DECITABINE

DECITABINE
(de-sit'a-bine)
Dacogen
Classifications: antineoplastic agent; antimetabolite; pyrimidine;
Therapeutic:antineoplastic
; antimetabolite
Prototype: 5-Fluorouracil
Pregnancy Category: D

Availability

50 mg lyophilized powder for injection

Action

Decitabine is an antimetabolite that exerts antineoplastic effects after its direct incorporation into DNA and inhibition of DNA transferase, causing loss of cell differentiation and cell death. Nonproliferating cells are resistant to the effects of decitabine.

Therapeutic Effect

Decitabine-induced changes in neoplastic cells may restore normal function to genes that are critical for control of cellular differentiation and proliferation.

Uses

Treatment of patients with myelodysplastic syndrome (MDS). This includes previously treated and untreated patients with de novo and secondary MDS of all French-American-British (FAB) subtypes (i.e., refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.

Unlabeled Uses

Treatment of chronic myelogenous leukemia (CML).

Contraindications

Hypersensitivity to decitabine; conception within 2 mo of drug use; renal failure patients with Clcr <2 mg/mL; liver dysfunction with transaminase >2 x upper limit of normal (ULN), or serum bilirubin >1.5 mg/dL; active infection; pregnancy (category D), lactation. Safety and efficacy in children not established.

Cautious Use

Moderate to severe renal failure; hepatic impairment.

Route & Dosage

Myelodysplastic Syndrome
Adult: IV 15 mg/m2 q8h x 3 d. Patient should receive a minimum of 4 cycles of therapy repeated q6wk.

Administration

Intravenous

PREPARE: IV infusion: Caution should be exercised when handling and preparing decitabine. Procedures for proper handling and disposal of antineoplastic drugs should be applied. Reconstitute each vial with 10 mL sterile water for injection to yield approximately 5 mg/mL at pH 6.7–7.3. Immediately after reconstitution, further dilute with NS, D5W, or RL to a final drug concentration of 0.1–1 mg/mL. Use within 15 min of reconstitution (see Storage).  

ADMINISTER: IV infusion: Premedicate with standard antiemetic therapy. Give decitabine over 3 h. NOTE: Withhold dose and notify physician of any of the following: absolute neutrophil count (ANC) <1000/mcL; platelet count <50,000/mcL; serum creatinine at 2 mg/dL or higher; ALT, total bilirubin 2 x ULN; or an active or uncontrolled infection.  

  • Store vials at 15°–30° C (59°– 86° F). Unless used within 15 min of reconstitution, the diluted solution must be prepared using cold (2°–8° C) infusion fluids and stored at 2°–8° C (36°–46° F) for up to a maximum of 7 h until administration.

Adverse Effects (≥5%)

Body as a Whole: Fatigue, pyrexia, Mycobacterium avium complex infection, peripheral edema, bacteremia, candidal infection, cellulitis, injection site reactions, rigors, tenderness, transfusion reaction, sinusitis, staphylococcal infection. CNS: Intracranial hemorrhage, anxiety, confusional state, dizziness, headache, hypesthesia, insomnia, pyrexia. CV: Cardiorespiratory arrest, cardiac murmur, hypotension. GI: Nausea, vomiting, constipation, diarrhea, abdominal distention and discomfort, anorexia, dyspepsia, gastroesophageal reflux disease, glossodynia, gingival bleeding, hemorrhoids, lip ulceration, stomatitis, tongue ulceration. Hematologic: Anemia, neutropenia, thrombocytopenia, hematoma, leukopenia, lymphadenopathy, thrombocythemia. Metabolic: Hyperglycemia, increased AST, decreased blood albumin, increased blood alkaline phosphatase, altered blood bicarbonate, decreased blood bilirubin, decreased blood chloride, increased blood lactate dehydrogenase, increased blood urea, decreased total protein, dehydration, hyperbilirubinemia, altered potassium levels, hypoalbuminemia, hypomagnesemia, hyponatremia. Musculoskeletal: Arthralgia, back pain, chest wall pain, musculoskeletal discomfort, myalgia, pain in limb. Respiratory: Cough, lung crackles, hypoxia, pharyngitis, pneumonia, pulmonary edema, rales. Skin: Alopecia, ecchymosis, erythema, pallor, petechiae, pruritus, rash, skin lesion, swelling face, urticaria. Special Senses: Blurred vision. Urogenital: Dysuria, urinary frequency, urinary tract infection.

Pharmacokinetics

Distribution: Negligible plasma protein binding. Half-Life: 0.2–0.8 h.

Nursing Implications

Assessment & Drug Effects

  • Monitor for and report S&S of pulmonary or peripheral edema, cardiac arrhythmias, new-onset depression, or infection.
  • Lab tests: CBC with differentials and platelet count prior to each chemotherapy cycle; baseline and periodic LFTs and serum creatinine.
  • Avoid IM injections with platelet counts <50,000/mcL.
  • Monitor diabetics for loss of glycemic control.

Patient & Family Education

  • Do not accept vaccinations during treatment with decitabine.
  • Avoid contact with anyone who recently received the oral poliovirus vaccine.
  • Women of childbearing age should avoid becoming pregnant while receiving decitabine.
  • Men should not father a child while receiving decitabine and for 2 mo after the end of therapy.
  • Report any of the following to a health care provider: signs of infection such as fever, chills, sore throat; signs of bleeding such as easy bruising, black, tarry stools, blood in the urine; irregular heart rate; significant tiredness or weakness.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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© 2006-2017 medpill.info Last Updated On: 09/19/2017 (0)
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