DOSAGE AND ADMINISTRATION
Acute Iron Intoxication
Intramuscular Administration
This route is preferred and should be used for ALL PATIENTS NOT IN SHOCK.
A dose of 1000 mg should be administered initially. This may be followed by 500 mg every 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4-12 hours. The total amount administered should not exceed 6000 mg in 24 hours. For reconstitution instructions for intramuscular administration see Table 1 below.
Table 1: Preparation for Intramuscular Administration
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RECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION WITH STERILE WATER FOR INJECTION
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Vial Size
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Amount of Sterile Water for Injection Required for Reconstitution
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Total Drug Content after Reconstitution
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Final Concentration per mL after Reconstitution
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500 mg
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2 mL
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500 mg/2.35 mL
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213 mg/mL
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2 grams
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8 mL
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2 grams/9.4 mL
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213 mg/mL
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The reconstituted deferoxamine mesylate solution is a yellow-colored solution. The drug should be completely dissolved before the solution is withdrawn. Deferoxamine Mesylate for Injection reconstituted with Sterile Water for Injection
IS FOR SINGLE USE ONLY. Discard unused portion.
Intravenous Administration
THIS ROUTE SHOULD BE USED ONLY FOR PATIENTS IN A STATE OF CARDIOVASCULAR COLLAPSE AND THEN ONLY BY SLOW INFUSION. THE RATE OF INFUSION SHOULD NOT EXCEED 15 MG/KG/HR FOR THE FIRST 1000 MG ADMINISTERED. SUBSEQUENT IV DOSING, IF NEEDED, MUST BE AT A SLOWER RATE, NOT TO EXCEED 125 MG/HR.
The reconstituted solution is added to physiologic saline, (e.g., 0.9% sodium chloride, 0.45% sodium chloride), glucose in water, or Ringer's lactate solution.
An initial dose of 1000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4-12 hours. The total amount administered should not exceed 6000 mg in 24 hours.
As soon as the clinical condition of the patient permits, intravenous administration should be discontinued and the drug should be administered intramuscularly. For reconstitution instructions for intravenous administration see Table 2 below.
Table 2: Preparation for Intravenous Administration
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RECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION WITH STERILE WATER FOR INJECTION
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Vial Size
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Amount of Sterile Water for Injection Required for Reconstitution
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Total Drug Content after Reconstitution
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Final Concentration per mL after Reconstitution
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500 mg
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5 mL
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500 mg/5.3 mL
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95 mg/mL
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2 grams
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20 mL
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2 grams/21.1 mL
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95 mg/mL
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The reconstituted deferoxamine mesylate solution is an isotonic, clear and colorless to slightly yellowish solution. The drug should be completely dissolved before the solution is withdrawn. Deferoxamine Mesylate for Injection reconstituted with Sterile Water for Injection
IS FOR SINGLE USE ONLY. Discard unused portion.
Chronic Iron Overload
The more effective of the following routes of administration must be chosen on an individual basis for each patient.
Intramuscular Administration
A daily dose of 500-1000 mg should be administered intramuscularly. In addition, 2000 mg should be administered intravenously with each unit of blood transfused; however, deferoxamine mesylate should be administered separately from the blood. The rate of intravenous infusion must not exceed 15 mg/kg/hr. The total daily dose should not exceed 1000 mg in the absence of a transfusion, or 6000 mg even if transfused three or more units of blood or packed red blood cells. For reconstitution instructions for intramuscular administration see Table 3 below.
Table 3: Preparation for Intramuscular Administration
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RECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION WITH STERILE WATER FOR INJECTION
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|
Vial Size
|
Amount of Sterile Water for Injection Required for Reconstitution
|
Total Drug Content after Reconstitution
|
Final Concentration per mL after Reconstitution
|
|
500 mg
|
2 mL
|
500 mg/2.35 mL
|
213 mg/mL
|
|
2 grams
|
8 mL
|
2 grams/9.4 mL
|
213 mg/mL
|
The reconstituted deferoxamine mesylate solution is a yellow-colored solution. The drug should be completely dissolved before the solution is withdrawn. Deferoxamine Mesylate for Injection reconstituted with Sterile Water for Injection
IS FOR SINGLE USE ONLY. Discard unused portion.
Subcutaneous Administration
A daily dose of 1000-2000 mg (20-40 mg/kg/day) should be administered over 8-24 hours, utilizing a small portable pump capable of providing continuous mini-infusion. The duration of infusion must be individualized. In some patients, as much iron will be excreted after a short infusion of 8-12 hours as with the same dose given over 24 hours. For reconstitution instructions for subcutaneous administration see Table 4 below.
Table 4: Preparation for Subcutaneous Administration
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RECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION WITH STERILE WATER FOR INJECTION
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|
Vial Size
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Amount of Sterile Water for Injection Required for Reconstitution
|
Total Drug Content after Reconstitution
|
Final Concentration per mL after Reconstitution
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|
500 mg
|
5 mL
|
500 mg/5.3 mL
|
95 mg/mL
|
|
2 grams
|
20 mL
|
2 grams/21.1 mL
|
95 mg/mL
|
The reconstituted deferoxamine mesylate solution is an isotonic, clear and colorless to slightly yellowish solution. The drug should be completely dissolved before the solution is withdrawn. Deferoxamine Mesylate for Injection reconstituted with Sterile Water for Injection
IS FOR SINGLE USE ONLY. Discard unused portion.
Stability after Reconstitution
The product should be used immediately after reconstitution (commencement of treatment within 3 hours) for microbiological safety. When reconstitution is carried out under validated aseptic conditions (in a sterile laminar flow hood using aseptic technique), the product may be stored at room temperature for a maximum period of 24 hours before use. Do not refrigerate reconstituted solution. Reconstituting Deferoxamine Mesylate for Injection in solvents or under conditions other than indicated may result in precipitation. Turbid solutions should not be used.
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