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تعداد آیتم قابل مشاهده باقیمانده : -5 مورد

Decitabine: Drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Dacogen [DSC]
Brand Names: Canada
  • Demylocan
Pharmacologic Category
  • Antineoplastic Agent, Antimetabolite;
  • Antineoplastic Agent, DNA Methylation Inhibitor
Dosing: Adult

Dosage guidance:

Safety: Do not substitute decitabine/cedazuridine oral tablets for IV decitabine within a treatment cycle.

Clinical considerations: Refer to the protocol or institutional guidance for additional details of off-label dosing.

Acute myeloid leukemia, newly diagnosed

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

Adults ≥60 years of age: IV: 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: IV: 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: IV: 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:

3-day regimen: IV: 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: IV: 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): IV: 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).

Lower- risk myelodysplastic syndromes (off-label dosing): IV: 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).

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.

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

Dosing: Liver 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.

Acute 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: May require growth factor support and/or antimicrobial agents.

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. Myelosuppression and worsening neutropenia are more common in first two treatment cycles and may not correlate with progression of underlying myelodysplastic syndromes.

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 2024 [table 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 2023; NIOSH 2024; 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, decitabine/cedazuridine.

High alert medication:

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).

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 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

Cedazuridine: May increase serum concentration of Cytidine Deaminase Substrates. 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

Reproductive Considerations

Evaluate pregnancy status prior to therapy. Patients who could become pregnant should use effective contraception during treatment and for 6 months after the last decitabine dose. Patients with partners who could become pregnant 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, in utero exposure to decitabine may cause fetal harm. 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 (at baseline, prior to each cycle, and as needed to monitor response and for toxicity); liver enzymes (at baseline and periodically); serum creatinine (at baseline and periodically). Evaluate pregnancy status prior to treatment in patients who could become pregnant. 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 | Decitabine elfa;
  • (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
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