ICLUSIG- ponatinib hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ponatinib hydrochloride (UNII: 96R6PU3D8J) (ponatinib - UNII:4340891KFS)

Available from:

ARIAD Pharmaceuticals, Inc.

INN (International Name):

ponatinib hydrochloride

Composition:

ponatinib 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Iclusig (ponatinib) is a kinase inhibitor indicated for the: - Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated. - Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML [see Warnings and Precautions (5.7)]. None. Risk Summary Based on its mechanism of action and findings in animals, Iclusig can cause fetal harm when administered to a pregnant woman [see Data] . There are no available data on Iclusig use in pregnant women. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower than human exposur

Product summary:

Iclusig tablets are available in the following configurations: Store Iclusig tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Keep away from children.

Authorization status:

New Drug Application

Patient Information leaflet

ARIAD Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
ICLUSIG® (EYE-CLUE-SIG)
(PONATINIB)
TABLETS
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 11 2016
What is the most important information I should know about Iclusig?
Iclusig can cause serious side effects, including:
Blood clots or blockage in your blood vessels (arteries and veins).
Blood clots or blockage in your blood
vessels may lead to heart attack, stroke, or death. A blood clot or
blockage in your blood vessels can
prevent proper blood flow to your heart, brain, bowels (intestines),
legs, eyes, and other parts of your
body. You may need emergency surgery or treatment in a hospital. Get
medical help right away if you
get any of the following symptoms:
•
chest pain or pressure
•
pain in your arms, legs, back,
neck or jaw
•
shortness of breath
•
numbness or weakness on one
side of your body
•
leg swelling
•
trouble talking
•
headache
•
dizziness
•
severe stomach area
pain
•
decreased vision or loss
of vision
Blood clots or blockage in your blood vessels can happen in people
with or without risk factors for heart
and blood vessel disease, including people 50 years of age or younger.
The most common risk factors for
these problems are a history of high blood pressure (hypertension),
high levels of fat in the blood
(hyperlipidemia), and heart disease. Blood clots or blockages in your
blood vessels happen more often in
people as they get older, and in people with a past history of
decreased blood flow, high blood pressure,
diabetes, or high levels of fats in the blood.
Heart problems. Iclusig can cause heart problems, including heart
failure which can be serious and may
lead to death. Heart failure means your heart does not pump blood well
enough. Iclusig can also cause
irregular slow or fast heartbeats and heart attack. Your healthcare
provider will check you for heart
problems during your treatment with Iclusig. Get medical help right
away if you get any of the following
symptoms: shortness

Summary of Product characteristics

ICLUSIG- PONATINIB HYDROCHLORIDE TABLET, FILM COATED
ARIAD PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ICLUSIG SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ICLUSIG.
ICLUSIG (PONATINIB) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART FAILURE,
AND
HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ARTERIAL OCCLUSION HAS OCCURRED IN AT LEAST 35% OF ICLUSIG-TREATED
PATIENTS INCLUDING FATAL MYOCARDIAL
INFARCTION, STROKE, STENOSIS OF LARGE ARTERIAL VESSELS OF THE BRAIN,
SEVERE PERIPHERAL VASCULAR DISEASE, AND
THE NEED FOR URGENT REVASCULARIZATION PROCEDURES. PATIENTS WITH AND
WITHOUT CARDIOVASCULAR RISK
FACTORS, INCLUDING PATIENTS LESS THAN 50 YEARS OLD, EXPERIENCED THESE
EVENTS. INTERRUPT OR STOP ICLUSIG
IMMEDIATELY FOR ARTERIAL OCCLUSION. A BENEFIT-RISK CONSIDERATION
SHOULD GUIDE A DECISION TO RESTART
ICLUSIG (5.1).
VENOUS THROMBOEMBOLISM HAS OCCURRED IN 6% OF ICLUSIG-TREATED PATIENTS.
MONITOR FOR EVIDENCE OF
THROMBOEMBOLISM. CONSIDER DOSE MODIFICATION OR DISCONTINUATION OF
ICLUSIG IN PATIENTS WHO DEVELOP
SERIOUS VENOUS THROMBOEMBOLISM (5.2).
HEART FAILURE, INCLUDING FATALITIES, OCCURRED IN 9% OF ICLUSIG-TREATED
PATIENTS. MONITOR CARDIAC
FUNCTION. INTERRUPT OR STOP ICLUSIG FOR NEW OR WORSENING HEART FAILURE
(5.3).
HEPATOTOXICITY, LIVER FAILURE AND DEATH HAVE OCCURRED IN
ICLUSIG-TREATED PATIENTS. MONITOR HEPATIC
FUNCTION. INTERRUPT ICLUSIG IF HEPATOTOXICITY IS SUSPECTED (2.3, 5.4).
RECENT MAJOR CHANGES
Boxed Warning
11/2016
Indications and Usage (1)
11/2016
Warnings and Precautions (5)
11/2016
INDICATIONS AND USAGE
Iclusig is a kinase inhibitor indicated for the:
Treatment of adult patients with chronic phase, accelerated phase, or
blast phase chronic myeloid leukemia (CML) or
Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is
indicated.
Treatment of adult patients with T315I-positive CML (chronic phase,
acc