Possible Side Effects of PROLEUKIN Therapy

While PROLEUKIN® (aldesleukin) for injection therapy is an important option for some metastatic melanoma and metastatic kidney cancer patients, it is important to understand that PROLEUKIN is a complicated therapy that requires, at minimum, a short hospital stay, and there are side effects. At recommended doses, one of the most common side effects during PROLEUKIN therapy is a condition known as capillary leak syndrome (CLS). CLS results in swelling caused by fluids leaking out of blood vessels into surrounding tissues (edema). CLS can cause a drop in blood pressure (hypotension) and decrease blood flow to body organs. It may also cause side effects such as changes in the rhythm of the heart beat, severe chest pain, difficulty breathing, heart attacks, decreased function of the kidneys, and decreased mental alertness that may result in a coma. In early studies of PROLEUKIN therapy, this syndrome was not well understood or managed. In general, adverse events are frequent, often serious, and sometimes fatal.

PROLEUKIN therapy is routinely administered in a limited number of institutions by a trained team of physicians and nurses with considerable experience in managing CLS and other side effects. These teams know the most about the side effects that can occur during PROLEUKIN therapy. What this means for the patient is that side effects are generally manageable and reversible, typically occur in the hospital under the watchful eyes of the treatment team, and tend to resolve within 3 days when treatment is stopped.

"In the majority of metastatic melanoma and metastatic kidney cancer patients, side effects associated with PROLEUKIN therapy are reversible. Most patients will return to their baseline health status by the time that they return to the treatment center for evaluation of their treatment."
Dr. Ralph Hauke, Medical Oncologist, University of Nebraska Medical Center, Omaha, NE.

Other side effects associated with PROLEUKIN therapy include impairment of the immune system, increased infections, and inflammatory disorders. Some patients may also experience flu-like symptoms (fever, chills, and muscle and joint pain), as well as fatigue, skin rash, and sweating. Any existing infection must be treated before starting treatment.

You can learn more about side effects that might possibly occur during PROLEUKIN therapy by visiting the PROLEUKIN Learning Center.

PROLEUKIN therapy is typically given to patients in generally good health without any previous heart, lung, kidney, or central nervous system problems. PROLEUKIN therapy must be administered in a hospital by a doctor and healthcare team experienced in treating patients with cancer.