Aldesleukin
Aldesleukin is an immune-activating medication used to treat metastatic renal cell carcinoma (kidney cancer that has spread) and metastatic melanoma (skin cancer that has spread) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Proleukin carries three serious boxed warnings that every patient should know:
- Capillary Leak Syndrome (CLS): Proleukin can cause fluid to leak out of blood vessels throughout the body. This can lead to dangerously low blood pressure, difficulty breathing, severe swelling, and failure of the heart, kidneys, or liver — and can be fatal. Proleukin must be given in a hospital with an intensive care unit. It must not be used in patients who already have significant heart, lung, kidney, or liver problems.
- Neurological toxicity: Proleukin can cause serious brain and nervous system problems, including severe confusion, coma, and permanent neurological damage. Watch for sudden confusion, agitation, or seizures and report them immediately.
- Serious infections: Proleukin weakens the body's ability to fight bacteria, increasing the risk of severe infections including sepsis (a life-threatening bloodstream infection) and bacterial endocarditis (infection of the heart). Any pre-existing bacterial infection must be fully treated before Proleukin is started.
📖 Aldesleukin: Patient Information Guide
A plain-language walkthrough of Aldesleukin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Aldesleukin is an immune-activating cancer medicine. Based on the available product evidence, the following uses are supported:
- Proleukin (intravenous): Treatment of adults with metastatic renal cell carcinoma — kidney cancer that has spread to other parts of the body
- Proleukin (intravenous): Treatment of adults with metastatic melanoma — skin cancer that has spread to other parts of the body
⚙️How it works▾
Aldesleukin is a synthetic (lab-made) form of interleukin-2, a protein naturally made by the immune system to help grow and activate cancer-fighting cells. When given by IV, it stimulates immune cells — including natural killer (NK) cells and lymphokine-activated killer (LAK) cells — to multiply and become more aggressive at attacking tumor cells. It also triggers the release of other immune-signaling proteins, such as interferon gamma and tumor necrosis factor, that contribute to the anti-tumor effect.
The full extent of how it fights cancer is not completely understood, but its effects on the immune system are dose-dependent — meaning higher doses tend to produce stronger immune responses, along with more significant side effects.
💊How it's taken▾
Proleukin is given only by intravenous infusion in a hospital with intensive care facilities — it is never taken at home. Each infusion is given over 15 minutes, every 8 hours, for up to 14 doses per cycle. After a rest period, a second cycle of up to 14 more doses may follow, for a maximum of 28 doses per course of treatment.
- Courses are separated by at least 7 weeks from hospital discharge before the next course begins
- Doses are not reduced for side effects — instead, doses are withheld or skipped based on how well the body tolerates treatment
- Your team will evaluate your response about 4 weeks after each course before deciding whether to continue
🤒Side effects — in detail▾
Most people receiving Proleukin experience significant side effects — your care team will monitor you around the clock. The most common reactions (occurring in 30% or more of patients) include:
- Low blood pressure (hypotension)
- High bilirubin levels (a liver marker) — hyperbilirubinemia
- Shortness of breath (dyspnea)
- Rash
- Diarrhea
- Decreased urine output (oliguria)
- Chills and fever
- Nausea and vomiting
- Low platelet count (thrombocytopenia)
- Confusion (confusional state)
- Elevated creatinine (a sign of kidney stress)
Serious and potentially life-threatening reactions — including capillary leak syndrome, severe neurological effects, sepsis, and kidney failure — can also occur and require immediate medical attention. Fatal reactions occurred in a small percentage of patients in clinical trials.
⚠️Warnings & precautions▾
- Capillary Leak Syndrome (CLS): The most dangerous risk. Fluid leaks from blood vessels into tissues, causing very low blood pressure, breathing difficulty, dangerous swelling, and potential organ failure. Can be fatal. Must be given in a hospital ICU setting only.
- Neurological toxicity: Can cause confusion, coma, seizures, or permanent brain damage. Brain metastases (cancer spread to the brain) must be treated before starting Proleukin. Avoid combining with other drugs that affect the nervous system.
- Serious infections: Proleukin weakens the ability of white blood cells (neutrophils) to fight bacteria. Sepsis and heart-valve infections (bacterial endocarditis) have occurred. Active infections must be treated first.
- Kidney toxicity: Serious reduction in kidney function, including kidney failure, can occur. Creatinine levels are checked daily during treatment.
- Immune-mediated reactions: Can trigger or worsen autoimmune conditions affecting any organ — including the thyroid, joints, eyes, skin, heart, and nervous system.
- Embryo-fetal harm: Proleukin may cause loss of pregnancy or fetal harm. Pregnancy must be ruled out before starting treatment, and effective contraception is required.
- Eosinophilia: High levels of a type of white blood cell (eosinophils) can infiltrate heart and lung tissue, causing serious damage.
- Delayed reactions to contrast dye: Patients who receive iodinated contrast dye (used in imaging scans) after Proleukin treatment — even months later — may have an unusual reaction resembling Proleukin's side effects.
🔀What it interacts with▾
Formal drug interaction studies have not been conducted for Proleukin, but important interactions have been observed in real-world use:
- Glucocorticoids (e.g., prednisone, dexamethasone): May blunt Proleukin's anti-cancer effectiveness — avoid using together when possible
- Iodinated contrast media (CT scan dye): Can trigger a delayed reaction similar to Proleukin's own side effects, sometimes occurring weeks or months after treatment ends — tell any imaging team about your Proleukin treatment history
- Antihypertensive drugs (blood pressure medications): May worsen the low blood pressure that Proleukin already causes
- Nephrotoxic drugs (drugs hard on the kidneys): Increase the risk of serious kidney damage when combined with Proleukin
- Hepatotoxic drugs (drugs hard on the liver): Increase risk of liver toxicity
- Neurotoxic drugs: Combining with Proleukin may raise the risk of severe brain or nerve-related side effects
- CYP enzyme substrates (many common medications): Proleukin releases cytokines that can suppress liver enzyme activity, causing certain other drugs to build up to potentially harmful levels — your team will monitor for this
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- People with significant heart problems (including reduced heart pumping ability or significant coronary artery disease) — Proleukin is contraindicated
- People with significant lung impairment (including an FEV1 below certain thresholds) — Proleukin is contraindicated
- People with significant kidney or liver impairment — Proleukin is contraindicated
- People with significant central nervous system impairment — Proleukin is contraindicated
- Organ transplant recipients — Proleukin is contraindicated due to the risk of triggering organ rejection
- People with a known severe allergy (hypersensitivity) to aldesleukin or any component of Proleukin — contraindicated
- People with active bacterial infections — these must be fully treated before starting Proleukin
- People with autoimmune diseases — Proleukin can worsen these conditions
- People with seizure disorders or abnormal brain imaging — Proleukin should generally be avoided
- Pregnant women — Proleukin may cause loss of pregnancy or serious harm to the fetus; effective contraception is required during treatment
- Breastfeeding women — advised not to breastfeed during treatment due to risk of serious harm to the infant
- Children — safety and effectiveness have not been established in pediatric patients
- Adults 65 and older — clinical studies did not include enough older adults to determine if they respond differently
🚑If you take too much▾
Taking more Proleukin than recommended is associated with a faster onset of severe or life-threatening toxicities. Treatment of an overdose is supportive — meaning the care team manages symptoms as they arise. The label notes that life-threatening toxicities from overdose may be eased by giving dexamethasone (a steroid) intravenously.
📡Pharmacodynamics — effects in the body▾
Aldesleukin produces immune effects that increase with dose. These include activation of cellular immunity, a rise in certain white blood cell types (lymphocytosis and eosinophilia), a drop in platelet count (thrombocytopenia), and increased release of immune-signaling proteins such as tumor necrosis factor, IL-1, and interferon gamma. The precise relationship between drug exposure and its anti-tumor response — and how long those effects last — is not yet fully understood.
🔬Pharmacokinetics — how your body processes it▾
After an intravenous infusion of Proleukin, aldesleukin moves quickly out of the bloodstream and into body tissues, with a distribution half-life (the time for half the drug to leave the blood) of about 13 minutes. It then clears from the body more slowly, with an elimination half-life of about 85 minutes. The drug is broken down (metabolized) into amino acids in the kidneys and is excreted through the urine, with very little unchanged drug remaining. Blood levels of aldesleukin rise proportionally with the Proleukin dose given.
📦How to store it▾
Store unopened vials refrigerated at 2° to 8°C (36° to 46°F) in the original carton to protect from light.
📄 Written from Aldesleukin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Aldesleukin
42 supplements and herbal products have documented interactions with Aldesleukin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 37
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Aldesleukin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Aldesleukin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Proleukin treating — and how is it different from regular chemotherapy? ▾
Why do I have to be in the hospital for this? Can't I get it as an outpatient? ▾
What side effects should I actually expect, and which ones mean I need to call someone right away? ▾
I take blood pressure medication. Is that going to be a problem? ▾
Can I get pregnant or father a child while on this treatment? ▾
Are there any medications or supplements I need to avoid while on Proleukin? ▾
Is Aldesleukin available over the counter? ▾
When was Aldesleukin first available? ▾
Who makes Aldesleukin? ▾
💬 Answers drafted from Aldesleukin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Aldesleukin comes
Aldesleukin is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Proleukin is used to treat adults with metastatic renal cell carcinoma (kidney cancer that has spread)
- Proleukin is used to treat adults with metastatic melanoma (skin cancer that has spread)
- Proleukin is given only in a hospital inpatient setting with an intensive care unit available
- Proleukin is administered as an intravenous infusion over 15 minutes, every 8 hours, in cycles with scheduled rest periods between them
- Proleukin must be reconstituted and diluted by trained staff before administration — it must not be shaken, and no in-line filters should be used during infusion
- Proleukin should not be mixed or given through the same IV line as other drugs
Oral solution
📊 Aldesleukin across the U.S. market
How Aldesleukin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Aldesleukin products
A representative set of FDA-listed product records for Aldesleukin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1.1 mg/mL | Intravenous | Clinigen Limited × 2 listings | BLA | View NDC → |
| 1.1 mg/mL | Intravenous | Iovance Biotherapeutics, Inc | BLA | View NDC → |
| 💊Oral solution | ||||
| 4 [hp_C]/30 mL | Oral | Guna spa | UNAPPROVED HOMEOPATHIC | View NDC → |
| 💊Bulk drug substance | ||||
| 1.1 mg/1.1 mg | — | Boehringer Ingelheim Pharma GmbH and Co. KG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1.1 mg/mL | — | Boehringer Ingelheim RCV GmbH & Co KG | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Aldesleukin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Aldesleukin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Aldesleukin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Aldesleukin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 70223 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1719781In current FDA listingsClinical drug / strength (SCD) 22000000 UNTRxCUI 307816
Look up RxCUI 70223 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Aldesleukin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Aldesleukin belongs to the Lymphocyte Growth Factor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Iovance Biotherapeutics, Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.