Aldesleukin: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Aldesleukin. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Hypotension71%
Diarrhea67%
Oliguria63%
Chills52%
Vomiting50%
Hemic and lymphatic42%
Thrombocytopenia37%
Nausea35%
Vasodilation34%
Fever33%
Anemia29%
Malaise28%
Asthenia23%
Tachycardia23%
Supraventricular tachycardia22%
Stomatitis22%
Anorexia20%
Nausea and vomiting19%
Infection16%
Leukopenia16%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

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.

Source: FDA labeling via NIH DailyMed (set 4e2b687e…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.