a include:
• tiredness, weakness, fatigue • loss of appetite • frequent or loose bowel movements (diarrhea) • swelling, pain and redness of the lining in your mouth, throat, stomach and bowel (mucositis) • weight loss • infection • voice changes or hoarseness
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Stivarga. 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 do I store Stivarga?
• Store Stivarga tablets at room temperature between 68° F to 77° F (20° C to 25° C). • Keep Stivarga in the bottle that it comes in. Do not put Stivarga tablets in a daily or weekly pill box. • The Stivarga bottle contains a desiccant to help keep your medicine dry. Keep the desiccant in the bottle. • Keep the bottle of Stivarga tightly closed. • Safely throw away (discard) any unused Stivarga tablets after 28 days of opening the bottle.
Keep Stivarga and all medicines out of the reach of children.
General information about Stivarga.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Stivarga for a condition for which it was not prescribed. Do not give Stivarga to other people even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Stivarga. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Stivarga this is written for healthcare professionals.
For more information, go to www.STIVARGA-US.com or call 1-888-842-2937.
What are the ingredients in Stivarga?
Active ingredient: regorafenib
Inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone and colloidal silicon dioxide.
Film coat: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured in Germany
Distributed and marketed by:
Bayer HealthCare Pharmaceuticals Inc.,
Wayne, NJ 07470
© 2012 Bayer HealthCare Pharmaceuticals Inc.
Issued: 09/2012
STIVARGA
regorafenib tablet, film coated
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:50419-171
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
REGORAFENIB (REGORAFENIB)
REGORAFENIB
40 mg
Inactive Ingredients
Ingredient Name
Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LECITHIN, SOYBEAN
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
POVIDONE
Product Characteristics
Color
