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Aldesleukin

Aldesleukin is an immune-stimulating medication used to treat metastatic renal cell carcinoma (kidney cancer that has spread) and metastatic melanoma (skin cancer that has spread) in adults.

Brand name Proleukin
Drug class Lymphocyte Growth Factor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 →

✓No current FDA shortage listed · checked Oct 6, 2026
Aldesleukin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Aldesleukin (Proleukin) is a man-made interleukin-2, an immune signal that multiplies and activates white blood cells to attack tumors, given by IV infusion for adults with kidney cancer or melanoma that has spread; on the market since about 1992, it is an older specialist immunotherapy now reserved for fit patients. It is one of the toughest cancer treatments to get through, with fever, chills, nausea, diarrhea and low blood pressure expected during each hospital course. Its boxed warning centers on capillary leak syndrome (fluid leaking out of blood vessels, causing swelling, breathing trouble and dangerous drops in blood pressure), plus serious brain effects such as confusion and life-threatening infections, which is why it is given only in hospitals with an intensive care unit.

Clinical pearls

  • Tell anyone ordering a CT scan that you have had aldesleukin, since iodinated contrast dye can trigger a delayed reaction, even months later.
  • Avoid steroids like prednisone during treatment unless your oncology team prescribes them, because they can blunt its cancer-fighting effect.
  • Share every medicine you take, since blood pressure drugs add to its pressure drops and liver-processed drugs can build up.
  • Organ transplant recipients cannot receive it, because the immune boost can trigger rejection; an existing autoimmune disease may also flare.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Proleukin carries three serious boxed warnings that every patient should know about.

1. Capillary Leak Syndrome (CLS): Proleukin can cause a life-threatening condition where blood vessels leak fluid throughout the body, causing dangerous drops in blood pressure and organ failure. This can be fatal. Proleukin must only be given in a hospital with an intensive care unit, and it must not be used in patients who already have significant heart, lung, kidney, or liver problems.

2. Neurological Toxicity: Proleukin can cause serious brain and nervous system effects, including severe confusion, coma, or permanent neurological damage. Your care team will stop or adjust treatment if these occur.

3. Serious Infections: Proleukin weakens the immune system's ability to fight bacteria, raising the risk of life-threatening infections including sepsis (infection in the bloodstream) and bacterial endocarditis (infection of the heart lining). Any existing bacterial infections must be fully treated before starting Proleukin.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection
Earliest FDA record1992
Companies listing it with the FDA1
FDA label last updatedDec 20, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Aldesleukin, written from its FDA label.

What Aldesleukin is used for

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Aldesleukin is an immunotherapy used to treat advanced cancers in adults. The following uses are supported by the FDA label for Proleukin given intravenously:

  • 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 Aldesleukin works

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Aldesleukin is a synthetic (lab-made) form of interleukin-2, a protein your immune system naturally produces to grow and activate white blood cells that fight disease. It stimulates the proliferation of lymphocytes (immune cells), boosts the activity of natural killer (NK) cells and lymphokine-activated killer (LAK) cells that can destroy cancer cells, and triggers the release of immune signaling proteins like interferon gamma and tumor necrosis factor. The full mechanism behind its anti-tumor effects is not completely understood, but the result is a broad activation of the body's immune response against cancer.

Aldesleukin's effects on the immune system are dose-dependent, meaning higher doses produce stronger immune responses — but also more serious side effects. The body also develops antibodies against aldesleukin in many patients, though the impact of those antibodies on how well the drug works is not fully clear.

Aldesleukin dosage

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Proleukin is given only as an intravenous (IV) infusion in a hospital with intensive care capabilities — it is never taken by mouth or self-administered. Each infusion is delivered over 15 minutes and is typically scheduled every 8 hours in cycles, with rest periods built in between cycles. Your oncology team will determine the full course of treatment, evaluate your response, and adjust or stop doses based on how your body tolerates the medication. Follow your care team's instructions exactly — dose timing and modifications are managed by medical professionals throughout your stay.

Dosing details from the FDA-approved label

From the Aldesleukin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Metastatic renal cell carcinoma and metastatic melanoma
    • 600,000 IU/kg (0.037 mg/kg) every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses (Cycle 1, Days 1-5)
    • Rest period Days 6-14. Cycle 2, Days 15-19: 600,000 IU/kg (0.037 mg/kg) every 8 hours
    • Maximum of 14 doses
    • Maximum: A maximum of 28 doses (2 cycles) per treatment course
    • Separate each treatment course by a rest period of at least 7 weeks from the date of hospital discharge; no dose reduction for adverse reactions, withhold or interrupt a dose instead.
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Administer Proleukin in an inpatient hospital setting with an intensive care facility. Evaluate cardiovascular, pulmonary, neurologic and renal function before beginning Proleukin. ( 2.1 ) See Full Prescribing Information for Premedication and Supportive medications. ( 2.3 ) Recommended dosage: 600,000 IU/kg (0.037 mg/kg) every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Following 9 days of rest, repeat the schedule for a maximum of another 14 doses (total of 28 doses per course, as tolerated). ( 2.2 ) Evaluate patients approximately 4 weeks after completion of a course of therapy and again immediately prior to the start of the next course. ( 2.2 ) Dose modification for toxicity should be accomplished by withholding or interrupting a dose. ( 2.4 ) Follow reconstitution and dilution procedures. ( 2.5 ) 2.1 Recommended Evaluation and Testing Before Initiating Proleukin Conduct baseline hematologic, chemistry, renal and hepatic function tests. Additionally, evaluate cardiac ejection fraction, coronary artery disease as appropriate, pulmonary function with PFTs, and evaluate for renal, hepatic, and CNS impairment prior to initiating treatment with Proleukin [see Contraindications (4) , Warnings and Precautions (5.1 , 5.2) ]. Verify pregnancy status of females of reproductive potential prior to initiating Proleukin [see Warnings and Precautions (5.6) , Use in Specific Populations (8.1 , 8.3) ]. 2.2 Recommended Dosage Administer Proleukin in an inpatient hospital setting. An intensive care facility with specialists skilled in cardiopulmonary or intensive care medicine must be available [see Warnings and Precautions (5.1) ] . The recommended dosage of Proleukin for metastatic renal cell carcinoma and metastatic melanoma is described in Table 1. Administer Proleukin as an intravenous infusion after dilution [see Dosage and Administration (2.5) ] . Administer pre-infusion medications and supportive treatment, as appropriate, prior to and during each infusion [see Dosage and Administration (2.3) ]. Discontinue Proleukin for unacceptable toxicity [see Dosage and Administration (2.4) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Aldesleukin side effects

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The most common side effects of Proleukin (occurring in 30% or more of patients) include:

Common side effects

  • Low blood pressure (hypotension)
  • Shortness of breath (dyspnea)
  • Chills and fever
  • Nausea and vomiting
  • Diarrhea
  • Skin rash
  • Decreased urine output (oliguria)
  • Confusion or disorientation
  • Elevated bilirubin levels (hyperbilirubinemia), which can cause yellowing of the skin or eyes
  • Low platelet count (thrombocytopenia), which can increase bleeding risk
  • Rising creatinine levels (a sign of kidney stress)

When to get medical help

  • Call your doctor or seek emergency care if you develop sudden swelling, difficulty breathing, or a sharp drop in blood pressure — these can be signs of capillary leak syndrome, a life-threatening reaction
  • Tell your care team right away if you feel confused, agitated, or have seizures — Proleukin can cause serious neurological (brain and nervous system) effects
  • Seek immediate help for signs of serious infection: high fever, chills, or feeling very unwell, as Proleukin raises your risk of severe infections including sepsis
  • Report any signs of kidney problems — very little or no urine output, or ankle/leg swelling that is getting worse
  • Tell your doctor immediately if you develop symptoms of an immune reaction such as new joint pain, rash covering large areas, or changes in vision
  • Seek care if you experience symptoms of anaphylaxis (severe allergic reaction): throat tightening, hives, or sudden drop in blood pressure

Seek immediate medical attention for signs of capillary leak syndrome (sudden swelling, severe low blood pressure, difficulty breathing), serious neurological changes (seizures, coma, severe confusion), signs of infection (high fever, chills, feeling critically unwell), or a severe allergic reaction.

Aldesleukin warnings and precautions

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  • Capillary Leak Syndrome (CLS): The most serious risk — fluid leaks from blood vessels, causing dangerous blood pressure drops, swelling, and potentially fatal organ failure. Proleukin must only be given in a hospital ICU setting, and must not be used in patients with pre-existing significant heart, lung, kidney, liver, or brain impairment.
  • Neurological Toxicity: Can cause confusion, agitation, coma, permanent brain damage, or seizures. Existing brain metastases must be treated before starting Proleukin.
  • Serious Infections: Proleukin impairs the immune system's ability to fight bacteria, raising the risk of life-threatening sepsis and bacterial endocarditis (infection of the heart lining). Existing infections must be cleared first.
  • Renal (Kidney) Toxicity: Can cause reduced urine output and kidney failure. Kidney function is monitored closely throughout treatment.
  • Immune-Mediated Reactions: Can trigger or worsen autoimmune conditions affecting any organ — including thyroid, joints, eyes, skin, and heart.
  • Embryo-Fetal Toxicity: Can cause serious harm or loss of pregnancy. Effective contraception is required during treatment; do not breastfeed.
  • Eosinophilia: Can cause a serious buildup of immune cells (eosinophils) in heart and lung tissue.
  • Delayed Reactions to Contrast Dye: Patients who have received Proleukin may have atypical reactions to iodinated contrast media (used in CT scans) — even months after treatment ends.

Aldesleukin interactions

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Proleukin has several important interactions to be aware of — always tell every member of your care team that you are receiving or have recently received this medication:

  • Glucocorticoids (steroids like prednisone or dexamethasone): May reduce Proleukin's effectiveness against cancer; avoid combining when possible
  • Blood pressure-lowering drugs (antihypertensives): Can worsen the low blood pressure Proleukin already causes
  • Drugs that harm the kidneys or liver: Combined use increases the risk of serious kidney or liver damage
  • Drugs that cause neurotoxicity: Combined use raises the risk of severe nervous system side effects
  • Iodinated contrast dye (CT scan / X-ray dye): Can trigger delayed, Proleukin-like reactions — sometimes hours to months after Proleukin treatment ends; always inform imaging staff of your treatment history
  • CYP enzyme substrates (many common medications): Proleukin can slow down liver enzymes that break down other drugs, raising their blood levels and risk of side effects; your doctor will monitor for this

Interactions listed in the FDA-approved label

From the Aldesleukin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Glucocorticoids: Coadministration with glucocorticoids may reduce aldesleukin antitumor effectiveness. Avoid concomitant use of glucocorticoids.
  • Radiographic iodinated contrast media: Administration of radiographic iodinated contrast media following interleukin-2 resulted in acute, atypical adverse reactions that resemble the immediate side effects caused by Proleukin in some patients. Monitor for delayed adverse reactions in patients receiving iodinated contrast media following Proleukin.
  • Cytochrome P-450 (CYP) substrates: Aldesleukin causes release of cytokines that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. Monitor for toxicity or drug concentration changes of such CYP substrates when co-administered with Proleukin.
Read the label’s full interactions text

7 DRUG INTERACTIONS Drug interaction studies with Proleukin have not been conducted. The drug interaction information described below have been observed post-marketing. See Full Prescribing Information for important drug interactions. ( 7 ) 7.1 Effect of Other Drugs on Proleukin Glucocorticoids Avoid concomitant use of glucocorticoids. Coadministration with glucocorticoids may reduce aldesleukin antitumor effectiveness. 7.2 Effect of Proleukin on Other Drugs Radiographic Iodinated Contrast Media Monitor for delayed adverse reactions in patients receiving iodinated contrast media following Proleukin. Administration of radiographic iodinated contrast media following administration of interleukin-2 resulted in acute, atypical adverse reactions that resemble the immediate side effects caused by Proleukin in some patients [see Warnings and Precautions (5.8) ] . Effect on Cytochrome P-450 Substrates For certain CYP substrates, minimal changes in the concentration may lead to serious adverse reactions. Monitor for toxicity or drug concentration changes of such CYP substrates when co-administered with Proleukin. Aldesleukin causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿42 supplements and herbs with documented Aldesleukin interactions, ranked by severity Check Aldesleukin against a supplement or herb →

Before taking Aldesleukin

▾
  • Tell your doctor if you have any heart problems, including reduced heart function or coronary artery disease — Proleukin is contraindicated in significant cardiac impairment
  • Tell your doctor if you have any significant lung, kidney, liver, or brain (CNS) problems — these are also contraindications
  • Tell your doctor if you have received an organ transplant — Proleukin is contraindicated and may cause transplant rejection
  • Tell your doctor if you have any active bacterial infection — it must be fully treated before starting Proleukin
  • Tell your doctor about any autoimmune conditions — Proleukin can make these worse
  • Tell your doctor if you have a seizure disorder or any abnormal brain imaging findings — Proleukin may worsen these
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding — Proleukin may harm the fetus and should not be used during breastfeeding
  • If you are a woman of childbearing age, a pregnancy test is required before starting Proleukin, and effective contraception must be used throughout treatment
  • Proleukin has not been studied or approved for use in children
  • Older adults (65+) were not studied in large enough numbers to draw firm conclusions about whether they respond differently

Aldesleukin overdose

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Taking more Proleukin than recommended can cause serious or life-threatening side effects to appear more quickly and severely. Treatment for overdose is supportive — meaning medical staff will manage symptoms as they arise. The label notes that intravenous dexamethasone may help reduce some of the most dangerous toxic effects.

What Aldesleukin does in the body

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Aldesleukin produces dose-dependent effects on the immune system. After administration, it activates cellular immunity and triggers measurable changes in the blood, including an increase in lymphocytes (lymphocytosis), a rise in eosinophils (eosinophilia), and a decrease in platelets (thrombocytopenia). It also stimulates the production of immune signaling proteins, including tumor necrosis factor, interleukin-1, and gamma interferon. The precise relationship between these immune effects and the drug's anti-tumor activity is not fully established.

How your body processes Aldesleukin

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After a Proleukin IV infusion, aldesleukin is rapidly distributed out of the bloodstream and into body tissues — with a distribution half-life of about 13 minutes. The drug is then cleared from the blood with an elimination half-life of about 85 minutes. Aldesleukin is broken down (metabolized) into amino acids in the kidneys, and excreted in the urine; very little unchanged drug appears in urine. Blood levels of aldesleukin rise proportionally with the dose given.

How to store Aldesleukin

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Store unopened vials refrigerated at 2° to 8°C (36° to 46°F) in the original carton to protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

42

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.

Severity mix
  • Major · 4
  • Moderate · 37
  • Minor · 1
ASARABACCA Major BEER Major SIBERIAN COCKLEBUR Major WINE Major ARISTOLOCHIA Moderate ASHWAGANDHA Moderate BLACK COHOSH Moderate BOLDO Moderate +34 more
Every supplement checked against Aldesleukin — ranked by severity The full interaction hub: 4 major · 37 moderate · 1 minor · every one linked to its full report. Check Aldesleukin against your exact supplements

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.

1

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.

MAGNESIUM Insignificant Depletion
See the full Aldesleukin nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Aldesleukin: pharmacist answers to common questions

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, and why has my doctor prescribed it for me?

▾
Proleukin is the brand name for aldesleukin, a man-made version of a natural immune protein called interleukin-2. It's approved to treat two types of advanced cancer: metastatic kidney cancer (renal cell carcinoma) and metastatic melanoma — meaning cancers that have spread beyond where they started. It works by supercharging your immune system to help it recognize and attack cancer cells. Your oncologist chose it because it's one of the few treatments specifically approved for these advanced cancers in adults.

Will I be able to take this at home, or do I have to stay in the hospital?

▾
You will need to be in the hospital for every dose — there's no at-home version of this treatment. Proleukin is given as a short IV drip (about 15 minutes) every 8 hours in cycles. The hospital must have an intensive care unit available because this medication can cause serious reactions that need immediate medical attention. It's a demanding treatment, but being in the hospital means your care team can watch you closely and step in quickly if needed.

What side effects should I actually expect, and which ones should make me call for help right away?

▾
Most people on Proleukin experience low blood pressure, chills, fever, nausea, diarrhea, skin rash, and feeling generally unwell — these are common and your team will be watching for them the whole time. The reactions to take very seriously are: sudden severe swelling, trouble breathing, or a big drop in blood pressure (signs of capillary leak syndrome); feeling very confused, having a seizure, or being hard to wake up (neurological effects); or signs of a bad infection like high fever and feeling critically ill. These aren't things to wait on — tell your nurse or doctor immediately.

I'm also on other medications. Is that a problem?

▾
Possibly, yes — it's important that your full care team knows every medication you take, including over-the-counter drugs and supplements. A few specific concerns: steroid medications (like prednisone) can reduce how well Proleukin works against your cancer. Blood pressure medications can make the low blood pressure from Proleukin even worse. And if you ever need a CT scan with dye (iodinated contrast), tell the imaging team you've received Proleukin — even months later, that dye can cause unusual reactions in people who've had this treatment. Your oncologist will review everything before you start.

Can I get pregnant or breastfeed while on this treatment?

▾
No — Proleukin can cause serious harm to an unborn baby, including pregnancy loss. If you could become pregnant, a pregnancy test is required before you start, and you'll need to use reliable contraception throughout treatment. Breastfeeding is also not safe during Proleukin therapy because the drug could harm a nursing baby. If pregnancy is something you're planning for in the future, have that conversation with your doctor before starting — they can help you think through timing and options.

If I've had Proleukin treatment, is there anything I need to watch out for after I finish?

▾
Yes — a few things to keep in mind even after treatment ends. If you need imaging with contrast dye (like a CT scan), always tell the radiology team you've received Proleukin. Some patients have had delayed reactions to contrast dye — even months after finishing treatment — that look similar to Proleukin side effects, like fever, rash, or low blood pressure. Also watch for any signs of thyroid problems (fatigue, weight changes, feeling unusually cold or hot) or blood sugar issues, as Proleukin can affect both. Keep your follow-up appointments so your team can monitor you properly.

Is Aldesleukin available over the counter?

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No. Aldesleukin is a prescription medicine: every Aldesleukin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Aldesleukin first available?

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The earliest FDA record we hold for Aldesleukin is from 1992: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Aldesleukin was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Aldesleukin on HelloPharmacist

📊Aldesleukin supplement interactions42 checked — ranked by severity 🌿Drug & Supplement CheckerAldesleukin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Aldesleukin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Aldesleukin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Aldesleukin forms and strengths (how it comes)

Aldesleukin is available in 1 form. 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Aldesleukin inactive ingredients by manufacturer.

Injection

Into a vein
Brands Proleukin
How this form is used
What it may be used for
  • Proleukin is used intravenously to treat adults with metastatic renal cell carcinoma (kidney cancer that has spread)
  • Proleukin is used intravenously to treat adults with metastatic melanoma (skin cancer that has spread)
Important instructions
  • Proleukin is administered by a 15-minute intravenous infusion in a hospital with an intensive care facility — it cannot be given at home
  • Proleukin is given in cycles: doses every 8 hours for up to 14 doses, followed by a rest period, then up to 14 more doses
  • Proleukin must be reconstituted and diluted by trained medical staff before administration; do not shake the vial
  • Proleukin should not be given through the same IV line as other medications, and in-line filters must not be used
Available strengths 1 strength
1.1 mg/mL
1 FDA-listed product record ⓘ

Aldesleukin on the U.S. market: products, makers and brands

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.

1 company lists 1 Aldesleukin product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 1992. Brand names on the directory include Proleukin; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
1992
Earliest FDA record ⓘ

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.

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 Iovance Biotherapeutics, Inc BLA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Aldesleukin NDCs →

Aldesleukin 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.

The FDA’s enforcement reports list no Aldesleukin recalls since July 2021.

✅No Aldesleukin recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

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.

Ingredient (IN) Aldesleukin RxCUI 70223 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 1719781 In current FDA listings
    Clinical drug / strength (SCD) 22000000 UNT RxCUI 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.

Aldesleukin brand names

Aldesleukin is sold under one brand name in the FDA directory — Proleukin. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Proleukin

Who makes Aldesleukin: manufacturers and labelers

One company lists Aldesleukin products with the FDA. By number of product records, the largest are Iovance Biotherapeutics, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Iovance Biotherapeutics, Inc 1

Aldesleukin drug class (RxNorm)

Aldesleukin belongs to the Lymphocyte Growth Factor class.

Pharmacologic class Lymphocyte Growth Factor
Drug family (ATC) Interleukins

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.

Sources for this Aldesleukin page

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 20, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Aldesleukin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Aldesleukin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Iovance Biotherapeutics, Inc
Linked label effective
Dec 20, 2024
Composite sections available
23
Linked SPL Set ID
f3c516ad-d405-4fbe-af6a-962080dbfa7d
Linked SPL Document ID
29ba86b1-f672-482e-e063-6394a90a931f
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Iovance Biotherapeutics, Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →