* The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/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/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/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/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
=====LYMPHOMA=====
* The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/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/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
LYMPHOMA
=====CNS LYMPHOMA=====
* The recommended dose is 185 mg/m2/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/m2 (10 mg/kg), during the time of the entire conditioning treatment.
The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/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/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
=====MULTIPLE MYELOMA=====
* The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
CNS LYMPHOMA
=====Solid tumours=====
* The recommended dose in solid tumours ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/ m2/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/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
The recommended dose is 185 mg/m2/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/m2 (10 mg/kg), during the time of the entire conditioning treatment.
=====BREAST CANCER=====
* The recommended dose ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/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/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
MULTIPLE MYELOMA
=====CNS TUMOURS=====
* The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
=====OVARIAN CANCER=====
* The recommended dose is 250 mg/m2/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/m2 (13.51 mg/kg), during the time of the entire conditioning treatment.
Solid tumours
=====GERM CELL TUMOURS=====
* The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
The recommended dose in solid tumours ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/ m2/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/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
=====ALLOGENEIC HPCT=====
======Haematological diseases======
BREAST CANCER
* The recommended dose in haematological diseases ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) 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 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
=====LYMPHOMA=====
The recommended dose ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/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/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
* The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
=====MULTIPLE MYELOMA=====
CNS TUMOURS
* The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2 (5 mg/kg), during the time of the entire conditioning treatment.
=====LEUKEMIA=====
The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
* The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) 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 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
=====THALASSEMIA=====
OVARIAN CANCER
* The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
The recommended dose is 250 mg/m2/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/m2 (13.51 mg/kg), during the time of the entire conditioning treatment.
GERM CELL TUMOURS
The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
ALLOGENEIC HPCT
Haematological diseases
The recommended dose in haematological diseases ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) 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 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
LYMPHOMA
The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
MULTIPLE MYELOMA
The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2 (5 mg/kg), during the time of the entire conditioning treatment.
LEUKEMIA
The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) 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 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
THALASSEMIA
The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Thiotepa in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Thiotepa in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Thiotepa in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Thiotepa in adult patients.
|fdaLIADPed=AUTOLOGOUS HPCT
|fdaLIADPed======AUTOLOGOUS HPCT=====
======Solid tumours======
Solid tumours
* The recommended dose in solid tumours ranges from 150 mg/m2/day (6 mg/kg/day) to 350 mg/ m2/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/m2 (42 mg/kg), during the time of the entire conditioning treatment.
=====CNS TUMOURS=====
The recommended dose in solid tumours ranges from 150 mg/m2/day (6 mg/kg/day) to 350 mg/ m2/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/m2 (42 mg/kg), during the time of the entire conditioning treatment.
* The recommended dose ranges from 250 mg/m2/day (10 mg/kg/day) to 350 mg/m2/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/m2 (42 mg/kg), during the time of the entire conditioning treatment.
=====ALLOGENEIC HPCT=====
CNS TUMOURS
======Haematological diseases======
* The recommended dose in haematological diseases ranges from 125 mg/m2/day (5 mg/kg/day) to 250 mg/ m2/day (10 mg/kg/day) 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 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
The recommended dose ranges from 250 mg/m2/day (10 mg/kg/day) to 350 mg/m2/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/m2 (42 mg/kg), during the time of the entire conditioning treatment.
=====LEUKEMIA=====
* The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
ALLOGENEIC HPCT
======THALASSEMIA======
* The recommended dose ranges from 200 mg/m2/day (8 mg/kg/day) to 250 mg/m2/day (10 mg/kg/ day) divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Haematological diseases
=====REFRACTORY CYTOPENIA=====
* The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
The recommended dose in haematological diseases ranges from 125 mg/m2/day (5 mg/kg/day) to 250 mg/ m2/day (10 mg/kg/day) 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 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
=====GENETIC DISEASES=====
* The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
LEUKEMIA
=====SICKLE CELL ANAEMIA=====
* The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
======Reconstitution======
* TEPADINA® must be reconstituted with 1.5 ml of sterile water for injections.
THALASSEMIA
* Using a syringe fitted with a needle, aseptically withdraw 1.5 ml of sterile water for injections.
* Inject the content of the syringe into the vial through the rubber stopper.
The recommended dose ranges from 200 mg/m2/day (8 mg/kg/day) to 250 mg/m2/day (10 mg/kg/ day) divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
* Remove the syringe and the needle and mix manually by repeated inversions.
* Only clear colourless solutions, without any particulate matter, must be used.
REFRACTORY CYTOPENIA
======Further dilution in the infusion bag======
* The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9 %) in order to obtain a final TEPADINA®concentration between 0.5 and 1 mg/ml.
The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
=====Administration=====
* TEPADINA® infusion solution should be inspected visually for particulate matter and opalescence prior to administration. Solutions containing a precipitate should be discarded.
GENETIC DISEASES
* 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.
The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
* 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.
SICKLE CELL ANAEMIA
The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
Reconstitution
TEPADINA® must be reconstituted with 1.5 ml of sterile water for injections.
Using a syringe fitted with a needle, aseptically withdraw 1.5 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 must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9 %) in order to obtain a final TEPADINA®concentration between 0.5 and 1 mg/ml.
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.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Thiotepa in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Thiotepa in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Thiotepa in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Thiotepa in pediatric patients.
|contraindications=* existing hepatic, renal or bone marrow damage (may use low dosage and frequent monitoring if need outweighs risk)
|contraindications=* Existing hepatic, renal or bone marrow damage (may use low dosage and frequent monitoring if need outweighs risk)
* hypersensitivity to thiotepa
* Hypersensitivity to thiotepa
|postmarketing=decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion)
|postmarketing=* Decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion)
infection
* Infection
liver disorders including blocking of a liver vein
* Liver disorders including blocking of a liver vein
the graft attacks your body (graft versus host disease)
* The graft attacks your body (graft versus host disease)
respiratory complications.
respiratory complications.
increased susceptibility to infection
* Increased susceptibility to infection
whole-body inflammatory state (sepsis)
* Whole-body inflammatory state (sepsis)
decreased counts of white blood cells, platelets and red blood cells (anaemia)
* Decreased counts of white blood cells, platelets and red blood cells (anaemia)
the transplanted cells attack your body (graft versus host disease)
* The transplanted cells attack your body (graft versus host disease)
dizziness, headache, blurred vision
dizziness, headache, blurred vision
uncontrolled shaking of the body (convulsion)
* Uncontrolled shaking of the body (convulsion)
sensation of tingling, pricking or numbness (paraesthesia)
* Sensation of tingling, pricking or numbness (paraesthesia)
partial loss of movement
* Partial loss of movement
cardiac arrest
* Cardiac arrest
nausea, vomiting, diarrhoea
* Nausea, vomiting, diarrhoea
inflammation of the mucosa of the mouth (mucositis)
* Inflammation of the mucosa of the mouth (mucositis)
irritated stomach, gullet, intestine
* Irritated stomach, gullet, intestine
inflammation of the colon
* Inflammation of the colon
anorexia, decreased appetite
* Anorexia, decreased appetite
high glucose in the blood
* High glucose in the blood
skin rash, itching, shedding
* Skin rash, itching, shedding
skin colour disorder (do not confuse with jaundice - see below)
* Skin colour disorder (do not confuse with jaundice - see below)
redness of the skin (erythema)
* Redness of the skin (erythema)
hair loss
* Hair loss
back and abdominal pain, pain
* Back and abdominal pain, pain
muscle and joint pain
* Muscle and joint pain
abnormal electrical activity in the heart (arrhythmia)
* Abnormal electrical activity in the heart (arrhythmia)
inflammation of lung tissue
* Inflammation of lung tissue
enlarged liver
* Enlarged liver
altered organ function
* Altered organ function
blocking of a liver vein (VOD)
* Blocking of a liver vein (VOD)
yellowing of the skin and eyes (jaundice)
* Yellowing of the skin and eyes (jaundice)
hearing impaired
* Hearing impaired
lymphatic obstruction
* Lymphatic obstruction
high blood pressure
* High blood pressure
increased liver, renal and digestive enzymes
* Increased liver, renal and digestive enzymes
abnormal blood electrolytes
* Abnormal blood electrolytes
weight gain
* Weight gain
fever, general weakness, chills
* Fever, general weakness, chills
bleeding (haemorrhage)
* Bleeding (haemorrhage)
nasal bleeding
* Nasal bleeding
general swelling due to fluid retention (oedema)
* General swelling due to fluid retention (oedema)
pain or inflammation at the injection site
* Pain or inflammation at the injection site
eye infection (conjunctivitis)
* Eye infection (conjunctivitis)
decreased sperm cell count
* Decreased sperm cell count
vaginal bleeding
* Vaginal bleeding
absence of menstrual periods (amenorrhea)
* Absence of menstrual periods (amenorrhea)
memory loss
* Memory loss
delaying in weight and height increase
* Delaying in weight and height increase
bladder disfunction
* Bladder disfunction
underproduction of testosterone
* Underproduction of testosterone
insufficient production of thyroid hormone
* Insufficient production of thyroid hormone
deficient activity of the pituitary gland
* Deficient activity of the pituitary gland
confusional state
* Confusional state.
|useInPregnancyFDA=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.
|useInPregnancyFDA=* 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.
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.
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.
|useInPregnancyAUS=(Description)
|useInPregnancyAUS=(Description)
|useInLaborDelivery=(Description)
|useInLaborDelivery=(Description)
Line 260:
Line 206:
|PK=(Description)
|PK=(Description)
|nonClinToxic=(Description)
|nonClinToxic=(Description)
|fdaPatientInfo=TEPADINA® 15 mg
|storage=* Keep out of the reach and sight of children.
powder for concentrate for solution for infusion
* Do not use TEPADINA® after the expiry date which is stated on the carton and vial label, after EXP. The expiry date refers to the last day of that month.
Thiotepa
* Store and transport refrigerated (2 °C - 8 °C).
* Do not freeze.
Read all of this leaflet carefully before you start using this medicine.
* After reconstitution the product is stable for 8 hours when stored at 2 °C - 8 °C.
* After dilution the product is stable for 24 hours when stored at 2 °C - 8 °C and for 4 hours when stored at 25 °C. From a microbiological point of view, the product should be used immediately.
Keep this leaflet. You may need to read it again.
* Any unused product or waste material should be disposed of in accordance with local requirements.
If you have any further questions, ask your doctor.
|fdaPatientInfo=* WHAT TEPADINA® IS AND WHAT IT IS USED FOR
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
:* TEPADINA® contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.
In this leaflet:
:* 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.
* BEFORE YOU USE TEPADINA®
What TEPADINA® is and what it is used for
:* Do not use TEPADINA®
Before you use TEPADINA®
:* if you are allergic (hypersensitive) to thiotepa,
How to use TEPADINA®
:* if you are pregnant or think you may be pregnant (see below),
Possible side effects
:* if you are breast-feeding,
How to store TEPADINA®
:* if you are receiving yellow fever vaccination, live virus and bacterial vaccines.
Further information
* Take special care with TEPADINA®
1. WHAT TEPADINA® IS AND WHAT IT IS USED FOR
* You should tell your doctor if you have:
:* Liver or kidney problems,
TEPADINA® contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.
:* Heart or lung problems,
:* Seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).
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.
* 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.
2. BEFORE YOU USE TEPADINA®
* TEPADINA® may cause another type of cancer in the future. Your doctor will discuss this risk with you.
=====Pregnancy and breast-feeding=====
Do not use TEPADINA®
* 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.
if you are allergic (hypersensitive) to thiotepa,
* 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® .
if you are pregnant or think you may be pregnant (see below),
* 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.
if you are breast-feeding,
=====Using other medicines=====
if you are receiving yellow fever vaccination, live virus and bacterial vaccines.
* Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Take special care with TEPADINA®
* HOW TO USE TEPADINA®
:* Your doctor will calculate the dose according to your body surface or weight and your disease.
You should tell your doctor if you have:
* 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.
liver or kidney problems,
=====Frequency of administration=====
heart or lung problems,
* 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.
seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).
* POSSIBLE SIDE EFFECTS
You will have to take regular blood tests during treatment to check your blood cell counts.
:* 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
You will have to use anti-infectives to prevent and manage infections.
:* Decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion)
:* Infection
TEPADINA® may cause another type of cancer in the future. Your doctor will discuss this risk with you.
:* Liver disorders including blocking of a liver vein
:* The graft attacks your body (graft versus host disease)
Pregnancy and breast-feeding
:* Respiratory complications
:* Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
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.
* Side effects of TEPADINA® may occur with certain frequencies, which are defined as follows:
* Very common
Both women and men using TEPADINA® must use effective contraceptive methods during treatment.
:* Affects more than 1 user in 10
* Common
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® .
:* Affects 1 to 10 users in 100
* Uncommon
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.
:* Affects 1 to 10 users in 1,000
* Rare
Using other medicines
:* Affects 1 to 10 users in 10,000
* Very rare
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
:* Affects less than 1 user in 10,000
* Not known
3. HOW TO USE TEPADINA®
:* Frequency cannot be estimated from the available data.
=====Very common side effects=====
Your doctor will calculate the dose according to your body surface or weight and your disease.
* Increased susceptibility to infection
* Whole-body inflammatory state (sepsis)
How TEPADINA® is given
* Decreased counts of white blood cells, platelets and red blood cells (anaemia)
* The transplanted cells attack your body (graft versus host disease)
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.
* Dizziness, headache, blurred vision
* Uncontrolled shaking of the body (convulsion)
Frequency of administration
* Sensation of tingling, pricking or numbness (paraesthesia)
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.
4. 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 complications
Your 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.
Very common side effects
increased susceptibility to infection
whole-body inflammatory state (sepsis)
decreased counts of white blood cells, platelets and red blood cells (anaemia)
the transplanted cells attack your body (graft versus host disease)
dizziness, headache, blurred vision
uncontrolled shaking of the body (convulsion)
sensation of tingling, pricking or numbness (paraesthesia)
partial loss of movement
partial loss of movement
cardiac arrest
* Cardiac arrest
nausea, vomiting, diarrhoea
* Nausea, vomiting, diarrhoea
inflammation of the mucosa of the mouth (mucositis)
* Inflammation of the mucosa of the mouth (mucositis)
irritated stomach, gullet, intestine
* Irritated stomach, gullet, intestine
inflammation of the colon
* Inflammation of the colon
anorexia, decreased appetite
* Anorexia, decreased appetite
high glucose in the blood
* High glucose in the blood
skin rash, itching, shedding
* Skin rash, itching, shedding
skin colour disorder (do not confuse with jaundice - see below)
* Skin colour disorder (do not confuse with jaundice - see below)
redness of the skin (erythema)
* Redness of the skin (erythema)
hair loss
* Hair loss
back and abdominal pain, pain
* Back and abdominal pain, pain
muscle and joint pain
* Muscle and joint pain
abnormal electrical activity in the heart (arrhythmia)
* Abnormal electrical activity in the heart (arrhythmia)
inflammation of lung tissue
* Inflammation of lung tissue
enlarged liver
* Enlarged liver
altered organ function
* Altered organ function
blocking of a liver vein (VOD)
* Blocking of a liver vein (VOD)
yellowing of the skin and eyes (jaundice)
* Yellowing of the skin and eyes (jaundice)
hearing impaired
* Hearing impaired
lymphatic obstruction
* Lymphatic obstruction
high blood pressure
* High blood pressure
increased liver, renal and digestive enzymes
* Increased liver, renal and digestive enzymes
abnormal blood electrolytes
* Abnormal blood electrolytes
weight gain
* Weight gain
fever, general weakness, chills
* Fever, general weakness, chills
bleeding (haemorrhage)
* Bleeding (haemorrhage)
nasal bleeding
* Nasal bleeding
general swelling due to fluid retention (oedema)
* General swelling due to fluid retention (oedema)
pain or inflammation at the injection site
* Pain or inflammation at the injection site
eye infection (conjunctivitis)
* Eye infection (conjunctivitis)
decreased sperm cell count
* Decreased sperm cell count
vaginal bleeding
* Vaginal bleeding
absence of menstrual periods (amenorrhea)
* Absence of menstrual periods (amenorrhea)
memory loss
* Memory loss
delaying in weight and height increase
* Delaying in weight and height increase
bladder disfunction
* Bladder disfunction
underproduction of testosterone
* Underproduction of testosterone
insufficient production of thyroid hormone
* Insufficient production of thyroid hormone
deficient activity of the pituitary gland
* Deficient activity of the pituitary gland
confusional state
* Confusional state
Common side effects
=====Common side effects=====
* Anxiety, confusion
anxiety, confusion
* Abnormal bulging outward of one of the arteries in the brain (intracranial aneurysm)
abnormal bulging outward of one of the arteries in the brain (intracranial aneurysm)
* Creatinine elevated
creatinine elevated
* Allergic reactions
allergic reactions
* Occlusion of a blood vessel (embolism)
occlusion of a blood vessel (embolism)
* Heart rhythm disorder
heart rhythm disorder
* Heart inability
heart inability
* Cardiovascular inability
cardiovascular inability
* Oxygen deficiency
oxygen deficiency
* Fluid accumulation in the lungs (pulmonary oedema)
fluid accumulation in the lungs (pulmonary oedema)
* Pulmonary bleeding
pulmonary bleeding
* Respiratory arrest
respiratory arrest
* Blood in the urine (haematuria) and moderate renal insufficiency
blood in the urine (haematuria) and moderate renal insufficiency
* Inflammation of the urinary bladder
inflammation of the urinary bladder
* Discomfort in urination and decrease in urine output (disuria and oliguria)
discomfort in urination and decrease in urine output (disuria and oliguria)
* Increase in the amount of nitrogen components in the blood stream (BUN increase)
increase in the amount of nitrogen components in the blood stream (BUN increase)
* Cataract
cataract
* Inability of the liver
inability of the liver
* Cerebral haemorrhage
cerebral haemorrhage
* Cough
cough
* Constipation and upset stomach
constipation and upset stomach
* Obstruction of the bowel
obstruction of the bowel
* Perforation of stomach
perforation of stomach
* Changes in muscle tone
changes in muscle tone
* Gross lack of coordination of muscle movements
gross lack of coordination of muscle movements
* Bruises due to a low platelet count
bruises due to a low platelet count
* Menopausal symptoms
menopausal symptoms
* Cancer (second primary malignancies)
cancer (second primary malignancies)
* Abnormal brain function
abnormal brain function
=====Uncommon side effects=====
Uncommon side effects
* Inflammation and exfoliation of the skin (erythrodermic psoriasis)
inflammation and exfoliation of the skin (erythrodermic psoriasis)
delirium, nervousness, hallucination, agitation
delirium, nervousness, hallucination, agitation
gastrointestinal ulcer
gastrointestinal ulcer
inflammation of the muscular tissue of the heart (myocarditis)
* Inflammation of the muscular tissue of the heart (myocarditis)
abnormal heart condition (cardiomyopathy)
abnormal heart condition (cardiomyopathy)
male and female infertility
* Male and female infertility
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or nurse.
* If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or nurse.
=====FURTHER INFORMATION=====
5. HOW TO STORE TEPADINA®
* What TEPADINA® contains
:* The active substance is thiotepa. One vial contains 15 mg thiotepa. After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
Keep out of the reach and sight of children.
Do not use TEPADINA® after the expiry date which is stated on the carton and vial label, after EXP. The expiry date refers to the last day of that month.
Store and transport refrigerated (2 °C - 8 °C).
Do not freeze.
After reconstitution the product is stable for 8 hours when stored at 2 °C - 8 °C.
After dilution the product is stable for 24 hours when stored at 2 °C - 8 °C and for 4 hours when stored at 25 °C. From a microbiological point of view, the product should be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
6. FURTHER INFORMATION
What TEPADINA® contains
The active substance is thiotepa. One vial contains 15 mg thiotepa. After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
TEPADINA ® does not contain any other ingredients.
TEPADINA ® does not contain any other ingredients.
What TEPADINA® looks like and contents of the pack
* What TEPADINA® looks like and contents of the pack
:* TEPADINA® is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.
TEPADINA® is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.
* Each carton contains 1 vial.
Each carton contains 1 vial.
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|alcohol=Alcohol-Thiotepa interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Thiotepa interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/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/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
LYMPHOMA
The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/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/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
CNS LYMPHOMA
The recommended dose is 185 mg/m2/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/m2 (10 mg/kg), during the time of the entire conditioning treatment.
MULTIPLE MYELOMA
The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
Solid tumours
The recommended dose in solid tumours ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/ m2/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/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
BREAST CANCER
The recommended dose ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/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/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
CNS TUMOURS
The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
OVARIAN CANCER
The recommended dose is 250 mg/m2/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/m2 (13.51 mg/kg), during the time of the entire conditioning treatment.
GERM CELL TUMOURS
The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/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/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
ALLOGENEIC HPCT
Haematological diseases
The recommended dose in haematological diseases ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) 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 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
LYMPHOMA
The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
MULTIPLE MYELOMA
The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2 (5 mg/kg), during the time of the entire conditioning treatment.
LEUKEMIA
The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) 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 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
THALASSEMIA
The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Thiotepa in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Thiotepa in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
AUTOLOGOUS HPCT
Solid tumours
The recommended dose in solid tumours ranges from 150 mg/m2/day (6 mg/kg/day) to 350 mg/ m2/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/m2 (42 mg/kg), during the time of the entire conditioning treatment.
CNS TUMOURS
The recommended dose ranges from 250 mg/m2/day (10 mg/kg/day) to 350 mg/m2/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/m2 (42 mg/kg), during the time of the entire conditioning treatment.
ALLOGENEIC HPCT
Haematological diseases
The recommended dose in haematological diseases ranges from 125 mg/m2/day (5 mg/kg/day) to 250 mg/ m2/day (10 mg/kg/day) 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 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
LEUKEMIA
The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
THALASSEMIA
The recommended dose ranges from 200 mg/m2/day (8 mg/kg/day) to 250 mg/m2/day (10 mg/kg/ day) divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
REFRACTORY CYTOPENIA
The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
GENETIC DISEASES
The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
SICKLE CELL ANAEMIA
The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/ kg), during the time of the entire conditioning treatment.
Reconstitution
TEPADINA® must be reconstituted with 1.5 ml of sterile water for injections.
Using a syringe fitted with a needle, aseptically withdraw 1.5 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 must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9 %) in order to obtain a final TEPADINA®concentration between 0.5 and 1 mg/ml.
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.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Thiotepa in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Thiotepa in pediatric patients.
Contraindications
Existing hepatic, renal or bone marrow damage (may use low dosage and frequent monitoring if need outweighs risk)
Hypersensitivity to thiotepa
Warnings
There is limited information regarding Thiotepa Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Thiotepa Clinical Trials Experience in the drug label.
Postmarketing Experience
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 complications.
Increased susceptibility to infection
Whole-body inflammatory state (sepsis)
Decreased counts of white blood cells, platelets and red blood cells (anaemia)
The transplanted cells attack your body (graft versus host disease)
dizziness, headache, blurred vision
Uncontrolled shaking of the body (convulsion)
Sensation of tingling, pricking or numbness (paraesthesia)
Partial loss of movement
Cardiac arrest
Nausea, vomiting, diarrhoea
Inflammation of the mucosa of the mouth (mucositis)
Irritated stomach, gullet, intestine
Inflammation of the colon
Anorexia, decreased appetite
High glucose in the blood
Skin rash, itching, shedding
Skin colour disorder (do not confuse with jaundice - see below)
Redness of the skin (erythema)
Hair loss
Back and abdominal pain, pain
Muscle and joint pain
Abnormal electrical activity in the heart (arrhythmia)
Inflammation of lung tissue
Enlarged liver
Altered organ function
Blocking of a liver vein (VOD)
Yellowing of the skin and eyes (jaundice)
Hearing impaired
Lymphatic obstruction
High blood pressure
Increased liver, renal and digestive enzymes
Abnormal blood electrolytes
Weight gain
Fever, general weakness, chills
Bleeding (haemorrhage)
Nasal bleeding
General swelling due to fluid retention (oedema)
Pain or inflammation at the injection site
Eye infection (conjunctivitis)
Decreased sperm cell count
Vaginal bleeding
Absence of menstrual periods (amenorrhea)
Memory loss
Delaying in weight and height increase
Bladder disfunction
Underproduction of testosterone
Insufficient production of thyroid hormone
Deficient activity of the pituitary gland
Confusional state.
Drug Interactions
There is limited information regarding Thiotepa Drug Interactions in the drug label.
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.
There is limited information regarding the compatibility of Thiotepa and IV administrations.
Overdosage
There is limited information regarding Thiotepa overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
There is limited information regarding Thiotepa Clinical Studies in the drug label.
How Supplied
There is limited information regarding Thiotepa How Supplied in the drug label.
Storage
Keep out of the reach and sight of children.
Do not use TEPADINA® after the expiry date which is stated on the carton and vial label, after EXP. The expiry date refers to the last day of that month.
Store and transport refrigerated (2 °C - 8 °C).
Do not freeze.
After reconstitution the product is stable for 8 hours when stored at 2 °C - 8 °C.
After dilution the product is stable for 24 hours when stored at 2 °C - 8 °C and for 4 hours when stored at 25 °C. From a microbiological point of view, the product should be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
Images
Drug Images
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|?Pill Imprint
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|template=DrugPageImages
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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.
BEFORE YOU USE TEPADINA®
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, live virus and bacterial vaccines.
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 (if treated with phenytoin or fosphenytoin).
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 TO USE TEPADINA®
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.
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 complications
Your 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.
Very common side effects
Increased susceptibility to infection
Whole-body inflammatory state (sepsis)
Decreased counts of white blood cells, platelets and red blood cells (anaemia)
The transplanted cells attack your body (graft versus host disease)
Dizziness, headache, blurred vision
Uncontrolled shaking of the body (convulsion)
Sensation of tingling, pricking or numbness (paraesthesia)
partial loss of movement
Cardiac arrest
Nausea, vomiting, diarrhoea
Inflammation of the mucosa of the mouth (mucositis)
Irritated stomach, gullet, intestine
Inflammation of the colon
Anorexia, decreased appetite
High glucose in the blood
Skin rash, itching, shedding
Skin colour disorder (do not confuse with jaundice - see below)
Redness of the skin (erythema)
Hair loss
Back and abdominal pain, pain
Muscle and joint pain
Abnormal electrical activity in the heart (arrhythmia)
Inflammation of lung tissue
Enlarged liver
Altered organ function
Blocking of a liver vein (VOD)
Yellowing of the skin and eyes (jaundice)
Hearing impaired
Lymphatic obstruction
High blood pressure
Increased liver, renal and digestive enzymes
Abnormal blood electrolytes
Weight gain
Fever, general weakness, chills
Bleeding (haemorrhage)
Nasal bleeding
General swelling due to fluid retention (oedema)
Pain or inflammation at the injection site
Eye infection (conjunctivitis)
Decreased sperm cell count
Vaginal bleeding
Absence of menstrual periods (amenorrhea)
Memory loss
Delaying in weight and height increase
Bladder disfunction
Underproduction of testosterone
Insufficient production of thyroid hormone
Deficient activity of the pituitary gland
Confusional state
Common side effects
Anxiety, confusion
Abnormal bulging outward of one of the arteries in the brain (intracranial aneurysm)
Creatinine elevated
Allergic reactions
Occlusion of a blood vessel (embolism)
Heart rhythm disorder
Heart inability
Cardiovascular inability
Oxygen deficiency
Fluid accumulation in the lungs (pulmonary oedema)
Pulmonary bleeding
Respiratory arrest
Blood in the urine (haematuria) and moderate renal insufficiency
Inflammation of the urinary bladder
Discomfort in urination and decrease in urine output (disuria and oliguria)
Increase in the amount of nitrogen components in the blood stream (BUN increase)
Cataract
Inability of the liver
Cerebral haemorrhage
Cough
Constipation and upset stomach
Obstruction of the bowel
Perforation of stomach
Changes in muscle tone
Gross lack of coordination of muscle movements
Bruises due to a low platelet count
Menopausal symptoms
Cancer (second primary malignancies)
Abnormal brain function
Uncommon side effects
Inflammation and exfoliation of the skin (erythrodermic psoriasis)
