Decitabine Kit

Decitabine Kit Manufacturers

• Sun Pharma Global Fze
  

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  Decitabine Kit | Sun Pharma Global Fze

  

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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 greater than or equal to 1,000/μL and platelets greater than or equal to 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/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 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 greater than or equal to 1,000/μL platelets greater than or equal to 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 greater than or equal to 2 mg/dL; 2) Serum Glutamate Pyruvate Transaminase (SGPT), total bilirubin greater than or equal to 2 times Upper Limit of Normal (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 published1.

  
  

  Decitabine for Injection 50 mg/vial should be aseptically reconstituted with 10 mL of Diluent for Decitabine for Injection; 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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• Sun Pharma Global Fze
  

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  Decitabine Kit | Bimeda, Inc. Division Of Cross Vetpharm Group

  

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  DOSAGE AND ADMINISTRATION:  Sustain III Boluses (Sulfamethazine Sustained Release Boluses) are designed to be administered orally to beef cattle and non-lactating dairy cattle (See WARNING).  Sustain III Boluses should be given according to the following dosage schedule:

  No. of boluses                                       Animal Body Weight
         1                                                             200 lbs.
  
         1.5                                                          300 lbs.
  
         2                                                             400 lbs.
  
         2.5                                                          500 lbs.
  
         3                                                             600 lbs.
  
         3.5                                                          700 lbs.
  
         4                                                             800 lbs.
  
         4.5                                                          950 lbs.
  
         5                                                            1,000 lbs.

  This bolus may be divided for better approximation of correct dose; however, care should be taken not to crush the bolus.  Care should also be taken to ensure the entire dose has been swallowed by the animal.  Observe animals following administration to ensure boluses are not reguritated.  Lubricate Sustain III before dosing animals.

  Sustain III Boluses are designed to provide a therapeutic sulfamethazine level in approximately 6 hours and persist in providing this level for 72 hours (3 days).  After 72 hours, all animals should be re-examined for persistence of observable disease signs.  If signs are present, consult your veterinarian.  It is strongly recommended that a second dose be given to provide for an additional 72 hours of therapy, particularly in those more severe cases.  The dosage schedule should be used at each 72-hour interval.

  Fluid intake must be adequate at all times throughout the three-day therapy provided by the sustained release bolus.

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