5 mg/kg given intravenously approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide. (2.1) The recommended dose of TEPADINA for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. (2.1) The recommended dose of TEPADINA for treatment of malignant effusions is 0.6 to 0.8 mg/kg intracavitary. (2 Läs hela dokumentet