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Nexavar Consumer (continued)
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 notice skin problems (such as rash, blisters, redness, swelling, pain), especially on the palms of your hands or the soles of your feet. Your doctor may prescribe medication for your skin or change your treatment plan.
Tell your doctor right away if you have any serious side effects, including: bone/muscle pain, depression, easy bruising or bleeding, headache, tongue/mouth sores or pain, numbness/tingling of the hands/feet, shortness of breath, swollen hands/ankles/feet, signs of liver problems (such as stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).
Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, severe abdominal/stomach pain, bloody vomit, coughing up blood, bloody stools, difficulty speaking, loss of balance, sudden vision changes, seizures, mental/mood changes (e.g., confusion), severe dizziness, fainting, fast/irregular heartbeat.
This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.
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 Nexavar (sorafenib) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking sorafenib, 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: bleeding problems, heart problems (such as heart attack, angina), high blood pressure, liver problems.
Sorafenib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using sorafenib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using sorafenib safely.
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.
To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.
If you need to have a surgical or dental procedure, tell your doctor or dentist that you are using sorafenib.
Wash your hands well to prevent the spread of infections.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. To avoid pregnancy, both males and females using sorafenib must use reliable form(s) of birth control during treatment and for at least 2 weeks after stopping this drug. Consult your doctor for more details.
It is not known whether this drug 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.
Additional Nexavar Information
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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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