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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Decitabine: Drug information

Decitabine: Drug information
(For additional information see "Decitabine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Dacogen [DSC]
Brand Names: Canada
  • Demylocan
Pharmacologic Category
  • Antineoplastic Agent, Antimetabolite;
  • Antineoplastic Agent, DNA Methylation Inhibitor
Dosing: Adult
Acute myeloid leukemia, newly diagnosed

Acute myeloid leukemia, newly diagnosed (off-label use): IV:

Adults ≥60 years of age: 20 mg/m2 over 1 hour once daily for 5 days every 28 days until relapse, disease progression, or unacceptable toxicity (Ref).

Adults ≥65 years of age: 20 mg/m2 once daily for 5 days every 28 days (in combination with venetoclax) until relapse, disease progression, or unacceptable toxicity (Ref).

Acute myeloid leukemia, with unfavorable-risk cytogenetics and/or TP53 mutation: 20 mg/m2 once daily for 10 days every 28 days for at least 2 cycles, although 3 or more cycles may be required (Ref) or 20 mg/m2 once daily for 5 days every 28 days (in combination with venetoclax) until relapse, disease progression, or unacceptable toxicity (Ref).

Myelodysplastic syndromes

Myelodysplastic syndromes: IV:

3-day regimen: 15 mg/m2 over 3 hours every 8 hours (45 mg/m2/day) for 3 days (Ref); repeat every 6 weeks upon hematologic recovery (ANC ≥1,000/mm3 and platelets ≥50,000/mm3); treatment is recommended for a minimum of 4 cycles (complete or partial response may take longer than 4 cycles).

5-day regimen: 20 mg/m2 over 1 hour once daily for 5 days (Ref); repeat every 4 weeks upon hematologic recovery (ANC ≥1,000/mm3 and platelets ≥50,000/mm3); treatment is recommended for a minimum of 4 cycles (complete or partial response may take longer than 4 cycles).

Higher- risk myelodysplastic syndromes (CMML subtype): 20 mg/m2 once daily for 5 days every 4 weeks; patients were assessed after 4 cycles, responders continued for an additional 2 cycles; patients who completed 6 cycles could continue with maintenance decitabine (Ref). Refer to protocol for additional details.

Lower- risk myelodysplastic syndromes (off-label dosing): 20 mg/m2 over 1 hour once daily for 3 days; repeat every 4 weeks when possible; continue until disease progression or unacceptable toxicity (Ref). Refer to protocol for dosage adjustment details.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Preexisting impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); consider the potential risks and benefits prior to initiating treatment in patients with preexisting impairment.

Renal toxicity during treatment: Serum creatinine ≥2 mg/dL: Temporarily withhold decitabine; do not resume until after resolution.

Dosing: Hepatic Impairment: Adult

Preexisting impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); consider the potential risks and benefits prior to initiating treatment in patients with preexisting impairment.

Hepatotoxicity during treatment: ALT and/or bilirubin ≥2 times ULN: Temporarily withhold decitabine; do not resume until after resolution.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Myelodysplastic syndromes: IV:

Hematologic toxicity: ANC <1,000/mm3 and platelets <50,000/mm3: Delay subsequent decitabine treatment cycles until hematologic recovery to ANC ≥1,000/mm3 and platelets ≥50,000/mm3.

3-day regimen : Hematologic toxicity lasting >6 weeks: Delay the next decitabine cycle and reduce the next dose as follows:

Hematologic toxicity lasting >6 weeks but <8 weeks: Delay decitabine dose for up to 2 weeks and upon re-initiation, temporarily reduce decitabine dose to 11 mg/m2 every 8 hours (33 mg/m2/day) for 3 days (99 mg/m2/cycle).

Hematologic toxicity lasting >8 weeks but <10 weeks: Assess bone marrow for disease progression; in the absence of disease progression, delay decitabine dose for up to 2 more weeks and reduce decitabine dose to 11 mg/m2 every 8 hours (33 mg/m2/day) for 3 days (99 mg/m2/cycle); maintain or increase decitabine dose with subsequent cycles if clinically indicated.

Nonhematologic toxicity:

Active or uncontrolled infection: Temporarily withhold decitabine; do not resume decitabine until after resolution.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Edema (5% to 18%), heart murmur (16%), hypotension (6% to 11%), peripheral edema (25% to 27%)

Dermatologic: Cellulitis (9% to 12%), ecchymoses (9% to 22%), erythema of skin (5% to 14%), pallor (23%), pruritus (9% to 11%), skin lesion (5% to 11%), skin rash (11% to 19%)

Endocrine & metabolic: Hyperglycemia (6% to 33%), hyperkalemia (13%), hypoalbuminemia (24%), hypokalemia (12% to 22%), hypomagnesemia (5% to 24%), hyponatremia (19%)

Gastrointestinal: Abdominal pain (14%), anorexia (16% to 23%), constipation (30% to 35%), decreased appetite (8% to 16%), diarrhea (28% to 34%), dyspepsia (10% to 12%), nausea (40% to 42%), stomatitis (11% to 12%), vomiting (16% to 25%)

Hematologic & oncologic: Anemia (31% to 82%), febrile neutropenia (20% to 29%; grades 3/4: 23%), leukopenia (6% to 28%), lymphadenopathy (12%), neutropenia (38% to 90%; grades 3/4: 87%), oral mucosal petechiae (13%), petechia (12% to 39%), thrombocytopenia (27% to 89%; grades 3/4: 85%)

Hepatic: Hyperbilirubinemia (14%), increased serum alkaline phosphatase (11%)

Local: Localized tenderness (11%)

Nervous system: Anxiety (9% to 11%), chills (16%), confusion (8% to 12%), dizziness (18% to 21%), fatigue (46%), headache (23% to 28%), hypoesthesia (11%), insomnia (14% to 28%), lethargy (12%), pain (5% to 13%), rigors (22%)

Neuromuscular & skeletal: Arthralgia (17% to 20%), asthenia (15%), back pain (17% to 18%), limb pain (18% to 19%)

Respiratory: Cough (27% to 40%), dyspnea (29%), epistaxis (13%), pharyngitis (16%), pneumonia (20% to 22%), rales (8% to 14%)

Miscellaneous: Fever (6% to 53%)

1% to 10%:

Cardiovascular: Cardiac failure (5%), chest discomfort (7%), chest pain (6%), chest wall pain (7%), hypertension (6%), tachycardia (8%)

Dermatologic: Alopecia (8%), catheter-site erythema (5%), excoriation of skin (5%), facial swelling (6%), night sweats (5%), urticaria (6%), xeroderma (8%)

Endocrine & metabolic: Decreased serum bicarbonate (5%), decreased serum total protein (5%), dehydration (6% to 8%), hypochloremia (6%), increased lactate dehydrogenase (8%), increased serum bicarbonate (6%), weight loss (9%)

Gastrointestinal: Abdominal distention (5%), dysphagia (5% to 6%), gastroesophageal reflux disease (5%), gingival hemorrhage (8%), glossalgia (5%), hemorrhoids (8%), loose stools (7%), mucosal swelling (9%), oral candidiasis (6%), oral changes (soft tissue: 6%), oral mucosa ulcer (lip: 5%), tongue ulcer (7%), toothache (6%), upper abdominal pain (5% to 6%)

Genitourinary: Dysuria (6%), urinary frequency (5%), urinary tract infection (7%)

Hematologic & oncologic: Bruise (9%), hematoma (5%), pancytopenia (5%), thrombocythemia (5%)

Hepatic: Ascites (10%), decreased serum bilirubin (5%), increased serum aspartate aminotransferase (10%)

Hypersensitivity: Transfusion reaction (7%)

Infection: Bacteremia (5%), candidiasis (10%), staphylococcal bacteremia (8%), staphylococcal infection (7%), tooth abscess (5%)

Local: Catheter infection (8%), catheter pain (5%), swelling at injection site (5%)

Nervous system: Depression (9%), falling (8%), malaise (5%), mouth pain (5%), myasthenia (5%)

Neuromuscular & skeletal: Muscle spasm (7%), musculoskeletal pain (5% to 6%; includes discomfort), myalgia (5% to 9%), ostealgia (6%)

Ophthalmic: Blurred vision (6%)

Otic: Otalgia (6%)

Renal: Increased blood urea nitrogen (10%)

Respiratory: Abnormal breath sounds (5% to 10%), hypoxia (10%), paranasal sinus congestion (5%), pharyngolaryngeal pain (8%), pleural effusion (5%), post nasal drip (5%), pulmonary edema (6%), pulmonary signs and symptoms (crepitations: 5%), sinusitis (5% to 6%), upper respiratory tract infection (10%)

Frequency not defined:

Cardiovascular: Acute cardiorespiratory failure, acute myocardial infarction, atrial fibrillation, cardiomyopathy, pulmonary embolism, supraventricular tachycardia

Gastrointestinal: Cholecystitis, gingival pain

Genitourinary: Urethral bleeding

Hematologic & oncologic: Bone marrow depression, postprocedural hemorrhage, splenomegaly, upper gastrointestinal hemorrhage

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Infection: Abscess (peridiverticular), fungal infection, sepsis

Local: Catheter site hemorrhage

Nervous system: Intracranial hemorrhage, mental status changes

Renal: Acute kidney injury

Respiratory: Hemoptysis, mycobacterium avium complex, pulmonary aspergillosis, pulmonary infection (pseudomonas), pulmonary infiltrates, respiratory tract infection

Miscellaneous: Mass (pulmonary), postoperative pain

Postmarketing:

Dermatologic: Sweet's syndrome (acute febrile neutrophilic dermatosis)

Hematologic & oncologic: Differentiation syndrome

Respiratory: Interstitial pulmonary disease

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Myelosuppression (neutropenia, thrombocytopenia, and anemia) commonly occurs with decitabine, including Grades 3 and 4 neutropenia, thrombocytopenia, and neutropenic fever; may be serious or fatal. Monitor blood counts (including platelets) at baseline, prior to each cycle, and as needed to monitor response and for toxicity. Myelosuppression and worsening neutropenia are more common in first two treatment cycles and may not correlate with progression of underlying myelodysplastic syndromes. Hematologic toxicity may require dose reduction, treatment delay, discontinuation, growth factor support, and/or antimicrobial agents. Monitor for infection.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Intravenous:

Dacogen: 50 mg (1 ea [DSC])

Generic: 50 mg (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Generic: 50 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (reconstituted) (Decitabine Intravenous)

50 mg (per each): $120.00 - $1,951.00

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.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Demylocan: 50 mg (1 ea)

Administration: Adult

IV: Infuse over 1 to 3 hours (depending on dosing regimen). For the treatment of myelodysplastic syndromes, infuse over 3 hours (15 mg/m2 dose) or over 1 hour (20 mg/m2 dose). Premedication with antiemetics is recommended (according to the manufacturer). For the treatment of acute myeloid leukemia (off-label use), decitabine has been infused over 1 hour (Ref).

SubQ (off-label route): Subcutaneous administration of the 5-day decitabine regimen has been reported in a limited number of patients with higher-risk myelodysplastic syndromes; however, the complete response rate was lower in the subcutaneous arm compared to the 5-day regimen administered IV (Ref). Other schedules of subcutaneous decitabine have been reported in a small study in patients with low- or intermediate-risk myelodysplastic syndromes (Ref). Multiple subcutaneous injections may be required to administer a single dose (depending on institutional subcutaneous volume policy).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 1]).

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 2016; USP-NF 2020).

Use: Labeled Indications

Myelodysplastic syndromes: Treatment of myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups

Use: Off-Label: Adult

Acute myeloid leukemia

Medication Safety Issues
Sound-alike/look-alike issues:

Dacogen may be confused with DACTINomycin

Decitabine may be confused with azaCITIDine

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Cedazuridine: May increase the serum concentration of Cytidine Deaminase Substrates. Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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 diminish the therapeutic effect 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

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect 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 enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect 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 diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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 enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect 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 combination

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Evaluate pregnancy status prior to therapy. Females of reproductive potential should use effective contraception during treatment and for 6 months after the last decitabine dose. Males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last decitabine dose.

Pregnancy Considerations

Based on the mechanism of action and information from animal reproduction studies, decitabine may cause fetal harm if exposure occurs during pregnancy. Information related to the use of decitabine in pregnancy is limited.

Breastfeeding Considerations

It is not known if decitabine is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends against breastfeeding during therapy and for at least 2 weeks after the last decitabine dose.

Monitoring Parameters

Monitor CBC with differential and platelets (prior to treatment and with each cycle; more frequently if needed); liver enzymes (prior to treatment initiation and periodically); serum creatinine (prior to treatment initiation and periodically). Evaluate pregnancy status prior to treatment in females of reproductive potential. Monitor for signs/symptoms of infection.

The American Society of Clinical Oncology hepatitis B screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends hepatitis B virus (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.

Mechanism of Action

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).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: ~63 to 89 L/m2 (Cashen 2008)

Metabolism: Possibly via deamination by cytidine deaminase

Half-life elimination: ~0.5 to 0.6 hours

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Dacogen;
  • (AR) Argentina: Cribina | Dacogen | Detavi | Oxidina | Signum;
  • (AT) Austria: Dacogen;
  • (BE) Belgium: Dacogen;
  • (BR) Brazil: Altryxen | Dacogen | Deci | Decitabina | Redtibin;
  • (CH) Switzerland: Dacogen | Decitabin accord | Decitabin sandoz;
  • (CL) Chile: Dacogen;
  • (CN) China: Xin mei;
  • (CO) Colombia: Dacogen | Decicip | Decitabina | Hb evotabin | Nalbine | Redtibin;
  • (DE) Germany: Dacogen;
  • (EE) Estonia: Dacogen;
  • (EG) Egypt: Dacogen;
  • (ES) Spain: Dacogen;
  • (FI) Finland: Dacogen;
  • (FR) France: Dacogen;
  • (GB) United Kingdom: Dacogen;
  • (GR) Greece: Dacogen;
  • (HK) Hong Kong: Dacogen;
  • (HU) Hungary: Dacogen;
  • (ID) Indonesia: Dacogen;
  • (IE) Ireland: Dacogen;
  • (IN) India: Dacogen | Decitas | Decitex | Deczuba | Visvin | Xalibo;
  • (IT) Italy: Dacogen;
  • (KR) Korea, Republic of: Dacogen | Debikin | Decilid;
  • (LB) Lebanon: Dacogen;
  • (LT) Lithuania: Dacogen;
  • (LV) Latvia: Dacogen;
  • (MY) Malaysia: Dacogen | Decitas | Redtibin;
  • (NL) Netherlands: Dacogen;
  • (NO) Norway: Dacogen;
  • (PE) Peru: Dacogen;
  • (PH) Philippines: Dacogen | Decbine;
  • (PR) Puerto Rico: Dacogen;
  • (PT) Portugal: Dacogen;
  • (RO) Romania: Dacogen;
  • (RU) Russian Federation: Dacogen;
  • (SA) Saudi Arabia: Dacogen;
  • (SE) Sweden: Dacogen;
  • (SG) Singapore: Dacogen;
  • (SI) Slovenia: Dacogen;
  • (TH) Thailand: Dacogen;
  • (TR) Turkey: Dacogen | Desibem | Desitab;
  • (TW) Taiwan: Dacogen | Demylocan;
  • (UA) Ukraine: Dacogen;
  • (ZA) South Africa: Dacogen
  1. <800> Hazardous Drugs–Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Cashen AF, Schiller GJ, O’Donnell, MR, et al, “Multicenter Phase II Study of Decitabine for the First-Line Treatment of Older Patients With Acute Myeloid Leukemia,” J Clin Oncol, 2010, 28(4):556-61. [PubMed 20026803]
  3. Cashen AF, Shah AK, Todt L, et al, “Pharmacokinetics of Decitabine Administered as a 3-h Infusion to Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS),” Cancer Chemother Pharmacol, 2008, 61(5):759-66. [PubMed 17564707]
  4. Dacogen (decitabine) [prescribing information]. Rockville, MD: Otsuka America Pharmaceutical Inc; November 2021.
  5. DiNardo CD, Pratz KW, Letai A, et al. Safety and preliminary efficacy of venetoclax with decitabine or azacitidine in elderly patients with previously untreated acute myeloid leukaemia: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018;19(2):216-228. doi:10.1016/S1470-2045(18)30010-X [PubMed 29339097]
  6. DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133(1):7-17. doi:10.1182/blood-2018-08-868752 [PubMed 30361262]
  7. Garcia-Manero G, Jabbour E, Borthakur G, et al. Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes. J Clin Oncol. 2013;31(20):2548-2553. doi: 10.1200/JCO.2012.44.6823. [PubMed 23733767]
  8. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  9. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  10. Jabbour E, Short NJ, Montalban-Bravo G, et al. Randomized phase 2 study of low-dose decitabine vs low-dose azacitidine in lower-risk MDS and MDS/MPN. Blood. 2017;130(13):1514-1522. doi:10.1182/blood-2017-06-788497 [PubMed 28774880]
  11. Kantarjian H, Issa JP, Rosenfeld CS, et al. Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study. Cancer. 2006;106(8):1794-1803. doi: 10.1002/cncr.21792 [PubMed 16532500]
  12. Kantarjian H, Oki Y, Garcia-Manero G, et al. Results of a randomized study of 3 schedules of low-dose decitabine in higher-risk myelodysplastic syndrome and chronic myelomonocytic leukemia. Blood. 2007a;109(1):52-57. doi: 10.1182/blood-2006-05-021162. [PubMed 16882708]
  13. Kantarjian HM, O'Brien S, Shan J, et al. Update of the decitabine experience in higher risk myelodysplastic syndrome and analysis of prognostic factors associated with outcome. Cancer. 2007b;109(2):265-273. doi: 10.1002/cncr.22376. [PubMed 17133405]
  14. Kantarjian HM, Thomas XG, Dmoszynska A, et al. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012;30(21):2670-2677. [PubMed 22689805]
  15. Santini V, Allione B, Zini G, et al. A phase II, multicentre trial of decitabine in higher-risk chronic myelomonocytic leukemia. Leukemia. 2018;32(2):413-418. doi: 10.1038/leu.2017.186 [PubMed 28607470]
  16. Saunthararajah Y, Hillery CA, Lavelle D, et al. Effects of 5-aza-2'-deoxycytidine on fetal hemoglobin levels, red cell adhesion, and hematopoietic differentiation in patients with sickle cell disease. Blood. 2003;102(12):3865-3870. doi:10.1182/blood-2003-05-1738 [PubMed 12907443]
  17. Sekeres MA, Guyatt G, Abel G, et al. American Society of Hematology 2020 guidelines for treating newly diagnosed acute myeloid leukemia in older adults. Blood Adv. 2020;4(15):3528-3549. doi:10.1182/bloodadvances.2020001920 [PubMed 32761235]
  18. Steensma DP, Baer MR, Slack JL, et al. Multicenter study of decitabine administered daily for 5 days every 4 weeks to adults with myelodysplastic syndromes: the alternative dosing for outpatient treatment (ADOPT) trial. J Clin Oncol. 2009;27(23):3842-3848. doi:10.1200/JCO.2008.19.6550 [PubMed 19528372]
  19. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed October 5, 2016.
  20. Welch JS, Petti AA, Miller CA, et al. TP53 and decitabine in acute myeloid leukemia and myelodysplastic syndromes. N Engl J Med. 2016;375(21):2023-2036. doi:10.1056/NEJMoa1605949 [PubMed 27959731]
  21. Yawn BP, Buchanan GR, Afenyi-Annan AN, et al. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014;312(10):1033-1048. doi:10.1001/jama.2014.10517 [PubMed 25203083]
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