Dosing and uses of Dacogen (decitabine)
Adult dosage forms and strengths
powder for injection
- 50mg/vial
Myelodysplastic Syndromes
3-day regimen: 15 mg/m² IV infusion over 3 hr repeated q8hr x3 days; repeat q6weeks
5-day regimen: 20 mg/m² IV infusion over 1 hr qDay x5 days, repeat cycle q4weeks
Dosage modifications
Decrease dose/withhold dose if hematologic toxicities develop
Renal impairment: Not studied; use caution
Hepatic Impairment: Not studied; use caution
Sickle Cell Disease (Orphan)
Orphan designation for treatment sickle cell disease in combination with tetrahydrouridine
Orphan indication sponsor
- EpiDestiny Inc; 7536 Royal Portrush Drive; Solon, Ohio 44139
Pediatric dosage forms and strengths
Safety and efficacy not established
Dacogen (decitabine) adverse (side) effects
>10%
Neutropenia (90%)
Thrombocytopenia (89%)
Anemia (82%)
Pyrexia (53%)
Nausea (42%)
Cough (40%),
Petechiae (39%)
Constipation (35%)
Diarrhea (34%)
Hyperglycemia (33%)
Febrile neutropenia (29%)
Headache (28%)
Insomnia (28%)
Leukopenia (28%)
Vomiting (25%)
Peripheral edema (25%)
Hypoalbuminemia (24%)
Hypomagnesemia (24%)
Pallor (23%)
Hypokalemia (22%)
Pneumonia (22%)
Rigors (22%)
Ecchymosis (22%)
Arthralgia (20%)
Limb pain (19%)
Hyponatremia (19%)
Rash (19%)
Edema (18%)
Dizziness (18%)
Back pain (17%)
Appetite decreased (16%)
Pharyngitis (16%)
Cardiac murmur (16%)
Anorexia (16%)
Hyperbilirubinemia (14%)
Abdominal pain (14%)
Erythema (14%)
Crackles in lung (14%)
Oral mucosal petechiae (13%)
Pain (13%)
Hyperkalemia (13%)
Confusional state (12%)
Lethargy (12%)
Stomatitis (12%)
Dyspepsia (12%)
Lymphadenopathy (12%)
Cellulitis (12%)
Anxiety (11%)
Hypoesthesia (11%)
Tenderness (11%)
Blood alkaline phosphatase increased (11%)
Skin lesion (11%)
Pruritus (11%)
1-10%
Aspartate aminotransferase increase (10%)
Blood urea increase (10%)
Breath sounds decrease (10%)
Hypoxia (10%)
Candidal infection (10%)
Ascites (10%)
Blood lactate dehydrogenase increase (8%)
Catheter related infection (8%)
Gingival bleeding (8%)
Hemorrhoids (8%)
Alopecia (8%)
Fall (8%)
Rales (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%)
Dysuria (6%)
Dysphagia (6%)
Pulmonary edema (6%)
Blurred vision (6%)
Oral soft tissue disorder (6%)
Urticaria (6%)
Swelling of face (6%)
Blood Cl decrease (6%)
Blood bicarbonate increase (6%)
Musculoskeletal discomfort (6%)
Hypotension (6%)
Dehydration (6%)
Intermittent pyrexia (6%)
Lip ulceration (5%)
Thrombocythemia (5%)
Hematoma (5%)
Abdominal distension (5%)
Upper abdominal pain (5%)
Gastro-esophageal refllux disease (5%)
Glossodynia (5%)
Myalgia (5%)
Malaise (5%)
Crepitations (5%)
Catheter site erythema (5%)
Catheter site pain (5%)
Injection site swelling (5%)
Urinary frequency (5%)
Sinusitis (5%)
Postnasal drip (5%)
Bacteremia (5%)
Abrasion (5%)
Protein total decrease (5%)
Blood bicarbonate decrease (5%)
Blood bilirubin decreased (5%)
Warnings
Contraindications
Hypersensitivity
Cautions
Use caution in renal/hepatic impairment
Avoid pregnancy
Bone marrow suppression may occur (dose limiting); dose adjustment may be necessary
Pregnancy and lactation
Pregnancy category: d
Lactation: not known if excreted in breast milk, do not nurse
Pregnancy categories
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.
Pharmacology of Dacogen (decitabine)
Mechanism of action
Inhibits DNA methyltransferase, causing hypomethylation of DNA & cellular differentiation or apoptosis
Pharmacokinetics
Protein Bound: <1%
Vd: 63-89 L/m²
Half-life: 30-35 min
Administration
IV Compatibilities
Solution: NS, D5W, Lr
IV Preparation
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
IV Administration
Infuse IV continuously over 3 hr
Storage
Store diluted solution at 2-8°C (36-46°F) not to exceed 7 hr
Store vials at 25°C (77°F)
