"June 12, 2012 -- The FDA on Monday approved a new drug for the treatment of a type of late-stage breast cancer. The drug helped stop cancer growth for about six months longer than existing medications.
Pertuzumab, to be marketed under"...
Herceptin Consumer (continued)
Diarrhea, redness/irritation at injection (IV) site, muscle/joint/back pain, stomach/abdominal pain, trouble sleeping, nausea, vomiting, mouth sores, 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.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: bone pain, increased coughing, swelling of the hands/ankles/feet, sudden unexplained weight gain, unusual tiredness, severe headache, tingling/numbness (e.g., in the hands, feet, leg), mental/mood changes, fast/pounding heartbeat, easy bruising/bleeding.
Get medical help right away if you have any very serious side effects, including: weakness on one side of the body, slurred speech, vision changes, confusion.
This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.
This medication can sometimes cause a serious infusion (IV) reaction. Immediately tell your doctor of the following side effects that occur while this drug is being given or within 24 hours after your treatment is finished, such as chills, fever, flushing, nausea, headache, dizziness, fainting, rash, and weakness. (See also Warning section.)
Trastuzumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away 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 Herceptin (trastuzumab) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before using trastuzumab, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), 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: previous cancer treatments (including radiation therapy to the chest), current infection, virus infection with returning symptoms (e.g., herpes, shingles), heart disease, high blood pressure, lung problems, previous severe reaction to monoclonal antibody treatment.
Trastuzumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
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 drug may make you dizzy. 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.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Caution is advised when using this drug in the elderly because they may be at greater risk for heart problems (e.g., heart failure).
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of childbearing age should discuss the use of reliable forms of birth control with their doctors while using this medication and for at least 7 months after treatment has stopped. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 7 months after the last dose.
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