Aldesleukin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Metastatic renal cell carcinoma Induction: 18 MIU/m2/24 hr for 5 days, followed by 2-6 days rest; continue for another 5 days then after a 3 wk of rest, a 2nd cycle may be given. Maintenance: 4 cycles at 4-wk intervals. Metastatic melanoma Induction: 600,000 IU/kg 8 hrly for up to 14 doses; repeated after 9 days. SC Metastatic renal cell carcinoma Induction: 1st wk: 18 MIU/day for 5 days, followed by 2 days rest. Next 3 wk: 18 MIU on days 1 and 2 and 9 MIU on days 3-5 of each wk, followed by 2 days rest. 4-wk cycle repeated after an interval of 1 wk. Maintenance: 4 cycles at 4-wk intervals.
Dosage Details
Intravenous
Metastatic renal cell carcinoma
Adult: Induction: 18 MIU/m2 per 24 hr via continuous infusion for 5 days, followed by 2-6 days rest; continue for another 5 days, then after a 3 wk of rest, a 2nd cycle may be given. Maintenance: 4 cycles at 4-wk intervals (to responders or in patients whose disease stabilises).

Intravenous
Metastatic melanoma
Adult: Induction: 600,000 IU/kg 8 hrly via infusion over 15 min, for up to 14 doses; repeated after 9 days. Further courses may be given at intervals of at least 7 wk to responders.

Subcutaneous
Metastatic renal cell carcinoma
Adult: Induction: 1st wk: 18 MIU once daily for 5 days, followed by 2 days rest. Next 3 wk: 18 MIU on days 1 and 2 and 9 MIU on days 3-5 of each wk, followed by 2 days rest. 4-wk cycle repeated after an interval of 1 wk. Maintenance: 4 cycles at 4-wk intervals (to responders or in patients whose disease stabilises).
Reconstitution
Reconstitute w/ 1.2 mL of sterile water for inj to a concentration of 18 MIU/mL (inject sterile water towards the side of the vial). Swirl gently. Further dilute w/ 50 mL of dextrose 5% in water (use smaller vol for doses ≤1.5 mg); avoid concentrations <30 mcg/mL and >70 mcg/mL as an increased variability in drug delivery has been observed.
Incompatibility
Incompatible w/ fluorouracil, ganciclovir, lorazepam, pentamidine, prochlorperazine edisilate, promethazine. Avoid dilution w/ NaCl or bacteriostatic water for inj.
Contraindications
Organ allograft, severe cardiac disease and major organ dysfunction, CNS metastases, seizure disorder, abnormal serum bilirubin/creatinine, WBC <4,000/mm3, platelet <100,000/mm3, haematocrit <30%. Retreatment in patient who has experienced drug-related toxicities during previous course of therapy, including sustained ventricular tachycardia (≥5 beats), uncontrolled/unresponsive cardiac arrhythmia, chest pain (w/ ECG changes consistent of angina/MI), cardiac tamponade, intubation for ≥72 hr, renal failure requiring dialysis >72 hr, coma/toxic psychosis for >48 hr, bowel ischaemia/perforation, GI bleeding requiring surgery. Concomitant use w/ cisplatin, vinblastine, dacarbazine, and corticosteroids. Lactation.
Special Precautions
Patient w/ pre-existing cardiac or pulmonary disease, auto-immune disease (e.g. Crohn’s disease), active infection, effusions from serosal surfaces, hypercalcaemia. Withhold treatment in patients who develop lethargy or somnolence during treatment. Hepatic and renal impairment. Pregnancy.
Adverse Reactions
Tachycardia, arrhythmia, chest pain, myocardial ischaemia, cyanosis, transient ECG changes, palpitations; dyspnoea, cough, pulmonary oedema, pleural effusion, hypoxia, haemoptysis, epistaxis, nasal congestion, rhinitis; irritability, anxiety, depression, confusion, drowsiness, insomnia; nausea, diarrhoea, stomatitis, raised liver enzymes, GI disturbance, fever, flu-like symptoms (e.g. malaise, rigor, chills, arthralgia, myalgia), rashes, pruritus, dizziness, headache, paraesthesia, somnolence, neuropathy, syncope, speech disorder, taste loss, lethargy; leucopenia, anaemia, thrombocytopenia, eosinophilia, impaired neutrophil function; hypo- and hyperthyroidism; sepsis, bacterial endocarditis, peritonitis, pneumonia, catheter site infection; cerebral vasculitis. Rarely, leukoencephalopathy, uraemia, oliguria, anuria, resp failure, agranulocytosis, neutropenic fever, necrosis.
Potentially Fatal: Capillary leak syndrome resulting in hypotension, reduced organ perfusion, and oedema. Rarely, cholecystitis, liver failure.
Patient Counseling Information
This drug may cause hallucination, somnolence, syncope, and convulsions, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for wt, vital signs, fluid input/output, thyroid abnormalities or other autoimmune phenomena. Perform thallium stress test prior to treatment; baseline and periodic CBC w/ differential and platelet counts, blood chemistries (including electrolytes), chest x-ray, pulmonary function tests and arterial blood gas, renal and hepatic function tests.
Drug Interactions
Increased toxicity w/ hepatotoxic (e.g. methotrexate, asparaginase), nephrotoxic (e.g. aminoglycosides, indometacin), myelotoxic (e.g. cytotoxic chemotherapy), and cardiotoxic (e.g. doxorubicin) drugs in these organ systems. Delayed AR may occur w/ subsequent admin of iodinated contrast media. Increased renal toxicity w/ NSAIDs. May potentiate hypotension w/ β-blockers. May exacerbate autoimmune and inflammatory disorders (e.g. glomerulonephritis, thyroiditis, myasthenia gravis, Stevens-Johnson syndrome) and cause severe rhabdomolysis, MI, myocarditis, and ventricular hypokinesia w/ interferon-α.
Potentially Fatal: Reduced antineoplastic activity w/ corticosteroids. May cause tumor lysis syndrome w/ cisplatin, vinblastine, and dacarbazine.
Action
Description: Aldesleukin, a modified human recombinant interleukin-2 (IL-2), is produced using an Escherichia coli strain containing an analogue of human IL-2 gene. It enhances mitogenesis of T and B cells, natural killer (NK) cells, and thymocytes, stimulates lymphokine-activated killer (LAK), and tumour-infiltrating lymphocyte (TIL) cells, and induces interferon-γ production.
Pharmacokinetics:
Absorption: Bioavailability: 35-47% (SC). Time to peak plasma concentration: 2-6 hr (SC).
Distribution: Distributed primarily into plasma, lymphocytes, lungs, liver, kidney, and spleen. Volume of distribution: 6.3-7.9 L.
Metabolism: Metabolised in the kidneys into amino acids.
Excretion: Via urine (mainly as metabolites). Elimination half-life: 85 min (IV); 5.3 hr (SC).
Storage
Store between 2-8°C. Protect from light. Do not freeze.
ATC Classification
L03AC01 - aldesleukin ; Belongs to the class of interleukins. Used as immunostimulants.
References
Anon. Aldesleukin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/08/2016.

Buckingham R (ed). Interleukin-2. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/08/2016.

Joint Formulary Committee. Aldesleukin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/08/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Aldesleukin. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 12/08/2016.

Proleukin Injection, Powder, Lyophilized, for Solution (Prometheus Laboratories Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 12/08/2016.

Disclaimer: This information is independently developed by MIMS based on Aldesleukin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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