- Approval Id
- e0d1a37839138bf1
- Drug Name
- TRECONDI POWDER FOR SOLUTION FOR INFUSION 5 G PER VIAL
- Product Name
- TRECONDI POWDER FOR SOLUTION FOR INFUSION 5 G PER VIAL
- Approval Number
- SIN16922P
- Approval Date
- 2023-12-26
- Registrant
- LINK HEALTHCARE SINGAPORE PTE LTD
- Licence Holder
- LINK HEALTHCARE SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- **4.2 Posology and method of administration**
Administration of treosulfan should be supervised by a physician experienced in conditioning treatment followed by alloHSCT.
Posology
_Adults with AML and MDS_
Treosulfan is given in combination with fludarabine.
The recommended dose and schedule of administration is:
- Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -4, -3, -2) before stem cell infusion (day 0). The total treosulfan dose is 30 g/m²;
- Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²;
- Treosulfan should be administered before fludarabine on days -4, -3, -2 (FT10 regimen).
_Elderly_
No dose adjustment is necessary in any subset of the elderly population.
_Renal and hepatic impairment_
No dose adjustment is necessary for mild or moderate impairment, but treosulfan is contraindicated in patients with severe impairment (see section 4.3).
_Paediatric population_
Treosulfan is given in combination with fludarabine, with thiotepa (intensified regimen; FT10–14TT regimen) or without thiotepa (FT10–14 regimen).
The recommended dose and schedule of administration is:
- Treosulfan 10–14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0). The total treosulfan dose is 30–42 g/m²;
The dose of treosulfan should be adapted to the patient’s BSA as follows (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_):
- Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -7, -6, -5, -4, -3) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²;
- Treosulfan should be administered before fludarabine;
- Thiotepa (intensified regimen 5 mg/kg twice a day), given as two intravenous infusions over 2– 4 hours on day -2 before stem cell infusion (day 0).
The safety and efficacy of treosulfan in children less than 1 month of age has not yet been established.
Method of administration
Treosulfan is for intravenous use as a two-hour infusion.
_Precautions to be taken before handling or administering the medicinal product_
When handling treosulfan, inhalation, skin contact or contact with mucous membranes should be avoided. Pregnant personnel should be excluded from handling cytotoxics.
Intravenous administration should be performed using a safe technique to avoid extravasation (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
For instructions on reconstitution of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **4.1 Therapeutic indications**
Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) at increased risk of toxicity with standard conditioning therapies, and in paediatric patients older than one month with malignant diseases.
- Contraindications
- **4.3 Contraindications**
- Hypersensitivity to the active substance
- Active non-controlled infectious disease
- Severe concomitant cardiac, lung, liver, and renal impairment
- Fanconi anaemia and other DNA breakage repair disorders
- Pregnancy (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
- Administration of live vaccine
- Atc Code
- L01AB02
- Atc Item Name
- treosulfan
- Pharma Manufacturer Name
- LINK HEALTHCARE SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/b395bf2a2da020b4/link-healthcare-singapore-pte-ltd
