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

PINK (light)

Score

 no score

Shape

OVAL

Size

16mm
 
Flavor

Imprint Code

 BAYER

Contains

Packaging

#

Item Code

Package Description

Multilevel Packaging

1

NDC:50419-171-03

3 BOTTLE, PLASTIC in 1 BOX

contains a BOTTLE, PLASTIC (50419-171-01)
 
1

NDC:50419-171-01

28 TABLET, FILM COATED in 1 BOTT