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Dacogen

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Dacogen

Indications
Dosage
How Supplied

INDICATIONS

Dacogen (decitabine injection) is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (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 groups.

DOSAGE AND ADMINISTRATION

There are two regimens for Dacogen (decitabine injection) administration. With either regimen it is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles.

Complete blood counts and platelet counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of treatment.

Treatment Regimen – Option 1

Dacogen (decitabine injection) is administered at a dose of 15 mg/m² by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. This cycle should be repeated every 6 weeks. Patients may be premedicated with standard anti-emetic therapy.

If hematologic recovery (ANC ≥ 1,000/μL and platelets ≥ 50,000/μL) from a previous Dacogen (decitabine injection) treatment cycle requires more than 6 weeks, then the next cycle of Dacogen (decitabine injection) therapy should be delayed and dosing temporarily reduced by following this algorithm:

  • Recovery requiring more than 6, but less than 8 weeks-Dacogen (decitabine injection) dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m² every 8 hours (33 mg/m²/day, 99 mg/m²/cycle) upon restarting therapy.
  • Recovery requiring more than 8, but less than 10 weeks-Patient should be assessed for disease progression (by bone marrow aspirates); in the absence of progression, the Dacogen (decitabine injection) dose should be delayed up to 2 more weeks and the dose reduced to 11 mg/m² every 8 hours (33 mg/m²/day, 99 mg/m²/cycle) upon restarting therapy, then maintained or increased in subsequent cycles as clinically indicated.

Treatment Regimen – Option 2

Dacogen (decitabine injection) is administered at a dose of 20 mg/m² by continuous intravenous infusion over 1 hour repeated daily for 5 days. This cycle should be repeated every 4 weeks. Patients may be premedicated with standard anti-emetic therapy.

If myelosuppression is present, subsequent treatment cycles of Dacogen (decitabine injection) should be delayed until there is hematologic recovery (ANC ≥ 1,000/μL platelets ≥ 50,000/μL ).

Patients with Non-hematologic Toxicity

Following the first cycle of Dacogen (decitabine injection) treatment, if any of the following non-hematologic toxicities are present, Dacogen (decitabine injection) treatment should not be restarted until the toxicity is resolved: 1) serum creatinine ≥ 2 mg/dL; 2) SGPT, total bilirubin ≥ 2 times ULN; 3) and active or uncontrolled infection.

Instructions for Intravenous Administration

Dacogen (decitabine injection) is a cytotoxic drug and caution should be exercised when handling and preparing Dacogen (decitabine injection) . Procedures for proper handling and disposal of antineoplastic drugs should be applied. Several guidances on this subject have been published.1-4 .

Dacogen (decitabine injection) should be aseptically reconstituted with 10 mL of Sterile Water for Injection (USP); upon reconstitution, each mL contains approximately 5.0 mg of decitabine at pH 6.7-7.3. Immediately after reconstitution, the solution should be further diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer's Injection to a final drug concentration of 0.1 - 1.0 mg/mL. Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold (2°C - 8°C) infusion fluids and stored at 2°C - 8°C (36°F - 46°F) for up to a maximum of 7 hours until administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is evidence of particulate matter or discoloration.

HOW SUPPLIED

Dosage Forms And Strengths

Dacogen (decitabine) for Injection is supplied as a sterile, lyophilized white to almost white powder, in a single-dose vial, packaged in cartons of 1 vial. Each vial contains 50 mg of decitabine.

Storage And Handling

NDC 62856-600-01, 50 mg single-dose vial individually packaged in a carton.

Storage

Store vials at 25°C (77°F); excursions permitted to 15-30°C (5986°F).

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html3. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J Health-Syst Pharm. 2006;63:1172-1193.

4. Polovich M., White JM, Kelleher LO (eds). Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.) 2005. Pittsburgh, PA: Oncology Nursing Society.

Manufactured by Pharmachemie B.V. Haarlem, The Netherlands. Manufactured for Eisai Inc., Woodcliff Lake, NJ 07677. Revised: 03/2010

Last reviewed on RxList: 4/1/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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