Decitabine

Decitabine is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation or apoptosis. Decitabine inhibits DNA methylation in vitro, which is achieved at concentrations that do not cause major suppression of DNA synthesis.

• Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British 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 groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British 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 groups.ICD-10: C95.90, D64.9

• None. None.contraindicated

Three Day Regimen : Administer Decitabine for Injection at a dose of 15 mg/m 2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. Repeat cycle every 6 weeks. ( 2.1 ) Five Day Regimen : Administer Decitabine for Injection at a dose of 20 mg/m 2 by continuous intravenous infusion over 1 hour repeated daily for 5 days. Repeat cycle every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage Pre-Medications and Baseline Testing Consider pre-medicating for nausea with antiemetics. Conduct baseline laboratory testing: complete blood count (CBC) with platelets, serum hepatic panel, and serum creatinine. Decitabine for Injection Regimen Options Three Day Regimen Administer Decitabine for Injection at a dose of 15 mg/m 2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. Repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/mcL and platelets at least 50,000/mcL) for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles. Delay and reduce dose for hematologic toxicity [see Dosage and Administration ( 2.2 )] . Five Day Regimen Administer Decitabine for Injection at a dose of 20 mg/m 2 by continuous intravenous infusion over 1 hour daily for 5 days. Delay and reduce dose for hematologic toxicity [see Dosage and Administration ( 2.2 )] . Repeat cycles every 4 weeks upon hematologic recovery (ANC at least 1,000/mcL and platelets at least 50,000/mcL) for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles.

Neutropenia and Thrombocytopenia : Perform complete blood counts and platelet counts. ( 5.1 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception ( 5.2 , 8.1 , 8.3 ) 5.1 Myelosuppression Fatal and serious myelosuppression occurs in Decitabine for Injection-treated patients. Myelosuppression (anemia, neutropenia, and thrombocytopenia) is the most frequent cause of Decitabine for Injection dose reduction, delay, and discontinuation. Neutropenia of any grade occurred in 90% of Decitabine for Injection-treated patients with grade 3 or 4 occurring in 87% of patients. Grade 3 or 4 febrile neutropenia occurred in 23% of patients. Thrombocytopenia of any grade occurred in 89% of patients with grade 3 or 4 occurring in 85% of patients. Anemia of any grade occurred in 82% of patients. Perform complete blood count with platelets at baseline, prior to each cycle, and as needed to monitor response and toxicity. Manage toxicity using dose-delay, dose-reduction, growth factors, and anti-infective therapies as needed [see Dosage and Administration ( 2.2 )] . Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS. 5.2 Embryo-Fetal Toxicity Based on findings from human data, animal studies and its mechanism of action, Decitabine for Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] .

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Decitabine for Injection was studied in 3 single-arm studies (N = 66, N = 98, N = 99) and 1 controlled supportive care study (N = 83 Decitabine for Injection, N = 81 supportive care). The data described below reflect exposure to Decitabine for Injection in 83 patients in the MDS trial. In the trial, patients received 15 mg/m 2 intravenously every 8 hours for 3 days every 6 weeks. The median number of Decitabine for Injection cycles was 3 (range 0 to 9). Most Common Adverse Reactions: neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from human data, animal studies, and the mechanism of action, Decitabine for Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] . Limited published data on Decitabine for Injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). In animal reproduction studies, administration of decitabine to pregnant mice and rats during organogenesis caused adverse developmental outcomes including malformations and embryo-fetal lethality starting at doses approximately 7% of the recommended human dose on a mg/m 2 basis (see Data ) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage in the U.S. general population is 2% to 4% and 15% to 20% of clinically recognized pregnancies, respectively.

Metabolism

Pharmacokinetic (PK) parameters were evaluated in patients. Eleven patients received 20 mg/m 2 infused over 1 hour intravenously (treatment Option 2).

There is no known antidote for overdosage with Decitabine for Injection. Higher doses are associated with increased myelosuppression including prolonged neutropenia and thrombocytopenia. Standard supportive measures should be taken in the event of an overdose.

• Jul 11, 2013ANDAANDA203131Dr Reddys
• Jan 23, 2014NDANDA205582Sun Pharm
• Feb 27, 2017ANDAANDA203475Accord Hlthcare
• May 31, 2017ANDAANDA204607Pharmascience Inc
• Sep 22, 2017ANDAANDA206033Chemi Spa
• Aug 28, 2019ANDAANDA212265Msn
• Sep 16, 2019ANDAANDA210984Novast Labs
• Jul 7, 2020NDANDA212576Taiho Oncology

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Decitabine, Injection, 50 mg (NDC 50742-430-01)To be discontinued
  Sponsor: Ingenus Pharmaceuticals LLC
  Updated Feb 20, 2026
• Decitabine, Injection, 50 mg (NDC 68001-573-41)To be discontinued
  Sponsor: Ingenus Pharmaceuticals LLC
  Updated Feb 20, 2026

1. 1Off Label Use54311%
2. 2Febrile Neutropenia4889.9%
3. 3Death3847.8%
4. 4Myelosuppression3667.4%
5. 5Drug Ineffective3567.2%
6. 6Pneumonia3396.9%
7. 7Neutropenia3196.5%
8. 8Product Use In Unapproved Indication2966.0%
9. 9Pyrexia2905.9%
10. 10Thrombocytopenia2595.3%
11. 11Acute Myeloid Leukaemia2444.9%
12. 12Platelet Count Decreased2424.9%
13. 13Nausea2274.6%
14. 14Fatigue2224.5%
15. 15Sepsis2204.5%

Recent PubMed references pinned to Decitabine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia.
  The New England journal of medicine · 2026 · Roboz GJ, Zeidan AM, Mannis GN, et al.
  PMID 42235013DOI 10.1056/NEJMoa2510223
• Venetoclax combined with chidamide and decitabine successfully induced remission in relapsed/refractory classical Hodgkin lymphoma: a case report and literature review.
  Frontiers in immunology · 2026 · Jin X, Tang Y, Wu Y, et al.
  PMID 42220531DOI 10.3389/fimmu.2026.1757010
• Dpep, a Cell-Penetrating Peptide Targeting ATF5, CEBPB and CEBPD, Synergistically Combines with ABT-263 and Decitabine to Inhibit Cancer Cell Growth and Overcome Dpep Resistance.
  Cells · 2026 · Zhou Q, Nguyen TTT, Angelastro JM, et al.
  PMID 42121927DOI 10.3390/cells15090826
• 5-HT1A receptor agonist properties of DNA methyltransferase inhibitor decitabine in mice exposed to the forced swim test.
  Behavioural brain research · 2026 · Sales AJ, Fronza MG, Pedrazzi JF, et al.
  PMID 41999775DOI 10.1016/j.bbr.2026.116229
• A survival prognostic model for high-risk myelodysplastic syndrome patients treated with decitabine.
  Hematology (Amsterdam, Netherlands) · 2026 · Liu Y, Niu H, Wei Y, et al.
  PMID 41972336DOI 10.1080/16078454.2026.2657628
• Baiting-enhanced extravasation of lipid nanoparticles for targeted co-delivery of decitabine and siTNF-α to the bone marrow niche in leukemia therapy.
  Journal of controlled release : official journal of the Controlled Release Society · 2026 · Zhu Y, Li Q, Zhou Y, et al.
  PMID 41905408DOI 10.1016/j.jconrel.2026.114874
• The combined inhibitory effect of butaselen and decitabine against lung cancer cells.
  Scientific reports · 2026 · Chen Y, Lin C, Lu Y, et al.
  PMID 41872448DOI 10.1038/s41598-026-45054-7
• Composite nanovesicles for enhanced chemodynamic cancer therapy via decitabine-mediated epigenetic reactivation.
  Journal of controlled release : official journal of the Controlled Release Society · 2026 · Zhao X, Qiu L
  PMID 41871782DOI 10.1016/j.jconrel.2026.114849

The 10 most recently updated of 559 ClinicalTrials.gov registrations naming Decitabine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia
  Recruiting · Phase 1 · Interventional · 47 enrolled · National Cancer Institute (NCI)
  NCT07012044updated 2026-06-12
• Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
  Recruiting · Phase 1 · Phase 2 · Interventional · 44 enrolled · M.D. Anderson Cancer Center
  NCT06383572updated 2026-06-12
• Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
  Recruiting · Phase 1 · Interventional · 32 enrolled · National Cancer Institute (NCI)
  NCT05673200updated 2026-06-11
• A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
  Recruiting · Phase 1 · Interventional · 40 enrolled · M.D. Anderson Cancer Center
  NCT06191978updated 2026-06-11
• Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia
  Active not recruiting · Phase 1 · Interventional · 58 enrolled · National Cancer Institute (NCI)
  NCT03041688updated 2026-06-11
• Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)
  Recruiting · Phase 2 · Interventional · 54 enrolled · National Cancer Institute (NCI)
  NCT06577441updated 2026-06-11
• MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
  Recruiting · Phase 2 · Interventional · 2,000 enrolled · National Cancer Institute (NCI)
  NCT05564390updated 2026-06-11
• Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 52 enrolled · M.D. Anderson Cancer Center
  NCT04655755updated 2026-06-11
• ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
  Recruiting · Phase 1 · Phase 2 · Interventional · 42 enrolled · M.D. Anderson Cancer Center
  NCT05010122updated 2026-06-11
• Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
  Recruiting · Phase 1 · Interventional · 54 enrolled · National Cancer Institute (NCI)
  NCT06484062updated 2026-06-11

Frequently asked questions

How does Decitabine work?

Decitabine is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation or apoptosis. Decitabine inhibits DNA methylation in vitro, which is achieved at concentrations that do not cause major suppression of DNA synthesis.

What is Decitabine used for?

According to FDA labeling, Decitabine carries indications including: Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British 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 groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British 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 groups.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Decitabine?

Decitabine is classified as Pyrimidine analogues, Nucleoside Metabolic Inhibitor, DNA Methyltransferase Inhibitors, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity, Increased Cellular Death.

What are the brand names for Decitabine?

Decitabine is marketed under brand names including Dacogen, Inqovi.

What are the contraindications for Decitabine?

Decitabine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.