FDA-approved in April 2011 as the first medication
for advanced medullary thyroid cancer (aMTC)
CAPRELSA can cause a change in the electrical activity of your heart called QT prolongation, which can cause irregular heartbeats and that may lead to death. You should not take CAPRELSA if you have had a condition called long QT syndrome since birth.
Your health care provider should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH) as well as the electrical activity of your heart, with a test called an electrocardiogram (ECG). These tests should be performed before starting CAPRELSA and regularly during CAPRELSA treatment.
Call your health care provider right away if you feel faint, light-headed, or feel your heart beating irregularly while taking CAPRELSA. These may be symptoms related to QT prolongation.
CAPRELSA may cause other serious side effects, including:
Be sure to tell your health care provider about all your health conditions, including any heart problems. Also tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Do not take other medicines while taking CAPRELSA until you have talked with your health care provider or pharmacist.
Tell your health care provider if you are pregnant or plan to become pregnant. CAPRELSA can cause harm to your unborn baby.
CAPRELSA can make your skin sensitive to the sun, so you should limit exposure to the sun. While taking CAPRELSA and for 4 months after stopping your CAPRELSA treatment, use sun block and wear clothes that cover your skin, including your head, arms and legs when you go outdoors.
Use caution before driving or using machinery. Keep in mind that CAPRELSA may make you feel tired or weak, or cause blurred vision.
It takes a long time to get rid of CAPRELSA from your body and you may be at risk for side effects related to CAPRELSA after you have stopped your treatment.
The most common side effects of CAPRELSA include diarrhea (57%), rash (53%), acne (35%), nausea (33%), high blood pressure (33%), headache (26%), feeling tired (24%), upper respiratory tract infections (23%), loss of appetite (21%), and stomach (abdominal) pain (21%).
CAPRELSA is a prescription medicine used to treat medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body, and the tumors are growing or causing symptoms. Because of the risks associated with CAPRELSA, your health care provider should carefully consider whether to prescribe CAPRELSA for you if your tumors are growing slowly or if you are not having symptoms.
Please read Prescribing Information , including Boxed WARNING.
Please read Medication Guide.
This information does not take the place of talking to your health care provider about your medical condition or treatment.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
CAPRELSA is a registered trademark of the AstraZeneca group of companies.
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©2014 AstraZeneca. All rights reserved. 2977326 Last Updated 11/14