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.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Arterial Occlusion Events, Venous Thromboembolic Events, Heart Failure, and Hepatotoxicity. Arterial occlusive events (AOEs), including fatalities, have occurred in ponatinib hydrochloride-treated patients.

AOEs included 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 age 50 years or younger, experienced these events.

Monitor for evidence of AOEs.

Interrupt or discontinue ponatinib hydrochloride based on severity.

Consider benefit-risk to guide a decision to restart ponatinib hydrochloride.Venous thromboembolic events (VTEs) have occurred in ponatinib hydrochloride-treated patients.

Monitor for evidence of VTEs.

Interrupt or discontinue ponatinib hydrochloride based on severity.Heart failure, including fatalities, occurred in ponatinib hydrochloride-treated patients.

Monitor for heart failure and manage patients as clinically indicated.

Interrupt or discontinue ponatinib hydrochloride for new or worsening heart failure.Hepatotoxicity, liver failure and death have occurred in ponatinib hydrochloride-treated patients.

Monitor liver function tests.

Interrupt or discontinue ponatinib hydrochloride based on severity.

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:

More common side effects

• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chest pain
• chills
• cloudy urine
• confusion
• constipation
• cough or hoarseness
• coughing up blood
• decreased urine output
• difficult, burning, or painful urination
• difficulty with breathing or swallowing
• dilated neck veins
• dizziness
• fainting
• frequent urge to urinate
• increased menstrual flow or vaginal bleeding
• indigestion
• irregular breathing
• joint pain, stiffness, or swelling
• lightheadedness
• lower back, side, or stomach pain
• nervousness
• nosebleeds
• pains in the chest, groin, or legs, especially calves of the legs
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• paralysis
• pinpoint red spots on the skin
• pounding in the ears
• prolonged bleeding from cuts
• rapid weight gain
• rapid, shallow breathing
• red or black, tarry stools
• red or dark brown urine
• severe headaches of sudden onset
• slow or fast heartbeat
• sore throat
• sudden loss of coordination
• sudden slurred speech
• sudden vision changes
• tingling of the hands or feet
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual weight gain or loss

Less common side effects

• anxiety
• burning, numbness, tingling, or painful sensations
• chest discomfort
• fast, pounding, or irregular heartbeat or pulse
• pain, redness, or swelling in the arms or legs
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Incidence not known

• blistering, peeling, loosening of the skin
• bloody, black, or tarry stools
• blue-green halos seen around objects
• clay-colored stools
• dark urine
• decreased appetite
• diarrhea
• dry eyes
• fever
• headache
• heartburn
• indigestion
• itching or skin rash
• joint or muscle pain
• loss of appetite
• nausea and vomiting
• red irritated eyes
• red skin lesions, often with a purple center
• sensitivity of the eyes to light
• sensitivity to heat
• severe vomiting, sometimes with blood
• sore throat
• stomach cramps or tenderness
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting of material that looks like coffee grounds, severe and continuous
• weight loss
• yellow eyes or skin

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:

More common side effects

• back or bone pain
• cracked lips
• difficulty having a bowel movement (stool)
• difficulty with moving
• dryness, itching, pain, redness, swelling, tenderness, or warmth on the skin
• lack or loss of strength
• muscle aches, pain, or stiffness
• stuffy or runny nose

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]

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.

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