Prescription medicine
Treosulfan Brand names: Grafapex
Treosulfan (Grafapex) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the treosulfan FDA label on DailyMed (effective January 31, 2025, Medexus Pharma, Inc.); the NDA 214759 record on Drugs@FDA; every treosulfan label on DailyMed.
Highlights of the record
FDA label of January 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
MYELOSUPPRESSION.
GRAFAPEX causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. GRAFAPEX causes severe and prolonged myelosuppression. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters.
Used for
From the label: indications and usageGRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).
Forms and strengths
- 1000 mg/g
- 5000 mg/5g
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- January 21, 2025 Grafapex, Medexus; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 12, 2026 Grafapex injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,640 through July 30, 2026
What is treosulfan used for?
From the label: indications and usageGRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). […]
Source: FDA drug label (GRAFAPEX), Medexus Pharma, Inc., effective January 31, 2025 (SPL set 2d06b03c-17aa-0492-e063-6294a90abd8f), via openFDA; the full label on DailyMed
Is there a generic for treosulfan (Grafapex)?
No generic treosulfan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Grafapex injection, the last expiring on October 12, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the treosulfan label say about other medicines?
The treosulfan label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Busulfan | warnings and precautions | Morbidity and Mortality at Dosages Higher than Recommended In MC‑FludT.14/L Trial I (NCT00822393), 330 adult patients were randomized to treosulfan at 14 g/m 2 /day (1.4 times the recommended dose) for three consecutive days or busulfan at 3.2 mg/kg/day for two days, in combination with fludarabine as a preparative … |
| Clonazepam | warnings and precautions | WARNINGS AND PRECAUTIONS Seizures: Monitor signs of neurological adverse reactions and consider clonazepam prophylaxis for patients at higher risk. ( 5.2 ) Skin disorders: |
| Fludarabine | warnings and precautions | … recommended dose) for three consecutive days or busulfan at 3.2 mg/kg/day for two days, in combination with fludarabine as a preparative regimen for allogeneic transplantation. |
Source: FDA drug label (GRAFAPEX), Medexus Pharma, Inc., effective January 31, 2025 (SPL set 2d06b03c-17aa-0492-e063-6294a90abd8f), via openFDA; the full label on DailyMed
What do FAERS reports show for treosulfan?
The FDA Adverse Event Reporting System holds 2,640 reports that list treosulfan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 579 are coded as a death and 478 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Treosulfan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other