Deferoxamine Mesylate
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Questions & Answers
Side Effects & Adverse Reactions
Ocular and auditory disturbances have been reported when deferoxamine mesylate was administered over prolonged periods of time, at high doses, or in patients with low ferritin levels. The ocular disturbances observed have been blurring of vision; cataracts after prolonged administration in chronic iron overload; decreased visual acuity including visual loss, visual defects, scotoma; impaired peripheral, color, and night vision; optic neuritis, cataracts, corneal opacities, and retinal pigmentary abnormalities. The auditory abnormalities reported have been tinnitus and hearing loss including high frequency sensorineural hearing loss. In most cases, both ocular and auditory disturbances were reversible upon immediate cessation of treatment (see PRECAUTIONS/Information for Patients and ADVERSE REACTIONS/Special Senses).
Visual acuity tests, slit-lamp examinations, funduscopy and audiometry are recommended periodically in patients treated for prolonged periods of time. Toxicity is more likely to be reversed if symptoms or test abnormalities are detected early.
Increases in serum creatinine (possibly dose-related), acute renal failure and renal tubular disorders, associated with the administration of deferoxamine, have been reported in postmarketing experience (see ADVERSE REACTIONS). Monitor patients for changes in renal function.
High doses of deferoxamine mesylate and concomitant low ferritin levels have also been associated with growth retardation. After reduction of deferoxamine mesylate dose, growth velocity may partially resume to pretreatment rates (see PRECAUTIONS/Pediatric Use).
Adult respiratory distress syndrome, also reported in children, has been described following treatment with excessively high intravenous doses of deferoxamine mesylate in patients with acute iron intoxication or thalassemia.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Deferoxamine Mesylate for Injection, USP is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias.
Acute Iron Intoxication
Deferoxamine mesylate is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis.
Chronic Iron Overload
Deferoxamine mesylate can promote iron excretion in patients with secondary iron overload from multiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). Long-term therapy with deferoxamine mesylate slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis.
Iron mobilization with deferoxamine mesylate is relatively poor in patients under the age of 3 years with relatively little iron overload. The drug should ordinarily not be given to such patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated.
Deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder.
History
There is currently no drug history available for this drug.
Other Information
Deferoxamine Mesylate for Injection, USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Deferoxamine mesylate is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP in sterile, lyophilized form. Deferoxamine mesylate is N-[5-[3-[(5-Aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N-hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesulfonate (salt), and its structural formula is:
Deferoxamine mesylate USP is a white to off-white powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79. The molecular formula is C25H48N6O8 • CH4O3S.
Sources
Deferoxamine Mesylate Manufacturers
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Hospira, Inc.
![Deferoxamine Mesylate Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Deferoxamine Mesylate | Hospira, Inc.
Acute Iron Intoxication
Intramuscular Administration
This route is preferred and should be used for ALL PATIENTS NOT IN SHOCK.
A dose of 1,000 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 to 12 hours. The total amount administered should not exceed 6,000 mg in 24 hours. For reconstitution instructions for intramuscular administration see Table 1.
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 1,000 MG ADMINISTERED. SUBSEQUENT IV DOSING, IF NEEDED, MUST BE AT A SLOWER RATE, NOT TO EXCEED 125 MG/HR.
For reconstitution instructions for intravenous administration see Table 2. 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 1,000 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 to 12 hours. The total amount administered should not exceed 6,000 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.
CHRONIC IRON OVERLOAD
SUBCUTANEOUS ADMINISTRATION
A daily dose of 1,000 to 2,000 mg (20 to 40 mg/kg/day) should be administered over 8 to 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 to 12 hours as with the same dose given over 24 hours. For reconstitution instructions for subcutaneous administration see Table 3.
Intravenous Administration
The standard recommended method of Deferoxamine Mesylate for Injection, USP administration is via slow subcutaneous infusion over 8 to 12 hours. In patients with intravenous access, the daily dose of Deferoxamine Mesylate for Injection, USP can be administered intravenously. The standard dose is 20 to 40 mg/kg/day for children and 40 to 50 mg/kg/day over 8 to 12 hours in adults for 5 to 7 days per week. In children, average doses should not exceed 40 mg/kg/day until growth has ceased. In adults, average doses should not exceed 60 mg/kg/day. The intravenous infusion rate should not exceed 15 mg/kg/hr. For reconstitution instructions for intravenous administration see Table 2.
In patients who are poorly compliant, Deferoxamine Mesylate for Injection, USP may be administered prior to or following same day blood transfusion (for example 1 gram over 4 hours on the day of transfusion); however, the contribution of this mode of administration to iron balance is limited. Deferoxamine Mesylate for Injection, USP should not be administered concurrently with the blood transfusion as this can lead to errors in interpreting side effects such as rash, anaphylaxis and hypotension.
Intramuscular Administration
A daily dose of 500 to 1,000 mg may be administered intramuscularly. The total daily dose should not exceed 1,000 mg. For reconstitution instructions for intramuscular administration see Table 1.
Table 1: Preparation for Intramuscular AdministrationRECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH STERILE WATER FOR INJECTION
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
Table 2: Preparation for Intravenous AdministrationRECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH STERILE WATER FOR INJECTION
Vial Size
Amount of Sterile Water for Injection Required for Reconstitution
Total Drug Content after Reconstitution
Final Concentration per mL after Reconstitution
500 mg
5 mL
500 mg/5.3 mL
95 mg/mL
2 grams
20 mL
2 grams/21.1 mL
95 mg/mL
Table 3: Preparation for Subcutaneous AdministrationRECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH STERILE WATER FOR INJECTION
Vial Size
Amount of Sterile Water for Injection Required for Reconstitution
Total Drug Content after Reconstitution
Final Concentration per mL after Reconstitution
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 yellow-colored solution. The drug should be completely dissolved before the solution is withdrawn. Deferoxamine Mesylate for Injection, USP 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, USP in solvents or under conditions other than indicated may result in precipitation. Turbid solutions should not be used.
-
Hospira, Inc.
Deferoxamine Mesylate | Hospira, Inc.
Acute Iron Intoxication
Intramuscular Administration
This route is preferred and should be used for ALL PATIENTS NOT IN SHOCK.
A dose of 1,000 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 to 12 hours. The total amount administered should not exceed 6,000 mg in 24 hours. For reconstitution instructions for intramuscular administration see Table 1.
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 1,000 MG ADMINISTERED. SUBSEQUENT IV DOSING, IF NEEDED, MUST BE AT A SLOWER RATE, NOT TO EXCEED 125 MG/HR.
For reconstitution instructions for intravenous administration see Table 2. 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 1,000 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 to 12 hours. The total amount administered should not exceed 6,000 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.
CHRONIC IRON OVERLOAD
SUBCUTANEOUS ADMINISTRATION
A daily dose of 1,000 to 2,000 mg (20 to 40 mg/kg/day) should be administered over 8 to 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 to 12 hours as with the same dose given over 24 hours. For reconstitution instructions for subcutaneous administration see Table 3.
Intravenous Administration
The standard recommended method of Deferoxamine Mesylate for Injection, USP administration is via slow subcutaneous infusion over 8 to 12 hours. In patients with intravenous access, the daily dose of Deferoxamine Mesylate for Injection, USP can be administered intravenously. The standard dose is 20 to 40 mg/kg/day for children and 40 to 50 mg/kg/day over 8 to 12 hours in adults for 5 to 7 days per week. In children, average doses should not exceed 40 mg/kg/day until growth has ceased. In adults, average doses should not exceed 60 mg/kg/day. The intravenous infusion rate should not exceed 15 mg/kg/hr. For reconstitution instructions for intravenous administration see Table 2.
In patients who are poorly compliant, Deferoxamine Mesylate for Injection, USP may be administered prior to or following same day blood transfusion (for example 1 gram over 4 hours on the day of transfusion); however, the contribution of this mode of administration to iron balance is limited. Deferoxamine Mesylate for Injection, USP should not be administered concurrently with the blood transfusion as this can lead to errors in interpreting side effects such as rash, anaphylaxis and hypotension.
Intramuscular Administration
A daily dose of 500 to 1,000 mg may be administered intramuscularly. The total daily dose should not exceed 1,000 mg. For reconstitution instructions for intramuscular administration see Table 1.
Table 1: Preparation for Intramuscular AdministrationRECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH
STERILE WATER FOR INJECTIONVial 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
Table 2: Preparation for Intravenous AdministrationRECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH
STERILE WATER FOR INJECTIONVial Size
Amount of Sterile Water for Injection Required for Reconstitution
Total Drug Content after Reconstitution
Final Concentration per mL after Reconstitution
500 mg
5 mL
500 mg/5.3 mL
95 mg/mL
2 grams
20 mL
2 grams/21.1 mL
95 mg/mL
Table 3: Preparation for Subcutaneous AdministrationRECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH
STERILE WATER FOR INJECTIONVial Size
Amount of Sterile Water for Injection Required for Reconstitution
Total Drug Content after Reconstitution
Final Concentration per mL after Reconstitution
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 yellow-colored solution. The drug should be completely dissolved before the solution is withdrawn. Deferoxamine Mesylate for Injection, USP 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, USP in solvents or under conditions other than indicated may result in precipitation. Turbid solutions should not be used.
![Deferoxamine Mesylate Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2e87cc7e-8856-4ec6-8c74-0356a352f522&name=CartonNDC0409-2336-13-01.jpg)
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