rious skin reactions may be life threatening and you may need to be treated in a hospital. Call your healthcare provider right away if you experience any of these symptoms.
o
Skin rash or acne
o
Dry skin
o
Itching
o
Blisters on your skin
o
Blisters or sores in your mouth
o
Peeling of your skin
o
Fever
o
Muscle or joint aches
o
Redness or swelling of your face, hands, or soles of your feet
•
Breathing problems (interstitial lung disease). Caprelsa may cause a breathing problem called interstitial lung disease that can lead to death. Tell your healthcare provider right away if you experience sudden or worsening shortness of breath or cough.
•
Stroke. Strokes have been reported in some people who have taken Caprelsa and in some cases have caused death. Stop taking Caprelsa and call your healthcare provider right away if you have symptoms of a stroke which may include:
o
numbness or weakness of the face, arm or leg, especially on one side of the body
o
sudden confusion, trouble speaking or understanding
o
sudden trouble seeing in one or both eyes
o
sudden trouble walking, dizziness, loss of balance or coordination
o
sudden, severe headache
•
Bleeding. Bleeding can happen during your treatment with Caprelsa. Tell your healthcare provider right away if you have severe bleeding while you are taking Caprelsa.
•
Heartfailure. Caprelsa can cause heart failure that can lead to death. You may have to stop taking Caprelsa if you have heart failure. Heart failure may not be reversible after stopping Caprelsa. Your healthcare provider should monitor you for signs and symptoms of heart failure.
•
Diarrhea. Diarrhea is often a symptom of medullary thyroid cancer. Caprelsa can also cause diarrhea or make diarrhea worse. Your healthcare provider should check your blood levels to monitor your electrolytes more frequently if you have diarrhea.
•Thyroidhormones. You can have changes in your thyroid hormone when taking Caprelsa. Your healthcare provider should monitor your thyroid hormone levels while taking Caprelsa.
•High blood pressure (hypertension). If you develop high blood pressure or your high blood pressure gets worse, your healthcare provider may lower your dose of Caprelsa or tell you to stop taking Caprelsa until your blood pressure is under control. Your healthcare provider may prescribe another medicine to control your high blood pressure.
•eversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen while taking Caprelsa. Call your healthcare provider right away if you have:
oheadaches
oseizures
oconfusion
ochanges in vision
oproblems thinking
The most common side effects of Caprelsa include:
•diarrhea
•rash
•acne
•nausea
•high blood pressure
•headache
•feeling tired
•loss of appetite
•stomach (abdominal) pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Caprelsa. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Caprelsa?
•Store Caprelsa tablets at 59°F to 86°F (15 |