decitabine


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decitabine

(de-sit-a-been) ,

Dacogen

(trade name)

Classification

Therapeutic: antineoplastics
Pregnancy Category: D

Indications

Treatment of various myelodysplastic syndromes (MDS).

Action

Inhibits DNA methyltransferase, causing apoptosis. Has more effect on rapidly replicating cells.

Therapeutic effects

Improved hematologic and clinical manifestations of MDS.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Mostly metabolized by the liver.
Half-life: 0.5 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IVrapidend of infusionunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Patients with child-bearing potential (males and females);Impaired hepatic/renal function; Geriatric: May be more sensitive to effects; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • confusion (most frequent)
  • fatigue (most frequent)
  • insomnia (most frequent)
  • depression
  • lethargy

Ear, Eye, Nose, Throat

  • blurred vision

Respiratory

  • cough (most frequent)

Cardiovascular

  • atrial fibrillation
  • pulmonary edema
  • tachycardia

Gastrointestinal

  • abdominal pain (most frequent)
  • constipation (most frequent)
  • diarrhea (most frequent)
  • stomatitis (most frequent)
  • vomiting (most frequent)
  • ↑ liver enzymes

Dermatologic

  • petechiae (most frequent)
  • rash

Fluid and Electrolyte

  • edema (most frequent)
  • hypokalemia (most frequent)
  • hypomagnesemia (most frequent)
  • ascites

Hematologic

  • bleeding (life-threatening)
  • anemia (most frequent)
  • neutropenia (most frequent)
  • thrombocytopenia (most frequent)

Local

  • injection site irritation

Metabolic

  • hyperglycemia (most frequent)

Musculoskeletal

  • arthralgia (most frequent)
  • myalgia (most frequent)

Miscellaneous

  • infection (life-threatening)
  • fever (most frequent)
  • lymphadenopathy

Interactions

Drug-Drug interaction

↑ risk of myelosuppression with other antineoplastics, immunosuppressants, or radiation therapy.May ↓ antibody response to and ↑ risk of adverse reactions from live virus vaccines.

Route/Dosage

Intravenous (Adults) 15 mg/m2 as a continuous infusion over 3 hr repeated q 8 hr for 3 days; cycle should be repeated q 6 wk for a minimum of 4 cycles or 20 mg/m2 as a continuous infusion over 1 hr repeated daily for 5 days; cycle should be repeated q 4 wk for a minimum of 4 cycles.

Availability (generic available)

Lyophilized powder for injection (requires reconstitution): 50 mg/vial

Nursing implications

Nursing assessment

  • Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae, guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
  • Lab Test Considerations: Monitor CBC prior to each dosing cycle and periodically as needed. May cause neutropenia, thrombocytopenia, and anemia; occur more frequently in 1st or 2nd treatment cycles. Use early institution of growth factors and antimicrobial agents to prevent infections.
    • Obtain liver chemistries and serum creatinine prior to initiation of treatment. May cause hyperbilirubinemia and hypoalbuminemia.
    • May cause hyperglycemia, hypomagnesemia, hyponatremia, hypokalemia, and hyperkalemia.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)

Implementation

  • high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order, calculations, and infusion pump settings.
    • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling IV medication. Discard IV equipment in specially designated containers (see ).
    • Premedicate patient with standard antiemetic therapy.
    • If hematologic recovery (ANC ≥1,000 cells/mm3 and platelets ≥50,000 cells/mm3) from previous treatment cycle requires more than 6, but less than 8 wk—delay dosing for up to 2 wk and temporarily reduce dose to 11 mg/m2 (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy.
    • If hematologic recovery requires more than 8, but less than 10 wk—Patient should be assessed for disease progression (by bone marrow aspirates); in the absence of progression, delay dose for up to 2 more wk and reduce dose as above upon restarting, then maintain or increase in subsequent cycles as clinically indicated.
  • Intravenous Administration
  • pH: 6.7–7.3.
  • Intermittent Infusion: Reconstitute with 10 mL of sterile water for injection for a concentration of 5 mg/mL. Diluent: Immediately after reconstitution, dilute further with 0.9% NaCl, D5W, or LR.Concentration: 0.1–1.0 mg/mL. Unless used within 15 min of reconstitution, dilute solution must be prepared using cold infusion fluids and refrigerated until administration (maximum of 7 hr).
  • Rate: Administer over 3 hr or over 1 hr, depending on treatment regimen chosen.

Patient/Family Teaching

  • Caution patient to avoid crowds and persons with known infections. Report symptoms of infection (fever, chills, cough, hoarseness, sore throat, lower back or side pain, painful or difficult urination) immediately.
  • Instruct patient to report unusual bleeding. Advise patient of thrombocytopenia precautions (use soft toothbrush and electric razor, avoid falls, do not drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate gastric bleeding).
  • Inform patient that this medication may have teratogenic effects. Advise women to use effective contraception and avoid becoming pregnant during treatment. Advise men not to father a child during or for 2 mo after treatment.

Evaluation/Desired Outcomes

  • Improved hematologic and clinical manifestations of MDS.

decitabine

/de·ci·ta·bine/ (DAC) (de-si´tah-bēn″) a cytotoxic compound used as an antineoplastic in the treatment of acute leukemia.

decitabine

an agent that prevents DNA methylation, halting growth of rapid proliferation blasts.
indications This drug is used to treat naive and experienced myelodysplastic syndrome.
contraindications Pregnancy, lactation, severe neurotoxicity, severe blood dyscrasias, and known hypersensitivity to this drug prohibit its use. Its use is also contraindicated in children.
adverse effects Adverse effects of this drug include confusion, abdominal pain, dyspepsia, hematoma, and cellulitis. Life-threatening side effects include neutropenia, thrombocytopenia, leukopenia, and anemia. Common side effects include headache; anxiety; dizziness; hypoesthesia; insomnia; edema; murmur; hypotension; nausea; anorexia; vomiting; diarrhea; constipation; stomatitis; alopecia; ecchymosis; erythema; pallor; petechiae; pruritus; rash; swelling of the face; urticaria; decreased potassium, sodium, magnesium, and albumin; increased or decreased glucose; myalgia; arthralgia; back pain; chest wall pain; pain in the limbs; cough; crackles; hypoxia; pharyngitis; pneumonia; and pulmonary edema.

decitabine

Oncology An antimetabolic anticancer agent
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References in periodicals archive ?
Data and posters from bortezomib, decitabine and JNJ56022473 (formerly CSL362) will be presented as well.
Azacytidine and decitabine took the FDA approval for the treatment of Myelodysplastic syndrome in the early 20th century.
The combination of Pracinostat and azacitidine or decitabine has been generally well-tolerated in the study, with no unexpected toxicities.
The discovery, which allows for a combination of decitabine and gemcitabine to be delivered in pill form, marks a major step forward in patient feasibility for the drugs, which previously had been available solely via injection or intravenous therapy (IV).
FDA has approved the drugs azacitidine, decitabine and lenalidomide for treatment.
DACO-016 compared decitabine to a patient's choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with AML.
has announced 1-year survival data from a Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes (MDS) refractory to hypomethylating agents, such as azacitidine and decitabine.
Examples are azacytidine and decitabine, which are used in the treatment of a specific type of blood cancer called acute myeloid leukemia.
Two drugs, decitabine and azacitidine, are being used to remove the aberrant mythylation, reactivating genes that had been silenced.
In the April 15 Cancel, Issa and his colleagues published the results of a trial of a demethylating drug called decitabine.
The method comprises: delivering to a patient suffering from cancer a therapeutically effective amount of a DNA methylation inhibitor such as decitabine, in combination with an effective amount of an anti-neoplastic agent whose activity as an anti-neoplastic agent in vivo is adversely affected by aberrant DNA methylation.
EuroGen), an "Orphan Medicinal Product" designation for the anticancer drug decitabine as a treatment for myelodysplastic syndrome (MDS).