Dacogen

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.
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References in periodicals archive ?
Eisai also gained rights to the Gliadel Wafer, a chemotherapy agent, and Dacogen for myelodysplastic syndromes.
Lexi Pharma team members have collectively filed 15 New Drug Applications and have been involved in the development and launch of successfully marketed products including: Byetta, Bydureon, Camptosar, Dacogen, Ellence, Emcyt, Erbitux, Folotyn, Panretin, Symlin, Sutent, Targretin, Vidaza, Velcade, and Zarnestra.
Behanzin et al., "The European Medicines Agency review of decitabine (Dacogen) for the treatment of adult patients with acute myeloid leukemia: summary of the scientific assessment of the Committee for Medicinal Products for Human Use," The Oncologist, vol.
On basis of Drugs the market is segmented by gleevec, ga101, dacogen, bosutinib, graspa, revlimid, omapro, marqibo, vasaroxine, tosedosat, sapacitabine, vidaza, and other drugs.
Moreover, DNMT inhibitors, including 5-azacytidine (azacitidine; Vidaza) and 5-aza-20-deoxycytidine (decitabine; Dacogen) for myeloid cancers and cutaneous T cell lymphoma, have been recommended by the US Food and Drug Administration [87].
The medications made by it incorporate Risperdal, rivaroxaban, topamax, Bapineuzumab, dacogen, and so on.
"Exclusive supply medicines Pharmacy Service Area Health Mrida (Dacogen 50 mg powder, JP SOL Inyect Stelara 45 mg and 250 mg Zytiga COMP)."
The epigenetics drugs market report estimates the market size (Revenue USD million - 2013 to 2020) for key market segments based on the drug type (ChIP technology, DNA methylation), and their mechanism of action such as DNMT inhibitors - Azacitidine (vidaza) and Decitabine (dacogen); and HDAC inhibitors or HDIs - Romidepsin (istodax), Vorinostat (zolinza), and forecasts growth trends (CAGR% - 2016 to 2020).
In patients ineligible for intensive first-line chemotherapy, options are very poor, with the more recently approved Vidaza and Dacogen as the treatment options, which both offer unsatisfactory survival.
Decitabine (DacoGen, Pharmachemie BV) was stored as a stable freeze-dried powder in 50 mL vials, reconstituted in 10 mL of sterile water for injection, and diluted to a final volume of 25 mL.
The methylation inhibitor 5-aza-deoxycytadine (decitabine; Dacogen, MGI Pharma Inc.) is a nucleoside analogue that promotes DNA cytosine methylation and also has a similar effect to HDACi in promoting HIV transcription in vitro, but only in a subset of latently infected resting CD4+ T cells.
Royalty revenue for Dacogen remains unchanged from our prior guidance and is expected to increase up to 5% from the prior year to a range from $52 million to $55 million.