fects of INLYTA include:
• diarrhea (frequent or loose bowel movements)
• high blood pressure
• tiredness or feeling weak
• decreased appetite
• nausea
• hoarseness
• rash, redness, itching or peeling of your skin on your hands and feet
• decreased weight
• vomiting
• constipation
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of INLYTA. For more information, ask your doctor 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 INLYTA?
•Store INLYTA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep INLYTA and all medicines out of the reach of children.
General information about INLYTA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INLYTA for a condition for which it was not prescribed. Do not give INLYTA to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about INLYTA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about INLYTA that is written for healthcare professionals.
For more information, go to www.inlyta.com or call 877-744-5675.
What are the ingredients in INLYTA?
Active ingredient: axitinib
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441. The Opadry II red 32K15441 film coating contains: lactose monohydrate, HPMC 2910/Hypromellose 15cp, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
LAB-0438-1.0
January 2012
PRINCIPAL DISPLAY PANEL - 1 mg Bottle Label
Pfizer
NDC 0069-0145-01
Inlyta®
(axitinib) tablets
1 mg
180 Tablets
Rx only
PRINCIPAL DISPLAY PANEL - 5 mg Bottle Label
Pfizer
NDC 0069-0151-11
Inlyta®
(axitinib) tablets
5 mg
60 Tablets
Rx only
INLYTA
axitinib tablet, film coated
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:0069-0145
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
axitinib (axitinib)
axitinib
1 mg
Inactive Ingredients
Ingredient Name
Strength
cellulose, microcrystalline
lactose monohydrate
croscarmellose sodium
magnesium stearate
titanium dioxide
triacetin
ferric oxide red
HYPROMELLOSE 2910 (15000 MPA.S)
Product Characteristics
Color
RED
Score
no score
Shape
OVAL
Size
9mm
Flavor
Imprint Code
Pfizer;1;XNB
Contains
Packaging
#
Item Code
Package Description
Multilevel Packaging
1
NDC:00
