Label: GRAFAPEX- treosulfan injection, powder, lyophilized, for solution

  • NDC Code(s): 59137-335-01, 59137-365-01
  • Packager: Medexus Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 31, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use GRAFAPEX™ safely and effectively. See full prescribing information for GRAFAPEX. GRAFAPEX (treosulfan) for injection, for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: 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)] .
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  • 1 INDICATIONS AND USAGE
    1.1 Acute Myeloid Leukemia - GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - The recommended dosage of GRAFAPEX is 10 g/m - 2by intravenous infusion given daily for three days, beginning on Day -4 prior to transplantation in combination with ...
  • 3 DOSAGE FORMS AND STRENGTHS
    For injection: 1 g/vial or 5 g/vial treosulfan as a white, sterile, lyophilized powder in single-dose vials for reconstitution.
  • 4 CONTRAINDICATIONS
    GRAFAPEX is contraindicated in patients with hypersensitivity to any component of the drug product.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myelosuppression - Profound myelosuppression with pancytopenia is the desired therapeutic effect of GRAFAPEX-based preparative regimens, occurring in all patients. Time to neutrophil counts ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression - [see Warnings and Precautions ( 5.1)] Seizures - [see ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of GRAFAPEX on Other Drugs - Certain CYP2C19 and CYP3A4 Substrates - Monitor for adverse reactions of certain CYP2C19 or CYP3A4 substrates where minimal concentration changes may lead ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on its mechanism of action, GRAFAPEX can cause fetal harm when administered to a pregnant woman because it is genotoxic and affects dividing cells - [see ...
  • 10 OVERDOSAGE
    The principal toxic effect of treosulfan in cases of overdose are myeloablation and prolonged pancytopenia, mucositis, skin toxicity, nausea, vomiting and gastritis. In case of overdosage ...
  • 11 DESCRIPTION
    GRAFAPEX for injection contains treosulfan, an alkylating drug. Treosulfan is known chemically as L-‑threitol ‑1,4-‑dimethanesulfonate. Treosulfan is soluble in water (7% m/v) at 25ᴼC. Treosulfan ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Treosulfan is an alkylating agent. DNA alkylation is thought to be responsible for the cytotoxic activities of treosulfan. Treosulfan showed hematopoietic stem cell ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis and Mutagenesis - No carcinogenicity study has been conducted. Treosulfan was mutagenic in the in vitro bacterial ...
  • 14 CLINICAL STUDIES
    The efficacy of GRAFAPEX was evaluated in a randomized active-controlled trial (MC‑FludT.14/L Trial II; NCT00822393) comparing GRAFAPEX to busulfan in combination with fludarabine as a ...
  • 15 REFERENCES
    “OSHA Hazardous Drugs.” OSHA.  http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - GRAFAPEX (treosulfan) for injection is a white, sterile, lyophilized powder for reconstitution. It is supplied in a carton containing one single-dose vial ...
  • 17 PATIENT COUNSELING INFORMATION
    Infections - Inform patients of the increased risk of infections after treatment with GRAFAPEX that may require antibiotic, antiviral, or antifungal treatment and hospitalization. Advise patients ...
  • PRINCIPAL DISPLAY PANEL - GRAFAPEX™ 1 g
    Carton Label - GRAFAPEX™ 1 g - NDC 59137- 335-01 - GRAFAPEX™ (treosulfan) for injection - 1 g/vial - For intravenous infusion - after reconstitution - WARNING: Hazardous ...
  • PRINCIPAL DISPLAY PANEL - GRAFAPEX™ 5 g
    Carton Label - GRAFAPEX™ 5 g - NDC59137- 365-01 - GRAFAPEX™ (treosulfan) for injection - 5 g/vial - For intravenous infusion - after reconstitiution - WARNING: Hazardous ...
  • INGREDIENTS AND APPEARANCE
    Product Information