TIENT COUNSELING INFORMATION
17.1 QT Interval
CAPRELSA can prolong the QT interval in a concentration-dependent manner. Torsades de pointes, ventricular tachycardia and sudden death have been reported in patients administered CAPRELSA. Patients should be advised that their electrolytes and the electrical activity of their heartbeat (via an ECG) should be monitored regularly during treatment with CAPRELSA.
17.2 Rash
Patients taking CAPRELSA should be told they may be more susceptible to sunburn and to use appropriate sun protection (e.g., sunscreen and/or clothing) while taking CAPRELSA and for at least 4 months after drug discontinuation. Patients should consult their physician promptly if they develop a skin rash.
17.3 Interstitial lung disease
Patients should be told to contact their physician promptly if they develop sudden onset or worsening of breathlessness, persistent cough or fever.
17.4 Diarrhea
Patients should be informed that they may experience diarrhea while taking CAPRELSA. Patients should also be advised to use standard anti-diarrheal medications and to seek medical attention if their diarrhea becomes persistent or severe. Patients with diarrhea should contact their physician to have their electrolytes monitored.
17.5 Reversible Posterior Leukoencephalopathy Syndrome
Patients should be told to contact their physician promptly if they experience seizures, headaches, visual disturbances, confusion or difficulty thinking.
17.6 Pregnancy and Nursing
Patients of childbearing potential must be told to use effective contraception during therapy and for at least four months following their last dose of CAPRELSA.
Breast-feeding mothers are advised to discontinue nursing while receiving CAPRELSA therapy.
17.7 Drug Handling
CAPRELSA tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided.
17.8 Medication Guide
MEDICATION GUIDE
CAPRELSA®(kap-rel-sah)
(vandetanib) Tablets
Read this Medication Guide before you start taking CAPRELSA and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about CAPRELSA?
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 healthcare 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). You should have these tests:
Before starting CAPRELSA
Regularly during CAPRELSA treatment:
2 to 4 weeks after starting CAPRELSA
8 to 12 weeks after starting CAPRELSA
Every 3 months thereafter
If your healthcare provider changes your dose of CAPRELSA
If you start taking medicine that causes QT prolongation
As instructed by your healthcare provider
Your healthcare provider may stop your CAPRELSA treatment for a while and restart you at a lower dose if you have QT prolongation.
Call your healthcare 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 prol |
