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Context, anatomy, and key evidence

← Peptide library

IL-2 protein

Aldesleukin

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

In this review, aldesleukin is described as low-dose IL-2. Proleukin has been associated with neurologic toxicities that can be life-threatening and may cause coma or permanent neurologic deficits. The product is a lyophilized powder in single-dose vials intended to be reconstituted and then administered intravenously. The labeled indication includes treatment of adult patients with metastatic melanoma.

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

Identity

In this review, aldesleukin is described as low-dose IL-2.

Sources[3]pubmedImmune Cell-Targeting Biologics for Alopecia Areata: A New Paradigm in Precision Medicine.Aldesleukin (low-dose IL-2)
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Aldesleukin (low-dose IL-2)”

    Immune Cell-Targeting Biologics for Alopecia Areata: A New Paradigm in Precision Medicine. · SUMMARY

    pubmed:41409530:045a36935745:045a36935745

How does it work?

Target, response, and disposition.

This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.

What has been studied?

What the evidence says.

This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.

Risks and interactions

Risks, organized for scanning.

Contraindications

A contraindication is stated for patients with known hypersensitivity to IL-2 itself or any excipient/component of the Proleukin formulation.

Sources[1]dailymedPROLEUKIN®Proleukin®(aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Proleukin®(aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation.”

    PROLEUKIN® · CONTRAINDICATIONS

    dailymed:4e2b687e-47f2-4f3c-80ab-e3224befffca:26194dfb0d85:26194dfb0d85

Contraindications

A labeled contraindication is a known history of severe hypersensitivity to aldesleukin or to formulation components.

Sources[2]dailymedThese highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992Proleukin is contraindicated in patients with a known history of severe hypersensitivity to aldesleukin or any component of the Proleukin formulation[seeAdverse Reactions (6.2)].
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Proleukin is contraindicated in patients with a known history of severe hypersensitivity to aldesleukin or any component of the Proleukin formulation[seeAdverse Reactions (6.2)].”

    These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 · 4 CONTRAINDICATIONS

    dailymed:f3c516ad-d405-4fbe-af6a-962080dbfa7d:a7f4d798f1b0:a7f4d798f1b0

Safety findings

Proleukin treatment has been associated with capillary leak syndrome, including life-threatening or fatal cases.

Sources[2]dailymedThese highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin.”

    These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 · WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS

    dailymed:f3c516ad-d405-4fbe-af6a-962080dbfa7d:a7f4d798f1b0:a7f4d798f1b0

Safety findings

Proleukin treatment has been associated with serious infections, including sepsis and bacterial endocarditis.

Sources[2]dailymedThese highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992Serious Infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Serious Infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin.”

    These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 · WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS

    dailymed:f3c516ad-d405-4fbe-af6a-962080dbfa7d:a7f4d798f1b0:a7f4d798f1b0

Safety findings

Proleukin has been associated with neurologic toxicities that can be life-threatening and may cause coma or permanent neurologic deficits.

Sources[2]dailymedThese highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin.”

    These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 · WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS

    dailymed:f3c516ad-d405-4fbe-af6a-962080dbfa7d:a7f4d798f1b0:a7f4d798f1b0

Products and regulatory status

Same ingredient. Different records.

Regulatory status

The labeled indication includes treatment of adult patients with metastatic melanoma.

Sources[1]dailymedPROLEUKIN®Proleukin is indicated for the treatment of adults with metastatic melanoma.[2]dailymedThese highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992Proleukin is indicated for the treatment of adults with metastatic melanoma.
Source records
2
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Proleukin is indicated for the treatment of adults with metastatic melanoma.”

    PROLEUKIN® · INDICATIONS AND USAGE

    dailymed:4e2b687e-47f2-4f3c-80ab-e3224befffca:26194dfb0d85:26194dfb0d85
  2. supports · Source-backed record
    “Proleukin is indicated for the treatment of adults with metastatic melanoma.”

    These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 · 1.2 Metastatic Melanoma

    dailymed:f3c516ad-d405-4fbe-af6a-962080dbfa7d:a7f4d798f1b0:a7f4d798f1b0

Regulatory status

The labeled indication includes adult metastatic renal cell carcinoma, specifying use in advanced (metastatic) RCC in adults.

Sources[1]dailymedPROLEUKIN®Proleukin®(aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Proleukin®(aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).”

    PROLEUKIN® · INDICATIONS AND USAGE

    dailymed:4e2b687e-47f2-4f3c-80ab-e3224befffca:26194dfb0d85:26194dfb0d85

Regulatory status

The labeled indication includes treatment of adult patients with metastatic renal cell carcinoma (RCC).

Sources[2]dailymedThese highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC).
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC).”

    These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 · 1.1 Metastatic Renal Cell Carcinoma

    dailymed:f3c516ad-d405-4fbe-af6a-962080dbfa7d:a7f4d798f1b0:a7f4d798f1b0

Administration context

The practical clinical context.

Administration

The product is a lyophilized powder in single-dose vials intended to be reconstituted and then administered intravenously.

Sources[1]dailymedPROLEUKIN®Proleukin (aldesleukin) for injection is a sterile, preservative-free white to off-white, lyophilized powder, which has a cake-like appearance, supplied in single-dose vials for intravenous administration after reconstitution.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Proleukin (aldesleukin) for injection is a sterile, preservative-free white to off-white, lyophilized powder, which has a cake-like appearance, supplied in single-dose vials for intravenous administration after reconstitution.”

    PROLEUKIN® · DESCRIPTION

    dailymed:4e2b687e-47f2-4f3c-80ab-e3224befffca:26194dfb0d85:26194dfb0d85

Dose records

Baseline renal function guidance specifies initiating Proleukin when serum creatinine is ≤1.5 mg/dL.

Sources[2]dailymedThese highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992Serum creatinine should be ≤1.5 mg/dL before beginning Proleukin.
Reported result
≤1.5 mg/dL
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Serum creatinine should be ≤1.5 mg/dL before beginning Proleukin.”

    These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 · 5.4 Renal Toxicity

    dailymed:f3c516ad-d405-4fbe-af6a-962080dbfa7d:a7f4d798f1b0:a7f4d798f1b0

Dose records

The labeled concentration after reconstitution is 18 million International Units per mL, corresponding to 1.1 mg aldesleukin per mL, when prepared with 1.2 mL Sterile Water for Injection, USP.

Sources[1]dailymedPROLEUKIN®When reconstituted with 1.2 mL Sterile Water for Injection, USP, each mL contains 18 million International Units (1.1 mg) aldesleukin,
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “When reconstituted with 1.2 mL Sterile Water for Injection, USP, each mL contains 18 million International Units (1.1 mg) aldesleukin,”

    PROLEUKIN® · DESCRIPTION

    dailymed:4e2b687e-47f2-4f3c-80ab-e3224befffca:26194dfb0d85:26194dfb0d85

Dose records

The labeled regimen uses frequent short IV infusions: 600,000 IU/kg (0.037 mg/kg) over 15 minutes every 8 hours, delivered in two cycles separated by a 9-day rest, with up to 28 total doses per course if tolerated.

Sources[1]dailymedPROLEUKIN®600,000 International Units/kg (0.037 mg/kg) dose administered every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Following 9 days of rest, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “600,000 International Units/kg (0.037 mg/kg) dose administered every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Following 9 days of rest, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated.”

    PROLEUKIN® · DOSAGE AND ADMINISTRATION

    dailymed:4e2b687e-47f2-4f3c-80ab-e3224befffca:26194dfb0d85:26194dfb0d85

Research status + gaps

What still needs better answers?

  • No publishable claim yet for: effect, interaction, mechanism
  • 60 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (25), assurance_score_below_0.72 (34), current_regulatory_source_required (13), extraction_ambiguity (46), high_risk_requires_regulatory_or_two_independent_sources (34), no_direct_support (58)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. PROLEUKIN® ↗

    dailymed · published 2019-05-23 · retrieved 2026-09-04T19:09:15Z

  2. These highlights do not include all the information needed to use PROLEUKIN®safely and effectively. See full prescribing information for PROLEUKIN.PROLEUKIN (aldesleukin) for injection, for intravenous useInitial U.S. Approval: 1992 ↗

    dailymed · published 2024-12-20 · retrieved 2026-09-04T19:09:19Z

  3. Immune Cell-Targeting Biologics for Alopecia Areata: A New Paradigm in Precision Medicine. ↗

    pubmed · published 2025-11-10 · retrieved 2026-08-25T22:30:24Z

Publication history and provenance

Version 5 · Automated assessment · 2026-09-04T19:09:19Z

e4155b57b0ce0cda5bf95d3f72a27318d31c3d2ccf5eb6a1aee33e0f21bb891b