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Drugs reference index «Decitabine»

Decitabine

Pronunciation: (de-SYE-ta-been)Class: Antineoplastic

Trade Names:Dacogen- Powder for injection, lyophilized 50 mg

Pharmacology

May cause hypomethylation of DNA and cellular differentiation or apoptosis by phosphorylation and direct incorporation into DNA.

Pharmacokinetics

Distribution

Undergoes biphasic distribution. Plasma protein binding is less than 1%.

Elimination

Total body Cl is approximately 124 L/h/m 2 with a terminal elimination t ½ of 0.51 h.

Special Populations

Hepatic/Renal Function Impairment

Have not been studied.

Indications and Usage

Treatment of myelodysplastic syndromes.

Contraindications

Standard considerations.

Dosage and Administration

Adults

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.

General Advice

  • 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.

Storage/Stability

Store vials at 59° to 86°F.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Cardiac murmur (16%); hypotension, pulmonary edema (6%); hematoma (5%); atrial fibrillation, cardiomyopathy, cardio-respiratory arrest, congestive cardiac failure, intracranial hemorrhage, MI, supraventricular tachycardia.

CNS

Pyrexia (53%); headache, insomnia (28%); dizziness (18%); decreased appetite (16%); confusional state, lethargy (12%); anxiety, hypesthesia (11%); intermittent pyrexia (6%); malaise (5%).

Dermatologic

Petechiae (39%); pallor (23%); ecchymosis (22%); rash (19%); erythema (14%); pruritus, skin lesion (11%); alopecia (8%); swelling face, urticaria (6%).

EENT

Pharyngitis (16%); blurred vision (6%); postnasal drip (5%).

GI

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.

Genitourinary

UTI (7%); dysuria (6%); urinary frequency (5%); renal failure, urethral hemorrhage.

Hematologic-Lymphatic

Neutropenia (90%); thrombocytopenia (89%); anemia (82%); febrile neutropenia (29%); leukopenia (28%); lymphadenopathy (12%); thrombocythemia (5%); myelosuppression, splenomegaly.

Hepatic

Hyperbilirubinemia (14%); cholecystitis.

Lab Tests

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%).

Local

Catheter-related infections (8%); catheter site erythema, catheter site pain, injection site swelling (5%); catheter site hemorrhage.

Metabolic-Nutritional

Hyperglycemia (33%); hypoalbuminemia (24%); hypomagnesemia (24%); hypokalemia (22%); hyponatremia (19%); hyperkalemia (13%); dehydration (6%).

Musculoskeletal

Rigors (22%); arthralgia (20%); limb pain (19%); back pain (17%); chest wall pain (7%); musculoskeletal discomfort (6%); myalgia (5%).

Respiratory

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.

Miscellaneous

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.

Precautions

Monitor

Perform CBCs and platelet counts as needed to monitor response and toxicity, but at least prior to each cycle.

Pregnancy

Category D .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Overdosage

Symptoms

Myelosuppression, including prolonged neutropenia and thrombocytopenia.

Patient Information

  • 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.

Copyright © 2009 Wolters Kluwer Health.

  • Decitabine MedFacts Consumer Leaflet (Wolters Kluwer)
  • decitabine Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information
  • Dacogen Consumer Overview

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