Hypertension

Inform patients of the possibility of new or worsening of existing hypertension. Advise patients to contact their health care provider for elevated blood pressure or if symptoms of hypertension occur including headache, dizziness, chest pain, or shortness of breath [see Warnings and Precautions (5.4)].

Pancreatitis

Inform patients of the possibility of developing pancreatitis that may be accompanied by nausea, vomiting, abdominal pain, or abdominal discomfort, and to promptly report these symptoms [see Warnings and Precautions (5.5)].

Hemorrhage

Inform patients of the possibility of serious bleeding and to immediately contact their health care provider with any signs or symptoms suggestive of hemorrhage such as unusual bleeding or easy bruising [see Warnings and Precautions (5.6)].

Fluid Retention

Inform patients of the possibility of developing fluid retention and to contact their health care provider for symptoms such as leg swelling, abdominal swelling, weight gain, or shortness of breath [see Warnings and Precautions (5.7)].

Myelosuppression

Inform patients of the possibility of developing low blood cell counts; inform patients to report immediately should fever develop, particularly in association with any suggestion of infection [see Warnings and Precautions (5.9)].

Compromised Wound Healing and Gastrointestinal Perforation

Advise patients to inform their health care provider if they plan to undergo a surgical procedure or had recent surgery [see Warnings and Precautions (5.11)].

Inform patients that cases of gastrointestinal perforation have been reported [see Warnings and Precautions (5.12)].

Embryo-Fetal Toxicity

Inform patients that Iclusig can cause fetal harm when administered to a pregnant woman. Advise women of the potential hazard to a fetus and to avoid becoming pregnant [see Warnings and Precautions (5.12) and Use in Specific Populations (8.1)].

Instructions for Taking Iclusig

Advise patients to take Iclusig exactly as prescribed and not to change their dose or to stop taking Iclusig unless they are told to do so by their health care provider. Iclusig may be taken with or without food. Iclusig tablets should be swallowed whole. Patients should not crush or dissolve the tablets.

Patients should not take two doses at the same time to make up for a missed dose.

Lactose

Inform patients that Iclusig contains 121 mg of lactose monohydrate in a 45 mg daily dose.

Manufactured for:
ARIAD Pharmaceuticals, Inc.
26 Landsdowne Street
Cambridge, MA 02139-4234

AIL150 Rev 0, ######_###_#

MEDICATION GUIDE
Iclusig® (eye-CLUE-sig)
(ponatinib)
Tablets

What is the most important information I should know about Iclusig?

Iclusig can cause serious side effects, including:

Blood clots in your blood vessels (arteries and veins). Blood clots in your blood vessels may lead to heart attack, stroke, or death. Get medical help right away if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of your body, trouble talking, headache, or dizziness.

Liver problems. Iclusig can cause liver probl