Therapy should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Administration has been associated with capillary leak syndrome, which may be severe and can result in death. Treatment is also associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma .
Aldesleukin injection is anticancer medicine that is used to treat metastatic kidney cancer (cancer that has already spread to the body) and metastatic skin cancer.
Aldesleukin is a man-made version of a substance called interleukin-2. Interleukins are produced naturally by cells in the body to help white blood cells work.
Aldesleukin causes very serious side effects in addition to its helpful effects. Some effects can be fatal. For that reason, aldesleukin injection is given only in the hospital. If severe side effects occur, which is common, treatment in an intensive care unit (ICU) may be necessary. Other effects may not be serious but may cause concern. Before you begin treatment with aldesleukin, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.
This medicine is to be administered only by or under the immediate supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of aldesleukin injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aldesleukin injection in the elderly. However, elderly patients are more likely to have shortness of breath or troubled breathing and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving aldesleukin injection.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
It is very important that your doctor check you closely to see if the medicine is working properly. Blood and urine tests, certain laboratory tests, and chest X-rays will be needed before receiving this medicine and to check for unwanted effects.
Capillary leak syndrome (CLS) may occur immediately after receiving this medicine. Your doctor will monitor your blood pressure and pulse rate frequently to avoid lowering of blood pressure (hypotension).
Tell your doctor or nurse right away if you have unusual drowsiness, dullness, sleepiness, tiredness, weakness, or feeling of sluggishness; or unusual or changes in mood or behavior, such as irritability, confusion, or depression after receiving the medicine. These could be signs of serious medical problems.
Aldesleukin can temporarily affect the white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.