TEPADINA 15 mg powder for concentrate for solution forinfusion
What is it and how is it used?
TEPADINA contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.
TEPADINA is used to prepare patients for bone marrow transplantation. It works by destroying bone marrow cells. This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells.
TEPADINA can be used in adults and children.
What do you have to consider before using it?
Do not use TEPADINA
■if you are allergic (hypersensitive) to thiotepa,
■if you are pregnant or think you may be pregnant (see below),
■if you are breast-feeding,
■if you are receiving yellow fever vaccination.
Take special care with TEPADINA
You should tell your doctor if you have:
■liver or kidney problems,
■heart or lung problems,
■seizures/fits (epilepsy) or have had them in the past.
You will have to take regular blood tests during treatment to check your blood cell counts.
You will have to use anti-infectives to prevent and manage infections.
TEPADINA may cause another type of cancer in the future. Your doctor will discuss this risk with you.
Pregnancy and breast-feeding
You must tell your doctor if you are or think you may be pregnant before you receive TEPADINA. You must not use TEPADINA during pregnancy.
Both women and men using TEPADINA must use effective contraceptive methods during treatment.
It is not known whether this medicinal product is excreted in breast milk. As a precautionary measure, women must not breast-feed during treatment with TEPADINA.
TEPADINA can impair male and female fertility. Male patients should seek for sperm preservation before therapy is started and should not father while treated and during the year after cessation of treatment.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
How is it used?
Your doctor will calculate the dose according to your body surface or weight and your disease.
How TEPADINA is given
TEPADINA is administered by a qualified healthcare professional as an intravenous infusion (drip in a vein) after dilution of the individual vial. Each infusion will last 2-4 hours.
Frequency of administration
You will receive your infusions every 12 or 24 hours. The duration of treatment can last up to 3 days. Frequency of administration and duration of treatment depend on your disease.
What are possible side effects?
Like all medicines, TEPADINA can cause side effects, although not everybody gets them.
The most serious side effects of TEPADINA therapy or the transplant procedure may include
■decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion)
■infection
■liver disorders including blocking of a liver vein
■the graft attacks your body (graft versus host disease)
■respiratory complicationsYour doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Side effects of TEPADINA may occur with certain frequencies, which are defined as follows very common affects more than 1 user in 10 common affects 1 to 10 users in 100 uncommon affects 1 to 10 users in 1,000 rare affects 1 to 10 users in 10,000 very rare affects less than 1 user in 10,000 not known frequency cannot be estimated from the available data.
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