decitabine

IV (Adults ): 15 mg/m² every 8 hr for 3 days; cycle should be repeated every 6 wk for a minimum of 4 cycles or 20 mg/m² once daily for 5 days; cycle should be repeated every 4 wk for a minimum of 4 cycles.

Availability ⬆ ⬇

(Generic available)

Lyophilized powder for injection: 50 mg/vial
In combination with: cedazuridine (Inqovi). See Appendix [not included in this PDA edition].

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. If infection occurs delay therapy until resolved. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy.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.
- If hematologic recovery (ANC ≥1,000 cells/mm³ and platelets ≥50,000 cells/mm³) from previous treatment cycle requires more >6, but <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 >8, but <10 wk, assess 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.
- Obtain liver function tests and serum creatinine prior to initiation of treatment. May cause hyperbilirubinemia and hypoalbuminemia. If ALT or total bilirubin ≥2 times upper limit of normal, delay therapy until return to normal.
- Obtain serum creatinine before starting therapy. If serum creatinine ≥2 mg/dL, delay therapy until return to normal.
- May cause hyperglycemia, hypomagnesemia, hyponatremia, hypokalemia, and hyperkalemia.

Implementation ⬆ ⬇

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.
- Premedicate patient with standard antiemetic therapy.

IV Administration:

Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling IV medication. Discard IV equipment in specially designated containers.
Intermittent Infusion: Reconstitution: 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 or D5W.Concentration: 0.1–1.0 mg/mL. If diluted with room temperature solutions, infuse within 15 min of dilution. If diluted using cold infusion fluids, may be refrigerated until administration (maximum of 4 hr). Do not infuse solutions that are discolored or contain particulate matter.
Rate: Administer over 3 hr or over 1 hr, depending on treatment regimen chosen.

Patient/Family Teaching ⬆ ⬇

Explain purpose of decitabine to patient.
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).
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breastfeeding during and for 1 wk after last dose. Advise men with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. May impair male fertility.

Evaluation/Desired Outcomes ⬆ ⬇

Improved hematologic and clinical manifestations of MDS.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

16714- NorthStar RxLLC
- 16714-749- Decitabine
  - 16714-749-01- 1 VIAL in 1 CARTON (16714-749-01) > 20 mL in 1 VIAL

16714- Northstar Rx LLC
- 16714-928- Decitabine
  - 16714-928-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-928-01) > 10 mL in 1 VIAL, SINGLE-DOSE

16729- Accord Healthcare Inc.
- 16729-224- Decitabine
  - 16729-224-05- 1 VIAL in 1 CARTON (16729-224-05) > 20 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-231- decitabine
  - 25021-231-20- 1 VIAL in 1 CARTON (25021-231-20) > 20 mL in 1 VIAL

43598- Dr.Reddy's Laboratories Inc.
- 43598-348- Decitabine
  - 43598-348-37- 1 VIAL, SINGLE-USE in 1 CARTON (43598-348-37) > 10 mL in 1 VIAL, SINGLE-USE

43598- Dr.Reddy's Laboratories Inc.
- 43598-427- Decitabine
  - 43598-427-37- 1 VIAL, SINGLE-USE in 1 CARTON (43598-427-37) > 10 mL in 1 VIAL, SINGLE-USE

47335- Sun Pharmaceutical Industries, Inc.
- 47335-361- decitabine
  - 47335-361-41- 1 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL (47335-362-40) * 10 mL in 1 VIAL, SINGLE-DOSE

50742- Ingenus Pharmaceuticals, LLC
- 50742-430- DECITABINE
  - 50742-430-01- 1 VIAL in 1 CARTON (50742-430-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

55111- Dr.Reddy's Laboratories Limited
- 55111-556- Decitabine
  - 55111-556-10- 1 VIAL, SINGLE-USE in 1 CARTON (55111-556-10) > 10 mL in 1 VIAL, SINGLE-USE

59148- Otsuka America Pharmaceutical, Inc.
- 59148-046- Dacogen
  - 59148-046-70- 1 VIAL in 1 CARTON (59148-046-70) > 20 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
- 63323-825- Decitabine
  - 63323-825-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-825-20) > 20 mL in 1 VIAL, SINGLE-DOSE

64679- Wockhardt USA LLC.
- 64679-067- Decitabine
  - 64679-067-02- 1 VIAL, SINGLE-USE in 1 CARTON (64679-067-02) > 20 mL in 1 VIAL, SINGLE-USE (64679-067-01)

67457- Mylan Institutional LLC
- 67457-316- Decitabine
  - 67457-316-25- 1 VIAL in 1 CARTON (67457-316-25) > 20 mL in 1 VIAL

68001- BluePoint Laboratories
- 68001-347- Decitabine
  - 68001-347-36- 1 VIAL, SINGLE-USE in 1 CARTON (68001-347-36) > 10 mL in 1 VIAL, SINGLE-USE (68001-347-28)

68001- BluePoint Laboratories
- 68001-422- Decitabine
  - 68001-422-37- 1 VIAL, SINGLE-USE in 1 CARTON (68001-422-37) > 20 mL in 1 VIAL, SINGLE-USE

68180- Lupin Pharmaceuticals, Inc.
- 68180-738- decitabine
  - 68180-738-01- 1 VIAL in 1 CARTON (68180-738-01) > 20 mL in 1 VIAL

69097- Cipla USA Inc.
- 69097-285- Decitabine
  - 69097-285-37- 1 VIAL, SINGLE-USE in 1 CARTON (69097-285-37) > 10 mL in 1 VIAL, SINGLE-USE

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-115- Decitabine
  - 69539-115-01- 1 VIAL, SINGLE-USE in 1 CARTON (69539-115-01) > 20 mL in 1 VIAL, SINGLE-USE

70121- Amneal Pharmaceuticals LLC
- 70121-1644- Decitabine
  - 70121-1644-1- 1 VIAL, SINGLE-USE in 1 CARTON (70121-1644-1) > 20 mL in 1 VIAL, SINGLE-USE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇