Treosulfan-Grafapex instruction manual in Chinese

1. Common name:Treosulfan, Qu'ao Shufan (transliteration)

Product name:Grafapex; Trecondi

2. Indications:

Treosulfan（Treosulfan)-Grafapex indications include the following:

1. Acute myeloid leukemia（AML）: Suitable for use in combination with fludarabine（fludarabine） as a preparation plan for allogeneic hematopoietic stem cell transplantation in adults and children with AML who are 1 year old and above.

2. Myelodysplastic syndrome (MDS): is suitable for use in combination with fludarabine as a preparation for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients with MDS who are 1 year old and above.

3. Usage and dosage:

1. Before medication: Before taking the first dose of Trioxovan, the patient should be given antiemetic drugs in advance, and continue to take antiemetic drugs according to a fixed schedule until the patient is finished taking Trioxovan.

2. Dosage: On days 4, 3 and 2, the recommended dose of trioxovan is 10 g/m2 per day, on days 6, 5, 4, 3 and 2; combined with fludarabine 30 mg/m2 per day, and allogeneic hematopoietic stem cell infusion on day 0.

4. Adverse reactions:

In clinical studies of trioxofan, common adverse reactions included musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection, and vomiting. Nonhematologic laboratory abnormalities includedelevations of GGT, bilirubin, ALT, AST, and creatinine.

5. Supply and storage:

Triosulfan for injection is a white sterile lyophilized powder for reconstitution. It comes in a carton containing a single-dose vial. Store at20°C to 25°C (68°F to 77°F), tolerancesBetween 15°C and 30°C.

6. Taboo:

Trioxovan is contraindicated in patients who are allergic to any component of the medicine.

7. Mechanism of action:

Trioxofan is an alkylating agent. DNA alkylation is believed to be responsible for the cytotoxic activity of trioxovan. Trioxovan exhibits hematopoietic stem cell depletion activity as well as immunosuppressive and antitumor activity in mouse leukemia models.

8. Listing situation:

Original drug:

United States: 2025-02-05, approved for marketing (trade name: GRAFAPEX);

EU: 2019-06-20, approved for marketing (trade name: Trecondi);

China: Not approved for marketing yet.

Reference materials:https://www.drugs.com/grafapex.html