Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION
 
See FDA Approved Patient Labeling
17.1 Hypertension
 
Advise patients that hypertension may develop during INLYTA treatment and that blood pressure should be monitored regularly during treatment [see Warnings and Precautions (5.1)].
17.2 Arterial/Venous Thromboembolic Events
 
Advise patients that arterial and venous thromboembolic events have been observed during INLYTA treatment and to inform their doctor if they experience symptoms suggestive of thromboembolic events [see Warnings and Precautions (5.2, 5.3)].
17.3 Hemorrhage
 
Advise patients that INLYTA may increase the risk of bleeding and to promptly inform their doctor of any bleeding episodes [see Warnings and Precautions (5.4)].

17.4 Gastrointestinal Disorders
 
Advise patients that gastrointestinal disorders such as diarrhea, nausea, vomiting, and constipation may develop during INLYTA treatment and to seek immediate medical attention if they experience persistent or severe abdominal pain because cases of gastrointestinal perforation and fistula have been reported in patients taking INLYTA [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)].

17.5 Abnormal Thyroid Function
 
Advise patients that abnormal thyroid function may develop during INLYTA treatment and to inform their doctor if symptoms of abnormal thyroid function occur [see Warnings and Precautions (5.6)].

17.6 Wound Healing Complications
 
Advise patients to inform their doctor if they have an unhealed wound or if they have surgery scheduled [see Warnings and Precautions (5.7)].

17.7 Reversible Posterior Leukoencephalopathy Syndrome
 
Advise patients to inform their doctor if they have worsening of neurological function consistent with RPLS (headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances) [see Warnings and Precautions (5.8)].

17.8 Pregnancy
Advise patients that INLYTA may cause birth defects or fetal loss and that they should not become pregnant during treatment with INLYTA. Both male and female patients should be counseled to use effective birth control during treatment with INLYTA. Female patients should also be advised against breast-feeding while receiving INLYTA [see Warnings and Precautions (5.12) and Use in Specific Populations (8.3)].
17.9 Concomitant Medications
 
Advise patients to inform their doctor of all concomitant medications, vitamins, or dietary and herbal supplements.
FDA-Approved Patient Labeling

LAB- 0561-1.0
 
January 2012

PATIENT INFORMATION
INLYTA® (in-ly-ta)
(axitinib)
Tablets
 
Read this Patient Information before you start taking INLYTA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
 
What is INLYTA?

INLYTA is a prescription medicine used to treat