Ponatinib (ICLUSIG)

Philadelphia chromosome positive (Ph+) Chronic myeloid leukemia

Philadelphia chromosome positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

Philadelphia chromosome positive (Ph+) Chronic myeloid leukemia

• Oral: Chronic phase: 45mg daily continuously with a reduction to 15 mg orally once daily upon achievement of molecular response.
  • Note: Patients with loss of response can re-escalate dose to a previously tolerated dosage of 30mg or 45mg daily continuously until progression of disease or unacceptable toxicity

• Oral: Accelerated or blast phase: 45mg daily continuously until disease progression or unacceptable toxicity

Philadelphia chromosome positive (Ph+) Acute lymphoblastic leukemia (ALL)

• Oral: 45mg daily continuously until disease progression or unacceptable toxicity

Available as 15 mg film-coated tablets. Contains lactose. Tablets should NOT be crushed or broken. Store at room temperature.

BCR-ABL Tyrosine Kinase Inhibitor

Take with or without food

If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.

Common: Anemia, Neutropenia, Thrombocytopenia, Fatigue, Alkaline phosphatase increase, ALT increase, AST increase, Lipase increase, Arterial ischemia, Hemorrhage, Hypertension.

Less Common: Atrial fibrillation, Atrioventricular block, Bradycardia, Heart failure, Myocardial infarction, Pericardial effusion, Peripheral ischemia, Sick sinus syndrome, Supraventricular tachycardia, Retinal toxicity, Gastrointestinal hemorrhage, Pancreatitis, Acute hepatic failure, Pneumonia, Sepsis, Ejection fraction decrease, Hyperuricemia, Cerebral vascular accident, Pleural effusion, Pulmonary hypertension, Peripheral arterial occlusive disease, Thromboembolic event.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, ALT, total bilirubin, serum creatinine, BUN, electrolytes, magnesium, calcium, phosphorous, serum lipase, uric acid, body weight, FISH, RT-PCR (for BCR/ABL transcripts) and BCR-ABL mutational analysis, HBsAg, HbcoreAb, Echocardiography, ECG.

Baseline and during treatment: Clinical toxicity assessment for bleeding, infection, thromboembolism, fluid retention (including regular weight monitoring), hypertension, cardiac and GI effects, tumor lysis syndrome, ocular and neurologic effects.

If clinically indicated: Echocardiography and ECG.

Monitoring for disease progression: BCR-ABL transcripts every 3 months until MMR achieved and maintained for at least 12 months. Frequency of transcript testing can then move to every 6 months.

• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.

BC Cancer. BC Cancer Drug Manual. Ponatinib.  Vancouver, British Columbia: BC Cancer Agency. Available at: http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Ponatinib_monograph.pdf. Updated February 1, 2018. Accessed January 22, 2024.

Lexicomp. Ponatinib Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Available at: https://online-lexi-com.qe2a-proxy.mun.ca/lco/action/doc/retrieve/docid/patch_f/4071522?cesid=2VaCyT8yGap&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dponatinib%26t%3Dname%26acs%3Dfalse%26acq%3Dponatinib. Updated January 24, 2024. Accessed January 31, 2024.

Cancer Care Ontario. Ponatinib Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/44406. Updated September 2020. Accessed January 22, 2024.

GMD Distribution Inc. for ARIAD Pharmaceuticals, Inc. ICLUSIG® Product monograph. Oakville, Ontario. Updated February 21, 2017.