atients 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.

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.

m 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. chronic iron overload 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 3. intravenous administration the standard recommended method of deferoxamine mesylate administration is via slow subcutaneous infusion over 8 – 12 hours. in patients with intravenous access, the daily dose of deferoxamine mesylate can be administered intravenously. the standard dose is 20 – 40 mg/kg/day for children and 40 – 50 mg/kg/day over 8 – 12 hours in adults for 5 – 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/hour. for reconstitution instructions for intravenous administration see table 2. in patients who are poorly compliant, deferoxamine mesylate 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 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 500-1000 mg may be administered intramuscularly. the total daily dose should not exceed 1000 mg. for reconstitution instructions for intramuscular administration see table 1. reconstitution and preparation table 1: preparation for intramuscular administration reconstitute deferoxamine mesylate 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 administrations reconstitute deferoxamine mesylate 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 administration reconstitute deferoxamine mesylate 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- 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 dose only. discard unused portion. 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.

scrasia (thrombocytopenia, leucopenia). hepatic: increased transaminases, hepatic dysfunction. musculoskeletal: muscle spasms. growth retardation and bone changes (e.g., metaphyseal dysplasia) are common in chelated patients given doses above 60 mg/kg, especially those who begin iron chelation in the first three years of life. if doses are kept to 40 mg/kg or below, the risk may be reduced (see warnings, precautions/pediatric use). nervous system: neurological disturbances including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, seizures; exacerbation or precipitation of aluminum-related dialysis encephalopathy (see precautions/information for patients). special senses: high-frequency sensorineural hearing loss and/or tinnitus are uncommon if dosage guidelines are not exceeded and if dose is reduced when ferritin levels decline. visual disturbances are rare if dosage guidelines are not exceeded. these may include decreased acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts (see warnings). respiratory: acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates) (see warnings). skin: very rare generalized rash. urogenital: dysuria, acute renal failure, increased serum creatinine and renal tubular disorders (see contraindications and warnings). postmarketing reports there are postmarketing reports of deferoxamine-associated renal dysfunction, including renal failure. monitor patients for changes in renal function (e.g., increased serum creatinine).