Prescription medicine
Aldesleukin Brand names: Proleukin
Aldesleukin (Proleukin) is a prescription medicine with an FDA approval on record since 1992. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the aldesleukin FDA label on DailyMed (effective December 20, 2024, Iovance Biotherapeutics, Inc); the BLA 103293 record on Drugs@FDA; every aldesleukin label on DailyMed.
Highlights of the record
FDA label of December 20, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC.
TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment. Administer Proleukin in a hospital setting with an intensive care facility. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4), Contraindications (4), Warnings and Precautions (5.1) ]. Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4), Warnings and Precautions (5.2) ]. Serious Infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat pre-existing bacterial infections prior to initiation of Proleukin therapy and withhold Proleukin as recommended [see Dosage and Administration (2.4), Warnings and Precautions (5.3) ]. WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITY, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS) including life-threatening or fatal reactions, has occurred in patients treated with Proleukin. […]
Used for
From the label: indications and usageProleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma.
Forms and strengths
- 1.1 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- May 5, 1992 Proleukin, Chiron; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,231 through July 30, 2026
What is aldesleukin used for?
From the label: indications and usageProleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 ) 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.2 Metastatic Melanoma Proleukin is indicated for the treatment of adults with metastatic melanoma.
FDA pharmacologic class: Lymphocyte Growth Factor.
Source: FDA drug label (PROLEUKIN), BLA103293 (Chiron), as published by Iovance Biotherapeutics, Inc, effective December 20, 2024 (SPL set f3c516ad-d405-4fbe-af6a-962080dbfa7d), via openFDA; the full label on DailyMed
Is there a generic for aldesleukin (Proleukin)?
No generic aldesleukin is approved (Drugs@FDA, October 8, 2026).
- 1992 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for aldesleukin?
The FDA Adverse Event Reporting System holds 1,231 reports that list aldesleukin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 207 are coded as a death and 602 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Aldesleukin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other