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deferoxamine mesylate
Overview
What is Desferal?
Desferal, deferoxamine mesylate USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Desferal is supplied as vials containing 500 mg of deferoxamine mesylate USP in sterile, lyophilized form. Deferoxamine mesylate is -[5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(-hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesul-fonate (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.
What does Desferal look like?
What are the available doses of Desferal?
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What should I talk to my health care provider before I take Desferal?
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How should I use Desferal?
Desferal is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias.
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.
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.
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 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.
What interacts with Desferal?
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What are the warnings of Desferal?
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What are the precautions of Desferal?
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What are the side effects of Desferal?
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What should I look out for while using Desferal?
Known hypersensitivity to the active substance.
Desferal is contraindicated in patients with severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney (see WARNINGS).
Ocular and auditory disturbances have been reported when Desferal 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 Desferal and concomitant low ferritin levels have also been associated with growth retardation. After reduction of Desferal dose, growth velocity may partially resume to pre-treatment rates (see PRECAUTIONS/Pediatric Use).
Adult respiratory distress syndrome, also reported in children, has been described following treatment with excessively high intravenous doses of Desferal in patients with acute iron intoxication or thalassemia.
What might happen if I take too much Desferal?
How should I store and handle Desferal?
Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylateCartons of 4 vials……………………………………………NDC 0078-0467-91Do not store above 25°C (77°F).Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936© NovartisT2018-35
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Desferal chelates iron by forming a stable complex that prevents the iron from entering into further chemical reactions. It readily chelates iron from ferritin and hemosiderin but not readily from transferrin; it does not combine with the iron from cytochromes and hemoglobin. Desferal does not cause any demonstrable increase in the excretion of electrolytes or trace metals. Theoretically, 100 parts by weight of Desferal is capable of binding approximately 8.5 parts by weight of ferric iron.
Desferal is metabolized principally by plasma enzymes, but the pathways have not yet been defined. The chelate is readily soluble in water and passes easily through the kidney, giving the urine a characteristic reddish color. Some is also excreted in the feces via the bile.
Non-Clinical Toxicology
Known hypersensitivity to the active substance.Desferal is contraindicated in patients with severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney (see WARNINGS).
Ocular and auditory disturbances have been reported when Desferal 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 Desferal and concomitant low ferritin levels have also been associated with growth retardation. After reduction of Desferal dose, growth velocity may partially resume to pre-treatment rates (see PRECAUTIONS/Pediatric Use).
Adult respiratory distress syndrome, also reported in children, has been described following treatment with excessively high intravenous doses of Desferal in patients with acute iron intoxication or thalassemia.
Vitamin C:
Gallium-67:
Flushing of the skin, urticaria, hypotension, and shock has occurred in a few patients when Desferal was administered by rapid intravenous injection. THEREFORE, DESFERAL SHOULD BE GIVEN INTRAMUSCULARLY OR BY SLOW SUBCUTANEOUS OR INTRAVENOUS INFUSION.
Iron overload increases susceptibility of patients to and infections. In some rare cases, treatment with Desferal has enhanced this susceptibility, resulting in generalized infections by providing these bacteria with a siderophore otherwise missing. In such cases, Desferal treatment should be discontinued until the infection is resolved.
In patients receiving Desferal, rare cases of mucormycosis, some with a fatal outcome, have been reported. If any of the suspected signs or symptoms occur, Desferal should be discontinued, mycological tests carried out and appropriate treatment instituted immediately.
In patients with severe chronic iron overload, impairment of cardiac function has been reported following concomitant treatment with Desferal and high doses of vitamin C (more than 500 mg daily in adults). The cardiac dysfunction was reversible when vitamin C was discontinued. The following precautions should be taken when vitamin C and Desferal are to be used concomitantly:
In patients with aluminum-related encephalopathy and receiving dialysis, Desferal may cause neurological dysfunction (seizures), possibly due to an acute increase in circulating aluminum (see ADVERSE REACTIONS). Desferal may precipitate the onset of dialysis dementia. Treatment with Desferal in the presence of aluminum overload may result in decreased serum calcium and aggravation of hyperparathyroidism.
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
At the Injection Site:
Hypersensitivity Reactions and Systemic Allergic Reactions:
Body as a Whole:
Infections with and have been reported in association with Desferal use (see PRECAUTIONS).
Cardiovascular:
Digestive:
Hematologic:
Hepatic:
Musculoskeletal:
Nervous
S
ystem:
Special Senses:
Respiratory:
Skin:
Urogenital:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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