Classifications: antineoplastic agent; antimetabolite; pyrimidine; Therapeutic:antineoplastic; antimetabolite
Pregnancy Category: D
50 mg lyophilized powder for injection
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
Decitabine-induced changes in neoplastic cells may restore normal function to genes that are critical for control of cellular
differentiation and proliferation.
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)
Treatment of chronic myelogenous leukemia (CML).
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.
Moderate to severe renal failure; hepatic impairment.
Route & Dosage
Adult: IV 15 mg/m2 q8h x 3 d. Patient should receive a minimum of 4 cycles of therapy repeated q6wk.
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 6.77.3. Immediately after reconstitution, further dilute with NS, D5W, or RL to a final drug concentration of 0.11
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.
Body as a Whole: Fatigue, pyrexia, Mycobacterium avium
- 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.
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.
Negligible plasma protein binding. Half-Life:
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
- 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.