Decitabine

Decitabine Manufacturers

• Dr.reddy’s Laboratories Inc
  

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  Decitabine | Dr.reddy's Laboratories Inc

  

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  There are two regimens for decitabine for 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.

  2.1 Treatment Regimen – Option 1

  Decitabine for 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 decitabine for injection treatment cycle requires more than 6 weeks, then the next cycle of decitabine for injection therapy should be delayed and dosing temporarily reduced by following this algorithm:

  Recovery requiring more than 6, but less than 8 weeks − Decitabine for injection dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m2every 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 decitabine for 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.   2.2 Treatment Regimen – Option 2

  Decitabine for 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 decitabine for injection should be delayed until there is hematologic recovery (ANC ≥ 1,000/μL platelets ≥ 50,000/μL).

  2.3 Patients with Non-hematologic Toxicity

  Following the first cycle of decitabine for injection treatment, if any of the following non-hematologic toxicities are present, decitabine for 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.

  2.4 Instructions for Intravenous Administration

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

  Decitabine for injection should be aseptically reconstituted with 10 mL of Sterile Water for Injection (USP); upon reconstitution, each mL contains approximately 5 mg of decitabine at pH 6.7 to 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 to 1 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.

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• Dr.reddy’s Laboratories Limited
  

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  Decitabine | Laboratoires M&l.

  

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  apply liberally 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

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• Dr.reddy’s Laboratories Inc
  

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  Decitabine | C.a Pharm Co., Ltd.

  

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  Dosage and administration:
  Take appropriate amount to the entire face and body, gently massage and tapping until absorbed.

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• Sandoz Inc
  

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  Decitabine | Sandoz Inc

  

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  There are two regimens for decitabine for 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.

  2.1 Treatment Regimen – Option 1

  Decitabine for 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 decitabine for injection treatment cycle requires more than 6 weeks, then the next cycle of decitabine for injection therapy should be delayed and dosing temporarily reduced by following this algorithm:

  • Recovery requiring more than 6, but less than 8 weeks − Decitabine for injection dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m 2 every 8 hours (33 mg/m 2/day, 99 mg/m 2/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 decitabine for injection dose should be delayed up to 2 more weeks and the dose reduced to 11 mg/m 2 every 8 hours (33 mg/m 2/day, 99 mg/m 2/cycle) upon restarting therapy, then maintained or increased in subsequent cycles as clinically indicated.   2.2 Treatment Regimen – Option 2

  Decitabine for 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 decitabine for injection should be delayed until there is hematologic recovery (ANC ≥ 1,000/μL platelets ≥ 50,000/μL).

  2.3 Patients with Non-hematologic Toxicity

  Following the first cycle of decitabine for injection treatment, if any of the following non-hematologic toxicities are present, decitabine for 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.

  2.4 Instructions for Intravenous Administration

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

  Decitabine for injection should be aseptically reconstituted with 10 mL of Sterile Water for Injection (USP); upon reconstitution, each mL contains approximately 5 mg of decitabine at pH 6.7 to 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 to 1 mg/mL. Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold (2˚C to 8˚C) infusion fluids and stored at 2˚C to 8˚C (36˚F to 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.

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