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Iclusig Side Effects

Generic Name: ponatinib

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

For the Consumer

Applies to ponatinib: oral tablet

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
  • extreme fatigue
  • 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 shortness of breath
  • 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 pain or discomfort
  • fast, pounding, or irregular heartbeat or pulse
  • pain, redness, or swelling in the arms or legs
  • sudden shortness of breath
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Incidence not known
  • Abdominal or stomach cramps or tenderness
  • blue-green halos seen around objects
  • clay-colored stools
  • dark urine
  • decreased appetite
  • diarrhea
  • dry eyes
  • fever
  • headache
  • itching or skin rash
  • loss of appetite
  • nausea and vomiting
  • sensitivity of the eyes to light
  • severe vomiting, sometimes with blood
  • unusual tiredness or weakness
  • yellow eyes or skin

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
  • dry skin
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • lack or loss of strength
  • muscle aches
  • muscle pain or stiffness
  • sore throat
  • stuffy or runny nose
  • trouble sleeping

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Iclusig (ponatinib)." Ariad Pharmaceuticals Inc, Cambridge, MA.

Some side effects of Iclusig may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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