Dosing & Uses
Dosage Forms & 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; repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/μL and platelets at least 50,000/μL) for a minimum of 4 cycles; a complete or partial response may take longer than 4 cycles; delay and reduce dose for hematologic toxicity
5-day regimen: 20 mg/m² IV infusion over 1 hr qDay x5 days, repeat cycle q4weeks upon hematologic recovery (ANC at least 1,000/μL and platelets at least 50,000/μL) for a minimum of 4 cycles; a complete or partial response may take longer than 4 cycles
Dosage Modifications
Hematologic Toxicity
- If hematologic recovery from previous treatment cycle requires more than 6 weeks, delay next cycle of therapy and reduce dose temporarily by following the following algorithm
- Recovery requiring more than 6, but less than 8 weeks: Delay dosing for up to 2 weeks and reduce dose temporarily to 11 mg/m2 q8hr (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy
- Recovery requiring more than 8, but less than 10 weeks: Perform bone marrow aspirate to assess for disease progression; in absence of progression, delay dosing for up to 2 more weeks and reduce dose to 11 mg/m2 q8hr (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy, then maintain or increase dose in subsequent cycles as clinically indicated
Non-hematologic Toxicity
- Delay subsequent treatment for any the following nonhematologic toxicities and do not restart until toxicities resolve:
- Serum creatinine > 2 mg/dL
- Alanine transaminase (ALT), total bilirubin greater than or equal to 2 times upper limit of normal (ULN)
- Active or uncontrolled infection
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
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse 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 reflux 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%)
Postmarketing Reports
Sweet’s syndrome (acute febrile neutrophilic dermatosis)
Differentiation syndrome
Interstitial lung disease
Warnings
Contraindications
Hypersensitivity
Cautions
Use caution in renal/hepatic impairment
Fatal and serious myelosuppression occurs in treated patients; myelosuppression (anemia, neutropenia, and thrombocytopenia) is the most frequent cause of dose reduction, delay, and discontinuation; manage toxicity using dose-delay, dose-reduction, growth factors, and anti-infective therapies as needed; myelosuppression and worsening neutropenia may occur more frequently in first or second treatment cycles, and may not necessarily indicate progression of underlying MDS
Therapy can cause fetal harm when administered to a pregnant woman; based on mechanism of action, drug alters DNA synthesis and is expected to result in adverse reproductive effects; advise men with female partners of childbearing potential to avoid fathering a child while receiving treatment and for 3 months following the last dose; counsel patients of childbearing potential to use effective contraception during this time
Bone marrow suppression may occur (dose limiting); dose adjustment may be necessary
Pregnancy & Lactation
Pregnancy
Based on findings from human data, animal studies, and the mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited published data on use throughout first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities); advise pregnant women of potential risk to fetus
Based on findings of decitabine in animals, male fertility may be compromised by treatment; reversibility of effect on fertility is unknown
Conduct pregnancy testing of females of reproductive potential prior to initiating treatment
Advise females of reproductive potential to avoid pregnancy and use effective contraception while receiving therapy and for 6 months following last dose
Advise males with female partners of reproductive potential to use effective contraception while receiving treatment and for 3 months following last dose
Animal data
- In animal reproduction studies, administration of decitabine to pregnant mice and rats during organogenesis caused adverse developmental outcomes and was teratogenic, fetotoxic, and embryotoxic starting at doses approximately 7% of the recommended human dose on a mg/m2 basis
Lactation
There are no data on presence of drug or metabolites in human milk, effects on breastfed child, or on milk production; because many drugs are excreted in human milk, and because of potential for serious adverse reactions in a nursing child, advise lactating women to avoid breastfeeding during treatment and for at least 1 week after last dose
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
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
Aseptically reconstitute drug with room temperature (20°C to 25°C) 10 mL of Sterile Water for Injection, USP.
Upon reconstitution, the final concentration of the reconstituted drug solution is 5 mg/mL; you must dilute the reconstituted solution with 0.9% sodium chloride injection or 5% dextrose injection prior to administration
Temperature of the diluent (0.9% sodium chloride injection or 5% dextrose injection) depends on time of administration after preparation
For administration within 15 minutes of preparation
- If drug is intended to be administered within 15 minutes from time of preparation, dilute reconstituted solution with room temperature (20-25 oC) 0.9% sodium chloride injection or 5% dextrose injection to a final concentration of 0.1 mg/mL to 1 mg/mL; discard unused portion
For delayed administration
- If drug is intended to be administered after 15 minutes of preparation, dilute reconstituted solution with cold (2-8 oC) 0.9% sodium chloride injection or 5% dextrose injection to a final concentration of 0.1 mg/mL to1 mg/mL
- Store at 2-8 oC for up to 4 hours; diluted stored solution must be used within 4 hours from time of preparation; discard unused portion
- Use the diluted, refrigerated solution within 4 hours from time of preparation or discard; parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
- Do not use if there is evidence of particulate matter or discoloration
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)
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Dacogen intravenous - | 50 mg vial | ![]() | |
Dacogen intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() | |
decitabine intravenous - | 50 mg vial | ![]() |
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Formulary
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