Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
ASCI
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
Treatment of chronic phase Ph+ CML:
- As first or second line in patients who have drug resistance to TKIs*, OR
- As second or subsequent line in patients who had disease progression on bosutinib in first line and who have drug resistance to TKIs*, OR
- As third-line in patients who had disease progression or intolerance to 2 or more prior TKIs
*Patients must have a documented mutational drug resistance to imatinib, dasatinib, and nilotinib, which makes them clinically inappropriate treatment choices. Refer to EAP for full criteria.
Asciminib will not be funded for patients with V299L or T315I mutation.
Refer to EAP for full funding criteria.
asciminib
Exceptional Access Program
(asciminib - For the treatment of Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, based on criteria)
(EAP Website)
Minimal
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
| Dose Levels | Once-daily Dosing | Twice-daily Dosing |
| 0 | 80 mg Daily | 40 mg BID |
| -1 | 40 mg Daily | 20 mg BID |
| -2 | Discontinue | Discontinue |
| Toxicity | Severity | Action |
| Thrombocytopenia and/or neutropenia |
Platelets < 50 x 109/L |
Hold until platelets ≥ 50 x 109/L and ANC ≥ 1 x 109/L. If resolved:
If recurrent, hold until platelets ≥ 50 x 109/L and ANC ≥ 1 x 109/L and restart at reduced dose. |
| Asymptomatic amylase and/or lipase elevation | > 2 x ULN |
Hold until resolved to < 1.5 x ULN. If resolved, restart at reduced dose. Discontinue if it does not resolve. Investigate for pancreatitis. Discontinue at recurrence. |
| Symptomatic amylase and/or lipase elevation | Any | Hold and investigate for pancreatitis. |
| Hypersensitivity | Grade 3 or 4 | Hold, then reduce dose or discontinue as clinically indicated. |
| Other related non-hematologic toxicities | Grade 3 or 4 |
Hold until ≤ grade 1. If resolved, restart at a reduced dose. Discontinue if it does not resolve. |
Hepatic Impairment
No dose adjustment required.
Renal Impairment
No dose adjustment required in patients with mild, moderate or severe renal impairment not requiring dialysis (absolute GFR ≥ 15 mL/min).
Asciminib has not been studied in patients with end stage renal disease requiring dialysis.
Dosage in the Elderly
No dose adjustment required in patients ≥ 65 years of age. No overall differences in safety or efficacy were observed between patients ≥ 65 years of age and younger patients. There is insufficient data in patients ≥ 75 years.
Refer to asciminib drug monograph(s) for additional details of adverse effects.
|
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
Refer to asciminib drug monograph(s) for additional details
- Avoid concomitant use of asciminib and itraconazole oral solution containing hydroxypropyl-β-cyclodextrin.
- Avoid concomitant use of asciminib and combined BCRP and OATP1B substrates due to increase in substrate exposure.
- Caution for additive effects when used concomitantly with other QT prolonging drugs.
- Caution for increased risk of toxicity when used concomitantly with CYP3A4, CYP2C9 or p-glycoprotein substrates that have narrow therapeutic indices.
- Caution for increased risk of toxicity when used concomitantly with OATP1B or BCRP substrates; adjust substrate dose as recommended by its product monograph.
Refer to asciminib drug monograph(s) for additional details
Administration
- Asciminib should be taken orally on an empty stomach, at least 1 hour before or 2 hours after food, at around the same time(s) each day.
- If administered as twice daily, the doses should be given approximately 12 hours apart.
- When switching from 40 mg BID to 80 mg once daily, patients should start taking the first once-daily dose about 12 hours after the last twice-daily dose. Then continue at 80 mg once daily.
- When switching from 80 mg once daily to 40 mg BID, patients should start taking the first twice-daily dose about 24 hours after the last once-daily dose. Then continue at 40 mg twice daily.
- If a dose is missed:
- Once-daily regimen: if a dose is missed by > 12 hours, the missed dose should be skipped and the next dose taken as scheduled.
- Twice-daily regimen: if a dose is missed by > 6 hours, the missed dose should be skipped and the next dose taken as scheduled.
- Store in original package (20ºC to 25ºC) to protect from moisture.
Contraindications
- Patients who have a hypersensitivity to this drug or any of its components
Warnings/Precautions
- Asciminib contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
- Cardiotoxicity occurred in patients with pre-existing cardiovascular conditions or risk factors, and/or previous exposure to multiple TKIs.
Pregnancy/Lactation
- This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
- Breastfeeding is not recommended during this treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
- Fertility effects: Probable
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
-
CBC; Baseline, every 2 weeks for the first 3 months, then monthly thereafter, and as clinically indicated
-
Amylase and lipase; Baseline, monthly, and as clinically indicated, more frequent monitoring in patients with a history of pancreatitis
-
Electrolytes; Baseline, at each visit, and as clinically indicated
-
Blood pressure; Baseline, at each visit, and as clinically indicated
-
ECG; Baseline and as clinically indicated
-
Liver function tests; Baseline and as clinically indicated
-
Renal function tests; Baseline and as clinically indicated
-
Clinical toxicity assessment for fatigue, bleeding, infection, musculoskeletal pain, hypersensitivity, thromboembolism, cardiac and GI effects; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Asciminib drug monograph. Ontario Health (Cancer Care Ontario).
CADTH reimbursement recommendation: Asciminib (Ph+ CML chronic phase). August 2022.
Rea D, Mauro MJ, Boquimpani C, et al. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood Nov 2021; 138(21): 2031-41.
July 2025 Updated to a full regimen monograph
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. 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, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
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.