Preparation & Administration

RECONSTITUTION

Reconstitution1
MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures.
MYLOTARG is supplied as a single-dose vial. Of note, 4.5 mg is the stated extractable volume from 1 vial. Each vial contains 5 mg of MYLOTARG. After reconstitution with 5 mL of Sterile Water for Injection, USP, the resulting concentration is 1 mg/mL of MYLOTARG that delivers 4.5 mL (4.5 mg).
Calculate the dose (mg) and number of vials of MYLOTARG required.
Prior to reconstitution, allow drug product vials to reach ambient temperature 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.
PROTECT FROM LIGHT. DO NOT FREEZE.
MYLOTARG contains no bacteriostatic preservatives. Use reconstituted solution immediately or after being refrigerated at 2-8°C (36-46°F) for up to 1 hour.
REFERENCE
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.

DILUTION

Dilution1
Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose according to patient BSA.1
Withdraw this amount from the vial(s) using a syringe. PROTECT FROM LIGHT.1
Discard any unused reconstituted solution left in the vial.1
Doses must be mixed to a concentration between 0.075 mg/mL to 0.234 mg/mL. For additional dilution information see below. PROTECT FROM LIGHT.1
Additional Dilution Information2
Doses must be mixed to a concentration between 0.075 mg/mL to 0.234 mg/mL. Doses less than 3.9 mg should be prepared for administration by syringe to reduce the potential impact of drug adsorption. Examples of appropriate infusion containers based on dose are summarized in the table below:
Gently invert the infusion container to mix the diluted solution. DO NOT SHAKE.1
The diluted solution should be used immediately or stored up to 6 hours at room temperature (15-25°C; 59-77°F), including the 2-hour infusion time and 1 hour, if needed, to allow the refrigerated diluted solution to equilibrate to room temperature. The diluted solution can be refrigerated at 2-8°C (36-46°F) for up to 12 hours, which includes up to 1 hour in the vial post reconstitution. PROTECT FROM LIGHT and DO NOT FREEZE.1
BSA=body surface area.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.
2. Data on file. Pfizer Inc, New York, NY.

ADMINISTRATION

Administration1
Use an in-line 0.2-micron polyethersulfone (PES) filter for infusion of MYLOTARG.
During the infusion, the IV bag needs to be protected from light using a light-blocking cover. The infusion line does not need to be protected from light.
Infuse the diluted solution over 2 hours.
Do not mix MYLOTARG with, or administer as an infusion with, other medicinal products.1
Use appropriate aseptic technique for the reconstitution and dilution procedures.1
Protect the reconstituted and diluted solution from light.1
REFERENCE
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.