thiotepa
Tepadina · ATC code L01AC01
Also known as: Tiyotepa · Brand names: Tepadina, Thiotepa Fresenius Kabi, Thionovia, Tiotepa Vivanta Generics, Tepakıt, Tepharix
- Key facts
- Active substance
- thiotepa
- Drug class
- Alkylating antineoplastic agent
- ATC code
- L01AC01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- TEPADINA 15 mg powder for concentrate for solution for infusion / TEPADINA 100 mg powder for concentrate for solution for infusion · TEPADINA 200 mg powder and solvent for solution for infusion / TEPADINA 400 mg powder and solvent for solution for infusion
- Marketing authorisation holder
- 7934
- Information as of
- 2026-10-29
Key facts
Thiotepa (Tepadina) is an alkylating cytotoxic agent used with other chemotherapy as conditioning before haematopoietic stem cell transplantation.
What it is used for
- In combination with other chemotherapy, with or without total body irradiation, as conditioning before allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adults and children.
- High-dose chemotherapy with HPCT support for solid tumours in adults and children.
Dosing
- Dose depends on the type of transplant, disease and combination partners; complex schemes – for details in adults and children see the full text.
- Adults, autologous HPCT for haematological diseases: 125 mg/m²/day to 300 mg/m²/day as a daily infusion on 2 up to 4 consecutive days; maximum cumulative dose 900 mg/m².
- Adults, autologous HPCT for solid tumours: 120 mg/m²/day to 250 mg/m²/day on 2 up to 5 days; maximum cumulative dose 800 mg/m².
- Adults, allogeneic HPCT for haematological diseases: 185 mg/m²/day to 481 mg/m²/day on 1 up to 3 days; maximum cumulative dose 555 mg/m².
- Give thiotepa after completion of any cyclophosphamide infusion, not concurrently.
Contraindications
- Hypersensitivity to the active substance.
- Pregnancy and lactation.
- Concomitant yellow fever vaccine and live virus and bacterial vaccines.
Important warnings
- Profound myelosuppression in all patients; daily white cell and platelet counts during therapy and for at least 30 days after transplant; consider anti-infective prophylaxis.
- Increased risk of hepatic veno-occlusive disease; caution in hepatic impairment with regular liver test monitoring.
- Monitor cardiac, renal and pulmonary function; leukoencephalopathy (sometimes fatal) seen after multiple previous therapies.
- Increased risk of secondary malignancy (known human carcinogen); fertility may be impaired.
Side effects
- Most frequent in thiotepa-containing conditioning: infections, cytopenia, acute and chronic GvHD, gastrointestinal disorders, haemorrhagic cystitis and mucosal inflammation.
- Serious haematologic, hepatic and respiratory toxicities are considered expected consequences of conditioning and transplantation.
Interactions
- Metabolised by CYP2B6 and CYP3A4: inhibitors (e.g. clopidogrel, ticlopidine, azole antifungals, macrolides, protease inhibitors) and inducers (e.g. rifampicin, carbamazepine, phenobarbital) alter levels – monitor clinically.
- Live vaccines no sooner than three months after stopping therapy; phenytoin and fosphenytoin not recommended; may reduce activation of cyclophosphamide.
Pregnancy and breastfeeding
- Contraindicated in pregnancy and lactation; women use contraception during and for at least 6 months after treatment, men should not father a child for at least 3 months after.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Tepadina7934 · EMEA/H/C/001046
- Thiotepa Riemser · genericEsteve Pharmaceuticals GmbH · EMEA/H/C/005434
Source: European Medicines Agency (EMA), product information
Austria
- Thiotepa Fresenius KabiFresenius Kabi Austria Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- ThionoviaVivanta Generics S.R.O. · 1 register entry
- ThiotepaMedac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel), Vivanta Generics S.R.O., Fresenius Kabi Deutschland Gmbh, Seacross Pharma (Europe) Ltd, Hexal Ag, Hikma Farmacêutica (Portugal), S.A. · 7 register entries
- Tiotepa Vivanta GenericsVivanta Generics S.R.O. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- TepadinaGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
- TepakıtBMED İLAÇ DANIŞMANLIK SAĞLIK ÜRÜN VE HİZMETLERİ TİC. LTD. ŞTİ. · 1 register entry
- TepharixBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 24 more European countries
- Belgium
- Thiotepa Fresenius Kabi
- Bulgaria
- Тиотепа Msn
- Croatia
- Tiotepa Fresenius Kabi, Tiotepa Msn
- Czechia
- Thiotepa Fresenius Kabi, Thiotepa Msn
- Denmark
- Thiotepa Abcur, Thiotepa Fresenius Kabi, Thiotepa Medac
- Estonia
- Thiotepa Fresenius Kabi, Thiotepa Msn
- Finland
- Thiotepa Abcur, Thiotepa Fresenius Kabi
- France
- Thionovia, Thiotepa Fresenius Kabi, Thiotepa Genopharm, Thiotepa Seacross, Thiotepa Vivanta, Tiotepa Hikma
- Hungary
- Thiotepa
- Iceland
- Tepadina, Thiotepa Abcur, Thiotepa Riemser
- Ireland
- Thiotepa Fresenius Kabi
- Italy
- Thionovia, Thiotepa Medac, Tiotepa Fresenius Kabi, Tiotepa Hikma, Tiotepa Seacross, Tiotepa Vivanta
- Latvia
- Thiotepa Fresenius Kabi, Thiotepa Msn
- Liechtenstein
- Tepadina, Thiotepa Riemser
- Lithuania
- Thiotepa Fresenius Kabi, Thiotepa Msn
- Netherlands
- Thiotepa
- Norway
- Tepadina, Thiotepa
- Poland
- Thiotepa Fresenius Kabi, Thiotepa Msn
- Portugal
- Tiotepa Fresenius Kabi, Tiotepa Hikma, Tiotepa Seacross
- Romania
- Thiotepa Fresenius Kabi, Thiotepa Msn
- Slovakia
- Thiotepa Fresenius Kabi, Thiotepa Msn
- Slovenia
- Thiotepa Msn
- Spain
- Thionovia, Thiotepa Vivanta, Tiotepa Hikma, Tiotepa Kabi, Tiotepa Seacross, Tiotepa Vivanta
- Sweden
- Thionovia, Thiotepa, Tiotepa Vivanta
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Tepadina – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/tepadina-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L01AC.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.