Pricing
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All price changes →Indications & Uses
Tepadina is indicated for:
Pharmacology
Thiotepa is a cytotoxic agent that acts on more than one site in the cell, and it is related chemically and pharmacologically to the nitrogen mustard. Its action is described as radiomimetic, meaning it works much like radiation therapy. It is believed to do this by releasing ethylene imine radicals. These radicals disrupt the bonds of DNA, for example by alkylation of guanine at the N-7. That breaks the linkage between the purine base and the sugar and frees the alkylated guanine.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For adults having autologous HPCT, the recommended dose of Thiotepa in haematological diseases is between 125 mg/m2/day (3.38 mg/kg/day) and 300 mg/m2/day (8.10 mg/kg/day). It is given as a single daily infusion on 2 up to 4 consecutive days before the transplant, depending on which other chemotherapeutic medicinal products are combined with it. The total cumulative dose must not go above 900 mg/m2 (24.32 mg/kg) during the entire conditioning treatment.
Lymphoma: the dose is again between 125 mg/m2/day (3.38 mg/kg/day) and 300 mg/m2/day (8.10 mg/kg/day), as a single daily infusion on 2 up to 4 consecutive days before autologous HPCT, depending on the combination with other chemotherapeutic medicinal products. The total maximum cumulative dose is 900 mg/m2 (24.32 mg/kg) during the entire conditioning treatment.
Central nervous system lymphoma: the recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion for 2 consecutive days before autologous HPCT. The total maximum cumulative dose during the entire conditioning treatment is 370 mg/m2 (10 mg/kg).
Multiple myeloma: the dose is between 150 mg/m2/day (4.05 mg/kg/day) and 250 mg/m2/day (6.76 mg/kg/day), as a single daily infusion for 3 consecutive days before autologous HPCT, depending on the combination with other chemotherapeutic medicinal products. The total cumulative dose must not exceed 750 mg/m2 (20.27 mg/kg) during the entire conditioning treatment.
Solid tumours: the recommended dose is between 120 mg/m2/day (3.24 mg/kg/day) and 250 mg/m2/day (6.76 mg/kg/day), divided in one or two daily infusions. It is given on 2 up to 5 consecutive days before autologous HPCT, depending on the combination with other chemotherapeutic medicinal products. The total maximum cumulative dose is 800 mg/m2 (21.62 mg/kg) during the entire conditioning treatment.
Breast cancer: the dose is between 120 mg/m2/day (3.24 mg/kg/day) and 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, on 3 up to 5 consecutive days before autologous HPCT, depending on the combination with other chemotherapeutic medicinal products. The total cumulative dose must not exceed 800 mg/m2 (21.62 mg/kg) during the entire conditioning treatment.
CNS tumours: the recommended dose is between 125 mg/m2/day (3.38 mg/kg/day) and 250 mg/m2/day (6.76 mg/kg/day), divided in one or two daily infusions. It is given on 3 up to 4 consecutive days before autologous HPCT, depending on the combination with other chemotherapeutic medicinal products. The total maximum cumulative dose is 750 mg/m2 (20.27 mg/kg) during the entire conditioning treatment.
Ovarian cancer: the recommended dose is 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion on 2 consecutive days before autologous HPCT. The total maximum cumulative dose during the entire conditioning treatment is 500 mg/m2 (13.51 mg/kg).
Germ cell tumours: the dose is between 150 mg/m2/day (4.05 mg/kg/day) and 250 mg/m2/day (6.76 mg/kg/day), as a single daily infusion for 3 consecutive days before autologous HPCT, depending on the combination with other chemotherapeutic medicinal products. The total cumulative dose must not exceed 750 mg/m2 (20.27 mg/kg) during the entire conditioning treatment.
For allogeneic HPCT in haematological diseases, the recommended dose is between 185 mg/m2/day (5 mg/kg/day) and 481 mg/m2/day (13 mg/kg/day), divided in one or two daily infusions. It is given on 1 up to 3 consecutive days before allogeneic HPCT, depending on the combination with other chemotherapeutic medicinal products. The total maximum cumulative dose is 555 mg/m2 (15 mg/kg) during the entire conditioning treatment.
Lymphoma: the recommended dose is 370 mg/m2/day (10 mg/kg/day), divided in two daily infusions before allogeneic HPCT. The total maximum cumulative dose during the entire conditioning treatment is 370 mg/m2 (10 mg/kg).
Multiple myeloma: the recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT. The total maximum cumulative dose during the entire conditioning treatment is 185 mg/m2 (5 mg/kg).
Leukaemia: the dose is between 185 mg/m2/day (5 mg/kg/day) and 481 mg/m2/day (13 mg/kg/day), divided in one or two daily infusions. It is given on 1 up to 2 consecutive days before allogeneic HPCT, depending on the combination with other chemotherapeutic medicinal products. The total cumulative dose must not exceed 555 mg/m2 (15 mg/kg) during the entire conditioning treatment.
Thalassemia: the recommended dose is 370 mg/m2/day (10 mg/kg/day), divided in two daily infusions and given before allogeneic HPCT. The total maximum cumulative dose during the entire conditioning treatment is 370 mg/m2 (10 mg/kg).
Side Effects
Side-effect information is not available for this brand yet.
Cautions & Contraindications
Warnings & Precautions
Treating patients with Thiotepa at the recommended dose and schedule causes profound myelosuppression, and this happens in all patients. Severe granulocytopenia, thrombocytopenia, anaemia or any combination of these may develop. Complete blood counts, including differential white blood cell counts and platelet counts, need to be done often during treatment and until the blood counts recover. Platelet and red blood cell support should be given as medically indicated, and so should growth factors such as Granulocyte-colony stimulating factor (G-CSF). Daily white blood cell counts and platelet counts are recommended during therapy with Thiotepa, and after transplant for at least 30 days.
Contraindications
Thiotepa must not be given to anyone who is hypersensitive to it. It is also contraindicated in pregnancy and during breastfeeding, and it must not be used together with the yellow fever vaccine or with live virus and bacterial vaccines.
Pregnancy & Breastfeeding
There are no data on the use of thiotepa during pregnancy. In pre-clinical studies, thiotepa has been shown to cause embryofoetal lethality and teratogenicity, as most alkylating agents do. For this reason, thiotepa is contraindicated during pregnancy.
It is not known whether thiotepa passes into human milk. Because of its pharmacological properties and its potential toxicity for breast-fed newborns and infants, breastfeeding is contraindicated during treatment with thiotepa.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Renal impairment: Nobody has studied Thiotepa in patients with kidney problems. Thiotepa and its metabolites are poorly excreted in the urine, so the dose is not recommended to be changed in patients with mild or moderate renal insufficiency. Still, caution is recommended.
Hepatic impairment: Thiotepa has not been studied in patients with liver impairment. The liver does most of the work of metabolizing Thiotepa, so caution is needed when it is given to patients who already have impaired liver function, especially those with severe hepatic impairment. For temporary changes in hepatic parameters, no dose change is recommended.
Elderly: Thiotepa has not been specifically investigated in elderly patients. In clinical studies, though, some patients over the age of 65 received the same cumulative dose as the other patients, and no dose adjustment was thought necessary.
Overdose
No one has reported an overdose of Thiotepa so far. If it did happen, the main adverse reactions expected are myeloablation and pancytopenia. There is no known antidote for Thiotepa. The patient's haematological status needs close monitoring, and strong supportive measures should be given as medically indicated.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Drug Interactions
Common questions about Tepadina 15 mg
What is Tepadina 15 mg IV Infusion?
Tepadina 15 mg IV Infusion is a medicine that contains Thiotepa. It is made by ZAS Corporation. It belongs to the Haematopoietic Agents group of medicines.
What is Tepadina used for?
Tepadina is used for: Cancer.
Can I take Tepadina during pregnancy or while breastfeeding?
There are no data on the use of thiotepa during pregnancy. In pre-clinical studies, thiotepa has been shown to cause embryofoetal lethality and teratogenicity, as most alkylating agents do. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Tepadina?
No one has reported an overdose of Thiotepa so far. If it did happen, the main adverse reactions expected are myeloablation and pancytopenia. In an emergency call 999 or go to the nearest hospital emergency department.
Can I take other medicines with Tepadina?
Some medicines can interact with Thiotepa, for example: Erythromycin, Carbamazepine, Rifampicin, Cyclophosphamide, Clarithromycin, Telithromycin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Tepadina?
Tepadina is a prescription (Rx) medicine. Take it as your doctor advises.