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busulfan

Busulfan Fresenius Kabi · ATC code L01AB01

Brand names: Busulfan Accord, Myleran, Busulfan Koanaa, Busulfan Ratiopharm, Busulfan Tillomed, Busilvex, Buslera, Busultu, Mylofan

Key facts
Active substance
busulfan
Drug class
Alkyl sulfonate
ATC code
L01AB01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion
Information as of
2026-10-28

Key facts

Busulfan (Busulfan Fresenius Kabi, concentrate for infusion) is an alkylating cytotoxic agent used as conditioning treatment before haematopoietic progenitor cell transplantation in adults and children.

What it is used for

  • Adults: busulfan followed by cyclophosphamide (BuCy2) as conditioning before conventional haematopoietic progenitor cell transplantation when the combination is the best available option.
  • Adults: busulfan following fludarabine (FB) as reduced-intensity conditioning.
  • Children: busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel).

Dosing

  • Adults, combination with cyclophosphamide: 0.8 mg/kg body weight as a two-hour infusion every 6 hours over 4 consecutive days (16 doses in total), followed by cyclophosphamide 60 mg/kg/day over 2 days starting at least 24 hours after the 16th busulfan dose.
  • Children (0 to 17 years): dose based on actual body weight – see the full text.
  • Fludarabine (FB) regimen: see the full text.
  • Administered under supervision of a physician experienced in conditioning treatment; adequate anticonvulsant prophylaxis.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Pregnancy.

Important warnings

  • Profound myelosuppression in all patients; frequent blood counts, anti-infective prophylaxis and transfusion/growth factor support as indicated.
  • Hepatic veno-occlusive disease is a major complication; caution in hepatic impairment with liver function monitoring.
  • Seizures with high-dose treatment; anticonvulsant prophylaxis is required.
  • Increased risk of a second malignancy; busulfan is classified as a human carcinogen.
  • Caution with paracetamol prior to (less than 72 hours) or during treatment.

Side effects

  • Profound cytopenia in all patients: leucopenia 96%, thrombocytopenia 94%, anaemia 88% (adults, combination with cyclophosphamide).
  • Acute graft-versus-host disease in 18% of allogeneic patients.
  • Infections, hepatic and respiratory toxicity and veno-occlusive disease as serious consequences of conditioning.

Interactions

  • Itraconazole and metronidazole may increase busulfan levels; monitor for toxicity. No interaction with fluconazole.
  • Paracetamol may decrease busulfan clearance; with deferasirox monitor busulfan plasma levels.
  • Ketobemidone may be associated with high busulfan levels.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy.
  • Women of childbearing potential: effective contraception during and up to 6 months after treatment.

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.

Full official text →

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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)

Source: European Medicines Agency (EMA), product information

Austria

  • Busulfan AccordAccord Healthcare B.V. · 1 register entry
  • MyleranAspen Pharma Trading Limited · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Busulfan AccordAccord Healthcare B.V. · 1 register entry
  • Busulfan KoanaaKoanaa Healthcare Spain S.L. · 1 register entry
  • Busulfan RatiopharmRatiopharm Gmbh · 1 register entry
  • Busulfan TillomedTillomed Pharma Gmbh · 1 register entry
  • MyleranAspen Pharma Trading Limited · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • BusilvexABDİ İBRAHİM OTSUKA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • BusleraBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • BusultuONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MylofanMONEMFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 22 more European countries
Belgium
Myleran
Croatia
Busulfan Pliva
Czechia
Myleran
Denmark
Busulfan Zentiva
Estonia
Myleran
France
Busulfan Accord, Busulfan Koanaa, Busulfan Tillomed, Myleran
Greece
Busulfan Bioars
Hungary
Busulfan Accord, Busulfan Teva
Iceland
Busulfan Fresenius Kabi, Myleran
Ireland
Myleran
Italy
Busulfan Accord, Busulfan Tillomed, Busulfano Teva, Myleran
Liechtenstein
Busulfan Fresenius Kabi
Lithuania
Myleran
Luxembourg
Myleran
Netherlands
Busulfan Teva, Myleran
Norway
Busulfan Fresenius Kabi
Poland
Busulfan Accord, Busulfan Zentiva, Myleran
Portugal
Bussulfano Accord, Myleran
Romania
Busulfan Accord, Myleran
Slovakia
Myleran
Spain
Busulfano Accord, Busulfano Aspen, Busulfano Glenmark, Busulfano Zentiva
Sweden
Busulfan Zentiva, Myleran

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. European Medicines Agency. Busulfan Fresenius Kabi – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/busulfan-fresenius-kabi-epar-product-information_en.pdf
  2. 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
  3. 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
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L01AB.

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.