Rejuvesol

Rejuvesol Manufacturers

• Citra Labs Llc
  

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  Rejuvesol | Fresenius Kabi Usa, Llc

  

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  2.1 Intravenous Dosing

  Mesna injection may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.

  Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide.  The total daily dose of mesna injection is 60% of the ifosfamide dose.  The recommended dosing schedule is outlined below in Table 1.

  
  

  Table 1:  Recommended Intravenous Dosing Schedule

   
  0 Hours
  4 Hours
  8 Hours
  Ifosfamide
  1.2 g/m2
  -
  -
  Mesna Injection1
  240 mg/m2
  240 mg/m2
  240 mg/m2
  

  1The dosing schedule should be repeated on each day that ifosfamide is administered.  When the dosage of ifosfamide is increased or decreased, the ratio of mesna injection to ifosfamide should be maintained.

  2.2 Intravenous and Oral Dosing
  

  Mesna injection may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of mesna tablets as outlined below. 
  
  Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration.  Mesna tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide.  The total daily dose of mesna is 100% of the ifosfamide dose.  The recommended dosing schedule is outlined in Table 2.

  
  
  

  Table 2:  Recommended Intravenous and Oral Dosing Schedule

  
   
  0 Hours
  2 Hours
  6 Hours
  Ifosfamide
  1.2 g/m2
  -
  -
  Mesna Injection1
  240 mg/m2
  -
  -
  Mesna Tablets
  -
  480 mg/m2
  480 mg/m2
  
  

  1The dosing schedule should be repeated on each day that ifosfamide is administered.  When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.
  
  The efficacy and safety of this ratio of intravenous and oral mesna has not been established as being effective for daily doses of ifosfamide higher than 2 g/m2.
  
  Patients who vomit within two hours of taking oral mesna should repeat the dose or receive intravenous mesna injection.

  
  2.3 Monitoring for Hematuria
  

  Maintain adequate hydration and sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria.  If severe hematuria develops when mesna injection is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.

  2.4 Preparation for Intravenous Administration and Stability
  

  Preparation
  Determine the volume of mesna injection for the intended dose. 
  
  Dilute the volume of mesna injection for the dose in any of the following fluids to obtain a final concentration of 20 mg/mL:

  5% Dextrose Injection, USP 5% Dextrose and 0.2% Sodium Chloride Injection, USP 5% Dextrose and 0.33% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP 0.9% Sodium Chloride Injection, USP Lactated Ringer’s Injection, USP
  

  Stability
  The mesna injection multiple dose vials may be stored and used for up to 8 days after initial puncture.
  
  Store diluted solutions at 25°C (77°F).  Use diluted solutions within 24 hours.
  
  Do not mix mesna injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.
  
  The benzyl alcohol contained in mesna injection vials can reduce the stability of ifosfamide.  Ifosfamide and mesna injection may be mixed in the same bag provided the final concentration of ifosfamide does not exceed 50 mg/mL.  Higher concentrations of ifosfamide may not be compatible with mesna injection and may reduce the stability of ifosfamide.
  
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.  Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.

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