decitabine (Rx)

Brand and Other Names:Dacogen
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 50mg/vial
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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

Safety and efficacy not established

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Interactions

Interaction Checker

and decitabine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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 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%)

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Use caution in renal/hepatic impairment

            Avoid pregnancy

            Bone marrow suppression may occur (dose limiting); dose adjustment may be necessary

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            Pregnancy & 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.

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            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

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            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)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.