Busulfan
Alkyl Sulfonates
Sold as Busilvex · MYLERAN
- Drug class
- Alkyl Sulfonates
- Availability
- Prescription only
- Routes
- Intravenous, Oral
- Markets covered
- 4
- Products on record
- 14
- FDA reports (12 mo)
- 1,293
Overview
Busulfan is an active pharmaceutical ingredient in the Alkyl Sulfonates group (L01AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 7 | March 22, 2025 |
| GB United Kingdom | MHRA | 4 | May 15, 2026 |
| US United States | FDA | 2 | June 27, 2024 |
| EU European Union | EMA | 1 | July 1, 2025 |
CACanada· Health Canada
7 products
Uses
MYLERAN® (busulfan) is indicated for:
Chronic granulocytic (myelocytic, myeloid) leukemia for the production of remissions. May be used with extreme caution in patients with prior radiation or P32 therapy and in those untreated by any other means. 1 Pediatrics Pediatrics (0-18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
In paediatric transplant recipients, dental development anomalies have been observed with busulfan-based conditioning regimens. (see WARNING AND PRECAUTIONS/Gastrointestinal AND ADVERSE REACTION sections). 2 Geriatrics Geriatrics (> 65 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
GBUnited Kingdom· MHRA
4 products
Uses
• Busulfan, followed by cyclophosphamide (BuCy2), is indicated as a conditioning treatment, prior to conventional haematopoietic progenitor cell transplantation (HPCT), in adult patients, when the combination is considered the best available option.
• Busulfan, following fludarabine (FB), is indicated as a conditioning treatment, prior to haematopoietic progenitor cell transplantation (HPCT), in adult patients, who are candidates for a reduced-intensity conditioning (RIC) regimen.
• Busulfan, followed by cyclophosphamide (BuCy4) or melphalan (BuMel), is indicated as a conditioning treatment, prior to conventional haematopoietic progenitor cell transplantation, in paediatric patients.
How to take
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Busulfan injection is an alkylating drug indicated for:
Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML) ( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
Busulfan followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Busulfan following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen. Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
How to take
Drug interactions
Known interactions involving Busulfan. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 00004618 · revised March 22, 2025
- [2]MHRA (UK) · PL113110560 · revised July 11, 2025
- [3]FDA DailyMed · 06883ac0-4b2a-4f… · revised June 27, 2024 [PDF]
- [4]European Medicines Agency · EMEA/H/C/002806 · revised July 1, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.