"Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
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Proleukin Consumer (continued)
Fever, chills, stomach upset, dry skin, muscle stiffness, diarrhea, mouth sores, dizziness, drowsiness, headache, weight gain, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor immediately if any of these unlikely but serious side effects occur: swollen belly, muscle pain/weakness, severe tiredness, confusion, difficulty speaking, trouble walking, vision changes (including temporary blindness), mental/mood changes (e.g., depression, agitation, hallucinations), unusual bleeding/bruising, swelling hands/feet, sudden weight gain, shortness of breath, thirst, flushing, rapid breathing.
Tell your doctor immediately if any of these rare but very serious side effects occur: fast heartbeat, yellowing eyes/skin, dark urine, vomit that looks like coffee grounds.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Proleukin (aldesleukin for injection) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.
This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders: a certain bowel disease (Crohn's disease), a certain connective tissue disease (scleroderma), thyroid disorders, arthritis, diabetes, a certain muscle/nerve disease (myasthenia gravis), a certain kidney disorder (glomerulonephritis), gallbladder problems (cholecystitis), a certain disease of blood vessels in the brain (cerebral vasculitis).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
If you are scheduled to have any X-ray or scanning procedure using injectable dye (e.g., iodinated contrast), tell your doctor that you are using this medication.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for kidney effects or shortness of breath while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Women who may become pregnant should use an effective form of birth control while using this medication. Discuss the use of birth control and the risks and benefits of using this medication with your doctor.
It is unknown if this medication passes into breast milk. Because of possible harm to a nursing infant, breast-feeding is not recommended while using this medication. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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