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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Guna-il 2
Generic Name
Aldesleukin
Active Ingredient
AldesleukinCategory
Lymphocyte Growth Factor [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 4 [hp_C]/30mL | SOLUTION/ DROPS | ORAL | 17089-380 |
Detailed information about Guna-il 2
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Guna-il 2, you must consult a qualified healthcare professional.
Aldesleukin is a recombinant lymphocyte growth factor used to treat metastatic renal cell carcinoma and metastatic melanoma by stimulating the immune system's T-cells and natural killer cells.
The standard FDA-approved dosage for Aldesleukin in the treatment of metastatic renal cell carcinoma and metastatic melanoma is a high-dose, intermittent pulse regimen. This is one of the most intensive medical treatments in oncology.
Aldesleukin is not FDA-approved for use in pediatric patients. The safety and effectiveness of this drug in children under the age of 18 have not been established. Clinical trials in children have shown that the toxicity profile is similar to that in adults, but the therapeutic benefit remains unproven in standard pediatric protocols.
Because Aldesleukin is highly toxic, doses are not usually "reduced" in the traditional sense; instead, doses are held (skipped) if the patient develops specific toxicities.
Aldesleukin is contraindicated in patients with a pre-existing abnormal creatinine clearance. During treatment, if serum creatinine rises significantly or if urine output drops (oliguria), subsequent doses must be held until renal function improves. Patients with pre-existing renal disease are at extreme risk for permanent kidney damage.
Patients with significant liver dysfunction should not receive Aldesleukin. During therapy, transient elevations in liver enzymes (ALT/AST) and bilirubin are common. If these levels exceed specific thresholds (typically 5 times the upper limit of normal), doses should be withheld.
Geriatric patients (aged 65 and older) are at a much higher risk for cardiac and renal toxicities. Clinical guidelines suggest extreme caution and rigorous pre-treatment screening (such as stress tests) for elderly candidates. Many centers limit the use of high-dose Aldesleukin to patients with high performance status regardless of age.
Aldesleukin is never self-administered. It is given as an intravenous infusion in a hospital setting, often in an Intensive Care Unit (ICU) or a specialized oncology step-down unit.
In the context of the high-dose hospital regimen, a "missed" dose usually refers to a dose that was intentionally withheld by the medical team due to side effects. If a dose is held, it is not "made up" later in the cycle. The schedule continues as planned, and the patient simply receives fewer total doses for that cycle. This is a safety measure to prevent life-threatening organ failure.
An overdose of Aldesleukin would lead to an immediate and severe exaggeration of its known side effects, particularly Capillary Leak Syndrome (CLS). Signs include a rapid drop in blood pressure, extreme swelling, difficulty breathing, and confusion.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance. The complexity of this regimen requires expert clinical management.
Nearly all patients receiving high-dose Aldesleukin will experience significant side effects. These are often expected signs that the immune system is being activated.
> Warning: Stop taking Aldesleukin and call your doctor immediately if you experience any of these. These symptoms often indicate the onset of life-threatening complications.
While most Aldesleukin side effects reverse within days or weeks of stopping the drug, some may persist:
Aldesleukin carries the most severe level of FDA warning (Black Box Warning) for two primary conditions:
Report any unusual symptoms to your healthcare provider immediately. During treatment, you will be monitored constantly by medical staff.
Aldesleukin is a high-alert medication. It should only be administered to patients who have normal cardiac and pulmonary function as determined by pre-treatment screening. Because of the multi-organ toxicities associated with this drug, it is only used when the potential benefits of treating metastatic cancer outweigh the significant risks of the therapy.
Patients undergoing Aldesleukin therapy require rigorous, daily monitoring:
Patients should not drive or operate heavy machinery during Aldesleukin treatment. The drug frequently causes confusion, dizziness, and somnolence (extreme sleepiness). These effects may persist for several days after the final dose of a cycle.
Alcohol should be strictly avoided during and immediately after Aldesleukin therapy. Alcohol can worsen the hypotension (low blood pressure) and CNS depression (confusion/drowsiness) caused by the medication.
Unlike many drugs, Aldesleukin does not require a "taper" (gradual reduction). However, the decision to stop treatment early is common if a patient develops life-threatening toxicity. If a patient experiences a major cardiac event, respiratory failure requiring intubation, or a persistent coma, the drug must be discontinued permanently for that patient.
> Important: Discuss all your medical conditions, including any history of heart, lung, or kidney disease, with your healthcare provider before starting Aldesleukin.
For each major interaction, the mechanism typically involves either a pharmacodynamic interaction (where two drugs have opposing or additive effects on the body) or additive organ toxicity (where two drugs both stress the same organ, like the kidneys).
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those you only take occasionally.
Aldesleukin must NEVER be used in patients with the following conditions, as the risk of death or permanent disability is unacceptably high:
These conditions require a careful risk-benefit analysis by a multidisciplinary medical team:
There is no known cross-sensitivity with other common drugs, but patients who have had severe reactions to other interleukins or growth factors should be monitored with extreme caution. Because it is produced in E. coli, patients with rare, severe allergies to E. coli-derived proteins should avoid this medication.
> Important: Your healthcare provider will evaluate your complete medical history, including heart and lung tests, before prescribing Aldesleukin.
Aldesleukin is classified as FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have suggested that the drug may be embryotoxic (harmful to the fetus). Because Aldesleukin causes severe physiological stress, including hypotension and reduced oxygenation, it poses a significant risk to fetal viability. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Women of childbearing age should use effective contraception during treatment.
It is not known whether Aldesleukin is excreted in human milk. However, because many drugs are excreted in milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug. Most clinical guidelines recommend that women do not breastfeed while receiving Aldesleukin.
As previously noted, safety and effectiveness in children under 18 have not been established. While some clinical trials have explored its use in pediatric neuroblastoma or leukemia, it is not a standard treatment. Children may be more susceptible to the rapid fluid shifts and febrile (fever) reactions associated with the drug.
Patients over the age of 65 are at a significantly higher risk for severe side effects. Data from clinical trials show that elderly patients have a higher incidence of:
Physicians often require more stringent cardiac and pulmonary screening for geriatric patients before considering them for high-dose therapy.
Aldesleukin is cleared by the kidneys. Patients with pre-existing renal impairment (Creatinine > 1.5 mg/dL) were excluded from original clinical trials. For those with mild impairment, the drug must be used with extreme caution. If a patient develops significant renal failure during a cycle (oliguria or rising creatinine), the drug must be held until the levels return to baseline.
Patients with pre-existing liver failure or cirrhosis are not candidates for Aldesleukin. While the drug is not primarily metabolized by the liver, the systemic inflammatory response it causes can lead to "shock liver" or severe jaundice in those with compromised hepatic function.
> Important: Special populations require individualized medical assessment and often require care in specialized academic medical centers.
Aldesleukin is a recombinant version of the human cytokine Interleukin-2 (IL-2). Its primary mechanism is immunomodulation. It does not have direct cytotoxic (cell-killing) effects on tumor cells. Instead, it binds to the IL-2 receptor on T-cells and Natural Killer (NK) cells. This binding activates the JAK-STAT signaling pathway within these cells, leading to gene transcription that promotes cell cycle progression and the production of other cytokines. This creates a massive expansion of the body's "cellular army," specifically targeting cells that express tumor-associated antigens.
The pharmacodynamic effects of Aldesleukin are widespread. Within hours of administration, there is a marked decrease in circulating lymphocytes as they migrate out of the blood and into the tissues (including the tumor). This is followed by a massive "rebound" lymphocytosis (increase in white cells) several days after treatment. The drug also causes a significant increase in eosinophils and various inflammatory markers like C-reactive protein (CRP).
| Parameter | Value |
|---|---|
| Bioavailability | 100% (IV) |
| Protein Binding | Not significantly bound to plasma proteins |
| Half-life (Alpha) | 13 minutes |
| Half-life (Beta) | 85 minutes |
| Tmax | End of 15-minute infusion |
| Metabolism | Renal catabolism (breakdown in kidney tubules) |
| Excretion | Not excreted as intact drug; broken into amino acids |
Aldesleukin is a Lymphocyte Growth Factor and a type of Cytokine Therapy. It is related to other immunotherapies like Interferon-alpha, though its mechanism and toxicity profile are distinct. In modern oncology, it is often compared to newer "checkpoint inhibitors" (like Pembrolizumab), though Aldesleukin remains unique in its ability to directly stimulate T-cell proliferation.
Common questions about Guna-il 2
Aldesleukin is primarily used to treat two types of advanced cancer: metastatic renal cell carcinoma (kidney cancer) and metastatic melanoma (skin cancer). It is an immunotherapy that works by stimulating the patient's own immune system to attack cancer cells rather than killing the cells directly. Because it is a very intensive treatment, it is usually reserved for patients who are otherwise healthy enough to tolerate its side effects. It is administered in a hospital setting, often in an ICU, because of the risk of severe complications. Some patients have achieved long-term, complete remission with this therapy, making it a vital option for specific cases.
The most common side effects include flu-like symptoms such as high fever, severe chills (rigors), fatigue, and muscle aches. Almost all patients experience low blood pressure (hypotension) and fluid retention, which can lead to significant weight gain and swelling during the treatment cycle. Gastrointestinal issues like nausea, vomiting, and diarrhea are also very frequent. Skin rashes and temporary changes in kidney or liver function tests are common as well. Most of these side effects begin shortly after the infusion starts and typically resolve within a few days after the treatment cycle is completed.
No, you should not drink alcohol while receiving Aldesleukin or during the recovery period immediately following a treatment cycle. Aldesleukin can cause significant changes in blood pressure and can affect your central nervous system, leading to confusion or drowsiness. Alcohol can dangerously worsen these effects, increasing the risk of severe hypotension (low blood pressure) and profound sedation. Since the treatment is administered in a hospital, your medical team will ensure you do not have access to alcohol. It is best to wait until your doctor confirms that your organ functions have returned to baseline before consuming alcohol.
Aldesleukin is generally not considered safe during pregnancy and is classified as FDA Category C. Animal studies suggest it may harm the developing fetus, and the severe physical stress the drug puts on the mother's body (such as low blood pressure and low oxygen levels) can be dangerous for a pregnancy. If you are a person of childbearing age, your doctor will likely perform a pregnancy test before starting treatment and recommend highly effective contraception. If you become pregnant while on this medication, you must notify your oncologist immediately. The risks to the fetus must be carefully weighed against the life-saving potential of the cancer treatment.
Aldesleukin begins stimulating the immune system almost immediately after the first infusion, but the visible effect on tumors takes much longer. Typically, a patient receives a full course (two cycles) of treatment over several weeks. Doctors usually perform the first follow-up scans (like CT or MRI) about four weeks after the entire course is finished to check for tumor shrinkage. In some cases, tumors may temporarily appear larger on scans due to the immune cells rushing into the tumor area—a phenomenon known as 'pseudoprogression.' Durable responses can sometimes take months to fully manifest, and your doctor will monitor you closely during this window.
Aldesleukin is administered in 'pulses' in a hospital, so there is no traditional withdrawal syndrome if you stop. However, the medical team will often stop the treatment suddenly if you develop a severe side effect, such as a heart problem, breathing failure, or extreme confusion. You do not need to 'taper' off the drug like you would with steroids or certain blood pressure medications. If a cycle is interrupted due to toxicity, your doctor will decide if it is safe to resume the next cycle later. Always follow the guidance of your inpatient oncology team regarding the timing and discontinuation of doses.
Because Aldesleukin is given by healthcare professionals in a hospital, you cannot 'miss' a dose in the traditional sense. However, doses are frequently 'held' (skipped) by the doctors if your blood pressure is too low or if your lab results show that your kidneys or heart are under too much stress. If a dose is skipped for safety reasons, it is usually not made up later; the team simply moves on to the next scheduled dose time or ends the cycle early. This is a standard safety protocol to prevent permanent organ damage. Your medical team will keep you informed about how many doses you have successfully received.
Yes, Aldesleukin very commonly causes rapid weight gain, but this is due to fluid retention rather than fat. This is part of 'Capillary Leak Syndrome,' where fluid moves from the blood vessels into the body's tissues. Patients can gain 10 to 20 pounds or more in a single week of treatment. This fluid usually causes visible swelling (edema) in the legs, arms, and sometimes the face. After the treatment cycle ends, the body naturally begins to shed this excess fluid through increased urination, and weight typically returns to baseline within one to two weeks.
Aldesleukin has many significant drug interactions, so it must be used with caution alongside other medicines. It should not be taken with steroids like prednisone, as they can make the treatment less effective. It also interacts with blood pressure medications and drugs that are hard on the kidneys, such as certain antibiotics or NSAIDs (like ibuprofen). You must provide your oncology team with a complete list of every medication, vitamin, and herbal supplement you take. They will often temporarily stop some of your usual medications during the week you are in the hospital to ensure the treatment is as safe as possible.
Currently, Aldesleukin is primarily available under the brand name Proleukin. While the patent for the original molecule has expired, it is a complex 'biologic' medication rather than a simple chemical drug. This means that instead of a simple generic, any alternative would be called a 'biosimilar.' As of 2026, there are few biosimilars available in many markets due to the complexity of the manufacturing process and the specialized nature of the treatment. Your hospital's pharmacy will provide the version that is approved and available for use in their facility.
Other drugs with the same active ingredient (Aldesleukin)