Aldesleukin

Intravenous
Metastatic renal cell carcinoma

Intravenous
Metastatic melanoma

Subcutaneous
Metastatic renal cell carcinoma

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.

Incompatible w/ fluorouracil, ganciclovir, lorazepam, pentamidine, prochlorperazine edisilate, promethazine. Avoid dilution w/ NaCl or bacteriostatic water for inj.

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.

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.

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.

IV/SC: C

This drug may cause hallucination, somnolence, syncope, and convulsions, if affected, do not drive or operate machinery.

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.

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.

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).

Store between 2-8°C. Protect from light. Do not freeze.

Cancer Immunotherapy

L03AC01 - aldesleukin ; Belongs to the class of interleukins. Used as immunostimulants.

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.