°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•Safely throw away medicine that is out of date or that you no longer need.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 film-coat: hypromellose 2910, macrogol 300, and titanium dioxide E171
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
Issued 07/2013
Caprelsa is a registered trademark of the AstraZeneca group of companies
©AstraZeneca 2013. All Rights Reserved.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg
NDC 0310-7820-30
30 tablets
Caprelsa®
(vandetanib) tablets
100 mg
Rx only
Dispense the accompanying
Medication Guide to each patient.
AstraZeneca
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 mg
NDC0310-7840-30
30 tablets
Caprelsa®
(vandetanib) tablets
300 mg
Rx only
Dispense the accompanying
Medication Guide to each patient.
AstraZeneca
Caprelsa
vandetanib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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 100 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONES
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
WATER
POLYETHYLENE GLYCOL 300
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code Z;100
Contains
Packaging
Item Code Package Description
1 NDC:0310-7820-30 30 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022405 07/25/2011
Caprelsa
vandetanib tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0310-7840
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Na
