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.
ACAL
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.
For relapsed/refractory mantle cell lymphoma
Acalabrutinib tablets and capsules are bioequivalent and have equivalent oral bioavailability except when co-administered with acid reducing agents. (Refer to Interactions section.)
| acalabrutinib | 100 mg | PO | BID |
| (This drug is not currently publicly funded for this regimen and intent) | |||
Minimal – No routine prophylaxis; PRN recommended
- 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.
Other Supportive Care:
- Consider prophylaxis for tumour lysis syndrome (TLS) in patients at higher risk of TLS.
- Consider prophylaxis in patients at increased risk for opportunistic infections (e.g. aspergillosis, fungal pneumonia, and Pneumocystis Jiroveci Pneumonia).
Doses should be modified according to the protocol by which the patient is being treated.
Consider the benefit-risk analysis of withholding acalabrutinib for at least 3 days pre-and post-surgery due to bleeding risk.
Dosage with toxicity
| Dose Level | Acalabrutinib Dose |
| 0 | 100 mg BID |
| -1 | 100 mg Daily |
| -2 | Discontinue |
| Toxicity | Occurrence |
Action |
|
Grade ≥ 3 non-hematologic toxicities OR Grade 3 thrombocytopenia with significant bleeding OR Grade 4 thrombocytopenia OR Grade 4 neutropenia lasting longer than 7 days |
First and second |
Hold until toxicity is Grade 1 or baseline. Resume at same dose. |
| Third |
Hold until toxicity is Grade 1 or baseline. Resume at 1 dose level ↓. |
|
| Fourth | Discontinue. |
Hepatic Impairment
| Hepatic Impairment | Total Bilirubin | AST | Acalabrutinib Dose | |
|
Mild or Moderate (Child-Pugh A or B) |
≤ 3 X ULN | and | Any | No dose adjustment required. |
| Severe (Child-Pugh C) | > 3 X ULN | and | Any | Avoid use. |
Renal Impairment
| Approximate Creatinine Clearance* (mL/min) | Acalabrutinib Dose |
| ≥ 30 | No dose adjustment required. |
| < 30 | No data available. |
*Reported as eGFR in mL/min/1.73m2, as estimated by MDRD.
Dosage in the Elderly
No dose adjustment is necessary due to age. Clinically relevant differences in safety or efficacy were not observed between those ≥ 65 years and < 65 years.
Refer to acalabrutinib drug monograph(s) for additional details of adverse effects.
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to acalabrutinib drug monograph(s) for additional details.
- Avoid use with strong CYP3A inhibitors due to ↑ acalabrutinib toxicity. If co-administration with a strong CYP3A inhibitor is short-term, hold acalabrutinib.
- When co-administrated with a moderate CYP3A inhibitor, ↓ dose of acalabrutinib to 100 mg daily.
- Avoid use with strong CYP3A inducers due to ↓ efficacy of acalabrutinib.
- Avoid use of acalabrutinib capsules with proton pump inhibitors due to ↓ acalabrutinib absorption. Take acalabrutinib capsules 2 hours before taking a H2-receptor antagonist. Separate dosing by at least 2 hours with antacids.
- Acalabrutinib tablets can be co-administered with gastric acid reducing agents.
Refer to acalabrutinib drug monograph(s) for additional details.
Administration:
- Administer acalabrutinib with or without food.
- Tablets and capsules should be swallowed whole with a glass of water and not crushed, dissolved, opened or divided. Acidic beverages (i.e. orange juice or grapefruit juice) decrease absorption of acalabrutinib capsules.
- If a dose is missed, patient may take within 3 hours of missed dose. If more than 3 hours, the dose should be skipped and taken at the next planned time. Extra doses should not be taken to make up for missed dose.
- Grapefruit, starfruit, Seville oranges, their juices or products should be avoided during acalabrutinib treatment.
- Store at room temperature, in original bottle, and away from children or pets.
Contraindications:
- Patients who are hypersensitive to acalabrutinib or to any ingredient in the formulation or component of the container.
Warnings/Precautions:
- Avoid in patients with severe hepatic impairment (Child-Pugh C or total bilirubin > 3 times ULN, regardless of AST levels).
- Avoid concomitant use of strong CYP3A4 inhibitors.
- Use caution in patients at risk of bleeding, including those receiving concomitant antiplatelet or anticoagulant medications. Consider the benefits and risks of withholding acalabrutinib for at least 3 days pre-and post-surgery.
- Use caution in patients at risk of cardiac arrhythmias (e.g. history of atrial fibrillation or infection / pneumonia).
- Use caution when driving or operating a vehicle or potentially dangerous machinery due to fatigue and dizziness.
Pregnancy and 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 treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
- Fertility effects: Unlikely
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 and at each visit
-
Renal and liver function tests; Baseline and at each visit
-
ECG; Baseline and as clinically indicated
-
Clinical toxicity assessment for cardiac symptoms, skin cancers, infection, hyperuricemia, GI effects, pain and bleeding; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Acalabrutinib drug monograph. Ontario Health (Cancer Care Ontario).
Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single -arm, multicentre, phase 2 trial. Lancet 2018;3941:659-67.
September 2023 Modified Drug regimen, Supportive measures, Interactions, Drug administration and Pregnancy/lactation sections
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.