Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C8H12N4O4 |
Molecular Weight | 228.2056 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 3 / 3 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
C1[C@@]([H])([C@@]([H])(CO)O[C@@]1([H])n2cnc(=N)nc2O)O
InChI
InChIKey=XAUDJQYHKZQPEU-KVQBGUIXSA-N
InChI=1S/C8H12N4O4/c9-7-10-3-12(8(15)11-7)6-1-4(14)5(2-13)16-6/h3-6,13-14H,1-2H2,(H2,9,11,15)/t4-,5+,6+/m0/s1
DescriptionSources: https://www.ncbi.nlm.nih.gov/pubmed/23369223Curator's Comment:: description was created based on several sources, including http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021790s018lbl.pdf, www.ncbi.nlm.nih.gov/pubmed/20501800
Sources: https://www.ncbi.nlm.nih.gov/pubmed/23369223
Curator's Comment:: description was created based on several sources, including http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021790s018lbl.pdf, www.ncbi.nlm.nih.gov/pubmed/20501800
Decitabine was first synthesized by Pliml and Sorm in the Institute of Organic Chemistry, Czechoslovak Academy of Sciences in 1964. Later, the drug was approved by FDA for the treatment of myelodysplastic syndromes in patients with cancer. Upon administration the decitabine is metabolized to the active phosphorylated metabolite which is incorporated into DNA and thus inhibits DNA methyltransferase (decitabine deplete DNMT1).
CNS Activity
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL2311221 |
|||
Target ID: CHEMBL1993 Sources: www.ncbi.nlm.nih.gov/pubmed/20501800 |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | DACOGEN Approved UseDacogen is a nucleoside metabolic inhibitor indicated for treatment of 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. Launch Date1.14652794E12 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
73.8 ng/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/17564707 |
15 mg/m² steady-state, intravenous dose: 15 mg/m² route of administration: Intravenous experiment type: STEADY-STATE co-administered: |
DECITABINE plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
163 ng × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/17564707 |
15 mg/m² steady-state, intravenous dose: 15 mg/m² route of administration: Intravenous experiment type: STEADY-STATE co-administered: |
DECITABINE plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
0.62 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/17564707 |
15 mg/m² steady-state, intravenous dose: 15 mg/m² route of administration: Intravenous experiment type: STEADY-STATE co-administered: |
DECITABINE plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
99% |
DECITABINE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
100 mg/m2 2 times / day steady, intravenous Highest studied dose Dose: 100 mg/m2, 2 times / day Route: intravenous Route: steady Dose: 100 mg/m2, 2 times / day Sources: |
unhealthy, 52 years (range: 23 - 78 years) n = 13 Health Status: unhealthy Condition: chronic myelogenous leukemia (CML) Age Group: 52 years (range: 23 - 78 years) Sex: M+F Population Size: 13 Sources: |
|
20 mg/m2 1 times / day steady, intravenous Recommended|MTD Dose: 20 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 59 years (range: 42–79 years) n = 6 Health Status: unhealthy Condition: unresectable liver-predominant metastases Age Group: 59 years (range: 42–79 years) Sex: M+F Population Size: 6 Sources: |
Other AEs: Anaemia, Lymphopenia... Other AEs: Anaemia (grade 1, 17%) Sources: Lymphopenia (grade 2, 17%) Neutropenia (grade 2, 17%) Leucopenia (grade 1, 17%) Thrombocytopaenia (grade 1, 17%) |
15 mg/m2 1 times / day steady, intravenous Dose: 15 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 1 times / day Sources: |
unhealthy, 61 years (range: 32–82 years) n = 16 Health Status: unhealthy Condition: CLL Age Group: 61 years (range: 32–82 years) Sex: M+F Population Size: 16 Sources: |
DLT: Hyperbilirubinemia, Thrombocytopenia... Dose limiting toxicities: Hyperbilirubinemia (grade 3, 2 patients) Sources: Thrombocytopenia (2 patients) |
20 mg/m2 1 times / day multiple, subcutaneous Dose: 20 mg/m2, 1 times / day Route: subcutaneous Route: multiple Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 65 years n = 14 Health Status: unhealthy Condition: myelodysplastic syndrome Age Group: 65 years Sex: M+F Population Size: 14 Sources: |
|
15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Disc. AE: Anemia, Neutropenia... Other AEs: Neutropenia, Thrombocytopenia... AEs leading to discontinuation/dose reduction: Anemia (grade 5, 6 patients) Other AEs:Neutropenia (grade 5, 6 patients) Thrombocytopenia (grade 5, 6 patients) Neutropenia (grade 3-4, 87%) Sources: Thrombocytopenia (grade 3-4, 85%) Febrile neutropenia (grade 3-4, 23%) Leukopenia (grade 3-4, 22%) |
15 mg/m2 1 times / day steady, intravenous Dose: 15 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 1 times / day Sources: |
unhealthy, 72 years (range: 68–75 years) n = 4 Health Status: unhealthy Condition: NHL Age Group: 72 years (range: 68–75 years) Sex: M+F Population Size: 4 Sources: |
DLT: Febrile neutropenia... Dose limiting toxicities: Febrile neutropenia (grade 3-4, 2 patients) Sources: |
660 mg/m2 single, intravenous Highest studied dose Dose: 660 mg/m2 Route: intravenous Route: single Dose: 660 mg/m2 Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: chronic myelogenous leukemia Population Size: 7 Sources: |
|
15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Other AEs: Neutropenia, Thrombocytopenia... Other AEs: Neutropenia (all grades, 83%) Sources: Page: p. 82Thrombocytopenia (all grades, 81%) Anemia (all grades, 54%) Splenomegaly (all grades, 2%) Thrombocythaemia (all grades, 4%) Tachycardia (all grades, 1%) Pulmonary edema (all grades, 1%) Nausea (all grades, 22%) Constipation (all grades, 8%) Diarrhea (all grades, 16%) Vomiting (all grades, 8%) Abdominal pain (all grades, 4%) Oral mucosal petechiae (all grades, 5%) Stomatitis (all grades, 7%) Loose stools (all grades, 2%) Tongue ulceration (all grades, 5%) Dysphagia (all grades, 2%) Pyrexia (all grades, 16%) Fatigue (all grades, 18%) Asthenia (all grades, 4%) Fall (all grades, 1%) Hyperbilirubinaemia (all grades, 4%) Hepatomegaly (all grades, 1%) Cellulitis (all grades, 2%) Urinary tract infection (all grades, 1%) Alanine aminotransferase increased (all grades, 1%) Aspartate aminotransferase increased (all grades, 1%) Alkaline phosphatase increased (all grades, 1%) Hypocalcemia (all grades, 7%) Hypoalbuminemia (all grades, 7%) Hypomagnesaemia (all grades, 2%) Hypokalemia (all grades, 4%) Decreased appetite (all grades, 4%) Anorexia (all grades, 6%) Dehydration (all grades, 1%) Arthralgia (all grades, 1%) Back pain (all grades, 1%) Headache (all grades, 10%) Dizziness (all grades, 2%) Hypoaesthesia (all grades, 1%) Insomnia (all grades, 5%) Depression (all grades, 2%) Cough (all grades, 6%) Dyspnea (all grades, 2%) Pharyngitis (all grades, 4%) Epistaxis (all grades, 4%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Anaemia | grade 1, 17% | 20 mg/m2 1 times / day steady, intravenous Recommended|MTD Dose: 20 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 59 years (range: 42–79 years) n = 6 Health Status: unhealthy Condition: unresectable liver-predominant metastases Age Group: 59 years (range: 42–79 years) Sex: M+F Population Size: 6 Sources: |
Leucopenia | grade 1, 17% | 20 mg/m2 1 times / day steady, intravenous Recommended|MTD Dose: 20 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 59 years (range: 42–79 years) n = 6 Health Status: unhealthy Condition: unresectable liver-predominant metastases Age Group: 59 years (range: 42–79 years) Sex: M+F Population Size: 6 Sources: |
Thrombocytopaenia | grade 1, 17% | 20 mg/m2 1 times / day steady, intravenous Recommended|MTD Dose: 20 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 59 years (range: 42–79 years) n = 6 Health Status: unhealthy Condition: unresectable liver-predominant metastases Age Group: 59 years (range: 42–79 years) Sex: M+F Population Size: 6 Sources: |
Lymphopenia | grade 2, 17% | 20 mg/m2 1 times / day steady, intravenous Recommended|MTD Dose: 20 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 59 years (range: 42–79 years) n = 6 Health Status: unhealthy Condition: unresectable liver-predominant metastases Age Group: 59 years (range: 42–79 years) Sex: M+F Population Size: 6 Sources: |
Neutropenia | grade 2, 17% | 20 mg/m2 1 times / day steady, intravenous Recommended|MTD Dose: 20 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 59 years (range: 42–79 years) n = 6 Health Status: unhealthy Condition: unresectable liver-predominant metastases Age Group: 59 years (range: 42–79 years) Sex: M+F Population Size: 6 Sources: |
Thrombocytopenia | 2 patients DLT |
15 mg/m2 1 times / day steady, intravenous Dose: 15 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 1 times / day Sources: |
unhealthy, 61 years (range: 32–82 years) n = 16 Health Status: unhealthy Condition: CLL Age Group: 61 years (range: 32–82 years) Sex: M+F Population Size: 16 Sources: |
Hyperbilirubinemia | grade 3, 2 patients DLT |
15 mg/m2 1 times / day steady, intravenous Dose: 15 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 1 times / day Sources: |
unhealthy, 61 years (range: 32–82 years) n = 16 Health Status: unhealthy Condition: CLL Age Group: 61 years (range: 32–82 years) Sex: M+F Population Size: 16 Sources: |
Leukopenia | grade 3-4, 22% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Febrile neutropenia | grade 3-4, 23% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Thrombocytopenia | grade 3-4, 85% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Neutropenia | grade 3-4, 87% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Anemia | grade 5, 6 patients Disc. AE |
15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Neutropenia | grade 5, 6 patients Disc. AE |
15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Thrombocytopenia | grade 5, 6 patients Disc. AE |
15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: |
unhealthy, 70 years (range: 65-76 years) n = 81 Health Status: unhealthy Condition: myelodysplastic syndromes Age Group: 70 years (range: 65-76 years) Sex: M+F Population Size: 81 Sources: |
Febrile neutropenia | grade 3-4, 2 patients DLT |
15 mg/m2 1 times / day steady, intravenous Dose: 15 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 1 times / day Sources: |
unhealthy, 72 years (range: 68–75 years) n = 4 Health Status: unhealthy Condition: NHL Age Group: 72 years (range: 68–75 years) Sex: M+F Population Size: 4 Sources: |
Alanine aminotransferase increased | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Alkaline phosphatase increased | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Arthralgia | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Aspartate aminotransferase increased | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Back pain | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Dehydration | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Fall | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Hepatomegaly | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Hypoaesthesia | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Pulmonary edema | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Tachycardia | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Urinary tract infection | all grades, 1% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Headache | all grades, 10% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Diarrhea | all grades, 16% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Pyrexia | all grades, 16% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Fatigue | all grades, 18% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Cellulitis | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Depression | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Dizziness | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Dysphagia | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Dyspnea | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Hypomagnesaemia | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Loose stools | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Splenomegaly | all grades, 2% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Nausea | all grades, 22% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Abdominal pain | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Asthenia | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Decreased appetite | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Epistaxis | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Hyperbilirubinaemia | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Hypokalemia | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Pharyngitis | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Thrombocythaemia | all grades, 4% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Insomnia | all grades, 5% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Oral mucosal petechiae | all grades, 5% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Tongue ulceration | all grades, 5% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Anemia | all grades, 54% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Anorexia | all grades, 6% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Cough | all grades, 6% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Hypoalbuminemia | all grades, 7% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Hypocalcemia | all grades, 7% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Stomatitis | all grades, 7% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Constipation | all grades, 8% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Vomiting | all grades, 8% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Thrombocytopenia | all grades, 81% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Neutropenia | all grades, 83% | 15 mg/m2 3 times / day steady, intravenous Recommended Dose: 15 mg/m2, 3 times / day Route: intravenous Route: steady Dose: 15 mg/m2, 3 times / day Sources: Page: p. 82 |
unhealthy n = 83 Health Status: unhealthy Population Size: 83 Sources: Page: p. 82 |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021790s000_Dacogen_BioPharmR.pdf#page=20 Page: 20.0 |
no | |||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
weak | ||||
Sources: https://pdf.hres.ca/dpd_pm/00049298.PDF#page=19 Page: 19.0 |
yes |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
weak |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
PubMed
Title | Date | PubMed |
---|---|---|
Targeting hypomethylation of DNA to achieve cellular differentiation in myelodysplastic syndromes (MDS). | 2001 |
|
The E-cadherin/catenin complex: an important gatekeeper in breast cancer tumorigenesis and malignant progression. | 2001 |
|
Demethylation by 5-aza-2'-deoxycytidine (5-azadC) of p16INK4A gene results in downregulation of vascular endothelial growth factor expression in human lung cancer cell lines. | 2001 |
|
Autoreactive murine Th1 and Th2 cells kill syngeneic macrophages and induce autoantibodies. | 2001 |
|
Unnatural enantiomers of 5-azacytidine analogues: syntheses and enzymatic properties. | 2001 Apr-Jul |
|
Cytogenetic responses in high-risk myelodysplastic syndrome following low-dose treatment with the DNA methylation inhibitor 5-aza-2'-deoxycytidine. | 2001 Aug |
|
Activation of the maternally preset program of apoptosis by microinjection of 5-aza-2'-deoxycytidine and 5-methyl-2'-deoxycytidine-5'-triphosphate in Xenopus laevis embryos. | 2001 Aug |
|
DNA methylation regulates placental lactogen I gene expression. | 2001 Aug |
|
Methylation of the E-cadherin gene promoter correlates with progression of prostate cancer. | 2001 Aug |
|
Reversion of transcriptional repression of Sp1 by 5 aza-2' deoxycytidine restores TGF-beta type II receptor expression in the pancreatic cancer cell line MIA PaCa-2. | 2001 Aug 15 |
|
Molecular mechanisms for aberrant expression of the human breast cancer specific gene 1 in breast cancer cells: control of transcription by DNA methylation and intronic sequences. | 2001 Aug 23 |
|
Identification and characterization of differentially methylated CpG islands in pancreatic carcinoma. | 2001 Dec 1 |
|
Antineoplastic action of 5-aza-2'-deoxycytidine and histone deacetylase inhibitor and their effect on the expression of retinoic acid receptor beta and estrogen receptor alpha genes in breast carcinoma cells. | 2001 Jul |
|
Loss of mismatch repair activity in simian virus 40 large T antigen-immortalized BPH-1 human prostatic epithelial cell line. | 2001 Jul |
|
Aberrant methylation of the adenomatous polyposis coli (APC) gene promoter 1A in breast and lung carcinomas. | 2001 Jul |
|
Promoter hypermethylation: a common cause of reduced p16(INK4a) expression in uveal melanoma. | 2001 Jul 1 |
|
Hypermethylation leads to silencing of the SYK gene in human breast cancer. | 2001 Jul 15 |
|
Decitabine with allogeneic peripheral blood stem cell transplantation in the therapy of leukemia relapse following a prior transplant: results of a phase I study. | 2001 Jun |
|
Cytosine methylation represses glutathione S-transferase P1 (GSTP1) gene expression in human prostate cancer cells. | 2001 Jun 15 |
|
Glypican-3 expression is silenced in human breast cancer. | 2001 Nov 1 |
|
CpG methylation as a basis for breast tumor-specific loss of NES1/kallikrein 10 expression. | 2001 Nov 1 |
|
Diminished expression of S100A2, a putative tumor suppressor, at early stage of human lung carcinogenesis. | 2001 Nov 1 |
|
Hypermethylation in human cancers of the RIZ1 tumor suppressor gene, a member of a histone/protein methyltransferase superfamily. | 2001 Nov 15 |
|
E-cadherin expression is commonly downregulated by CpG island hypermethylation in esophageal carcinoma cells. | 2001 Nov 8 |
|
5-Aza-2'-deoxycytidine induces histone hyperacetylation of mouse centromeric heterochromatin by a mechanism independent of DNA demethylation. | 2001 Nov 9 |
|
Reduced expression of syndecan-1 affects metastatic potential and clinical outcome in patients with colorectal cancer. | 2001 Oct |
|
Dynamic DNA methylation change in the CpG island region of p15 during human myeloid development. | 2001 Oct |
|
DNA hypermethylation is a mechanism for loss of expression of the HLA class I genes in human esophageal squamous cell carcinomas. | 2001 Oct |
|
Frequent epigenetic inactivation of RASSF1A by aberrant promoter hypermethylation in human gastric adenocarcinoma. | 2001 Oct 1 |
|
Synergistic activation of functional estrogen receptor (ER)-alpha by DNA methyltransferase and histone deacetylase inhibition in human ER-alpha-negative breast cancer cells. | 2001 Oct 1 |
|
Chloroplast DNA methylation and inheritance in Chlamydomonas. | 2001 Oct 1 |
|
Rexpression of HLA class I antigens and restoration of antigen-specific CTL response in melanoma cells following 5-aza-2'-deoxycytidine treatment. | 2001 Oct 15 |
|
CpG hypermethylation of the promoter region inactivates the estrogen receptor-beta gene in patients with prostate carcinoma. | 2001 Oct 15 |
|
Methylation in hMLH1 promoter interferes with its binding to transcription factor CBF and inhibits gene expression. | 2001 Oct 25 |
|
Methylation-dependent silencing of the reduced folate carrier gene in inherently methotrexate-resistant human breast cancer cells. | 2001 Oct 26 |
|
Evolving treatment options of myelodysplastic syndromes. | 2001 Sep |
|
Selection of drug-resistant transduced cells with cytosine nucleoside analogs using the human cytidine deaminase gene. | 2001 Sep |
|
Epigenetic regulation of the KAI1 metastasis suppressor gene in human prostate cancer cell lines. | 2001 Sep |
|
Hypermethylation of the tumor necrosis factor receptor superfamily 6 (APT1, Fas, CD95/Apo-1) gene promoter at rel/nuclear factor kappaB sites in prostatic carcinoma. | 2001 Sep |
|
CpG methylation of promoter region inactivates E-cadherin gene in renal cell carcinoma. | 2001 Sep |
|
Promoter hypermethylation of MGMT is associated with protein loss in gastric carcinoma. | 2001 Sep |
|
Methylation status in the promoter region of the human PGP9.5 gene in cancer and normal tissues. | 2001 Sep 10 |
|
Sensitization for death receptor- or drug-induced apoptosis by re-expression of caspase-8 through demethylation or gene transfer. | 2001 Sep 13 |
|
Hypermethylation of CpG islands in the mouse asparagine synthetase gene: relationship to asparaginase sensitivity in lymphoma cells. Partial methylation in normal cells. | 2001 Sep 14 |
|
Frequent epigenetic inactivation of RASSF1A in human bladder carcinoma. | 2001 Sep 15 |
|
Histone deacetylase and DNA methyltransferase in human prostate cancer. | 2001 Sep 28 |
|
Altered hox gene expression and cellular pathogenesis of 5-aza-2'-deoxycytidine-induced murine hindlimb dysmorphogenesis. | 2001 Sep-Oct |
|
Methylation-mediated silencing of TMS1/ASC is accompanied by histone hypoacetylation and CpG island-localized changes in chromatin architecture. | 2002 Feb 15 |
|
Reduced expression of insulin-like growth factor binding protein-3 and its promoter hypermethylation in human hepatocellular carcinoma. | 2002 Feb 25 |
|
Combined restriction landmark genomic scanning and virtual genome scans identify a novel human homeobox gene, ALX3, that is hypermethylated in neuroblastoma. | 2002 Mar |
Patents
Sample Use Guides
Regimen 1: administer decitabine (Dacogen) at a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3
days. Repeat cycle every 6 weeks. Regimen 2: administer decitabine at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily for 5 days. Repeat cycle every 4 weeks.
Route of Administration:
Intravenous
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Classification Tree | Code System | Code | ||
---|---|---|---|---|
|
FDA ORPHAN DRUG |
555916
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
NCI_THESAURUS |
C1557
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
FDA ORPHAN DRUG |
697019
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
FDA ORPHAN DRUG |
227106
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
FDA ORPHAN DRUG |
159702
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
NDF-RT |
N0000000233
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
FDA ORPHAN DRUG |
122298
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
NCI_THESAURUS |
C2083
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
FDA ORPHAN DRUG |
123399
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
FDA ORPHAN DRUG |
537716
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
WHO-VATC |
QL01BC08
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
EU-Orphan Drug |
EU/3/17/1881
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
EMA ASSESSMENT REPORTS |
DACOGEN (AUTHORIZED: LEUKEMIA, MYELOID)
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
LIVERTOX |
271
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
NDF-RT |
N0000175595
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
WHO-ATC |
L01BC08
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
||
|
FDA ORPHAN DRUG |
20687
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
Code System | Code | Type | Description | ||
---|---|---|---|---|---|
|
C981
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
DECITABINE
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
DB01262
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
776B62CQ27
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
SUB06932MIG
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
M4126
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | Merck Index | ||
|
CHEMBL1201129
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
15657
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | RxNorm | ||
|
790
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
6805
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
2353-33-5
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
451668
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
C014347
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
Decitabine
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
6374
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
2353-33-5
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY | |||
|
219-089-4
Created by
admin on Sat Jun 26 00:22:15 UTC 2021 , Edited by admin on Sat Jun 26 00:22:15 UTC 2021
|
PRIMARY |
ACTIVE MOIETY
SALT/SOLVATE (PARENT)