Gemtuzumab ozogamicin

Instructions for Reconstitution, Dilution, and Administration Use appropriate aseptic technique for the reconstitution and dilution procedures. Protect the reconstituted and diluted MYLOTARG solution from light. Reconstitution

MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

Calculate the dose (mg) and number of vials of MYLOTARG required.

Prior to reconstitution, allow drug product vials to reach room temperature (up to 30°C) for approximately 5 minutes.

Reconstitute each vial with 5 mL of Sterile Water for Injection, USP to obtain a concentration of 1 mg/mL of MYLOTARG that delivers 4.5 mL (4.5 mg).

Gently swirl the vial to aid dissolution. DO NOT SHAKE.

Inspect the reconstituted solution for particulates and discoloration. The reconstituted solution may contain small white to off-white, opaque to translucent, and amorphous to fiber-like particles.

MYLOTARG contains no bacteriostatic preservatives.

If the reconstituted solution cannot be used immediately, it may be stored in the original vial for up to 16 hours in a refrigerator (2°C to 8°C; 36°F to 46°F) or up to 3 hours at room temperature (up to 30°C). PROTECT FROM LIGHT. DO NOT FREEZE . Dilution

Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose according to patient body surface area. Withdraw this amount from the vial(s) using a syringe. PROTECT FROM LIGHT. Discard any unused reconstituted solution left in the vial. Doses must be mixed to a concentration between 0.075 mg/mL to 0.234 mg/mL according to the following instructions:

Doses less than 3.9 mg must be prepared for administration by syringe. Add the reconstituted MYLOTARG solution to a syringe with 0.9% Sodium Chloride Injection to a final concentration between 0.075 mg/mL to 0.234 mg/mL. PROTECT FROM LIGHT.

Doses greater than or equal to 3.9 mg are to be diluted in a syringe or a polyvinyl chloride (PVC) with di(2-ethylhexyl)phthalate (DEHP), non-PVC polyolefin, or ethylene vinyl acetate intravenous infusion bag in an appropriate volume of 0.9% Sodium Chloride Injection to ensure a final concentration between 0.075 mg/mL to 0.234 mg/mL.

PROTECT FROM LIGHT.

Gently invert the infusion container to mix the diluted solution. DO NOT SHAKE.

Following dilution with 0.9% Sodium Chloride Injection, MYLOTARG solution should be infused immediately. If not used immediately, the diluted solution may be stored up to 18 hours in a refrigerator (2°C to 8°C; 36°F to 46°F) and for up to 6 hours at room temperature (up to 30°C). The allowed time at room temperature (up to 30°C) includes the time required for preparation of the diluted solution, equilibration, if needed, and the 2 hours needed to administer to the patient.

PROTECT FROM LIGHT and DO NOT FREEZE. Administration

Use an in-line 0.2 micron polyethersulfone (PES) filter for infusion of MYLOTARG.

Protect the intravenous bag from light using a light-blocking cover during infusion. The infusion line does not need to be protected from light.

Infuse the diluted solution over 2 hours using an infusion set made of polyvinyl chloride (PVC) with DEHP, PVC non-DEHP, polyethylene, or polyurethane. The infusion must be completed prior to the end of the allowed 6-hour storage of the diluted solution at room temperature (up to 30°C).

Do not mix MYLOTARG with, or administer as an infusion with, other medicinal products.