"The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
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Ixempra Consumer (continued)
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
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.
This medication can lower your body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as painful urination, fever, chills, or persistent sore throat.
Painful sores on the lips, mouth, and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.
Tell your doctor right away if you have any serious side effects, including: swollen hands/ankles/feet, fainting, pale skin, easy/unusual bruising/bleeding, sudden weight gain, signs of a loss of too much body water (e.g., decreased urination, increased thirst, dry mouth).
Ixabepilone can sometimes affect how your nerves work (peripheral neuropathy). Tell your doctor immediately if you develop pain/burning/numbness/tingling of the hands/feet.
You may lessen these types of nerve problems by avoiding cold drinks and ice and by dressing warmly. Tell your doctor immediately if your nerve problems begin to interfere with your normal daily activities (e.g., walking, writing, eating).
Treatment with ixabepilone may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia), especially when this drug is given with capecitabine. You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next treatment. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, tell your doctor immediately.
Get medical help right away if any of these rare but very serious side effects occur: fast/irregular heartbeat, shortness of breath, chest pain, bloody/black stools, vomit that looks like coffee grounds, vision changes, seizures, sudden confusion.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), face flushing, tight feeling in chest, 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 Ixempra (ixabepilone) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using ixabepilone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), 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: bleeding problems, diabetes, heart problems (e.g., chest pain, heart failure, heart attack), liver problems, bone marrow problems (e.g., low white count, anemia), nerve problem (peripheral neuropathy).
This medication contains alcohol. It 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.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.
To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. It is recommended that women of child-bearing age and men using this medication use 2 effective forms of birth control (e.g., condoms and birth control pills) to prevent pregnancy. Consult your doctor for more information.
It is not known if ixabepilone passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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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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