Frequently Asked Questions
3. What diluents can be used to reconstitute Proleukin lyophilized powder?
Only sterile water for injection (without preservative), USP may be used. Other solutions,
including Bacteriostatic water for injection, USP and 0.9% Sodium Chloride Injection, USP are not compatible.
Shaking or the use of chemotherapy containment devices should be avoided because of the potential for aggregation.
4. How does one administer an IV bolus of Proleukin?
The dose of reconstituted Proleukin for bolus infusion should be diluted aseptically in 50mL of 5% Dextrose Injection, USP (D5W).
Clear the line of other solutions with 50 mLs of 5% Dextrose Injection (D5W) before Proleukin injection.
Do not use in-line filters. Do not infuse other solutions into the same line simultaneously. Infuse 50 mL dose over 15 minutes.
Clear the line with another 50 mL of D5W after IV administration.
6. How is Proleukin stored before and after dilution?
Store vials of lyophilized Proleukin in a refrigerator at 2-8°C (36-46°F) protected from light.
Reconstituted or diluted Proleukin is stable for up to 48 hours at refrigerated and room temperatures, 2-25°C (36-77°F).
However, since this product contains no preservative, the reconstituted and diluted solutions should be prepared aseptically
and stored in the refrigerator. Remove from refrigerator and bring to room temperature prior to infusion.
Do not freeze. Administer Proleukin within 48 hours of reconstitution. For more information about Proleukin stability and storage,
submit a medical information request
8. How is Proleukin’s biological potency measured?
Proleukin biological potency is determined by a lymphocyte proliferation bioassay and is expressed in
International Units by World Health Organization standard. The relationship between potency and protein mass is as follows:
18 million international units Proleukin = 1.1 mg protein.
10. What is the dose and schedule of administration?
600,000 International Units/kg (0.0337mg/kg) dose administered every 8 hours by a 15-minute
intravenous infusion for a maximum of 14 doses (cycle 1), followed by 9 days rest, the schedule is repeated for
another 14 doses (cycle 2). A maximum of 28 doses is administered per course (2 cycles) as tolerated. For additional
information regarding Proleukin dosing not provided in the package insert, please submit a
medical information request