Deferoxamine
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Desferal is contraindicated in patients with severe renal disease [see Contraindications] . For patients with renal impairment, dose selection should usually start at the low end of the dosing range. Deferoxamine can cause increases in serum creatinine (possibly dose-related), acute renal failure and renal tubular disorders [see Warnings and Precautions] .
Monitor patients for changes in renal function.
Dosing in liver impairment
Hepatic Impairment For patients with hepatic impairment, dose selection should usually start at the low end of the dosing range.
Preparation and administration
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Preparation Reconstitute Desferal prior to administration. Desferal should be further diluted for intravenous infusion. Use appropriate aseptic technique. Reconstitute each vial of Desferal with Sterile Water for Injection, USP per Table 1. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use if visibly opaque particles, discoloration or foreign particles are observed. The reconstituted Desferal solution is an isotonic, clear and colorless to slightly-yellowish solution. Discard unused portion. [See table below.] ** 500 mg Subcutaneous 5 mL 95 mg/mL If not used immediately, store at room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F), for a maximum period of 24 hours.
Do not refrigerate reconstituted solution.
| *Intravenous route of administration requires further dilution with 150 mL of 0.9% Sodium Chloride Injection, USP or 0.45% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP or Lactated Ringers Injection, USP. **Final concentration for intravenous administration is between 3 mg/mL to 3.5 mg/mL. | |||
| Vial size | Route of administration | Amount of Sterile Water for Injection, USP for reconstitution | Concentration after reconstitution |
| 500 mg | Intramuscular | 2 mL | 213 mg/mL |
| 500 mg | Intravenous* | 5 mL | 95 mg/mL** |
| 500 mg | Subcutaneous | 5 mL | 95 mg/mL |
Drug interactions
Check deferoxamine against a medication listLabel text (3 paragraphs)
Concurrent treatment with prochlorperazine may lead to temporary impairment of consciousness. ( 7.1 ) Imaging results may be distorted due to rapid urinary excretion of Desferal bound gallium-67. Discontinue Desferal 48 hours prior to scintigraphy. ( 7.2 )
7.1 Prochlorperazine Concurrent treatment with Desferal and prochlorperazine, a phenothiazine derivative, may lead to temporary impairment of consciousness.
7.2 Gallium-67 Imaging results may be distorted because of the rapid urinary excretion of Desferal-bound gallium-67. Discontinue Desferal 48 hours prior to scintigraphy.
Contraindications
Desferal is contraindicated in patients with: A history of a hypersensitivity reaction to deferoxamine or any of its inactive ingredients [see Description (11)] . Reactions have included anaphylaxis [see Warnings and Precautions (5.1)] . Severe renal disease or anuria since the drug and the iron chelate are excreted primarily by the kidney [see Warnings and Precautions (5.3)] . Known hypersensitivity to the active substance. ( 4 ) Patients with severe renal disease or anuria. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Deferoxamine is a parenterally administered iron chelating agent used to treat transfusion related chronic iron overload. Deferoxamine rarely causes serum aminotransferase elevations during therapy and has not been convincingly linked to instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on Desferal use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriages or adverse maternal or fetal outcomes. In animal reproduction studies subcutaneous administration of deferoxamine to pregnant animals (mice or rabbits) during organogenesis at doses approximately ≥ 0.2 (mice) and ≥ 0.7 (rabbits) times the maximum recommended human dose resulted in maternal toxicity and adverse developmental outcomes ( see Data ). Advise pregnant women of the potential risk to a fetus.
Consider the benefits and risks of Desferal for the mother and possible risks to the fetus when prescribing Desferal to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In an embryo-fetal developmental study in mice, pregnant animals administered subcutaneous doses of deferoxamine at 180, and 540 mg/kg/day from gestation day 7 to gestation day 12 resulted in a dose dependent delay and irregularities of fetal skeletal maturation at doses ≥ 0.2 times the MRHD. At the highest dose of 540 mg/kg, in 1/23 fetuses had a unilateral lesion to the eye lens (approximately 0.5 times the MRHD).
In the embryo-fetal developmental studies in rabbits, pregnant animals administered subcutaneous doses of deferoxamine either 200 mg/kg or 200, 300, and 540 mg/kg from gestation day 6 to gestation day 14 resulted in maternal toxicity and embryo-fetal developmental effects at 0.7 times the MRHD). Maternal toxicity included reduced fetal body weights and embryo-fetal effects included malformations of spina bifida, and increased incidence of abnormally ossified ribs and vertebrae. No maternal toxicity or embryo-fetal effects were observed in rats at deferoxamine doses tested (up to 0.9 times the MRHD).
Breastfeeding (LactMed)
Deferoxamine is poorly absorbed orally, so it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. Limited information indicates that maternal doses of deferoxamine up to 2 grams daily do not affect iron levels in breastmilk and did not cause any adverse effects in two breastfed infants. Some experts advocate breastfeeding in women receiving deferoxamine for iron overload caused by beta-thalassemia. However, since little published information is available on the use of deferoxamine during breastfeeding, monitoring of the infant's serum iron is recommended.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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