Adult Dosing
Metastatic renal cell carcinoma, metastatic melanoma
- 600,000 IU/kg IV over 15 mins q8 hrs x 14 doses
- Repeat another cycle after 9 days rest period; Max: 28 doses per course
- May repeat the course, after rest period of 7 wks, if there is some response to the treatment
Note:
- See package insert for toxicity-related dose adjustments
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Aldesleukin therapy is associated with severe adverse events; hence a thorough clinical evaluation should be performed to identify patients with significant cardiac, pulmonary, renal, hepatic, or CNS impairment in whom aldesleukin is contraindicated
- Serious life threatening or fatal adverse events can occur in patients with normal cardiovascular, pulmonary, hepatic, and CNS function; withhold the treatment rather than reducing the dose, if any adverse events, which require dose modification occur
- Aldesleukin therapy exacerbates pre-existing or initial presentation of autoimmune disease and inflammatory disorders like Crohn’s disease, scleroderma, thyroiditis, inflammatory arthritis, diabetes mellitus, oculo-bulbar myasthenia gravis, crescentic IgA glomerulonephritis, cholecystitis, cerebral vasculitis, Stevens-Johnson syndrome and bullous pemphigoid
- Prior to initiating aldesleukin therapy, all patients should have thorough evaluation and treatment of CNS metastases. New neurologic signs, symptoms, and anatomic lesions have been reported with aldesleukin therapy in patients without evidence of CNS metastases
- Neurologic signs and symptoms associated with aldesleukin therapy include changes in mental status, speech difficulties, cortical blindness, limb or gait ataxia, hallucinations, agitation, obtundation, and coma. Radiological findings included multiple or single cortical lesions on MRI and evidence of demyelination. Usually these signs and symptoms improve after discontinuation of therapy
- Capillary leak syndrome (CLS) has been reported with aldesleukin therapy [US Black Box Warning]
- Manage CLS with careful monitoring of the patient’s fluid and organ perfusion status. Flexibility in fluid and pressor management is essential for maintaining organ perfusion and blood pressure. Treat hypovolemia cautiously with administration of IV fluids, so that neither the consequences of hypovolemia (e.g., impaired organ perfusion) nor the consequences of fluid accumulations (e.g., pulmonary edema) exceed the patient’s tolerance
- Early administration of dopamine alone or in combination with phenylephrine in patients manifesting capillary leak syndrome, before the onset of hypotension, may help to maintain organ perfusion particularly to the kidney and thus preserve urine output. Prior to the use of any product mentioned, the physician should refer to the package insert for the respective product
- Withhold the aldesleukin treatment for failure to maintain organ perfusion as demonstrated by altered mental status, reduced urine output, a fall in the systolic blood pressure, cardiac arrhythmias. Soon after the cessation of aldesleukin treatment, recovery of CLS begins with rise in blood pressure, restored organ perfusion and reabsorption of extravasated fluid and protein
- Aldesleukin therapy impairs kidney and liver function, use of concomitant nephrotoxic or hepatotoxic medications may further increase toxicity to the kidney or liver
- Hypothyroidism, rarely preceded by hyperthyroidism, may be associated with aldesleukin therapy
- Mental status changes including irritability, confusion, or depression which occur while receiving aldesleukin may be indicators of bacteremia or early bacterial sepsis, hypoperfusion, occult CNS malignancy, or direct aldesleukin-induced CNS toxicity. Change in mental status solely due to aldesleukin recovers after several days
- Evaluate hematological parameters like CBC, differential count, platelet count, blood chemistries including electrolytes, renal and hepatic function tests and chest x-ray prior to beginning treatment and periodically thereafter
- Monitor pulmonary and cardiac function on a regular basis by clinical examination and assessment of vital signs during the aldesleukin treatment
Cautions: Use cautiously in
- History of cardiac diseases
- History of pulmonary diseases
- Autoimmune disorder
- Inflammatory disorder
- Indwelling central lines
- Seizure disorders
- Concomitant nephrotoxic agent
- Concomitant hepatotoxic agent
- Subsequent administration of radiographic iodinated contrast
- Elderly patients
Pregnancy Category:C
Breastfeeding: As per the manufacturer's data, it is unknown whether aldesleukin is excreted in human milk; but as many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Proleukin 22000000 UNIT SOLR [Vial] (PROMETHEUS)
1 unit = $1207.83
3 unit = $3502.8
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
