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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 (Cashen 2010; Kantarjian 2012).

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 (DiNardo 2018; DiNardo 2019).

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 (Welch 2016) or 20 mg/m2 once daily for 5 days every 28 days (in combination with venetoclax) until relapse, disease progression, or unacceptable toxicity (DiNardo 2018; DiNardo 2019).

Myelodysplastic syndromes

Myelodysplastic syndromes: IV:

3-day regimen: 15 mg/m2 over 3 hours every 8 hours (45 mg/m2/day) for 3 days (Kantarjian 2006); 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 (Steensma 2009); 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 (Santini 2018). 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 (Jabbour 2017). 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: Older Adult

Refer to adult dosing.

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.

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

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 (Cashen 2010; Kantarjian 2012).

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 (Kantarjian 2007a; Kantarjian 2007b). Other schedules of subcutaneous decitabine have been reported in a small study in patients with low- or intermediate-risk myelodysplastic syndromes (Garcia-Manero 2013). 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.

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.

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

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

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

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

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. 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

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

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

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

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

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

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

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

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

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

Metabolism: Possibly via deamination by cytidine deaminase

Half-life elimination: ~0.5 to 0.6 hours

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.

Brand Names: International
  • Cribina (AR);
  • Dacogen (AR, AT, BB, BE, BR, CH, CL, CN, CO, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, JO, KR, LB, LK, LT, LU, MT, MY, NL, NO, PE, PH, PL, PT, RO, RU, SE, SG, SI, SK, TH, TR, UY);
  • Decbine (PH);
  • Oxidina (AR, VE);
  • Redtibin (VE);
  • Xalibo (VN)


For country code abbreviations (show table)
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