ICLUSIG- ponatinib hydrochloride tablet, film coated 
ARIAD Pharmaceuticals, Inc.

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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 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:

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. Talk to your healthcare provider if this is a concern for you.

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 your heart function before and during your treatment with Iclusig. Get medical help right away if you get any of the following symptoms: shortness of breath, chest pain, fast or irregular heartbeats, dizziness, or feel faint.

Liver problems. Iclusig can cause liver problems, including liver failure, which can be severe and may lead to death. Your healthcare provider will do blood tests before and during your treatment with Iclusig to check for liver problems. Get medical help right away if you get any of these symptoms of liver problems during treatment:

See "What are the possible side effects of Iclusig?" for information about side effects.

What is Iclusig?

Iclusig is a prescription medicine used to treat adults who have:

It is not known if Iclusig is safe and effective in children less than 18 years of age.

What should I tell my healthcare provider before taking Iclusig?

Before you take Iclusig, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Iclusig and other medicines may affect each other causing side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Iclusig?

What are the possible side effects of Iclusig?

Iclusig may cause serious side effects, including:

The most common side effects of Iclusig include:

  • skin rash
  • stomach-area (abdomen) pain
  • tiredness
  • headache
  • dry skin
  • constipation
  • fever
  • joint pain
  • nausea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Iclusig. For more information, ask your healthcare provider 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 Iclusig?

Store Iclusig at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Iclusig and all medicines out of the reach of children.

General information about Iclusig

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Iclusig for a condition for which it was not prescribed. Do not give Iclusig to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Iclusig that is written for health professionals.

For more information, go to www.iclusig.com or call 1-855-552-7423.

What are the ingredients in Iclusig?

Active ingredient: ponatinib

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type B), colloidal silicon dioxide and magnesium stearate. The tablet coating consists of talc, polyethylene glycol, polyvinyl alcohol and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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

Revised: December 2013

Revised: 10/2014
 
ARIAD Pharmaceuticals, Inc.