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.
AZCTGILTVENE
Palliative
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.
This 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). 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.
The information provided in this document is intended for use only in the management of adults with leukemia, and for cancer centres with expertise in treating acute leukemia.
Treatment of:
- newly diagnosed FLT3-mutated AML who were unfit for intensive chemotherapy*, or
* Refer to NDFP and EAP for azacitidine and venetoclax funding criteria.
azaCITIDine
New Drug Funding Program
(Azacitidine in combination with Venetoclax (Outpatient) - Previously Untreated Acute Myeloid Leukemia)
(NDFP Website
)
venetoclax
Exceptional Access Program
(venetoclax - Venetoclax in combination with azacitidine - Previously untreated acute myeloid leukemia)
(EAP Website)
Cycle 1:
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azaCITIDine 1 | 75 mg /m² | Subcut | Days 1 to 7 |
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venetoclax 2 | 400 mg | PO | Days 1 to 28 |
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gilteritinib 3 | 80 mg | PO | Days 1 to 28 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
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3 Dose of 80 mg in phase II clinical trial; 80 or 120 mg in phase I. |
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| azaCITIDine | 75 mg /m² | Subcut | Days 1 to 5 |
| venetoclax | 400 mg | PO | Days 1 to 7 |
| gilteritinib | 80 mg | PO | Days 1 to 28 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
In the clinical trial, two doses of prophylactic intrathecal cytarabine were recommended on cycle 1, day 21 and again during cycle 2.
REPEAT EVERY 28 DAYS
For up to 24 cycles unless disease progression or unacceptable toxicity occurs
Venetoclax and gilteritinib: Outpatient prescription for home administration
Short NJ, Daver N, Dinardo CD, et al. Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or Refractory FLT3-Mutated AML. J Clin Oncol 2024 Jan 26:JCO2301911. doi: 10.1200/JCO.23.01911.
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.