Aldesleukin
Aldesleukin is a recombinant form of interleukin-2, a cytokine that stimulates the immune system to fight cancer cells. It is primarily used to treat metastatic renal cell carcinoma (kidney cancer) and metastatic melanoma. The medication works by activating and promoting the proliferation of immune cells, particularly T lymphocytes and natural killer cells, which then target and destroy cancer cells.
Aldesleukin is an immunotherapy drug used to treat certain metastatic kidney cancers and melanomas by stimulating the patient's own immune system to attack cancer cells.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L03AC01
- RxNorm
- 2145
- Generic
- Aldesleukin
- Class
- atc-l03
- Brands
- Proleukin
- Availability
- otc
- Pregnancy
- C
- Lactation
- unknown
- Half-life (h)
- 1.4
- Onset (min)
- 0
- Duration (h)
- 0
- Routes
- intravenous
- Forms
- lyophilized powder for injection
- Regions
- United States, European Union, Canada
- Monitoring
- vital signs, fluid balance, renal function, hepatic function, cardiac rhythm, pulmonary status, complete blood count, electrolytes, mental status
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid
discontinue therapy if pregnancy occurs; use only if maternal benefit outweighs fetal risk
comprehensive fetal monitoring including ultrasound
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 4 weeks after last dose
no specific monitoring required
pediatric_age
children adolescentsnot recommended
not established for use in pediatric patients; safety and efficacy not determined
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 plusstart at lower end of dosing range
use with caution; increased susceptibility to infections and organ dysfunction; assess renal and cardiac function before treatment
close monitoring of renal function, cardiac status, and for signs of infection
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentavoid or significantly reduce dose
not recommended in patients with serum creatinine > 1.5 times upper limit of normal; requires dose modification based on creatinine clearance
frequent renal function monitoring; monitor fluid balance closely
Use of this medication in this population requires careful consideration of risks and benefits.
hepatic_impairment
moderate severe hepatic impairmentavoid
not recommended in patients with significant hepatic impairment; contraindicated in patients with bilirubin > 3 times upper limit of normal
frequent liver function tests and monitoring for signs of hepatic toxicity
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
Initial FDA approval for Aldesleukin
Drug class
Immunological classification
Primary indications
Therapeutic indications
Mechanism of action
Pharmacological mechanism
Aldesleukin is FDA-approved for the treatment of metastatic renal cell carcinoma (stage IV kidney cancer) and metastatic melanoma. It may also be used off-label for other malignancies and is sometimes considered in clinical trials for combination therapy approaches.
As a recombinant interleukin-2, aldesleukin binds to IL-2 receptors on the surface of immune cells, triggering their activation, proliferation, and enhanced cytotoxic activity. This immunostimulatory effect enables T lymphocytes and natural killer cells to better recognize and destroy tumor cells.
Aldesleukin is typically administered in specialized healthcare settings with experience in cancer immunotherapy due to potentially severe side effects including capillary leak syndrome, hypotension, cardiac arrhythmias, and organ dysfunction. Patients require careful monitoring during and after treatment. This medication is generally contraindicated for patients with pre-existing cardiac, pulmonary, or organ dysfunction conditions.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 26, 2026. · Read our editorial policy