Proleukin (aldesleukin)
Clinigen / formerly Prometheus Therapeutics · Recombinant Interleukin-2 (IL-2) / Immunotherapy
What is Proleukin? Proleukin (aldesleukin) is recombinant interleukin-2 (IL-2) used for metastatic renal cell carcinoma and metastatic melanoma. High-dose aldesleukin can produce durable complete responses in a subset of patients but requires intensive care setting due to serious toxicity.
About Proleukin
| Brand Name | Proleukin |
| Generic / INN | aldesleukin |
| Drug Class | Recombinant Interleukin-2 (IL-2) / Immunotherapy |
| Manufacturer | Clinigen / formerly Prometheus Therapeutics |
| Administration | Intravenous (IV) infusion (high-dose) or SC injection (low-dose) |
| FDA Approval | 1992 |
FDA-Approved Uses for Proleukin
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Metastatic renal cell carcinoma (RCC) — adults
- Metastatic melanoma — adults
How Does Proleukin Work?
Aldesleukin is a recombinant form of human IL-2. It stimulates proliferation and activation of T lymphocytes, natural killer (NK) cells, and B cells, enhancing the immune system's ability to recognize and destroy cancer cells. Post-infusion, lifileucel (TIL therapy) requires high-dose aldesleukin to expand the infused tumor-infiltrating lymphocytes.
Dosage & Administration
High-dose: 600,000 IU/kg IV every 8 hours for up to 14 doses per cycle; repeat after rest. This regimen requires ICU-level monitoring and is associated with severe toxicity. Patient selection is critical.
Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.
Warnings, Precautions & Side Effects
General Warning
BOXED WARNINGS: Capillary leak syndrome (CLS) — can cause fatal multi-organ failure. Severe bacterial infections and sepsis. Severe cardiac, pulmonary, renal, and CNS toxicity. Proleukin must be administered in a hospital setting with intensive monitoring. Contraindicated in patients with organ allografts, abnormal thallium stress test, or abnormal pulmonary function tests.
- Capillary leak syndrome — boxed, potentially fatal
- Bacterial infections/sepsis — boxed
- Cardiac toxicity
- Pulmonary toxicity
- CNS toxicity (coma)
- Renal failure
Common Side Effects
- Capillary leak syndrome
- Hypotension
- Oliguria
- Fever/chills
- Confusion
- Nausea
- Anemia
- Thrombocytopenia
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze. Reconstituted solution: stable 48 hours refrigerated.
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Proleukin is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Proleukin. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Proleukin
Proleukin (aldesleukin) is recombinant IL-2 that activates the immune system against cancer. It is approved for metastatic renal cell carcinoma and metastatic melanoma. High-dose therapy can produce durable complete responses in a minority of patients.
High-dose IL-2 causes capillary leak syndrome — widespread plasma leakage from blood vessels — leading to severe hypotension, fluid accumulation in tissues, and potential multi-organ failure. It must be given in an ICU-level setting with intensive monitoring.
After lifileucel (TIL cell therapy) infusion, high-dose aldesleukin is administered to promote expansion and survival of the infused tumor-infiltrating lymphocytes in the patient's body.
Related Medications & Conditions
Related Medications
Keytruda (pembrolizumab) · Tecentriq (atezolizumab) · Lifileucel (requires IL-2 post-infusion) · Opdivo (nivolumab)
Related Conditions
Metastatic renal cell carcinoma · Metastatic melanoma