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This section provides healthcare professionals with answers to common questions about Proleukin.
The content contained in this website is not intended to be a substitute for professional medical advice related to any topic discussed. Patients are urged to consult with their treating physicians or other professionals. Never disregard professional, medical, or legal advice or delay seeking such advice because of something you have read on this website.
What is Proleukin?
Proleukin (aldesleukin) for injection is a recombinant version of interleukin-2 (IL-2), an endogenous cytokine that has multiple effects on immune response.1,2 Learn more.
How does Proleukin work?
Proleukin is a T-cell growth factor that causes widespread activation of the immune system to better recognize and kill cancer cells.3 Learn more.
Who may benefit the most from Proleukin?
Overall health status has been shown to correlate with how well patients will respond to Proleukin. Nearly all the patients in the Proleukin clinical trials had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.4,5,* Learn more.
*mRCC: PS 0 = 65% and PS 1 = 31%; mM: PS 0 = 71% and PS 1 = 27%.4,5
Have Proleukin patients been able to achieve durable complete responses?
Yes. In clinical trials, Proleukin has demonstrated durable complete responses of over 20 years in some mRCC patients and over 15 years in some mM patients.3,6-8 Objective response was seen in 16% of patients with mM (6% had a complete response and 10% had a partial response) and in 15% of patients with mRCC (7% had a complete response and 8% had a partial response).3,7,8 Learn more.
What possible side effects are associated with Proleukin?
Proleukin administration has been associated with capillary leak syndrome (CLS). CLS is associated with swelling that is caused by fluids leaking out of blood vessels into surrounding tissues. If CLS is not treated promptly, it may cause a drop in blood pressure and decreased flow of blood to the organs, and, subsequently, changes in heartbeat rhythms, severe chest pain, difficulty breathing, heart attack, decreased kidney function, and, possibly, coma. Other side effects that may occur include sudden low blood pressure, diarrhea, chills, nausea, confusion, scanty urination, and rash. In general, adverse events are frequent, often serious, and sometimes fatal.3
Please see full Prescribing Information, including Boxed Warning, for further details.
Side effects associated with Proleukin therapy vary, and rarely, if ever, do individual patients experience every potential side effect associated with treatment.
Are most treatment-related side effects reversible?
Yes. Most treatment-related side effects are rapidly reversible. These side effects can be managed at specialized IL-2 (Proleukin) Treatment Centers, and most improve within 2 to 3 days of stopping therapy.3-5
Are long-term side effects common with Proleukin?
No. Long-term sequelae associated with Proleukin are extremely rare.5
Why can't I administer Proleukin in my office?
Proleukin therapy must be administered in a hospital setting where trained healthcare professionals are experienced in administering IL-2 therapy.3
Will I be updated about my patients during treatment with Proleukin?
Yes. Usually, the specialized IL-2 Treatment Center team keeps you updated while your patient is receiving treatment with Proleukin.
Will insurance cover Proleukin?
Proleukin is an FDA-approved treatment for mRCC and mM patients. Most private insurance will pay for treatment; however, the precise amount covered may vary by plan. As with any cancer therapy, always check with the patient's insurance company to verify coverage.
References: 1. Jarkowski A III, Wong MKK. A re-assessment of the safety and efficacy of interleukin-2 for the treatment of renal cell carcinoma. Clin Med Ther. 2009;1:527-540. 2. Bosco MC, Curiel RE, Zea AH, Malabarba MG, Ortaldo JR, Espinoza-Delgado I. IL-2 signaling in human monocytes involves the phosphorylation and activation of p59hck. J Immunol. 2000;164(9):4575-4585. 3. Proleukin [package insert]. Yardley, PA: Clinigen, Inc; 2019. 4. Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995;13(3):688-696. 5. Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17(7):2105-2116. 6. Clark JI, Curti B, Davis EJ, et al. Long-term progression-free survival of patients with metastatic melanoma or renal cell carcinoma following high-dose interleukin-2. J Investig Med. Published online Feb 4, 2021. doi: 10.1136/jim-2020-001650. 7. Fisher RI, Rosenberg SA, Fyfe G. Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am. 2000;6(suppl 1):S55-S57. 8. Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am. 2000;6(suppl 1):S11-S14.