Quick answers
- What is Treosulfan used for?
- The FDA-approved label (Grafapex, Medexus Pharma, Inc., January 31, 2025) says: “GRAFAPEX 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).. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Treosulfan have a boxed warning?
- Yes. The FDA label for Grafapex has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Treosulfan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Treosulfan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Treosulfan?
- 1 company lists prescription products of Treosulfan in the FDA NDC Directory, including Medexus Pharma Inc..
What Treosulfan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GRAFAPEX 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).. …
— FDA label: Grafapex, Medexus Pharma, Inc., effective January 31, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Grafapex |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Medexus Pharma Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA214759 GRAFAPEX | Medexus | January 21, 2025 | 1, latest February 5, 2025 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2703570, 2703575, 2703577, 2703579 |
|---|---|
| SPL set ID of the quoted label | 2d06b03c-17aa-0492-e063-6294a90abd8f |
| FDA labels (SPL) | 1 |
| FDA applications | NDA214759 |
| Active ingredients (FDA) | TREOSULFAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Grafapex, Medexus Pharma, Inc., effective January 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →