What TEPADINA contains
- The active substance is thiotepa. One vial contains 100 mg thiotepa. After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
- TEPADINA does not contain any other ingredients.
What TEPADINA looks like and contents of the pack
TEPADINA is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa.
Each carton contains 1 vial.
Marketing Authorisation Holder
ADIENNE S.r.l.
Via Broseta 64/B
24128 Bergamo
Italy
+39 035 19964047
adienne@adienne.com
Manufacturer
RIEMSER Arzneimittel AG
7 An der Wiek
17493 Greifswald
Insel Riems
Germany
This leaflet was last approved in: {MM/YYYY}
The following information is intended for medical or healthcare professionals only.
PREPARATION GUIDE
TEPADINA 100 mg powder for concentrate for solution for infusion
Thiotepa
Read this guide prior to the preparation and administration of TEPADINA.
1. PRESENTATION
TEPADINA is supplied as 100 mg powder for concentrate for solution for infusion. TEPADINA must be reconstituted and diluted prior to administration.
2. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
General
Procedures for proper handling and disposal of anticancer medicinal products should be considered. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.As with other cytotoxic compounds, caution need to be exercised in handling and preparation of TEPADINA solutions to avoid accidental contact with skin or mucous membranes. Topical reactions associated with accidental exposure to thiotepa may occur. In fact, the use of gloves is recommended in preparing the solution for infusion. If thiotepa solution accidentally contacts the skin, immediately the skin must be thoroughly washed with soap and water. If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water.
Calculation of dose of TEPADINA
TEPADINA is administered at different doses in combination with other chemotherapeutic medicinal products in patients prior to conventional haematopoietic progenitor cell transplantation (HPCT) for haematological diseases or solid tumours.
TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.
Posology in adults
AUTOLOGOUS HPCT:
Haematological diseases
The recommended dose in haematological diseases ranges from 125 mg/m 2/day (3.38 mg/kg/day) to 300 mg/m 2/day (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m 2 (24.32 mg/kg), during the time of the entire conditioning treatment.
LYMPHOMA
The recommended dose ranges from 125 mg/m 2/day (3.38 mg/kg/day) to 300 mg/m 2/day (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m 2 (24.32 mg/kg), during the time of the entire conditioning treatment.
CNS LYMPHOMAThe recommended dose is 185 mg/m 2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 370 mg/m 2 (10 mg/kg), during the time of the entire conditioning treatment.
MULTIPLE MYELOMA
The recommended dose ranges from 150 mg/m 2/day (4.05 mg/kg/day) to 250 mg/m 2/day
Solid tumours
The recommended dose in solid tumours ranges from 120 mg/m 2/day (3.24 mg/kg/day) to 250 mg/m 2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 2 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m 2 (21.62 mg/kg), during the time of the entire conditioning treatment.
BREAST CANCER
The recommended dose ranges from 120 mg/m 2/day (3.24 mg/kg/day) to 250 mg/m 2/day (6.76 mg/kg/day) as a single daily infusion, administered from 3 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m 2 (21.62 mg/kg), during the time of
The recommended dose ranges from 125 mg/m 2/day (3.38 mg/kg/day) to 250 mg/m 2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 3 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m 2 (20.27 mg/kg), during the time of the entire conditioning treatment.
OVARIAN CANCER
The recommended dose is 250 mg/m 2/day (6.76 mg/kg/day) as a single daily infusion, administered in 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 500 mg/m 2 (13.51 mg/kg), during the time of the entire conditioning treatment.
GERM CELL TUMOURS
The recommended dose ranges from 150 mg/m 2/day (4.05 mg/kg/day) to 250 mg/m 2/day (6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m 2 (20.27 mg/kg), during the time of the entire
ALLOGENEIC HPCT:
Haematological diseases
The recommended dose in haematological diseases ranges from 185 mgm2day 5 mgkgday to 481 mgm2day 13 mgkgday divided in one or two daily infusions, administered from 1 up to 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mgm2 15 mgkg, during the time of the entire conditioning treatment. LYMPHOMA The recommended dose in lymphoma is 370 mgm2day 10 mgkgday divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mgm210 mgkg, during the time of the entire conditioning treatment. MULTIPLE MYELOMA The recommended dose is 185 mgm2day 5 mgkgday as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mgm2 5 mgkg, during the time of the entire conditioning treatment. LEUKEMIA The recommended dose ranges from 185 mgm2day 5 mgkgday to 481 mgm2day 13 mgkgday divided in one or two daily infusions, administered from 1 up to 2 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mgm2 15 mgkg, during the time of the entire conditioning treatment. THALASSEMIA The recommended dose is 370 mgm2day 10 mgkgday divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mgm210 mgkg, during the time of the entire conditioning treatment.
Posology in paediatric patients
AUTOLOGOUS HPCT:
Solid tumours
The recommended dose in solid tumours ranges from 150 mg/m 2/day (6 mg/kg/day) to 350 mg/m 2/day (14 mg/kg/day) as a single daily infusion, administered from 2 up to 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m 2 (42 mg/kg), during the time of the entire conditioning treatment.
CNS TUMOURS
The recommended dose ranges from 250 mg/m 2/day (10 mg/kg/day) to 350 mg/m 2/day (14 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m 2 (42 mg/kg), during the time of the entire conditioning treatment.
ALLOGENEIC HPCT:
Haematological diseases
The recommended dose in haematological diseases ranges from 125 mgm2day 5 mgkgday to 250 mgm2day 10 mgkgday divided in one or two daily infusions, administered from 1 up to 3 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 375 mgm2 15 mgkg, during the time of the entire conditioning treatment. LEUKEMIA The recommended dose is 250 mgm2day 10 mgkgday divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mgm210 mgkg, during the time of the entire conditioning treatment. THALASSEMIA The recommended dose ranges from 200 mgm2day 8 mgkgday to 250 mgm2day 10 mgkgday divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mgm2 10 mgkg, during the time of the entire conditioning treatment. REFRACTORY CYTOPENIA The recommended dose is 125 mgm2day 5 mgkgday as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mgm2 15 mgkg, during the time of the entire conditioning treatment. GENETIC DISEASES The recommended dose is 125 mgm2day 5 mgkgday as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mgm2 10 mgkg, during the time of the entire conditioning treatment. SICKLE CELL ANAEMIA The recommended dose is 250 mgm2day 10 mgkgday divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mgm210 mgkg, during the time of the entire conditioning treatment.
Reconstitution
TEPADINA must be reconstituted with 10 ml of sterile water for injections.
Using a syringe fitted with a needle, aseptically withdraw 10 ml of sterile water for injections. Inject the content of the syringe into the vial through the rubber stopper.
Remove the syringe and the needle and mix manually by repeated inversions.
Only clear colourless solutions, without any particulate matter, must be used.
Further dilution in the infusion bag
The reconstituted solution is hypotonic and should be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Administration
TEPADINA infusion solution should be inspected visually for particulate matter and opalescence prior to administration. Solutions containing a precipitate should be discarded.
It is recommended that the infusion solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
TEPADINA should be aseptically administered as a 2-4 hours infusion under room temperature and normal light conditions.
Prior to and following each infusion, the indwelling catheter line should be flushed with approximately 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Disposal
TEPADINA is for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.