Treosulfan (1 brand name, 1 dosage form, 1 route)
Available dosage forms: POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- GRAFAPEX
Boxed Warning
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)] .
Contraindications
GRAFAPEX is contraindicated in patients with hypersensitivity to any component of the drug product.
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)]
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, monitor blood counts frequently and provide vigorous supportive measures as medically indicated.