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.
CEDADECI
Myelodysplastic Syndrome (MDS)
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 the treatment of myelodysplastic syndromes (MDS), in patients who have IPSS intermediate-1, intermediate-2, and/or high-risk MDS*, adequate organ function, and have not had disease progression while on a hypomethylating agent
*Patient may have previously treated or untreated, de novo or secondary MDS, including all French-American-British (FAB) subtypes (Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), and chronic myelomonocytic leukemia (CMML)).
(Refer to EAP funding criteria)
decitabine / cedazuridine
Exceptional Access Program
(decitabine / cedazuridine - For the treatment of adult patients with myelodysplastic syndromes (MDS), according to clinical criteria)
(EAP Website)
Note: Decitabine/cedazuridine is not interchangeable with other decitabine products. Do not substitute.
| decitabine / cedazuridine | 35 / 100 mg | PO | Days 1 to 5 |
Low – No routine prophylaxis; PRN recommended
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Do not modify the recommended dose for the first 2 cycles.
Hematologic Toxicity
Dosage Reduction for Myelosuppression:
| Dose Level | Decitabine / Cedazuridine Dose |
| 0 | 1 tablet once daily on days 1 through 5 |
| -1 | 1 tablet once daily on days 1 through 4 |
| -2 | 1 tablet once daily on days 1 through 3 |
| -3 | 1 tablet once daily on days 1, 3, and 5 |
Dose modifications in the absence of active disease:
| Toxicity | Decitabine / Cedazuridine Dose |
| ANC < 1 x 109/L and/or Platelets < 50 x 109/L |
Hold, and:
|
*ANC ≥ 1 x 109/L and Platelets ≥ 50 x 109/L
Non-hematologic Toxicity
| Toxicity | Decitabine / Cedazuridine Dose |
| Serum creatinine ≥ 176.8 µmol /L |
Delay treatment until resolved; manage patient appropriately. Resume at same dose level or at 1 dose level ↓ (e.g., administer fewer days per cycle). |
| Bilirubin ≥ 2 x ULN | |
| ALT or AST ≥ 2 x ULN | |
| Active or uncontrolled infection | |
| Severe hypersensitivity | Discontinue; manage patient appropriately. |
Hepatic Impairment
| Hepatic Impairment | Decitabine / Cedazuridine Starting Dose |
| Mild (bilirubin > 1 to ≤ 1.5 × ULN) | No dosage adjustment necessary. |
| Moderate (bilirubin > 1.5 to 3 x ULN) | No data available. |
| Severe (bilirubin > 3 × ULN) |
Renal Impairment
|
Creatinine Clearance (mL / min) |
Decitabine / Cedazuridine Starting Dose |
| ≥ 60 | No dosage adjustment necessary. |
| ≥ 30 to 59 | No dosage adjustment necessary; monitor for increased incidence of adverse reactions. |
| 15 to 29 | Use with caution; No data available. |
| < 15 (ESRD) |
Dosage in the Elderly
No adjustment required. Overall, no differences in efficacy and safety were observed between patients ≥ 65 years and younger patients.
Refer to decitabine / cedazuridine 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 decitabine / cedazuridine drug monograph(s) for additional details.
- Avoid co-administration with drugs metabolized by cytidine deaminase (CDA).
- Avoid gastric acid reducing agents within 4 hours of decitabine / cedazuridine administration.
Refer to decitabine / cedazuridine drug monograph(s) for additional details
Administration
- Administer at approximately the same time each day for 5 days in each cycle.
- Tablets should be swallowed whole with water; do not cut, crush, or chew.
- Decitabine / cedazuridine should be taken on an empty stomach; do not consume food 2 hours before and 2 hours after each dose.
- Missed dose:
- If the missed dose is within 12 hours of the time it is usually taken, administer the missed dose as soon as possible and then resume the normal daily dosing schedule.
- If dose is missed by more than 12 hours of the time it is usually taken, the patient should wait and take the missed dose the following day at the usual time and extend the dosing period by 1 day for every missed dose to complete 5 daily doses for each cycle.
- If a dose is vomited, do not administer an additional dose, continue with the next scheduled dose.
- Store tablets in original packaging at room temperature (15 to 30°C).
Contraindications
- Patients who have a hypersensitivity to this drug or any of its components
Other Warnings/Precautions
- Caution with driving or using machinery as fatigue or dizziness may occur with treatment due to anemia.
- Contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
Pregnancy/Lactation
- Decitabine / cedazuridine is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment and for at least 6 months following the last dose in women and at least 3 months following the last dose in men.
- Breastfeeding is not recommended during decitabine / cedazuridine treatment and for at least 2 weeks after the last dose.
- Fertility Effects: Yes
- Prior to treatment, male patients should seek advice on conservation of sperm and female patients of childbearing potential should seek consultation regarding oocyte cryopreservation.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
-
CBC; Baseline, prior to each cycle, and as clinically indicated
-
Liver function tests; Baseline and as clinically indicated
-
Renal function tests; Baseline and as clinically indicated
-
Clinical toxicity assessment for infection, bleeding, fatigue, rash, hypersensitivity, tumour lysis syndrome, differentiation syndrome, GI and respiratory effects; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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CADTH reimbursement final recommendation: Decitabine and cedazuridine (MDS), September 2021.
Garcia-Manero, Guillermo. Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study. Blood. 2020; 136(6): 674-683.
Inqovi (decitabine/cedazuridine) product monograph. Oakville, Ontario: Taiho Pharma Canada Inc., July 2020.
January 2023 Added EAP funding criteria; updated Rationale/uses section
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.
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