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Brand Name :
Dacogen
(United States) [Available]Synonyms :
Decitabine
Class :
Anticancer and antimetabolites agent
Brand Name :
Dacogen
(United States) [Available]Synonyms :
Decitabine
Class :
Anticancer and antimetabolites agent
Dosage Forms & Strengths
Powder for injection
50 mg/vial
15
mg/m^2
Intravenous (IV)
over 3 hr
repeated every 8 hours for 3 days every 6 weeks
20
mg/m^2
Intravenous (IV)
over 1 hr
once daily for 5 days at 28-day cycle
For AML with TP53 mutation:
20 mg/m2 IV infused over 1 hour for 10 days for 28-day cycle
20 mg/m2 IV infused over 1 hour for 5 days for 28-days cycle in combination with venetoclax
Dose Adjustments
Require dose adjustment in case of renal dysfunction or hemodialysis
Terminate the use of docetaxel if total bilirubin > 2.5 times ULN
Administer 80% of the dose: AST/ALT > 2.5 to 5 times ULN
Discontinue the therapy with docetaxel: AST/ALT >5 times
Delay the treatment for 6 to 8 weeks: hematologic toxicity (ANC<1000/µl and platelets < 50,000/µl)
20
mg/m^2
Intravenous (IV)
over 1 hr
for 5 days for a 28-day cycle in combination with venetoclax
Terminate the therapy as soon as unacceptable adverse effects appear
avoid palifermin during pemetrexed therapy and before and after 24 hours of treatment
increases myelosuppression adverse effects
may increase excessive immunosuppressive effects
may increase excessive immunosuppressive effects
may increase excessive immunosuppressive effects
may reduce therapeutic effects of brincidofovir
may increase myelosuppressive effects
may increase the risk of excessive bone marrow suppression
may increase the adverse toxic effects of clozapine
may reduce therapeutic effects of the vaccine
may reduce therapeutic effects of dengue vaccine
may decrease serum potassium and metabolic acidosis
decitabine increases serum levels of ethotoin
may increase excessive immunosuppressive effects
may increase the risk of excessive bone marrow suppression
may increase the risk of excessive bone marrow suppression
may increase the risk of excessive bone marrow suppression
may increase the risk of excessive bone marrow suppression
When mometasone furoate is used together with decitabine, this leads to enhanced risk or seriousness of adverse outcomes
When decitabine is used together with andrographolide, this leads to enhanced risk or seriousness of bleeding
decitabine: it may increase the risk of myelosuppression with sulfamethoxazole
Actions and spectrum:
Action:
Decitabine is a selective inhibitor of DNA methyltransferases. Inhibition of DNA MTases results in hypomethylation of gene promoter, which tends to the induction of cellular senescence or cellular differentiation and reactivation of the tumor suppressor genes followed by apoptosis.
Frequency defined:
>10%
Alopecia
Nausea
Nail disease
Fluid retention
Vomiting
Neutropenia
1%-10%
Hypotension
Dysgeusia
Increased serum bilirubin
Frequency not defined:
Localized phlebitis
Deceased left ventricular ejection fraction
Fatigue
Nail hyperpigmentation
Post marketing report
Interstitial lung disease
Differentiation syndrome
Black Box Warning
The drug can cause severe immune reactions.
Contraindication/Caution:
Contraindication:
Hypersensitivity
Breastfeeding
Cautions:
Myelosuppression
Differentiation syndrome
Kidney failure
Respiratory, mediastinal, and thoracic disorders
Liver failure
Cardiac disease
Pregnancy Warnings: Therapy may lead to fetal complications.
Pregnancy category: N/A
Lactation: Excretion of the drug into the human breast milk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology: Decitabine is an antineoplastic agent. It is a pyrimidine analog.
Pharmacodynamics:
Decitabine is a nucleoside analog of cytidine. Once within the cell, cellular kinases phosphorylate it to decitabine triphosphate, which is its active triphosphate form.
It is integrated into DNA during the cell cycle’s S-phase.
Pharmacokinetics:
Absorption
Decitabine is typically administered intravenously due to its poor oral bioavailability.
Distribution
Less than 1% of decitabine is bound to proteins. The volume of distribution is 63-89 L/m2.
Metabolism
Decitabine undergoes metabolism primarily via deamination in the kidneys, liver, blood, and interstitial epithelium by cytidine deaminase.
Elimination and excretion
90% of the administered decitabine is eliminated through urine, of which 4% is in the unchanged form.
Half life
30-35 minutes
Administration:
Decitabine should be administered intravenously over 3 hours continuously.
Patient information leaflet
Generic Name: decitabine
Pronunciation: deh-SIH-tah-been
Why do we use decitabine?
Decitabine is primarily prescribed for the treatment of myelodysplastic syndromes diseases which are characterized by the improper formation or functional abnormalities of blood cells. The syndrome can lead to anemia, infections, or bleeding problems due to the failure of the bone marrow to produce mature and healthy red and white blood cells.
It is also administered for the management of acute myeloid leukemia in which excessive production of the abnormal white blood cells (myeloblasts) formation occurs in the bone marrow.
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