Tepadina

Product Overview

About Tepadina

Tepadina is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance thiotepa.

What it is used for

Tepadina is used in combination with chemotherapy (medicines to treat cancer) in two ways: as a ‘conditioning’ (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells). This type of transplant is used in patients who need to replace their blood-making cells because they have a blood disease such as a cancer of the blood (including leukaemia) or diseases causing low red blood cell counts (including thalassaemia or sickle-cell anaemia); during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed. Tepadina can be used for transplantation of cells from a donor and for transplantation of cells derived from the patient’s own body. Because the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, Tepadina was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 January 2007. The medicine can only be obtained with a prescription.

How it is used

Tepadina treatment must be supervised by a doctor who has experience in treatments given before transplantation. It must be given as an infusion into a large vein lasting two to four hours. The dose of Tepadina depends on the type of blood disease or solid tumour that the patient has and the type of transplantation to be carried out. The dose also depends on the patient’s body surface area (calculated using the height and weight of the patient) or on the patient’s weight. In adults, the daily dose ranges from 120 to 481 mg per square metre (m2) given for up to five days before transplantation. In children, the daily dose ranges from 125 to 350 mg/m2 given for up to three days before transplantation.

How it works

The active substance in Tepadina, thiotepa, belongs to a group of medicines called ‘alkylating agents’. These substances are ‘cytotoxic’. This means that they kill cells, especially cells that multiply rapidly, such as cancer or progenitor (or ‘stem’) cells (cells that can develop into different types of cell). Tepadina is used with other medicines before transplantation to destroy the abnormal cells and the patient’s existing blood-making cells. This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection. Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.

Active substance: thiotepa

Source: EMA EPAR