Grafapex Dosage

Generic name: TREOSULFAN 1000mg in 1g
Dosage form: injection, powder, lyophilized, for solution
Drug class: Alkylating agents

Medically reviewed by Drugs.com. Last updated on Jan 31, 2025.

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 fludarabine as outlined in Table 1.

Table 1: Dosage Regimen for GRAFAPEX-Based Allogeneic HSCT
Treatment	Day -6	Day -5	Day -4	Day-3	Day -2	Day 0
GRAFAPEX 10 g/m 2/day intravenous infusion			X	X	X
Fludarabine 30 mg/m 2/day intravenous infusion	X	X	X	X	X
Allogeneic hematopoietic stem cell infusion						X

Premedicate patients with antiemetics prior to the first dose of GRAFAPEX and continue antiemetics on a fixed schedule through completion of treosulfan administration.

Preparation and Administration Instructions

Reconstitute GRAFAPEX prior to intravenous infusion.

GRAFAPEX is a hazardous drug. Follow applicable special handling and disposal procedures. 1

Use aseptic technique to prepare GRAFAPEX.
Calculate the dose, the total volume of reconstituted GRAFAPEX solution required, and the number of GRAFAPEX vials needed.
Reconstitute each vial with 0.45% Sodium Chloride Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Sterile Water for Injection, in its original glass container using volumes described in Table 2 to obtain a final concentration of approximately 0.05 g/mL of GRAFAPEX. Reconstitution with Sterile Water for Injection alone is not recommended in children less than or equal to 12 years of age due to the resulting hypo-osmolarity of the final solution.

Table 2: Reconstitution Solution Volume
Strength	Volume
1 g/vial	20 mL
5 g/vial	100 mL

Shake the vial(s) to dissolve.
Inspect the reconstituted solution for discoloration and particulate matter. The reconstituted solution appears as a clear colorless solution. Solutions showing any sign of precipitation should not be used. In case that solubility issues occur, prolonged standing time or slight warming of the reconstituted solution (hand warm) may be useful.
Determine the volume of 0.05 g/mL reconstituted solution needed based on the required dose. Reconstituted solutions of GRAFAPEX may be combined into a larger glass vial, ethylene-vinyl acetate (EVA) bag or polyolefin (PO) bag. Discard any unused portion left in the vial(s).

If not used immediately store reconstituted GRAFAPEX solution at room temperature 20°C to 25°C (68°F to 77°F) for up to 24 hours. Do not use if the solution contains a precipitate.

Do not refrigerate.

Infuse GRAFAPEX intravenously over 2 hours. Confirm patency of the intravenous line prior to infusion. Monitor for extravasation; if extravasation occurs, stop the infusion .