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Iclusig is commonly used to treat certain cancers. Common side effects include a skin rash, joint and stomach pain, and headache. Call your health care provider right away if you get a fever, severe stomach or abdominal pain, chest pain, or changes in your heartbeat. Iclusig is a tablet that you will swallow. 

Uses

What is Iclusig used for?

Iclusig (ponatinib) is commonly used to treat the following blood cancers.

Iclusig may also be used for other conditions as determined by your health care provider.

How does Iclusig work (mechanism of action)?

Iclusig is a type of medicine known as a tyrosine kinase inhibitor (TKI). It works by targeting specific proteins. By blocking the action of these proteins, Iclusig can cause cancer cells to die, preventing them from growing or spreading.

How is Iclusig supplied (dosage forms)?

Brands and other names

  • Iclusig

Dosage forms and strengths

  • 10 mg, 15 mg, 30 mg, 45 mg oral tablets

How should I store Iclusig?

Iclusig should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Iclusig?

The most common side effects of Iclusig are listed below. Tell your health care provider if you have any of these side effects that bother you. Side effects may be different depending on the condition you are using the medicine for.

  • Skin rash
  • Joint pain
  • Stomach pain
  • Headache
  • Constipation
  • Dry skin
  • Tiredness
  • Fluid retention (see below)
  • Fever
  • Nausea
  • Inflammation of the pancreas (see below)
  • Liver damage (see below)
  • Blood disorders (see below)
  • Blood clots (see below)
  • Mouth sores
  • Nerve problems (see below)
  • Increased blood pressure (see below)
  • Heart rhythm changes (see below)

There may be other side effects of Iclusig that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Iclusig?

While less common, the most serious side effects of Iclusig are described below, along with what to do if they happen.

Severe Allergic Reactions. Iclusig may cause allergic reactions, which can be serious. Stop taking Iclusig and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Attack and Stroke. Iclusig can increase your risk of a heart attack or stroke, which can lead to death. This risk is higher in people who already have heart disease. Do not take Iclusig if you have had recent heart problems without talking to your health care provider. This could increase your risk of having a heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech

Blood Clots. Iclusig may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). Stop taking Iclusig and get emergency help if you have any of the following signs of blood clots.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Heart Failure. Iclusig may increase your risk of heart failure. Tell your health care provider right away if you have any of the following symptoms of heart failure.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Iclusig. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure (Hypertension). Iclusig may increase your blood pressure or worsen it if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Inflammation of the Pancreas (Pancreatitis). Iclusig may cause inflammation of the pancreas, which is called pancreatitis. Stop taking Iclusig and call your health care provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.

Nerve Problems. Nerves are the fibers that carry sensations from your body to the brain. Damage to these nerves, called peripheral neuropathy, can happen in people who are taking Iclusig. Stop taking Iclusig and call your health care provider if you develop pain, burning, tingling, numbness, or weakness in your arms, hands, legs, or feet.

Severe Eye Problems.  Iclusig may cause eye problems, such as dry eye and blurred vision. Rarely, these eye problems could lead to blindness. Contact your health care provider right away if you have any of the following symptoms.

  • Eye redness, itchiness, or pain
  • Swollen or itchy eyelids
  • Feeling like you have something in your eye
  • Eye dryness, watering, or discharge
  • Vision changes, such as blurry vision or sensitivity to light

Severe Bleeding. Iclusig can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Iclusig can also increase your risk of stomach bleeding and tears (perforation) in your gut. Call your health care provider right away if you have any of the following signs of severe bleeding while taking Iclusig.

  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots
  • Stomach pain that does not go away
  • Upset stomach
  • Feel faint

Fluid Retention (Edema). Iclusig can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. Call your health care provider right away if you have any of the following symptoms.

  • Chest pain
  • Irregular heartbeat
  • Shortness of breath
  • Stretched or shiny skin
  • Swollen body parts, such as the belly or ankles

Heart Rhythm Changes. Iclusig may cause heart rhythm problems that can lead to an irregular heartbeat and fainting. In rare cases, this may cause the heart to suddenly stop beating (cardiac arrest). Some people have a higher risk of this, including people who already have heart disease or who take other medicines that affect the heart. Get emergency help if you have any of the following signs of heart rhythm changes.

  • Chest pain
  • Shortness of breath
  • Feeling dizzy, lightheaded, or fainting
  • Changes in your heart rate or rhythm, such as a fast, slow, pounding, or skipping heartbeat

Blood Disorders. Iclusig can cause blood disorders, such as low red blood cells (anemia), low platelet levels (thrombocytopenia), and low neutrophil levels (neutropenia). Attend all of your appointments with your health care provider to have your blood cell counts checked, and stop taking Iclusig and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Tumor Lysis Syndrome. Iclusig can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while taking Iclusig and to keep all appointments for blood tests so your health care provider can see how your body is responding to Iclusig. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while taking Iclusig.

  • Nausea and vomiting
  • Weakness
  • Swelling or fluid retention
  • Shortness of breath
  • Muscle cramps
  • Seizures

Posterior Reversible Encephalopathy Syndrome (PRES). Iclusig may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

  • Changes in thinking or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision
  • Sudden severe headache
  • Seizures

Wound Healing Issues. Iclusig can make it difficult for your body to heal wounds. Tell your health care provider if you have any planned or emergency surgeries or if you have any injuries that occur while taking Iclusig.

Warnings & Precautions

Who should not use Iclusig?

Allergies to Ingredients. People who are allergic to any of the following should not take Iclusig.

  • Iclusig
  • Ponatinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Iclusig.

What should I know about Iclusig before using it?

Do not take Iclusig unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Iclusig with other people, even if they have the same condition as you. It may harm them.

People who are 65 or older can be at greater risk of some side effects from Iclusig. Talk to your health care provider about your risks if you are in this age group.

Keep Iclusig out of the reach of children.

Swallow Iclusig whole and do not crush, split, dissolve, or chew the tablets.

Iclusig may make it difficult for you to get pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Iclusig?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Iclusig is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems, including cardiomyopathy, heart failure, heart rhythm changes, and QT prolongation
  • Any family members who have heart problems, like QT prolongation
  • Bleeding problems
  • Blood clot problems, including prior strokes
  • Diabetes
  • High cholesterol
  • Liver problems
  • Pancreas problems, including pancreatitis
  • High blood pressure
  • Prior or planned surgery
  • Lactose intolerance
  • Eye problems
  • Nerve problems
  • Stomach or digestive problems, including stomach ulcers
  • Wounds that are healing

Other Medicines and Supplements. Iclusig may interact with other medicines and supplements. Before taking Iclusig, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Iclusig may cause harm to a fetus. Your health care provider will give you a test to make sure you are not pregnant before you start taking Iclusig. If you can get pregnant, you should use birth control while taking Iclusig and for three weeks after your last dose. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Iclusig passes into breast milk. You should not breastfeed while taking Iclusig and for one week after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Iclusig?

For more information about Iclusig, you can visit the drugmaker’s website at www.inclusig.com or call them at 844-817-6468.

Interactions

Does Iclusig interact with foods or drinks?

Grapefruit interacts with Iclusig. It is important to avoid eating grapefruit or drinking grapefruit juice while taking Iclusig. This is because grapefruit can interfere with your body’s ability to break down Iclusig, which can lead to high levels of the medicine and an increased risk of side effects.

It is unknown if drinking alcohol will affect Iclusig, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Iclusig interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Iclusig.

  • St. John’s wort, which is a supplement that may be used for depression
  • Ketoconazole, which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)

Many other medicines may alter the blood levels of Iclusig and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Iclusig. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Iclusig?

If you or someone else has used too much Iclusig, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Iclusig?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.