GRAFAPEX 1000 mg/g
treosulfan · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Medexus Pharma, Inc.
Grafapex (treosulfan) is an intravenous chemotherapy medication used to prepare the body for bone marrow or stem cell transplantation. It works by destroying cancer cells and bone marrow cells to make room for transplanted healthy cells.
Key Facts
- Brand Name
- GRAFAPEX
- Generic Name
- treosulfan
- NDC Code (Product)
59137-335- Manufacturer
- Medexus Pharma, Inc.
- Strength
- 1000 mg/g
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA214759
- Marketing Start
- 01/28/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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). ( 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). ( 1.2 ). 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 1 year of age and older with acute myeloid leukemia (AML). 1.2 Myelodysplastic Syndrome GRAFAPEX is indicated 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).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage: 10 g/m² body surface area (BSA) per day as a two hour intravenous infusion, given on three consecutive days (day -4, -3, -2) in conjunction with fludarabine before hematopoietic stem cell infusion (day 0). ( 2.1 , 2.2 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of GRAFAPEX is 10 g/m 2 by intravenous infusion given daily for three days, beginning on Day -4 prior to transplantation in combination with fludarabine as outlined in Table 1. Table 1: Dosage Regimen for GRAFAPEX-Based Allogeneic HSCT Treatment Day -6 Day -5 Day -4 Day-3 Day -2 Day -1 Day 0 GRAFAPEX 10 g/m 2 /day intravenous infusion X X X Fludarabine 30 mg/m 2 /day intravenous infusion X X X X X Allogeneic hematopoietic stem cell infusion X Premedicate patients with antiemetics prior to the first dose of GRAFAPEX and continue antiemetics on a fixed schedule through completion of treosulfan administration. 2.2 Preparation and Administration Instructions Reconstitute GRAFAPEX prior to intravenous infusion. GRAFAPEX is a hazardous drug. Follow applicable special handling and disposal…
Contraindications
4 CONTRAINDICATIONS GRAFAPEX is contraindicated in patients with hypersensitivity to any component of the drug product. Hypersensitivity to any component of the drug product. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Certain CYP2C19 and CYP3A4 Substrates: Monitor for adverse reactions of these substrates where minimal concentration changes may lead to serious or life-threatening toxicities. ( 7.1 ) 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 to serious or life-threatening toxicities, and reduce the dosage, as needed, if recommended in the prescribing information of these substrates. Treosulfan is a CYP2C19 and CYP3A4 inhibitor [see Clinical Pharmacology ( 12 )] . Concomitant use of GRAFAPEX is predicted to increase the exposure of CYP2C19 and CYP3A4 substrates based on a mechanistic understanding of treosulfan metabolism, which may increase the risk of their adverse reactions.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.2 )] Skin Disorders [see Warnings and Precautions ( 5.3 )] Injection Site Reactions and Tissue Necrosis [see Warnings and Precautions ( 5.4 )] Secondary Malignancies [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (≥20%) are musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection, and vomiting. ( 6.1 ) Selected Grade 3 or 4 nonhematological laboratory abnormalities are increased GGT, increased bilirubin, increased ALT, increased AST, and increased creatinine. To report SUSPECTED ADVERSE REACTIONS, contact Medexus Pharma, Inc. at 1-855-336 -3322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. MC‑FludT.14/L Trial II The safety of GRAFAPEX was e…
Frequently Asked Questions
What is GRAFAPEX used for?
Grafapex (treosulfan) is an intravenous chemotherapy medication used to prepare the body for bone marrow or stem cell transplantation. It works by destroying cancer cells and bone marrow cells to make room for transplanted healthy cells.
Is GRAFAPEX a controlled substance?
GRAFAPEX is not classified as a controlled substance by the DEA.
What is the generic name for GRAFAPEX?
The generic name for GRAFAPEX is treosulfan. There are no other listed brand versions of treosulfan.
What is the NDC code for GRAFAPEX 1000 mg/g?
The NDC (National Drug Code) for GRAFAPEX 1000 mg/g is 59137-335, listed by Medexus Pharma, Inc..
Other GRAFAPEX Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)