Application Nr Approved Date Route Status External Links
BLA103293 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Proleukin ® (aldesleukin) Is Indicated For The Treatment Of Adults With Metastatic Renal Cell Carcinoma (metastatic Rcc). Proleukin Is Indicated For The Treatment Of Adults With Metastatic Melanoma. Careful Patient Selection Is Mandatory Prior To The Administration Of Proleukin. See “ Contraindications ”, “ Warnings ” And “ Precautions ” Sections Regarding Patient Screening, Including Recommended Cardiac And Pulmonary Function Tests And Laboratory Tests. Evaluation Of Clinical Studies To Date Reveals That Patients With More Favorable Ecog Performance Status (ecog Ps 0) At Treatment Initiation Respond Better To Proleukin, With A Higher Response Rate And Lower Toxicity (see “ Clinical Pharmacology ” Section, “ Clinical Studies ” Section And “ Adverse Reactions ” Section). Therefore, Selection Of Patients For Treatment Should Include Assessment Of Performance Status. Experience In Patients With Ecog Ps >1 Is Extremely Limited.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Aldesleukin

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