Grafapex

With fludarabine as conditioning prior to allo-HSCT in adults and pediatric patients 1+ years with AML or MDS.

10 g/m2 IV on Days -4, -3, -2 prior to transplant (with fludarabine 30 mg/m2 on Days -6 to -2).

Injection: 5 g lyophilized powder in single-dose vial

None listed in the prescribing information.

• Myelosuppression: Severe and prolonged cytopenias expected.
• Infections: Serious and fatal infections reported.
• GVHD: Both acute and chronic reported.
• Hepatotoxicity: Including SOS/VOD.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Mucositis (65%), Nausea (55%), Febrile Neutropenia (48%), Diarrhea (42%), Vomiting (40%), Infections (38%), Pyrexia (36%), Rash (28%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Live Vaccines: Avoid until immune reconstitution.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Treosulfan is a prodrug alkylating agent that forms reactive epoxide intermediates at physiological pH, cross-linking DNA. It provides reduced-intensity conditioning with potentially lower toxicity than busulfan.

Half-life: ~1.5 hours. Elimination primarily renal (25-30% unchanged).

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• MC-FludT.14/L — Treosulfan/fludarabine vs busulfan/fludarabine conditioning. Phase III, n=570.
  🔬 NCT02784951 ↗ 📄 Primary Publication ↗

Grafapex has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: