Trade Names:Dacogen- Powder for injection, lyophilized 50 mg
May cause hypomethylation of DNA and cellular differentiation or apoptosis by phosphorylation and direct incorporation into DNA.
Undergoes biphasic distribution. Plasma protein binding is less than 1%.
Total body Cl is approximately 124 L/h/m 2 with a terminal elimination t ½ of 0.51 h.
Have not been studied.
Treatment of myelodysplastic syndromes.
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.Dose Adjustments or DelaysAdults
IV If hematologic recovery (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 restart of therapy.Recovery requiring more than 8 wk but less than 10 wk
Using bone marrow aspirates, assess for disease progression. 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.
Store vials at 59° to 86°F.
None well documented.
None well documented.
Cardiac murmur (16%); hypotension, pulmonary edema (6%); hematoma (5%); atrial fibrillation, cardiomyopathy, cardio-respiratory arrest, congestive cardiac failure, intracranial hemorrhage, MI, supraventricular tachycardia.
Pyrexia (53%); headache, insomnia (28%); dizziness (18%); decreased appetite (16%); confusional state, lethargy (12%); anxiety, hypesthesia (11%); intermittent pyrexia (6%); malaise (5%).
Petechiae (39%); pallor (23%); ecchymosis (22%); rash (19%); erythema (14%); pruritus, skin lesion (11%); alopecia (8%); swelling face, urticaria (6%).
Pharyngitis (16%); blurred vision (6%); postnasal drip (5%).
Nausea (42%); constipation (35%); diarrhea (34%); vomiting (25%); anorexia (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 (6%); abdominal distension, gastroesophageal reflux disease, glossodynia, lip ulceration, upper abdominal pain (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%); thrombocythemia (5%); myelosuppression, splenomegaly.
Hyperbilirubinemia (14%); cholecystitis.
Increased alkaline phosphatase (11%); increased aspartate aminotransferase, increased blood urea (10%); increased blood lactate dehydrogenase (8%); decreased blood albumin (7%); decreased blood chloride, increased blood bicarbonate (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%); hypoalbuminemia (24%); hypomagnesemia (24%); hypokalemia (22%); hyponatremia (19%); hyperkalemia (13%); dehydration (6%).
Rigors (22%); arthralgia (20%); limb pain (19%); back pain (17%); chest wall pain (7%); musculoskeletal discomfort (6%); myalgia (5%).
Cough (40%); pneumonia (22%); lung crackles (14%); decreased breathing sounds, hypoxia (10%); rales (8%); sinusitis (5%); bronchopulmonary aspergillosis, lung infiltration, pseudomonal lung infection, pulmonary embolism, pulmonary mass, respiratory arrest, upper respiratory tract infection.
Peripheral edema (25%); edema (18%); pain (13%); cellulitis (12%); tenderness (11%); candidal infections, fall (8%); chest discomfort, staphylococcal infection, transfusion reaction (7%); abrasion, bacteremia, crepitations (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.
Category D .
Safety and efficacy not established.
Myelosuppression, including prolonged neutropenia and thrombocytopenia.
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