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Proleukin 22 MIU Vial
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Indications & Clinical Uses
- Proleukin (aldesleukin) 22 million international units per vial is a recombinant form of interleukin-2, an immune-signalling protein, given by intravenous infusion in adults to treat metastatic renal cell carcinoma (advanced kidney cancer) and metastatic melanoma.
- It works by stimulating the patient's own immune cells to attack cancer cells.
- Because of its serious toxicity profile, Proleukin is given only in a hospital setting with intensive-care support available, under the supervision of a specialist experienced in this type of immunotherapy, following a defined multi-day infusion cycle.
- It is not a first-line or outpatient treatment and is reserved for selected patients who meet strict cardiac, pulmonary, renal, and hepatic fitness criteria before starting.
Side Effects
- Proleukin carries a boxed warning for capillary leak syndrome (CLS), a reaction in which fluid leaks out of blood vessels causing low blood pressure and reduced blood flow to vital organs; this can be life-threatening or fatal.
- The boxed warning also covers serious neurologic effects, which may cause permanent impairment, and serious infections including bacterial sepsis, particularly with an indwelling catheter.
- Very commonly reported effects (30% or more of patients) include low blood pressure, raised bilirubin, shortness of breath, rash, diarrhea, reduced urine output, chills, vomiting, low platelet count, nausea, confusion, and raised creatinine.
- Because these reactions are expected and closely monitored during hospital treatment, patients and families should discuss with the treating team what warning signs to report immediately between assessments.
Precautions & Warnings
- Before starting Proleukin, patients must have baseline tests of heart function (ejection fraction), lung function, and kidney function, and treatment is contraindicated in those with significant heart, lung, kidney, or liver impairment, an abnormal cardiac stress test, or a history of organ transplant, because immune stimulation can trigger transplant rejection.
- During each cycle, vital signs, weight, fluid balance, mental state, and blood tests are monitored closely, and infusions are given only in a facility equipped to manage capillary leak syndrome and its complications, such as an intensive care unit.
- Proleukin must be reconstituted only with the sterile water for injection supplied with it; saline or bacteriostatic water must not be used, as they alter the protein and reduce its effectiveness.
- Because of the intensity of treatment, this is not a medicine that is ever given or stored at home.
Avoid Interactions
- Glucocorticoids (steroid medicines) given at the same time as Proleukin can blunt its anti-tumor effect and are generally avoided unless they are being used specifically to manage a severe treatment reaction.
- Other drugs that affect the heart, kidneys, liver, or blood pressure, or that suppress the bone marrow, can add to Proleukin's toxicity and are reviewed carefully by the treating team before and during each cycle.
- Live vaccines should be avoided during treatment because Proleukin affects the immune system.
- Proleukin must not be reconstituted or mixed with saline or bacteriostatic water, only with the sterile water for injection provided, and should not be combined in the same line with other medicines.
- Tell the treating team about every other medicine, including over-the-counter drugs and supplements, before each infusion cycle.
References
Frequently Asked Questions
Proleukin (aldesleukin) is an immunotherapy infusion for adults with metastatic kidney cancer (renal cell carcinoma) or metastatic melanoma. It boosts your own immune cells to attack the cancer and is given only in hospital.
Proleukin is given as an intravenous infusion every 8 hours for up to 14 doses, followed by a rest period, then a repeat cycle. It requires a hospital stay with intensive monitoring throughout.
Proleukin has a boxed warning for capillary leak syndrome, which can cause dangerously low blood pressure and organ damage and can be fatal. It also warns of serious neurologic effects and severe infections, which is why it's given only in hospital.
Steroid medicines (glucocorticoids) can reduce how well Proleukin works and are avoided unless needed for a severe reaction. Live vaccines should also be avoided. Tell your care team about every other medicine you take.
Your heart, lung, and kidney function are checked before starting, and your vital signs, weight, fluid balance, and blood tests are monitored closely throughout each cycle in an intensive-care-capable unit to watch for capillary leak syndrome.
Proleukin is not given to people with significant heart, lung, kidney, or liver problems, an abnormal cardiac stress test, or a history of organ transplant, since stimulating the immune system this strongly can be dangerous or trigger transplant rejection.
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