ponatinib

Trade Name:

Iclusig®

Other Names:

Iclusig™

Appearance:

tablet

Monograph Name:

ponatinib

Monograph Body:

Drug Monograph

A - Drug Name

ponatinib

COMMON TRADE NAME(S): Iclusig®

B - Mechanism of Action and Pharmacokinetics

Ponatinib is a potent BCR-ABL tyrosine kinase inhibitor that binds to native BCR-ABL and mutant forms, including T315I.

Absorption

Dose proportional increases in C_max and AUC between 15 to 60 mg.

Bioavailability

Absolute bioavailability unknown.

Peak plasma levels

6 hours

Distribution

PPB

> 99%

Metabolism

Main enzymes involved

Esterases and/or amidases and by CYP3A4

Active metabolites

Inactive metabolites

Yes

Elimination

Feces

87%

Urine

Half-life

22 hours

C - Indications and Status

Health Canada Approvals:

Chronic myeloid leukemia (CML),
Acute lymphoblastic leukemia (Ph+ALL)

D - Adverse Effects

Emetogenic Potential:

Minimal – No routine prophylaxis; PRN recommended

Extravasation Potential: Not applicable

The following adverse effects were reported mainly in chronic phase CML patients or in pooled safety analyses.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Arrhythmia (3%) (atrial fibrillation)	E
	Arterial thromboembolism (19%)	E
	Artery aneurysm (rare)	E D L
	Artery dissection (rare)	E D L
	Cardiotoxicity (8%) (cardiac failure)	E D
	Hypertension (17%)	E
	Pulmonary hypertension (2%)	E
	Venous thromboembolism (5%)	E
Dermatological	Alopecia (6%)	E
	Rash (40%) (may be severe)	E
	Skin discolouration (1%) (also hyperpigmentation)	E
Gastrointestinal	Abdominal pain (29%)	E
	Anorexia, weight loss (6%)	E
	Constipation (20%)	E
	Diarrhea (9%)	E
	Dry mouth (6%)	E
	Dyspepsia (3%) (also GERD)	E
	GI perforation (rare)	E
	Nausea, vomiting (15%)	I E
General	Fatigue (19%)	E
	Fever (9%)	E
	Fluid retention (including effusions) (28%) (1% severe)	E
Hematological	Myelosuppression ± infection, bleeding (35%) (grade 3 or 4)	E
Hepatobiliary	↑ Amylase / lipase (41%) (12% severe)	E
	↑ LFTs (18%) (4% severe)	E
	Pancreatitis (7%)	E
Immune	Other Atypical infections (including HBV reactivation)	D
Metabolic / Endocrine	Abnormal electrolyte(s) (severe: decreased Na 5%; increased K 2%)	E
	Hyperglycemia (7%) (severe)	E
	Hyperuricemia (7%)	E
	Hypothyroidism (rare)	D
	↓ PO4 (9%) (severe)	E
	Tumour lysis syndrome (<1%)	E
Musculoskeletal	Musculoskeletal pain (18%)	E
Nervous System	Dizziness (6%)	E
	Headache (24%)	E
	Insomnia (2%)	E
	Peripheral neuropathy (13%) (2% severe)	E
	Posterior reversible encephalopathy syndrome (PRES) (%) (rare)	E
Ophthalmic	Eye disorders (13%) (corneal irritation, dry eye, eye pain, blurred vision)	E
	Retinal vascular disorder (3%) (retinal vein occlusion, retinal hemorrhage)	E
Respiratory	Cough, dyspnea (7%)	E
Vascular	Hot flashes (3%)	E
	Peripheral ischemia (3%)	E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects for ponatinib include myelosuppression ± infection, bleeding, rash, abdominal pain, headache, constipation, fatigue, musculoskeletal pain, hypertension, nausea, vomiting and ↑ amylase / lipase.

Arterial and venous thromboembolism and occlusions (including stroke, renal artery stenosis, peripheral vascular events, myocardial infarction, ocular, pulmonary embolism, mesenteric occlusions) occurred in 24% of patients with and without cardiovascular risk factors, some of which required revascularization procedures. The median onset of arterial occlusive events was 244 days, but may occur as early as two weeks. Renal artery stenosis has been reported and may be associated with worsening or treatment-resistant hypertension.

Vascular occlusive events were more frequent in older patients and those with a history of ischemia, hypertension, diabetes or hyperlipidemia. Peripheral vascular events sometimes required amputation. Before starting treatment, the cardiovascular status of the patient should be assessed and risk factors managed, with monitoring during treatment.

Severe cases of artery dissection (with or without hypertension) and artery aneurysm (including rupture) have been reported in patients using VEGFR TKIs.

Congestive heart failure and reduced left ventricular ejection fraction (LVEF) have been reported with an average onset of 196 days. LVEF should be evaluated prior to treatment. Symptomatic bradyarrhythmias and supraventricular tachyarrhythmias have been reported, with atrial fibrillation being the most common.

Severe hemorrhage (CNS, GI) occurred in 6% of patients with the incidence of this and severe neutropenia being higher in patients with acute or blast phase CML or Ph+ALL compared to chronic phase CML patients.

Hepatotoxicity that may be severe and life-threatening occurred within a week of starting treatment.

Pancreatitis was reported more frequently within the first two months of therapy.

Reactivation of hepatitis B virus (HBV) has been reported in patients who received BCR-ABL TKI’s and are chronic carriers of HBV. Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.

E - Dosing

Refer to protocol by which the patient is being treated.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Patients' cardiovascular status should be assessed and risk factors managed prior to starting treatment and monitored during treatment.

Ensure adequate hydration and correct hyperuricemia prior to starting treatment.

Adults:

Consider reducing the dose of ponatinib from 45 mg to 15 mg once daily for chronic phase CML patients who have achieved a MCyR (major cytogenetic response).

Consider discontinuation if a hematologic response has not been achieved by 3 months.

Oral: 45 mg Daily

Dosage with Toxicity:

Dose levels: 45 mg, 30 mg, 15 mg (if further dose reduction indicated, discontinue)

Doses reduced for toxicity may be re-escalated after toxicity has resolved, if clinically appropriate.

Toxicity	Severity	Action/ponatinib dose
Myelosuppression	ANC < 1 x 10⁹/L or platelets < 50 x 10⁹/L (unrelated to disease)	1st occurrence: Hold* until recovery, restart at the same dose. 2nd occurrence: Hold* until recovery, restart at ↓ 1 dose level from previous dose. 3rd occurrence: Hold* until recovery, restart at ↓ 1 dose level from previous dose.
Hemorrhage	Grade 3 or 4	Hold and investigate. Consider the risk vs. benefit of restarting.
LFTs	AST/ALT > 3 x ULN	Hold until recovery to ≤ grade 1, restart at ↓ 1 dose level from previous dose.
LFTs	AST/ALT ≥ 3 x ULN AND total bilirubin > 2 x ULN AND ALP < 2 x ULN	Discontinue`
Suspected Pancreatitis	Asymptomatic Amylase/lipase > 2 x ULN	Hold until recovery to ≤ grade 1 then restart at ↓1 dose level from previous dose.
	Amylase/Lipase elevations and symptomatic	Hold and investigate for pancreatitis.
	Grade 3 pancreatitis	Hold until recovery to < grade 2 then restart at ↓ 1 dose level from previous dose.
	Grade 4 pancreatitis	Discontinue
Hypertriglyceridemia	Grade 3 or 4	Manage patient appropriately to reduce pancreatitis risk.
Cardiac/ATE/VTE	Arterial or venous thromboembolic event	Discontinue unless benefit outweighs risk
	Blurred or decreased vision	Hold and refer for ophthalmic examination for suspected vascular occlusion. Consider the risk vs. benefit of restarting.
	LVEF < 50% and > 10% below baseline and asymptomatic	Hold until recovery. Discontinue if does not resolve within 4 weeks or is ≥ grade 3.
	Symptomatic CHF	Discontinue
	Arrhythmias	Hold and investigate.
	Hypertension	Treat to normalize blood pressure. Hold if not medically controlled and evaluate for renal artery stenosis.
Fluid retention		Hold, reduce or discontinue ponatinib as clinically indicated.
RPLS / PRES	Any	Hold if suspected Discontinue if confirmed or Restart if resolved and only if benefits outweigh risks
Other non-hematologic toxicity	Grade 3 or 4	Hold until recovery. Restart at ↓ 1 dose level from previous dose. If grade 4, consider discontinuation.
Major surgical procedures		Consider hold prior to surgery. Restart based on clinical judgement of adequate wound healing.
*Restart once ANC ≥ 1.5 x 10⁹/L and platelets ≥ 75 x 10⁹/L

Dosage with Hepatic Impairment:

The recommended starting dose is 30 mg once daily in patients with hepatic impairment (Child-Pugh A, B or C). There was an increase in adverse effects in patients with severe hepatic impairment.

Dosage with Renal Impairment:

Renal excretion is not a major route of elimination. Dosage adjustment is not recommended, but ponatinib has not been studied in patients with CrCl < 50 ml/min or end-stage renal disease.

Dosage in the elderly:

Patients aged 65 and older were more likely to experience reduced efficacy and adverse effects compared to younger patients. The dose should be selected with caution given the greater frequency of decreased hepatic, renal and cardiac function, other diseases and drug therapies in older patients.

Children:

The safety and efficacy of ponatinib in patients under 18 years have not been established.

F - Administration Guidelines

Ponatinib should be swallowed whole with or without food
Tablets should not be crushed, chewed or dissolved
If a dose is missed, an additional dose should not be taken. Patients should take the next dose at the usual time.

Store at room temperature (15^oC to 30^oC) in the original package.

G - Special Precautions

Contraindications:

patients who have a hypersensitivity to this drug or any of its components
patients who have uncontrolled hypertension or other unmanaged cardiac risk factors
patients with a history of myocardial infarction, prior revascularization or stroke unless the potential benefit outweighs the risk
patients with dehydration or untreated hyperuricemia

Other Warnings/Precautions:

Consultation with a liver disease expert is recommended prior to starting ponatinib in chronic HBV carriers (including those with active disease), and for patients who test positive for HBV infection while on treatment
patients aged 65 and older experienced reduced efficacy and increased adverse effects
use with caution in patients with a prior history of ischemia, hypertension, congestive heart failure or conditions that may impair left ventricular function, diabetes or hyperlipidemia
use with caution in patients with hepatic impairment
use with caution in patients at risk of bleeding, those receiving antiplatelets and/or anticoagulants
use with caution in patients with a history of pancreatitis or alcohol abuse
contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption

Other Drug Properties:

Carcinogenicity:
Increased incidence of squamous cell carcinoma of the clitoral gland was observed in animals

Pregnancy and Lactation:

Mutagenicity: No
Clastogenicity: No
Embryotoxicity: Yes
Fetotoxicity: Yes

Ponatinib is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment, and for at least 6 months after the last dose. It is unknown whether ponatinib affects the effectiveness of oral contraceptives. An alternative method of contraception should be used.
Excretion into breast milk: Unknown

Breastfeeding is not recommended.
Fertility effects: Likely

H - Interactions

Ponatinib is metabolized by CYP3A4 and is therefore susceptible to drug interactions with inducers and inhibitors.

AGENT	EFFECT	MECHANISM	MANAGEMENT
CYP3A4 inhibitors (i.e. ketoconazole, clarithromycin, ritonavir, fruit or juice from grapefruit, Seville oranges or starfruit)	↑ ponatinib concentration and/or toxicity (ketoconazole ↑ ponatinib exposure by 78%)	↓ metabolism of ponatinib	Caution. Consider reducing the starting dose of ponatinib to 30 mg with strong CYP3A4 inhibitors
CYP3A4 inducers (i.e. phenytoin, rifampin, dexamethasone, carbamazepine, phenobarbital, St. John’s Wort, etc)	↓ ponatinib concentration and/or efficacy (rifampin ↓ ponatinib exposure by 62%)	↑ metabolism of ponatinib	Avoid strong CYP3A4 inducers if possible. If not possible, monitor for reduced efficacy of ponatinib
Drugs that raise gastric pH (e.g. proton pump inhibitors, H2-receptor antagonists, antacids)	co-admin with lansoprazole reduced Cmax without change in overall systemic exposure	higher pH results in lower solubility of ponatinib	No need to adjust dose or separate administration
P-glycoprotein substrates (i.e. verapamil, digoxin, morphine, ondansetron)	↑ substrate concentration and/or toxicity	ponatinib is an inhibitor of P-gp	Caution and monitor
BCRP substrates (i.e. topotecan, methotrexate, rosuvastatin)	↑ substrate concentration and/or toxicity	ponatinib is an inhibitor of BCRP	Caution and monitor

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
Blood pressure	Baseline and as clinically indicated; ensure hypertension is controlled to minimize risk of arterial thromboembolism
CBC	Baseline, every 2 weeks for the first 3 months, and then monthly and as clinically indicated
Liver function tests	Baseline, at least monthly and as clinically indicated
Lipase, amylase	Baseline, every 2 weeks for the first 2 months, and then periodically or as clinically indicated
LVEF	Baseline, 3 months after treatment initiation, and as clinically indicated
Calcium, phosphate	Baseline and as clinically indicated
Eye exam and fundoscopy	Baseline, with blurred vision and as clinically indicated
Clinical toxicity assessment for bleeding, infection, thromboembolism, fluid retention (including regular weight monitoring), hypertension, cardiac and GI effects, tumour lysis syndrome, ocular and neurologic effects	Baseline and at each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

Exceptional Access Program (EAP Website )

ponatinib - For the treatment of Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia, according to specific clinical criteria
ponatinib - For the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), according to specific clinical criteria

K - References

BCR-ABL Tyrosine Kinase Inhibitors [GLEEVEC (imatinib mesylate), TASIGNA (nilotinib), BOSULIF (bosutinib), SPRYCEL (dasatinib), ICLUSIG (ponatinib hydrochloride)] - Risk of Hepatitis B Reactivation. Health Canada, May 4, 2016. [Accessed May 13, 2016]. Available from: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/58222a-eng.php

Cortes JE, Kim DW, Pinilla-Ibarz J, et al; PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013 Nov 7;369(19):1783-96.

Iclusig product monograph. ARIAD Pharmaceuticals Inc. February 21, 2017.

Product Monograph Update: Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs). Health Canada InfoWatch, June 2020.

December 2025 added general statement on hepatitis B testing, removed information on controlled distribution program

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.

Info Sheet Name:

ponatinib (patient)

Info Sheet Introduction:

• For treating chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

Info Sheet Date: Thursday, December 4, 2025 Info Sheet body:

ponatinib

Pronunciation:

poe NAT i nib

Other Name(s):

Iclusig™

Appearance:

tablet

This handout gives general information about this cancer medication.

You will learn:

who to contact for help
what the medication is
how it is given
what to expect while on medication

This handout was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.

This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.

Who do I contact if I have questions or need help?

My cancer health care provider is: _____________________________________________

During the day I should contact: _______________________________________________

Evenings, weekends and holidays: _____________________________________________

This page gives general information about this cancer medication.

You will learn:

who to contact for help
what the medication is
how it is given
what to expect while on this medication

This information was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.

This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.

What is this treatment for?

For treating chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

What should I do before I start this treatment?

Tell your doctor and pharmacist if you have or had significant medical condition(s), especially if you have or had:
- heart problems
- liver disease (including hepatitis)
- pancreas problems
- high blood pressure
- stroke, blood clots
- diabetes
- or any allergies
People with cancer have a higher risk of getting other cancers or developing blood clots. Some cancer medications may increase these risks, especially if used for a long period of time. Discuss any concerns about this medication with your health care team.
This drug contains a small amount of lactose. If you cannot tolerate lactose, talk to your doctor or pharmacist.

How is this treatment given?

Swallow whole with a glass of water, with or without food.
Do not crush or chew the tablets.
Do not eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while on this treatment. They may increase side effects.
If you miss a dose, skip this and take your next dose as you normally do. Do not take an extra dose to make up for the missed dose.

Will this treatment interact with other medications or natural health products?

This medication can interact with other medications and can result in the treatment not working as well or cause severe side effects.
Do not eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while on this treatment. They may increase side effects.
Make sure your health care team knows about all your medications (prescription, over-the-counter, herbals and supplements). Check with your health care team before starting or stopping any of them.
Drinking alcohol and smoking during your treatment may increase some side effects and make your medication less effective. Speak to your health care team about smoking and drinking alcohol while on treatment.

What to do if you feel unwell, have pain, a headache or a fever

For mild aches and pain or fever:

If you feel unwell, take your temperature before taking any medications for pain or fever. They may hide a fever.
You may take acetaminophen (Tylenol®) tablets. Ask your health care team about the right dose for you.
Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or aspirin (acetylsalicylic acid, ASA), including low dose aspirin for heart conditions, may increase your chance of bleeding. Talk to your health care team before you start or stop these medications.
Talk to your health care team or go to the closest emergency room right away if you have a fever. See the Fever pamphlet for more information.

How will this treatment affect sex, pregnancy and breastfeeding?

The use of this medication in men or women may cause harm to the unborn baby if pregnancy occurs. Let your health care team know if you or your partner is pregnant, becomes pregnant during treatment, or if you are breastfeeding
If there is ANY chance that you or your partner may become pregnant, you and your partner together must:
► Use 2 effective forms of birth control at the same time while receiving this drug: Keep using birth control until at least 6 months after the last dose. It is unknown if ponatinib affects how birth control pills work. Consider another method of contraception. Discuss with your healthcare team.
Tell your doctor right away if you or your partner becomes pregnant.
Do not breastfeed while using this drug.
This medication may affect fertility (ability to get pregnant)

How to safely store and handle this medication

Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.

Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.

What are the side effects of this treatment?

You may not have all of the side effects below. You may have side effects that are not listed.

Side effects and what to do	When to contact doctor?
Common Side Effects (in 25 to 49 out of 100 people)

Abnormal levels of pancreas tests (lipase, amylase)

Your doctor may monitor these regularly.

Rarely may be severe with pain in your belly extending to your back.

Contact your health care team if no improvement or if severe

Rash; dry, itchy skin (may be severe)

Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away.

To prevent and treat dry skin,

Use skin moisturizer.
Protect your skin from the sun and the cold.
Use sunscreen with UVA and UVB protection and a SPF of at least 30.

Contact your health care team if no improvement or if severe

Low platelets in the blood

Watch for bleeding (such as unusual nosebleeds or bleeding from the gums) or bruising easily (this is rare).
Very rarely, severe symptoms can happen. If you notice black coloured stools (poo), red or pink coloured urine (pee), red or brown coloured mucus when you cough, severe headache/confusion or bleeding that will not stop, you need to talk to your health care team or go to the nearest emergency room right away.

See the Low Platelet Count pamphlet for more information.

Fever, chills, infection

You have a fever if your temperature taken in your mouth (oral temperature) is:

38.3°C (100.9°F) or higher at any time OR
38.0°C (or 100.4°F) or higher for at least one hour.

While you are getting treatment:

Keep a digital thermometer at home and take your temperature if you feel hot or unwell (for example, chills).
Avoid taking medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen) as they may hide a fever.
Do not eat or drink anything hot or cold right before taking your temperature.
Wash your hands often to prevent infection.
Check with your doctor before getting any vaccines, surgeries, medical procedures or visiting your dentist.

If you have a fever, talk to your health care team or go to the closest emergency room.
See our Neutropenia (Low white blood cell count) pamphlet for more information.

Get emergency medical help right away

Pains or cramps in the belly

If you have constipation or diarrhea it may be causing the pain in your belly.
If the pain is severe, gets worse or doesn’t go away, talk to your health care team about other possible causes.

Contact your health care team if no improvement or if severe

Mild swelling in arms and legs; puffiness (may be severe, including rare buildup of fluid around the heart or lungs)

To help prevent swelling :

Eat a low-salt diet.
Avoid tight fitting clothing.

If you have swelling in your legs, keep your feet up when sitting.

Contact your health care team if no improvement or if severe

Side effects and what to do	When to contact doctor?
Less Common Side Effects (in 10 to 24 or more out of 100 people)

Headache; mild joint, muscle pain or cramps

Take your pain medication as prescribed by your doctor.
You can take acetaminophen (Tylenol®) tablets as needed for mild aches and pains. Ask your doctor or pharmacist about the right dose for you.
Talk to your doctor or pharmacist first before taking ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or aspirin. These medication may increase bleeding risk.
Rest often and try light exercise as it may help.

Contact your health care team if no improvement or if severe

Constipation

To help prevent constipation :

Drink more liquids and eat well. Drink at least 6 to 8 cups of liquids each day unless you have been told otherwise.
Be Active. Exercise can help to keep you regular.
Try to eat more fiber (e.g. fruits with skin, leafy greens and whole grains). If you take opioid pain medication, ask your health care team if eating more fibre is right for you.

To help treat constipation :

If you have not had a bowel movement in 2 to 3 days you may need to take a laxative. Ask your health care team what to do.

See the Constipation Pamphlet for more information.

Contact your health care team if no improvement or if severe

Blockage of an artery (blood vessel)

It can happen in your heart, chest, brain, belly or limb. It may be more severe and block a big artery and cause :

Stroke: you may feel confused and have a sudden loss of vision or trouble speaking or using your arms or legs.
Heart attack: you can have chest pain, shortness of breath, pain in your belly or arm.

Get emergency medical help right away

Fatigue (tiredness)

Be active and aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise.
Pace yourself, do not rush. Put off less important activities. Rest when you need to.
Eat well and stay hydrated by drinking at least 6 to 8 glasses of water or other liquids every day (unless your doctor told you to drink more or less).
Avoid driving or using machinery if you are feeling tired

See our Fatigue pamphlet for more information.

Contact your health care team if no improvement or if severe

Abnormal liver lab tests

You may have yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. Talk to your health care team if this happens.
May be severe, especially in patients whose hepatitis B virus becomes active again
Your doctor may monitor your liver regularly with a blood test.

Contact your health care team if no improvement or if severe

High blood pressure

Check your blood pressure regularly. Your doctor may prescribe medication to treat high blood pressure.
If you have a severe headache, severe dizziness, or if you faint, get emergency help right away as it may be a sign your blood pressure is too high.
May rarely be severe and lead to kidney problems

Contact your health care team if no improvement or if severe

Nausea and vomiting (generally mild)

May occur in hours to days after your treatment.

If you have nausea or vomiting:

Take anti-nausea medication(s) as prescribed to you by your doctor.
Drink clear liquids and have small meals. Get fresh air and rest.
Do not eat spicy, fried foods or foods with a strong smell.
Limit caffeine (e.g. coffee, tea) and alcohol.
Contact your health care team if the prescribed anti-nausea medications are not helping to control your nausea and vomiting.

Also see Nausea & Vomiting pamphlet for more information.

Contact your health care team if no improvement or if severe

Eye problems

You may have dry eyes, redness, irritation, pain, tearing, sensitivity to light or blurred vision.
Avoid wearing contact lenses.
You may try artificial tears or ointment.

Contact your health care team as soon as possible

Tingling, numb fingers and toes

May slowly get better after your treatment ends.
Contact your health care team if you have trouble doing up buttons, writing, picking up small objects, have pain or trouble moving.

Contact your health care team if no improvement or if severe

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

Irregular heartbeat, shortness of breath, chest pain, fainting spells or swelling in your legs, ankles and belly
Swelling and hardening of the vein in an arm or leg
Sudden severe pain in your upper back or belly, that moves up your neck or down your back, when you didn’t hurt yourself
Weakness on one side of your body
Trouble seeing or with swallowing
Unusual pulsating or throbbing feeling in your chest or belly
Trouble breathing or coughing up blood
Hair that breaks easily or sensitivity to cold
Joint pain, fever, confusion and/or kidney problems (difficulty peeing, swelling, unusual weight gain)
Feel very thirsty and pee more often
Severe headache, fainting, seizures, confusion, vision loss

For more information on how to manage your symptoms ask your health care provider, or visit: https://www.cancercareontario.ca/symptoms.

Notes

December 2025 Changed into new format

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):

ponatinib patient.pdf Info Sheet (French):

ponatinib pour le patient.pdf Monograph:

ponatinib.pdf Funding Program: Exceptional Access Program Funding Instance:

ponatinib - For the treatment of Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia, according to specific clinical criteria
ponatinib - For the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), according to specific clinical criteria

Phonetic Spelling:

poe NAT i nib

Cancer Type: Hematologic Leukemia - Acute Lymphoblastic (ALL) Leukemia - Chronic Myeloid (CML) Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Wednesday, December 3, 2025 Universal Date: 2025-12-04 00:00:00 AddThis: Title URL: ponatinib Drug Display Status: Active Revision Summary:
Drug Monograph: added general statement on hepatitis B testing, removed information on controlled distribution program
Patient Info Sheet EN: Changed into new format
Patient Info Sheet FR: Changed to new format (Passé au nouveau format)