Iclusig Side Effects

Generic name: ponatinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 27, 2023.

Note: This document provides detailed information about Iclusig Side Effects associated with ponatinib. Some dosage forms listed on this page may not apply specifically to the brand name Iclusig.

Applies to ponatinib: oral tablet.

Serious side effects of Iclusig

Along with its needed effects, ponatinib (the active ingredient contained in Iclusig) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ponatinib:

Other side effects of Iclusig

Some side effects of ponatinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use a highly effective form of birth control to keep from getting pregnant during treatment and for 3 weeks after your last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause blood clotting problems. Check with your doctor right away if you have chest pain, numbness or weakness in your arm, leg, or on one side of your body, trouble breathing, speech problems, or leg pain or swelling.

Check with your doctor right away if you have stomach pain, pale stools or dark urine, a loss of appetite, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause fluid retention and heart failure. Check with your doctor if you are rapidly gaining weight, have chest pain or discomfort, extreme tiredness or weakness, trouble breathing, or swelling of the hands, wrist, ankles, or feet. These may be symptoms of heart problems or too much water in your body.

Pancreatitis may occur with this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor immediately if you have vision changes, such as blurred vision, difficulty reading, or eye pain, dryness, irritation, or swelling, during treatment. Your doctor may want you to have your eyes checked by an eye doctor.

Check with your doctor right away if you are having decreased or increased sensitivity to pain or touch, or burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a nerve problem (eg, cranial or peripheral neuropathy).

Ponatinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your chance of having blood clots or a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Tell your doctor right away if you develop sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are using this medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You might need to stop using this medicine several weeks before having surgery. If you have questions about this, talk to your doctor.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to ponatinib: oral tablet.

General adverse events

A safety analysis showed a significant increase in grade 3 or greater adverse reactions (thrombocytopenia, neutropenia, rash, elevated ALT/AST, pancreatitis, elevated lipase) with an increase in dose intensity.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (74%), elevated blood pressure (68%), arterial ischemia (42%), arterial occlusion (35%), hemorrhage (28%), arrhythmia (19%), heart failure/left ventricular dysfunction (15%)
• Common (1% to 10%): Venous thromboembolism, atrial fibrillation, myocardial infarction, myocardial ischemia, congestive cardiac failure, coronary artery disease, angina pectoris, decreased ejection fraction, acute coronary syndrome, atrial flutter, peripheral arterial occlusive disease, peripheral ischemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing, palpitations, poor peripheral circulation, splenic infarction
• Uncommon (0.1% to 1%): Hypertensive crisis, renal artery stenosis, cardiac discomfort
• Frequency not reported: Ischemic cardiomyopathy, coronary arteriospasm^[Ref]

Dermatologic

• Very common (10% or more): Rash and related conditions (63%), dry skin (42%), pruritus (13%), alopecia (11%), cellulitis (11%), erythema (10%)
• Common (1% to 10%): Folliculitis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, skin pain, exfoliative dermatitis, hyperkeratosis, skin hyperpigmentation^[Ref]

Hematologic

• Very common (10% or more): Leukopenia (63%), myelosuppression (59%), neutropenia (59%), febrile neutropenia (25%), anemia (52%), thrombocytopenia (49%), lymphopenia (32%)
• Common (1% to 10%): Pancytopenia^[Ref]

Endocrine

• Very common (10% or more): Increased glucose (54%), decreased glucose (13%)
• Common (1% to 10%): Hypothyroidism^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (53%), abdominal pain (48%), increased lipase (42%), nausea (34%), diarrhea (29%), vomiting (27%), oral mucositis (23%), increased amylase (18%)
• Common (1% to 10%): GI hemorrhage, pancreatitis, gastroesophageal reflux disease, stomatitis, dyspepsia, abdominal distention, abdominal discomfort, dry mouth
• Frequency not reported: GI fistula, GI perforation^[Ref]

Other

• Very common (10% or more): Asthenia/fatigue (49%), pyrexia (40%), peripheral edema (25%), pain (60%), chills (13%), sepsis (13%)
• Common (1% to 10%): Effusions (pericardial, pleural, ascites), influenza-like illness, peripheral swelling, non-cardiac chest pain, face edema, malaise^[Ref]

Nervous system

• Very common (10% or more): Headache (43%), peripheral neuropathy (24%), dizziness (16%)
• Common (1% to 10%): Cranial neuropathy, cerebrovascular accident, cerebral infarction, lethargy, migraine, hyperesthesia, hypoesthesia, paresthesia, transient ischemic attack
• Uncommon (0.1% to 1%): Cerebral artery stenosis, cerebral hemorrhage, intracranial hemorrhage
• Postmarketing reports: Reversible posterior leukoencephalopathy syndrome/posterior reversible encephalopathy syndrome (RPLS/PRES)^[Ref]

Hepatic

• Very common (10% or more): Increased ALT (41%), increased alkaline phosphatase (40%), increased AST (35%), hepatotoxicity (29%), decreased albumin (27%), increased bilirubin (13%)
• Common (1% to 10%): Increased gamma-glutamyltransferase
• Uncommon (0.1% to 1%): Hepatic failure, jaundice
• Frequency not reported: Acute liver failure^[Ref]

Metabolic

• Very common (10% or more): Decreased phosphorus (33%), decreased calcium (30%), decreased appetite (31%), fluid retention (31%), decreased sodium (27%), increased creatinine (21%), decreased bicarbonate (19%), increased potassium (19%), decreased potassium (18%), decreased weight (13%), increased calcium (12%), increased sodium (10%)
• Common (1% to 10%): Hypertriglyceridemia, dehydration, increased blood cholesterol
• Uncommon (0.1% to 1%): Tumor lysis syndrome^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (33%), myalgia (24%), pain in extremity (23%), back pain (21%), bone pain (14%), muscle spasms (14%), musculoskeletal pain (11%)
• Common (1% to 10%): Neck pain, musculoskeletal chest pain^[Ref]

Respiratory

• Very common (10% or more): Cough (22%), dyspnea (20%), pleural effusion (19%), nasopharyngitis (18%), pneumonia (16%), upper respiratory tract infection (14%)
• Common (1% to 10%): Epistaxis, dysphonia, pulmonary hypertension, pulmonary embolism^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (14%)
• Common (1% to 10%): Hyperuricemia^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (13%)
• Common (1% to 10%): Confusional state, erectile dysfunction^[Ref]

Ocular

• Very common (10% or more): Ocular toxicities (14%; conjunctival irritation, corneal erosion/abrasion, dry eye, conjunctivitis, conjunctival hemorrhage, hyperemia, eye pain)
• Common (1% to 10%): Blurred vision, periorbital edema, eyelid edema, visual impairment, retinal toxicities (macular edema, retinal vein occlusion/thrombosis, retinal artery occlusion, retinal hemorrhage)
• Uncommon (0.1% to 1%): Vision loss^[Ref]

See also:

Further information

Iclusig side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer