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[Amount of drug] [Infusion volume] [Infusion rate]
[Prescribed dose] [ 50 ml] [15 minutes] *
[Final concentrations below 30 mcg/ml: Albumin must be added to the bag prior to aldesleukin at a final concentration of 0.1% if a lower concentration cannot be avoided. The addition of albumin should increase stability and decrease the extent of adsorbtion to the container.]
EACH VIAL CONTAINS 22 MILLION IU (1.3 MG) OF PROLEUKIN AND SHOULD BE RECONSTITUTED ASEPTICALLY WITH 1.2 ML OF STERILE WATER FOR INJECTION, USP. WHEN RECONSTITUTED AS DIRECTED, EACH ML CONTAINS 18 MILLION IU (1.1 MG) OF PROLEUKIN. During reconstitution, the Sterile Water for Injection, USP should be directed at the side of the vial and the contents gently swirled to avoid excess foaming. DO NOT SHAKE.
DO NOT FILTER.
|Stability / Miscellaneous|
The in vivo administration of PROLEUKIN in animals and humans produces multiple immunological effects in a dose dependent manner. These effects include activation of cellular immunity with profound lymphocytosis, eosinophilia, and thrombocytopenia, and the production of cytokines including tumor necrosis factor, IL-1 and gamma interferon. In vivo experiments in murine tumor models have shown inhibition of tumor growth. The exact mechanism by which PROLEUKIN mediates its antitumor activity in animals and humans is unknown.
INDICATIONS AND USAGE
PROLEUKIN is indicated for the treatment of adults with metastatic melanoma.
Careful patient selection is mandatory prior to the administration of PROLEUKIN. See package insert for the following: “CONTRAINDICATIONS”, “WARNINGS” and “PRECAUTIONS” sections regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests.
Evaluation of clinical studies to date reveals that patients with more favorable ECOG performance status (ECOG PS 0) at treatment initiation respond better to PROLEUKIN, with a higher response rate and lower toxicity (see package insert for the following: “CLINICAL PHARMACOLOGY” section, “Clinical Experience” subsection and “ADVERSE REACTIONS” section). Therefore, selection of patients for treatment should include assessment of performance status.
Experience in patients with ECOG PS >1 is extremely limited.
PROLEUKIN is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. Retreatment with PROLEUKIN is contraindicated in patients who have experienced the following drug-related toxicities while receiving an earlier course of therapy:
• Sustained ventricular tachycardia (≥5 beats)
• Cardiac arrhythmias not controlled or unresponsive to management
• Chest pain with ECG changes, consistent with angina or myocardial infarction
• Cardiac tamponade
• Intubation for >72 hours
• Renal failure requiring dialysis >72 hours
• Coma or toxic psychosis lasting >48 hours
• Repetitive or difficult to control seizures
• Bowel ischemia/perforation
• GI bleeding requiring surgery
DOSAGE AND ADMINISTRATION
Retreatment with PROLEUKIN is contraindicated in patients who have experienced the following toxicities:
Doses should be held and restarted according to the following:
Reconstitution and Dilution Directions:
1. PROLEUKIN® (aldesleukin) is a sterile, white to off-white, preservative-free, lyophilized powder suitable for IV infusion upon reconstitution and dilution. EACH VIAL CONTAINS 22 MILLION IU (1.3 MG) OF PROLEUKIN AND SHOULD BE RECONSTITUTED ASEPTICALLY WITH 1.2 ML OF STERILE WATER FOR INJECTION, USP. WHEN RECONSTITUTED AS DIRECTED, EACH ML CONTAINS 18 MILLION IU (1.1 MG) OF PROLEUKIN. The resulting solution should be a clear, colorless to slightly yellow liquid. The vial is for single-use only and any unused portion should be discarded.
2. During reconstitution, the Sterile Water for Injection, USP should be directed at the side of the vial and the contents gently swirled to avoid excess foaming. DO NOT SHAKE.
3. The dose of PROLEUKIN, reconstituted with Sterile Water for Injection, USP (without preservative) should be diluted aseptically in 50 mL of 5% Dextrose Injection, USP (D5W) and infused over a 15-minute period.
In cases where the total dose of PROLEUKIN is 1.5 mg or less (e.g., a patient with a body weight of less than 40 kilograms), the dose of PROLEUKIN should be diluted in a smaller volume of D5W. Concentrations of PROLEUKIN below 30 µg/mL and above 70 µg/mL have shown increased variability in drug delivery. Dilution and delivery of PROLEUKIN outside of this concentration range should be avoided.
4. Glass bottles and plastic (polyvinyl chloride) bags have been used in clinical trials with comparable results. It is recommended that plastic bags be used as the dilution container since experimental studies suggest that use of plastic containers results in more consistent drug delivery. In-line filters should not be used when administering PROLEUKIN.
5. Before and after reconstitution and dilution, store in a refrigerator at 2° to 8°C (36° to 46°F). Do not freeze. Administer PROLEUKIN within 48 hours of reconstitution. The solution should be brought to room temperature prior to infusion in the patient.
6. Reconstitution or dilution with Bacteriostatic Water for Injection, USP, or 0.9% Sodium Chloride Injection, USP should be avoided because of increased aggregation. PROLEUKIN should not be coadministered with other drugs in the same container.
7. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
NDC 0078-0495-61 Individually boxed single-use vial
Store vials of lyophilized PROLEUKIN in a refrigerator at 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT. Store in carton until time of use.
Reconstituted or diluted PROLEUKIN is stable for up to 48 hours at refrigerated and room temperatures, 2° to 25°C (36° to 77°F). However, since this product contains no preservative, the reconstituted and diluted solutions should be stored in the refrigerator.
Do not use beyond the expiration date printed on the vial. NOTE: This product contains no preservative
1) [PACKAGE INSERT DATA] : Novartis Pharmaceuticals Corporation. East Hanover, NJ 07936. PROLEUKIN® - Aldesleukin For Injection Package insert. October 2008.
2) Solimando, Dominic A. Drug Information Handbook for Oncology: A Complete Guide to Combination Chemotherapy Regimens, 8th ed. Hudson, OH: Lexi-Comp, Inc.; 2010.
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