Brand and Other Names:Dacogen
Dosing & Uses
Dosage Forms & Strengths
powder for injection
5-day regimen: 20 mg/sq.meter IV infusion over 1 hr qDay x5 days, repeat cycle q4weeks
Sickle cell anemia
Acute myeloid leukemia
Chronic myelogenous leukemia
Orphan indication sponsor
- Eisai, Inc; 300 Tice Blvd; Woodcliff Lake, NJ 07677
Decrease dose/withhold dose if hematologic toxicities develop
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Febrile neutropenia (29%)
Peripheral edema (25%)
Limb pain (19%)
Back pain (17%)
Appetite decreased (16%)
Cardiac murmur (16%)
Abdominal pain (14%)
Crackles in lung (14%)
Oral mucosal petechiae (13%)
Confusional state (12%)
Blood alkaline phosphatase increased (11%)
Skin lesion (11%)
Aspartate aminotransferase increase (10%)
Blood urea increase (10%)
Breath sounds decrease (10%)
Candidal infection (10%)
Blood lactate dehydrogenase increase (8%)
Catheter related infection (8%)
Gingival bleeding (8%)
Loose stools (7%)
Transfusion reaction (7%)
Tongue ulceration (7%)
Chest discomfort (7%)
Chest wall pain (7%)
Blood albumin decrease (7%)
Urinary tract infection (7%)
Staphylococcal infection (7%)
Oral candidiasis (6%)
Pulmonary edema (6%)
Blurred vision (6%)
Oral soft tissue disorder (6%)
Swelling of face (6%)
Blood Cl decrease (6%)
Blood bicarbonate increase (6%)
Musculoskeletal discomfort (6%)
Intermittent pyrexia (6%)
Lip ulceration (5%)
Abdominal distension (5%)
Upper abdominal pain (5%)
Gastro-esophageal refllux disease (5%)
Catheter site erythema (5%)
Catheter site pain (5%)
Injection site swelling (5%)
Urinary frequency (5%)
Postnasal drip (5%)
Protein total decrease (5%)
Blood bicarbonate decrease (5%)
Blood bilirubin decreased (5%)
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not nurse
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Inhibits DNA methyltransferase, causing hypomethylation of DNA & cellular differentiation or apoptosis
Protein Bound: <1%
Solution: NS, D5W, LR
Reconstituted with 10 mL SWI, THEN
Dilute with NS, D5W or LR to final drug concentration of 0.1-1 mg/mL
If not used within 15 min of reconstitution, prepare diluted soln using cold (2-8°C) infusion fluids
Infuse IV continuously over 3 hr
Store diluted solution at 2-8°C (36-46°F) not to exceed 7 hr
Store vials at 25°C (77°F)
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