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
- trouble talking
- 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. 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:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark "tea-colored" urine
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:
- a specific type of abnormal gene (T315I-positive) chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML), T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph + ALL)
- chronic phase, accelerated phase, or blast phase CML or Ph+ ALL who cannot receive any other tyrosine kinase inhibitor (TKI) medicines
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:
- have a history of blood clots in your blood vessels (arteries or veins)
- have heart problems, including heart failure, irregular heartbeats, and QT prolongation
- have diabetes
- have a history of high cholesterol
- have liver problems
- have had inflammation of your pancreas (pancreatitis)
- have high blood pressure
- have bleeding problems
- plan to have any surgical procedures
- are lactose (milk sugar) intolerant. Iclusig tablets contain lactose.
- drink grapefruit juice
- have any other medical conditions
- are pregnant or plan to become pregnant. Iclusig can harm your unborn baby. You should not become pregnant while taking Iclusig. Tell your healthcare provider right away if you become pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if Iclusig passes into your breast milk. You and your healthcare provider should decide if you will take Iclusig or breastfeed. You should not do both.
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?
- Take Iclusig exactly as your healthcare provider tells you to take it.
- Your healthcare provider may change your dose of Iclusig or tell you to stop taking Iclusig.
- Do not change your dose or stop taking Iclusig without talking to your healthcare provider.
- Swallow Iclusig tablets whole. Do not crush or dissolve Iclusig tablets.
- You may take Iclusig with or without food.
- If you miss a dose of Iclusig, take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.
- If you take too much Iclusig, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of Iclusig?
Iclusig may cause serious side effects, including:
- See "What is the most important information I should know about Iclusig?"
- High blood pressure. Your blood pressure should be checked regularly and any high blood pressure should be treated while you are taking Iclusig. Tell your healthcare provider if you get headaches, dizziness, chest pain or shortness of breath.
- Inflammation of the pancreas (pancreatitis). Symptoms include sudden stomach-area pain, nausea, and vomiting. Your healthcare provider should do blood tests to check for pancreatitis during treatment with Iclusig.
- Neuropathy. Iclusig may cause damage to the nerves in your arms, brain, hands, legs, or feet (Neuropathy). Tell your healthcare provider if you get any of these symptoms during treatment with Iclusig:
- muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet
- double vision and other problems with eye sight, trouble moving the eye, drooping of part of the face, sagging or drooping eyelids
- Effects on the eye. Serious eye problems that can lead to blindness or blurred vision may happen with Iclusig. Tell your healthcare provider if you get any of the following symptoms: perceived flashes of light, light sensitivity, floaters, dry or itchy eyes, and eye pain. Your healthcare provider will monitor your vision before and during your treatment with Iclusig.
- Severe bleeding. Iclusig can cause bleeding which can be serious and may lead to death. Tell your healthcare provider if you get any signs of bleeding while taking Iclusig including:
- vomiting blood or if your vomit looks like coffee-grounds
- pink or brown urine
- red or black (looks like tar) stools
- coughing up blood or blood clots
- unusual bleeding or bruising of your skin
- menstrual bleeding that is heavier than normal
- unusual vaginal bleeding
- nose bleeds that happen often
- drowsiness or difficulty being awakened
- change in speech
- Fluid retention. Your body may hold too much fluid (fluid retention). Tell your healthcare provider right away if you get any of these symptoms during treatment with Iclusig:
- swelling of your hands, ankles, feet, face, or all over your body
- weight gain
- shortness of breath and cough
- Low blood cell counts. Iclusig may cause low blood cell counts. Your healthcare provider will check your blood counts regularly during treatment with Iclusig. Tell your healthcare provider right away if you have a fever or any signs of an infection while taking Iclusig.
- Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:
Your healthcare provider may do blood tests to check for TLS.
- kidney failure and the need for dialysis treatment
- an abnormal heartbeat
- Possible wound healing problems. If you need to have a surgical procedure, tell your healthcare provider that you are taking Iclusig. You should stop taking Iclusig at least 1 week before any planned surgery.
- A tear in your stomach or intestinal wall (perforation). Tell your healthcare provider right away if you get:
- severe pain in your stomach-area (abdomen)
- swelling of the abdomen
- high fever
The most common side effects of Iclusig include:
- skin rash
- stomach-area (abdomen) pain
- dry skin
- joint pain
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.
ARIAD Pharmaceuticals, Inc.
26 Landsdowne Street
Cambridge, MA 02139-4234
Revised: December 2013