Finished product reference
Thiotepa
Injection, Powder, for Solution · Parenteral · 100 mg
- List code
- 52020
- Pharmacologic class
- Alkylating Drug
WARNING: SEVERE MYELOSUPPRESSION and CARCINOGENICITY TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters.
What it is and how it works
Mechanism class: Alkylating Activity
Indications
(thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1 , 14) For treatment of adenocarcinoma of the breast or ovary. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. For treatment of superficial papillary carcinoma of the urinary bladder. Class 3 Beta-Thalassemia TEPADINA is indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia . Adenocarcinoma of the Breast or Ovary TEPADINA is indicated for treatment of adenocarcinoma of the breast or ovary.
Dosage and administration (summary)
The recommended dosage of TEPADINA for class 3 beta-thalassemia is two administrations of 5 mg/kg given by intravenous infusion approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide. The recommended dosage of TEPADINA for treatment of adenocarcinoma of the breast or ovary is 0.3 mg/kg to 0.4 mg/kg by intravenous infusion. The recommended dosage of TEPADINA for treatment of malignant effusions is 0.6 mg/kg to 0.8 mg/kg intracavitary.
Contraindications
is contraindicated in: Patients with severe hypersensitivity to thiotepa [ see Warnings and Precautions ] Concomitant use with live or attenuated vaccines [ see Warnings and Precautions ] Hypersensitivity to the active substance . Concomitant use with live or attenuated vaccines .
Warnings and precautions
Cutaneous toxicity: Cleanse skin at least twice daily through 48 hours after the last dose of TEPADINA. Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. Myelosuppression The consequence of treatment with high doses of TEPADINA together with other chemotherapy at the recommended dose and schedule in the preparative regimen for class 3 beta- thalassemia is profound myelosuppression occurring in all patients.
Storage and supply
How Supplied TEPADINA (thiotepa) for injection is a lyophilized white powder supplied in a carton containing one single-dose Type I clear glass vial with a rubber stopper (not made with natural rubber latex) or in an aluminum overwrap containing one single-dose multichamber flexible bag as: TEPADINA 15 mg One vial contains 15 mg thiotepa ( NDC 7012…
Source: Thiotepa (Tepadina) — US FDA prescribing information, 2026-01-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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