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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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BOXED WARNING
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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 USAGE1.1 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 ...
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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3 DOSAGE FORMS AND STRENGTHSFor injection: 1 g/vial or 5 g/vial treosulfan as a white, sterile, lyophilized powder in single-dose vials for reconstitution.
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4 CONTRAINDICATIONSGRAFAPEX is contraindicated in patients with hypersensitivity to any component of the drug product.
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5 WARNINGS AND PRECAUTIONS5.1 Myelosuppression - Profound myelosuppression with pancytopenia is the desired therapeutic effect of GRAFAPEX-based preparative regimens, occurring in all patients. Time to neutrophil counts ...
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6 ADVERSE REACTIONSThe following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression - [see Warnings and Precautions ( 5.1)] Seizures - [see ...
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7 DRUG INTERACTIONS7.1 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 ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEThe 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 ...
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11 DESCRIPTIONGRAFAPEX 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 ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis and Mutagenesis - No carcinogenicity study has been conducted. Treosulfan was mutagenic in the in vitro bacterial ...
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14 CLINICAL STUDIESThe 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 ...
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15 REFERENCES“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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16 HOW SUPPLIED/STORAGE AND HANDLINGHow Supplied - GRAFAPEX (treosulfan) for injection is a white, sterile, lyophilized powder for reconstitution. It is supplied in a carton containing one single-dose vial ...
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17 PATIENT COUNSELING INFORMATIONInfections - Inform patients of the increased risk of infections after treatment with GRAFAPEX that may require antibiotic, antiviral, or antifungal treatment and hospitalization. Advise patients ...
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PRINCIPAL DISPLAY PANEL - GRAFAPEX™ 1 gCarton Label - GRAFAPEX™ 1 g - NDC 59137- 335-01 - GRAFAPEX™ (treosulfan) for injection - 1 g/vial - For intravenous infusion - after reconstitution - WARNING: Hazardous ...
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PRINCIPAL DISPLAY PANEL - GRAFAPEX™ 5 gCarton Label - GRAFAPEX™ 5 g - NDC59137- 365-01 - GRAFAPEX™ (treosulfan) for injection - 5 g/vial - For intravenous infusion - after reconstitiution - WARNING: Hazardous ...
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INGREDIENTS AND APPEARANCEProduct Information