Thiotepa Riemser

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

thiotepa

Available from:

Esteve Pharmaceuticals GmbH

ATC code:

L01AC01

INN (International Name):

thiotepa

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Hematopoietic Stem Cell Transplantation; Neoplasms

Therapeutic indications:

Thiotepa Riemser 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 Riemser 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

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2021-03-26

Patient Information leaflet

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
THIOTEPA RIEMSER 15 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
THIOTEPA RIEMSER 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
thiotepa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Thiotepa Riemser is and what it is used for
2.
What you need to know before you use Thiotepa Riemser
3.
How to use Thiotepa Riemser
4.
Possible side effects
5.
How to store Thiotepa Riemser
6.
Contents of the pack and other information
1.
WHAT THIOTEPA RIEMSER IS AND WHAT IT IS USED FOR
Thiotepa Riemser contains the active substance thiotepa, which belongs
to a group of medicines called
alkylating agents.
Thiotepa Riemser 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.
Thiotepa Riemser can be used in adults and children and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE THIOTEPA RIEMSER
DO NOT USE THIOTEPA RIEMSER
-
if you are allergic to thiotepa,
-
if you are pregnant or think you may be pregnant,
-
if you are breast-feeding,
-
if you are receiving yellow fever vaccination, live virus and
bacterial vaccines.
WARNING AND PRECAUTIONS
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 (if treated with
phenytoin or fosphenytoin).
Because Thiotepa Riemser destroys bone marrow cells responsible for
producing blood cells, regular
blood tests will be taken during treatment to check your blood cell
counts

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Thiotepa Riemser 15 mg powder for concentrate for solution for
infusion
Thiotepa Riemser 100 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thiotepa Riemser 15 mg powder for concentrate for solution for
infusion
One vial of powder contains 15 mg thiotepa.
After reconstitution with 1.5 mL of water for injections, each mL of
solution contains 10 mg thiotepa
(10 mg/mL).
Thiotepa Riemser 100 mg powder for concentrate for solution for
infusion
One vial of powder contains 100 mg thiotepa.
After reconstitution with 10 mL of water for injections, each mL of
solution contains 10 mg thiotepa
(10 mg/mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thiotepa Riemser 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Thiotepa Riemser administration must be supervised by a physician
experienced in conditioning
treatment prior to haematopoietic progenitor cell transplantation.
Posology
Thiotepa Riemser is administered at different doses, in combination
with other chemotherapeutic
medicinal products, in patients with haematological diseases or solid
tumours prior to HPCT.
Thiotepa Riemser posology is reported, in adult and paediatric
patients, according to the type of HPCT
(autologous or allogeneic) and disease.
3
_Adults_
_AUTOLOGOUS HPCT _
_Haematological diseases _
_ _
The recommended dose in haematological