Thiotepa

TEPADINA is indicated, in combination with other chemotherapy medicinal products: • with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; • when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Thiotepa for Injection USP (thiotepa for injection) is indicated: • in combination with other chemotherapeutic products as part of a high-dose chemotherapy (HDCT) consolidation regimen followed by autologous stem cell transplantation (ASCT) for adult patients with central nervous system (CNS) lymphoma and has been issued marketing authorization with conditions.

Patients should be advised of the nature of the authorization. html. Note that trials to verify the clinical benefit of the medicinal ingredient in Thiotepa for Injection USP are being carried out by the manufacturer of the Canadian Reference Product.

Thiotepa for Injection USP should be administered under the supervision of a physician who is experienced in the use of HDCT followed by SCT. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

2 Geriatrics There is limited clinical data on the use of high-dose thiotepa for injection as part of a HDCT regimen in geriatric patients (>65 years of age) with CNS lymphoma. Caution is needed in these patients.

TEPADINA is indicated, in combination with other chemotherapy medicinal products: • with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; • when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

INDICATIONS AND USAGE

Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: 1. Adenocarcinoma of the breast.

2. Adenocarcinoma of the ovary. 3. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 4. For the treatment of superficial papillary carcinoma of the urinary bladder.

While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin’s disease.