- Injection, lyophilized powder for solution 50 mg
May cause hypomethylation of DNA and cellular differentiation or apoptosis by phosphorylation and direct incorporation into DNA.
C max is approximately 73.8 ng/mL (treatment option 1, see Route/Dosage) and approximately 147 ng/mL (treatment option 2, see Route/Dosage). Cumulative AUC per cycle for treatment option 2 was 2.3-fold lower than for treatment option 1.
Undergoes biphasic distribution. Plasma protein binding is less than 1%.
May be eliminated through deamination by cytidine deaminase. Half-life is approximately 0.62 h (treatment option 1) and 0.54 h (treatment option 2).
Special PopulationsHepatic/Renal Function Impairment
Have not been studied.
Indications and Usage
Treatment of myelodysplastic syndromes.
Dosage and AdministrationAdults Treatment regimen – option 1
IV 15 mg/m 2 by continuous IV infusion over 3 h repeated every 8 h for 3 days. Repeat this treatment cycle every 6 wk for a minimum of 4 cycles. However, complete or partial response may take longer than 4 cycles. Treatment may be continued as long as there is continued benefit.Treatment regimen – option 2
IV 20 mg/m 2 by continuous IV infusion over 1 h repeated daily for 5 days. Repeat this treatment cycle every 4 wk for a minimum of 4 cycles. However, complete or partial response may take longer than 4 cycles.Dose Adjustments or Delays
Adults Hematologic toxicity (treatment regimen – option 1)
IV If hematologic recovery (absolute neutrophil count [ANC] 1,000/mcL or more and platelets 50,000/mcL or more) from a previous treatment cycle requires more than 6 wk, then delay the next cycle of therapy and temporarily reduce dosing as follows:Recovery requiring more than 6 wk but less than 8 wk
Delay decitabine dosing for up to 2 wk and temporarily reduce the dose to 11 mg/m 2 every 8 h (33 mg/m 2 /day; 99 mg/m 2 /cycle) upon restarting of therapy.Recovery requiring more than 8 wk but less than 10 wk
Assess for disease progression using bone marrow aspirates. In the absence of progression, delay the decitabine dose up to 2 more wk and reduce the dose to 11 mg/m 2 every 8 h (33 mg/m 2 /day; 99 mg/m 2 /cycle) upon restarting therapy, then maintain or increase dose in subsequent cycles as clinically indicated.Hematologic toxicity (treatment regimen – option 2)
IV If myelosuppression is present, subsequent treatment cycles of decitabine should be delayed until there is hematologic recovery (ANC at least 1,000/mcL and platelets at least 50,000/mcL).Nonhematologic toxicity
IV Treatment should not be restarted until the toxicity is resolved: serum creatinine at least 2 mg/dL; ALT, total bilirubin at least 2 times ULN; and active or uncontrolled infection.
- Unless used within 15 min of reconstitution, diluted solution must be prepared using cold (36° to 46°F) infusion fluids and stored at 36° to 46°F for a max of 7 h until administration.
- Use procedures for proper handling and disposal of antineoplastic drugs.
- Premedicate with standard antiemetic therapy before treatment.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Store vials at 59° to 86°F.
None well documented.
Cardiac murmur (16%); hypotension (11%); tachycardia (8%); hypertension, pulmonary edema (6%); congestive cardiac failure, hematoma (5%); atrial fibrillation, cardiomyopathy, cardiorespiratory arrest, intracranial hemorrhage, MI, supraventricular tachycardia.
Pyrexia (53%); fatigue (46%); headache, insomnia (28%); dizziness (21%); chills (16%); asthenia (15%); confusional state, lethargy (12%); anxiety, hypesthesia (11%); depression (9%); fall (8%); intermittent pyrexia (6%); malaise (5%); mental status changes.
Petechiae (39%); pallor (23%); ecchymosis (22%); rash (19%); erythema (14%); pruritus, skin lesion (11%); contusion (9%); alopecia, dry skin (8%); swelling face, urticaria (6%); night sweats (5%).
Pharyngitis (16%); epistaxis (13%); pharyngolaryngeal pain (8%); blurred vision, ear pain (6%); postnasal drip (5%).
Nausea (42%); constipation (35%); diarrhea (34%); vomiting (25%); anorexia, decreased appetite (16%); abdominal pain (14%); oral mucosal petechiae (13%); dyspepsia, stomatitis (12%); ascites (10%); gingival bleeding, hemorrhoids (8%); loose stools, tongue ulceration (7%); dysphagia, oral candidiasis, oral soft tissue disorder, toothache, upper abdominal pain (6%); abdominal distension, gastroesophageal reflux disease, glossodynia, lip ulceration, oral pain, tooth abscess (5%); upper GI hemorrhage.
UTI (7%); dysuria (6%); urinary frequency (5%); renal failure, urethral hemorrhage.
Neutropenia (90%); thrombocytopenia (89%); anemia (82%); febrile neutropenia (29%); leukopenia (28%); lymphadenopathy (12%); pancytopenia, thrombocythemia (5%); myelosuppression, splenomegaly.
Hyperbilirubinemia (14%); cholecystitis.
Increased blood alkaline phosphatase (11%); increased AST, increased blood urea (10%); increased blood LDH (8%); decreased blood albumin (7%); decreased blood chloride, increased blood bicarbonate, increased blood bilirubin (6%); decreased blood bicarbonate, decreased blood bilirubin, decreased total protein (5%).
Catheter-related infections (8%); catheter-site erythema, catheter-site pain, injection-site swelling (5%); catheter-site hemorrhage.
Hyperglycemia (33%); anorexia (23%); peripheral edema (27%); hypoalbuminemia, hypomagnesemia (24%); hypokalemia (22%); hyponatremia (19%); edema (18%); hyperkalemia (13%); decreased weight (9%); dehydration (8%).
Rigors (22%); arthralgia (20%); limb pain (19%); back pain, pain in extremity (18%); myalgia (9%); chest wall pain, muscle spasms (7%); bone pain, musculoskeletal discomfort (6%); musculoskeletal pain, muscular weakness, myalgia (5%).
Cough (40%); dyspnea (29%); pneumonia (22%); lung crackles (14%); decreased breathing sounds, hypoxia, upper respiratory tract infection (10%); respiratory tract infection (9%); rales (8%); pulmonary edema, sinusitis (6%); abnormal breath sounds, sinus congestion (5%); bronchopulmonary aspergillosis, hemoptysis, lung infiltration, pseudomonal lung infection, pulmonary embolism, pulmonary mass, respiratory arrest, upper respiratory tract infection.
Pain (13%); cellulitis (12%); tenderness (11%); candidal infections, fall, mucosal inflammation, staphylococcal bacteremia (8%); chest discomfort, staphylococcal infection, transfusion reaction (7%); chest pain (6%); abrasion, bacteremia, crepitations, pleural effusion (5%); hypersensitivity (eg, anaphylactic reaction), Mycobacterium avium complex infection, sepsis.
Perform CBCs and platelet counts as needed to monitor response and toxicity, but at least prior to each cycle. Obtain liver chemistries and serum creatinine prior to initiation of treatment.
Category D .
Safety and efficacy not established.
Use with caution.
Use with caution.
Neutropenia and thrombocytopenia may occur.
Myelosuppression, including prolonged neutropenia and thrombocytopenia.
- Caution patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
- Advise patients to notify health care provider of any underlying liver or kidney disease.
- Advise men not to father a child while receiving treatment and for 2 mo after. Advise men with female partners of childbearing potential to use effective contraception.
- Women of childbearing potential should be advised to avoid becoming pregnant while receiving decitabine and for 1 month following completion of treatment.
- Advise women to consult health care provider before breast-feeding.
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