Iclusig Side Effects

Generic name: ponatinib

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

Note: This document contains side effect information about ponatinib. Some dosage forms listed on this page may not apply to the brand name Iclusig.

Applies to ponatinib: oral tablet.

Warning

Oral route (Tablet)

Arterial Occlusion Events, Venous Thromboembolic Events, Heart Failure, and HepatotoxicityArterial 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

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

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

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

-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]