yroid 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.
Reversible 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:
headaches
seizures
confusion
changes in vision
problems 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°C to 30°C).
Safely throw away medicine that is out of date or that you no longer need. Ask your pharmacist how to safely throw away CAPRELSA tablets.
Keep CAPRELSA and all medicines out of the reach of children.
General information about CAPRELSA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAPRELSA for a condition for which it was not prescribed. Do not give CAPRELSA to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes important information about CAPRELSA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CAPRELSA that is written for health professionals.
For more information, go to www.caprelsa.com or call 1-800-236-9933.
What are the ingredients in CAPRELSA?
Active ingredient: vandetanib
Inactive ingredients:
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate
Tablet coating:hypromellose 2910, macrogol 300, and titanium dioxide E171
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distirbuted by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
Issued 06–2011
CAPRELSA is a registered trademark of the AstraZeneca group of companies
©AstraZeneca 2011
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CAPRELSA
vandetanib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-7820
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANDETANIB (VANDETANIB) VANDETANIB 100mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
WATER
POLYETHYLENE GLYCOL 300
Product Characteristics
Color WHITE S |
