Version July 2025
Dosage guidance:
Safety: Do not substitute decitabine/cedazuridine oral tablets for IV decitabine within a treatment cycle.
Clinical considerations: Administer anti-infective prophylaxis as clinically appropriate. Consider the use of antiemetics prior to each decitabine/cedazuridine dose.
Myelodysplastic syndromes: Note: Begin next cycle only if ANC ≥1,000/mm3 and platelets ≥50,000/mm3 (in the absence of active disease).
Oral: Decitabine 35 mg/cedazuridine 100 mg once daily on days 1 to 5 of each 28-day treatment cycle for a minimum of 4 cycles; continue until disease progression or unacceptable toxicity. May take longer than 4 cycles for a complete or partial response (Ref).
Missed dose: If a dose is missed within 12 hours of the time it is usually administered, administer the missed dose as soon as possible and then resume the normal daily dosing schedule. 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).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Kidney function may be estimated using the Cockcroft-Gault equation.
CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl ≥30 to 59 mL/minute: No dosage adjustment necessary; monitor for increased incidence of adverse reactions.
CrCl 15 to 29 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
CrCl <15 mL/minute (end-stage kidney disease): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Acute kidney toxicity during treatment: Serum creatinine ≥2 mg/dL: Delay the next cycle and resume at the same or at a reduced dose (eg, administer fewer days per cycle) upon resolution.
Initial dose titration in patients with preexisting hepatic impairment :
Mild impairment (total bilirubin >1 to 1.5 times ULN or AST > ULN): There are no dosage adjustments provided in the manufacturer’s labeling; however, mild impairment had no effect on decitabine or cedazuridine pharmacokinetics.
Moderate (total bilirubin >1.5 to 3 times ULN and any AST) to severe (total bilirubin >3 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Acute hepatotoxicity during treatment:
Serum bilirubin ≥2 times ULN: Delay the next cycle and resume at the same or at a reduced dose (eg, administer fewer days per cycle) upon resolution.
AST or ALT ≥2 times ULN: Delay the next cycle and resume at the same or at a reduced dose (eg, administer fewer days per cycle) upon resolution.
|
Usual (initial) dose |
Decitabine 35 mg/cedazuridine 100 mg once daily on days 1 through 5 of a 28-day treatment cycle |
|
Dose Reduction Level |
Decitabine/Cedazuridine Dose Reduction Schedule |
|
First |
Decitabine 35 mg/cedazuridine 100 mg once daily on days 1 through 4 |
|
Second |
Decitabine 35 mg/cedazuridine 100 mg once daily on days 1 through 3 |
|
Third |
Decitabine 35 mg/cedazuridine 100 mg once daily on days 1, 3, and 5 |
|
Adverse reaction |
Severity |
Decitabine/cedazuridine dosage modification |
|---|---|---|
|
a In the absence of active disease. | ||
|
b Hematologic recovery: ANC ≥1,000/mm3 and platelets ≥50,000/mm3. | ||
|
Hematologic toxicity | ||
|
Neutropeniaa |
ANC <1,000/mm3 (grade 3) |
Withhold decitabine/cedazuridine and monitor CBC as clinically indicated. Administer supportive care (growth factors and anti-infectives) for persistent severe neutropenia or febrile neutropenia as clinically indicated. Resume next cycle when ANC ≥1,000/mm3 and platelets ≥50,000/mm3. Hematologic recoveryb within 2 weeks of achieving remission: Continue decitabine/cedazuridine at same dose. Hematologic recoveryb does not occur within 2 weeks of achieving remission: Withhold decitabine/cedazuridine for up to 2 additional weeks; resume at reduced dose (administration on days 1 to 4). Consider further dose reduction if bone marrow suppression continues. Reduced dose may be continued or increased in subsequent cycles as clinically indicated. |
|
Thrombocytopeniaa |
Platelets <50,000/mm3 (grade 3) |
Withhold decitabine/cedazuridine and monitor CBC as clinically indicated. Resume next cycle when ANC ≥1,000/mm3 and platelets ≥50,000/mm3. Hematologic recoveryb within 2 weeks of achieving remission: Continue decitabine/cedazuridine at same dose. Hematologic recoveryb does not occur within 2 weeks of achieving remission: Withhold decitabine/cedazuridine for up to 2 additional weeks; resume at reduced dose (administration on days 1 to 4). Consider further dose reduction if bone marrow suppression continues. Reduced dose may be maintained or increased in subsequent cycles as clinically indicated. |
|
Nonhematologic toxicity | ||
|
Infection |
Any active or uncontrolled |
Withhold decitabine/cedazuridine; administer anti-infective treatment and prophylaxis as clinically indicated. Upon resolution, resume at same dose or reduced dose (eg, administer fewer days per cycle). |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. Also see decitabine.
>10%:
Dermatologic: Skin rash (12%)
Endocrine & metabolic: Decreased serum albumin (22%), decreased serum calcium (16%), decreased serum glucose (14%), increased serum glucose (19%)
Gastrointestinal: Constipation (20%), diarrhea (16%), nausea (25%), stomatitis (18%; grades 3/4: 1%)
Hematologic & oncologic: Anemia (71%; grades 3/4: 55%), febrile neutropenia (10% to 33%; grades 3/4: 10% to 32%), hemorrhage (24%; grades 3/4: 2%), leukopenia (79%; grades 3/4: 65%), neutropenia (73%; grades 3/4: 71%), thrombocytopenia (82%; grades 3/4: 76%)
Hepatic: Increased serum alanine aminotransferase (13%), increased serum alkaline phosphatase (22%), increased serum transaminase (12%)
Infection: Sepsis (6% to 14%)
Nervous system: Dizziness (16%), fatigue (29%), headache (22%)
Respiratory: Dyspnea (17%), pneumonia (7% to 21%)
1% to 10%:
Cardiovascular: Cardiac arrhythmia (3%), edema (10%), hypotension (4%)
Dermatologic: Cellulitis (4%), Sweet’s syndrome (1%)
Endocrine & metabolic: Decreased serum sodium (9%), weight loss (5%)
Gastrointestinal: Abdominal pain (9%), decreased appetite (10%), vomiting (5%)
Hepatic: Increased serum aspartate aminotransferase (6%)
Nervous system: Falling (4%), insomnia (6%), neuropathy (4%)
Neuromuscular & skeletal: Arthralgia (9%), myalgia (9%)
Renal: Increased serum creatinine (7%), renal insufficiency (9%)
Respiratory: Cough (7%), upper respiratory tract infection (6%)
Miscellaneous: Fever (7%)
<1%: Hematologic & oncologic: Tumor lysis syndrome
Postmarketing:
Cardiovascular: Cardiomyopathy
Hematologic & oncologic: Differentiation syndrome
Respiratory: Interstitial pulmonary disease
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to decitabine, cedazuridine, or any component of the formulation.
Concerns related to adverse effects:
• Bone marrow suppression: Fatal and serious myelosuppression can occur with decitabine/cedazuridine. New or worsening thrombocytopenia (including grades 3 or 4) occurred commonly. Neutropenia and anemia (including grades 3 or 4) were also common. Neutropenic fever occurred in one-third of patients; grades 3 or 4 neutropenic fever events were reported. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying myelodysplastic syndromes. Hematologic toxicity (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) is the most frequent cause of decitabine/cedazuridine treatment interruption and/or dose reduction.
• Infection: Serious and sometimes fatal complications due to infection have occurred with decitabine/cedazuridine. Pneumonia and sepsis have been observed, including grade 3 or 4 events; rare fatalities due to pneumonia, sepsis, and septic shock were also reported.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Inqovi: 35-100 MG
No
Tablets (Inqovi Oral)
35-100 mg (per each): $2,081.97
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Inqovi: 35-100 MG
Decitabine/cedazuridine is available through specialty distributors, specialty pharmacies, and various specialty institutions/accounts. Examples from the manufacturer may be found at https://www.inqovi.com/Content/pdf/pharmacy-guide.pdf.
Oral: Administer at approximately the same time of day. Swallow tablet whole; do not cut, crush, or chew. Administer on an empty stomach; do not consume food 2 hours before and 2 hours after dose. Consider the use of antiemetics prior to each decitabine/cedazuridine dose.
Decitabine is a hazardous agent (NIOSH 2024 [table 1]); decitabine/cedazuridine is a cytotoxic drug (per product labeling).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Myelodysplastic syndromes: Treatment of myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, in adults.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification
Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Evaluate pregnancy status prior to use in patients who could become pregnant.
Patients who could become pregnant should use effective contraception during therapy and for 6 months after the last dose of decitabine/cedazuridine. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last decitabine/cedazuridine dose.
Based on the mechanism of action, data from animal reproduction studies, as well as limited human data, in utero exposure to decitabine/cedazuridine may cause fetal harm.
It is not known if decitabine or cedazuridine are present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 2 weeks after the last decitabine/cedazuridine dose.
Monitor CBC (at baseline, prior to each cycle, and as clinically indicated); monitor serum creatinine, CrCl, AST, ALT, total bilirubin. Evaluate pregnancy status prior to use (in patients who could become pregnant). Monitor for signs/symptoms of infection. Monitor adherence.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Decitabine is a hypomethylating agent. After phosphorylation, decitabine is incorporated into DNA and inhibits DNA methyltransferase causing hypomethylation and subsequent cell death (within the S-phase of the cell cycle). Hypomethylation in cancer cells may restore normal function to genes that are necessary for control of cellular differentiation and proliferation.
Cedazuridine is a cytidine deaminase (CDA) inhibitor. CDA is an enzyme that catalyzes the degradation of cytidine, including the cytidine analog decitabine; high CDA levels in the GI tract and liver degrade decitabine and limit its oral bioavailability. The combination of cedazuridine with decitabine increases systemic decitabine exposure.
Distribution: V/Fss (apparent): Decitabine: 417 L; Cedazuridine: 296 L.
Metabolism: Decitabine: Primarily via cytidine deaminase, also via physiochemical degradation; Cedazuridine: Conversion to epimer via physiochemical degradation.
Bioavailability: Decitabine: Cedazuridine increases oral decitabine exposure; Cedazuridine: 20%.
Half-life elimination: Decitabine: 1.5 hours; Cedazuridine: 6.7 hours.
Time to peak: Decitabine: 1 hour (range: 0.3 to 3 hours); Cedazuridine: 3 hours (range: 1.5 to 6.1 hours).
Excretion: Cedazuridine: Feces (51%; 27% as unchanged drug); Urine (46%; 21% as unchanged drug).
Clearance (apparent): Decitabine: 197 L/hour; Cedazuridine: 30.3 L/hour.
