Deferoxamine 95 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Iron Chelator class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Deferoxamine is used to reduce excessive amounts of iron in the body. Deferoxamine is in a class of medications called iron chelating agents. It works by attaching to iron in the body so that it can be removed from the body.
Read the full MedlinePlus article ↗- No, that's actually a reassuring sign — it means deferoxamine is doing its job. When the drug binds to iron, it forms a complex that your kidneys filter out and pass into your urin...
- Why is my urine turning red or orange? Should I be worried?
- You need to be careful with vitamin C while on deferoxamine. High doses — more than 500 mg per day in adults — taken at the same time have been linked to serious heart problems, es...
- Can I take my vitamin C supplement while I'm on this medication?
Patient education
Supplement & herbal interactions
Deferoxamine Mesylate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $37.38 | $788.69 / 21.1 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0895 | $10.020 / J0895 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Deferoxamine Mesylate 2 g 00409-2337-25 | Hospira, | 4 vials | — | AP | FDA listed | — |
| Deferoxamine mesylate 2 g 60505-6237-06 | Apotex | 4 injections | — | AP | FDA listed | — |
| Deferoxamine 95 mg/mLthis 63323-0599-30 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Deferoxamine mesylate 2 g 68083-0173-01 | Gland | 4 injections | — | AP | FDA listed | — |
| Deferoxamine 95 mg/mL 63323-0597-10 | Fresenius | 1 vial | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0599-30 You're viewing this | 1 VIAL in 1 BOX (63323-599-30) / 21.1 mL in 1 VIAL | 2009-12-15 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: • As an adjunct to standard measures for the treatment of acute iron intoxication. ( 1.1 ) • For the treatment of transfusional iron overload in patients with chronic anemia. ( 1.2 ) Limitations of Use Deferoxamine Mesylate for Injection is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
1.1Acute Iron Intoxication Deferoxamine Mesylate for Injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication.
1.2Chronic Iron Overload Deferoxamine Mesylate for Injection is indicated for the treatment of transfusional iron overload in patients with chronic anemia.
1.3Limitations of Use Deferoxamine Mesylate for Injection is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The dosage (based on body weight in mg/kg/day), rates of administration, and mode of administration for both adults and pediatric patients are individually determined and adapted during the course of therapy based on the severity of the patient's iron overload. The minimum daily dose of Deferoxamine Mesylate for Injection is 20 mg/kg/day for both adults and pediatric patients. The maximum daily dose is 40 mg/kg/day for pediatric patients and 60 mg/kg/day for adults.
Acute Iron Intoxication: ( 2.1 ) • Intramuscular Administration: Use for patients not in shock. Initial dose is 1,000 mg. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4 hours to 12 hours.
Maximum dose is 6,000 mg in 24 hours. • Intravenous Administration: Only for patients in a state of cardiovascular collapse. Initial dose is 1,000 mg at a rate not to exceed 15 mg/kg/hr. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4 hours to 12 hours at a rate of up to 125 mg/hr.
Maximum dose is 6,000 mg in 24 hours Chronic Iron Overload : ( 2.2 ) • Subcutaneous Infusion: Average daily dose is between 20 and 60 mg/kg. In patients with serum ferritin level below 2,000 ng/mL require about 25 mg/kg/day. Patients with serum ferritin level between 2,000 and 3,000 ng/mL require about 35 mg/kg/day.
Patients with higher serum ferritin may require up to 55 mg/kg/day. • Intravenous Administration: 20 mg/kg/day to 40 mg/kg/day for pediatric patients and 40 mg/kg/day to 50 mg/kg/day over 8 hours to 12 hours in adults for 5 days to 7 days per week. In pediatric patients and adults, maximum dose should not exceed 40 mg/kg/day and 60 mg/kg/day, respectively. • Intramuscular Administration: 500 mg to maximum daily dose of 1,000 mg. See Full Prescribing Information for instructions on preparation of Deferoxamine Mesylate for Injection for administration.
( 2.3 ) Vitamin C (up to 200 mg) increases availability of iron for chelation and may be given as an adjuvant to iron chelation therapy. ( 2.4 )
2.1Recommended Dosage for Treatment of Acute Iron Intoxication for Adults and Pediatric Patients Intramuscular (IM) Administration Use for all patients not in shock. The initial recommended dose of Deferoxamine Mesylate for Injection is 1,000 mg intramuscularly (IM) once. If needed based on the clinical response, administer subsequent doses of 500 mg every 4 hours to 12 hours.
The maximum recommended daily dose is 6,000 mg in 24 hours. Intravenous (IV) Administration Administer Deferoxamine Mesylate for Injection intravenously (IV) to patients in a state of cardiovascular collapse and then only by slow infusion. As soon as the clinical condition of the patient permits, intravenous administration should be discontinued, and the drug should be administered intramuscularly.
The initial recommended IV dose of Deferoxamine Mesylate for Injection is 1,000 mg administered at an infusion rate of up to 15 mg/kg/hr. If needed based on the clinical response administer additional doses of 500 mg over 4 hours to 12 hours at a slower infusion rate of up to 125 mg/hr. The maximum recommended daily dose is 6,000 mg in 24 hours.
2.2Recommended Dosage for Treatment of Chronic Iron Overload for Adults and Pediatric Patients Subcutaneous Infusion Administration The average daily dose of Deferoxamine Mesylate for Injection is usually between 20 and 60 mg/kg. In general patients with serum ferritin level below 2,000 ng/mL require about 25 mg/kg/day. Patients with serum ferritin level between 2,000 and 3,000 ng/mL require about 35 mg/kg/day.
Patients with higher serum ferritin may require up to 55 mg/kg/day. It is not advisable to regularly exceed an average daily dose of 50 mg/kg/day except when very intensive chelation is needed in patients who have completed growth. If ferritin levels fall below 1,000 ng/mL, the risk of Deferoxamine Mesylate for Injection toxicity increases; it is important to monitor th…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 500 mg of deferoxamine mesylate (corresponding to 426.82 mg of deferoxamine as free base) is a white to off-white lyophilized powder in a single-dose vial for reconstitution. For injection: 2 grams of deferoxamine mesylate (corresponding to 1.707 g of deferoxamine as free base) is a white to off-white lyophilized powder in a single-dose vial for reconstitution. For injection: 500 mg and 2 g of deferoxamine mesylate is a white to off-white lyophilized powder in single-dose vial for reconstitution ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Deferoxamine Mesylate for Injection 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: More common with rapid intravenous infusion. Administer intramuscularly or by slow subcutaneous or intravenous infusion. ( 5.1 ) Auditory and Ocular Toxicity: Have been reported when administered over prolonged periods of time, at high doses, or in patients with low ferritin levels.
( 5.2 ) • Renal Toxicity: Cases of acute renal failure, renal tubular disorders and increase in serum creatinine have occurred. Monitor patients for changes in renal function. ( 5.3 ) • Respiratory Toxicity: Acute respiratory distress syndrome has occurred.
Risk increased with high intravenous doses. Recommended daily dose should not be exceeded. ( 5.4 ) • Growth Suppression: Has occurred in pediatric patients treated with high doses and concomitant low ferritin levels.
Dose reduction may partially resume growth velocity to pre-treatment rates. ( 5.5 ) • Serious Infections: Cases of mucormycosis and Yersinia infections, some fatal, have occurred. Discontinue Deferoxamine Mesylate for Injection and initiate appropriate treatment immediately.
( 5.6 ) • Cardiac Dysfunction with Concomitant Use of Vitamin C: Avoid coadministration in patients with cardiac failure. Delay Vitamin C for one month after start of Deferoxamine Mesylate for Injection. Avoid exceeding 200 mg daily in adults.
Monitor cardiac function with combined treatment. ( 5.7 ) • Risks of Deferoxamine Mesylate for Injection Treatment in Patients with Aluminum Overload: Risks include neurological dysfunction (including seizures), dialysis dementia, and aggravation of hyperparathyroidism. ( 5.8 ) • Effects on Ability to Drive and Use Machines: May cause dizziness.
( 5.9 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use effective contraception ( 5.10 , 8.1 , 8.3 )
5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have occurred in Deferoxamine Mesylate for Injection-treated patients. Reactions have included flushing of the skin, urticaria, hypotension, and shock. These reactions typically occur when Deferoxamine Mesylate for Injection was administered by rapid intravenous injection.
Therefore, administer Deferoxamine Mesylate for Injection intramuscularly or by slow subcutaneous or intravenous infusion.
5.2Auditory and Ocular Toxicity Ocular and auditory toxicities have been reported in Deferoxamine Mesylate for Injection-treated patients. The ocular toxicities observed have included 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 toxicities reported have been tinnitus and hearing loss, including high frequency sensorineural hearing loss.
Risk factors for both ocular and auditory disturbances include prolonged treatment duration, higher doses, or low ferritin levels. In most cases, both ocular and auditory disturbances were reversible upon immediate cessation of treatment [see Adverse Reactions ( 6 )] . 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.
5.3Renal Toxicity Renal toxicity, including increases in serum creatinine (possibly dose-related), acute renal failure and renal tubular disorders has occurred in Deferoxamine Mesylate for Injection-treated patients. Deferoxamine Mesylate for Injection is contraindicated in patients with severe renal disease [see Contraindications ( 4 )] . Monitor serum creatinine to assess for changes in renal function.
5.4Respiratory Toxicity Acute respiratory distress syndrome has occurred in Deferoxamine Mesylate for Injection-treated patients foll…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Auditory and Ocular Toxicity [see Warnings and Precautions ( 5.2 )] • Renal Toxicity [see Warnings and Precautions ( 5.3 )] • Respiratory Toxicity [see Warnings and Precautions ( 5.4 )] • Growth Suppression [see Warnings and Precautions ( 5.5 )] • Serious Infections [see Warnings and Precautions ( 5.6 )] • Cardiac Dysfunction with Concomitant Use of Vitamin C [see Warnings and Precautions ( 5.7 )] • Risks of Deferoxamine Mesylate for Injection Treatment in Patients with Aluminum Overload [see Warnings and Precautions ( 5.8 )] • Effects on Ability to Drive and Use Machines [see Warnings and Precautions ( 5.9 )] Most common adverse reactions are injection reactions (local and systemic), hypersensitivity reactions, infections with Yersinia and Mucormycosis, cardiovascular, gastrointestinal, hematologic, hepatic, musculoskeletal, urogenital, nervous, respiratory, ocular and hearing.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi, USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience The following adverse reactions associated with the use of deferoxamine mesylate for injection were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. At the Injection Site: Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema.
Injection site reactions may be associated with systemic allergic reactions ([see Body as a Whole, below)] Hypersensitivity Reactions and Systemic Allergic Reactions: Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema Body as a Whole: Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma Infections: Yersinia, mucormycosis Cardiovascular: Tachycardia, hypotension, shock Digestive: Abdominal discomfort, diarrhea, nausea, vomiting Hematologic: Blood dyscrasia (thrombocytopenia, leukopenia) Hepatic: Increased transaminases, hepatic dysfunction Musculoskeletal: Muscle spasms.
Growth retardation and bone changes (e.g., metaphyseal dysplasia) Nervous System: Neurological disturbances, including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, seizures; exacerbation or precipitation of aluminum-related dialysis encephalopathy Special Senses: High-frequency sensorineural hearing loss, tinnitus visual disturbances including acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts Respiratory: Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates) Skin: Generalized rash Urogenital: Dysuria, acute renal failure, increased serum creatinine and renal tubular disorders
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Concurrent treatment with prochlorperazine may lead to temporary impairment of consciousness. ( 7.1 ) • Imaging results may be distorted due to rapid urinary excretion of Deferoxamine Mesylate for Injection bound gallium-67. Discontinue Deferoxamine Mesylate for Injection 48 hours prior to scintigraphy. ( 7.2 )
7.1Prochlorperazine Concurrent treatment with Deferoxamine Mesylate for Injection and prochlorperazine, a phenothiazine derivative, may lead to temporary impairment of consciousness.
7.2Gallium-67 Imaging results may be distorted because of the rapid urinary excretion of Deferoxamine Mesylate for Injection-bound gallium-67. Discontinue Deferoxamine Mesylate for Injection 48 hours prior to scintigraphy.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Lactation: Advise not to breastfeed ( 8.2 ) • Geriatric Use: Increased risk of ocular disorders ( 8.5 )
8.1Pregnancy Risk Summary There are no available data on Deferoxamine Mesylate for Injection 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 Deferoxamine Mesylate for Injection for the mother and possible risks to the fetus when prescribing Deferoxamine Mesylate for Injection 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).
8.2Lactation There are no data on the presence of deferoxamine or its metabolite in either human or animal milk, the effects on the breastfed child, or the effects on milk production. It is not known whether deferoxamine is excreted in human milk. Because of the potential for serious adverse reactions in the breastfed child, advise patients not to breastfeed during treatment with Deferoxamine Mesylate for Injection, and for one week after the last dose.
8.3Females and Males of Reproductive Potential Based on animal data, Deferoxamine Mesylate for Injection can cause malformations at doses less than the human dose [see Use in Specific Populations ( 8.1 )]. Contraception Females Deferoxamine Mesylate for Injection can cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )]. Advise female patients of reproductive potential to use effective contraception during treatment with Deferoxamine Mesylate for Injection and for one month after the last dose.
8.4Pediatric Use Safety and effectiveness in pediatric patients 3 years of age and older have been established for the treatment of acute iron intoxication and for the treatment of transfusional iron overload in patients with chronic anemia. Safety and effectiveness in pediatric patients under the age of 3 years have not been established. Iron mobilization with Deferoxamine Mesylate for Injection is relatively poor in patients under the age of 3 years with relatively little iron overload.
Deferoxamine Mesylate for Injection is not recommended for use. The drug should ordinarily not be given to these patients unless significant iron mo…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on Deferoxamine Mesylate for Injection 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 Deferoxamine Mesylate for Injection for the mother and possible risks to the fetus when prescribing Deferoxamine Mesylate for Injection 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).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients 3 years of age and older have been established for the treatment of acute iron intoxication and for the treatment of transfusional iron overload in patients with chronic anemia. Safety and effectiveness in pediatric patients under the age of 3 years have not been established. Iron mobilization with Deferoxamine Mesylate for Injection is relatively poor in patients under the age of 3 years with relatively little iron overload.
Deferoxamine Mesylate for Injection is not recommended for use. The drug should ordinarily not be given to these patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated. High doses of Deferoxamine Mesylate for Injection and concomitant low ferritin levels have been associated with growth suppression in pediatric patients.
Monitor weight and height in pediatric patients receiving Deferoxamine Mesylate for Injection every 3 months [see Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.1 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical Studies of Deferoxamine Mesylate for Injection did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from the younger subjects. Postmarketing reports suggest a possible trend for an increased risk of eye disorders in the geriatric population, specifically the occurrence of color blindness, maculopathy, and scotoma. However, it is unclear if these eye disorders were dose related.
Although the number of reports was very small, certain elderly patients may be predisposed to eye disorders when taking Deferoxamine Mesylate for Injection. Postmarketing reports also suggest that there may be an increased risk of deafness and hearing loss in the geriatric population [see Adverse Reactions ( 6 )] . In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Acute Toxicity Intravenous LD 50 s (mg/kg): mice, 287; rats, 329. Inadvertent administration of an overdose or inadvertent intravenous bolus administration/rapid intravenous infusion may be associated with hypotension, tachycardia and gastrointestinal disturbances; acute but transient loss of vision, aphasia, agitation, headache, nausea, pallor, CNS depression, including coma, bradycardia and acute renal failure have been reported. Acute respiratory distress syndrome has been reported following treatment with excessively high intravenous doses of Deferoxamine Mesylate for Injection in patients with acute iron intoxication and in patients with thalassemia.
There is no specific antidote for Deferoxamine Mesylate for Injection overdose. In case of overdose, discontinue Deferoxamine Mesylate for Injection and provide symptomatic supportive care. Deferoxamine Mesylate for Injection is readily dialyzable.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Deferoxamine Mesylate for Injection 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. Deferoxamine Mesylate for Injection does not cause any demonstrable increase in the excretion of electrolytes or trace metals.
Theoretically, 100 parts by weight of Deferoxamine Mesylate for Injection is capable of binding approximately 8.5 parts by weight of ferric iron.
12.3Pharmacokinetics Deferoxamine Mesylate for Injection 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.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Deferoxamine Mesylate for Injection 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. Deferoxamine Mesylate for Injection does not cause any demonstrable increase in the excretion of electrolytes or trace metals.
Theoretically, 100 parts by weight of Deferoxamine Mesylate for Injection is capable of binding approximately 8.5 parts by weight of ferric iron.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Deferoxamine Mesylate for Injection, USP is supplied in single-dose vials containing 500 mg and 2 g of deferoxamine mesylate (corresponding to 426.82 mg and 1.707 g of deferoxamine as free base) as a sterile, white to off-white lyophilized powder. Product No. NDC No.
Strength Vial size 509710 63323-597-10 500 mg per vial 10 mL vial packaged individually. 509930 63323-599-30 2 grams per vial 30 mL vial packaged individually. Storage and Handling STORE AT: 20 ºC to 25 °C ( 68 ºF to 77 °F) [see USP Controlled Room Temperature].
The container closure is not made with natural rubber latex.
📦 Storage and Handling ▾
Storage and Handling STORE AT: 20 ºC to 25 °C ( 68 ºF to 77 °F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.
📋 Description ▾
11 DESCRIPTION Deferoxamine Mesylate for Injection, USP is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine Mesylate for Injection, USP is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 g of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N - [5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-( N- hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesul-fonate (salt), and its structural formula is: Deferoxamine mesylate is a white to almost white powder.
It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol. defer-struc-01.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Caution patients about the potential allergic reactions associated with rapid intravenous administration of Deferoxamine Mesylate for Injection and the need for monitoring allergic reactions during treatment [see Warnings and Precautions ( 5.1 )] . Caution patients about the potential auditory and ocular toxicities due to prolonged use of Deferoxamine Mesylate for Injection, conduct auditory testing and ophthalmic testing at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment [see Warnings and Precautions ( 5.2 )] .
Caution patients about the potential for kidney toxicity when taking Deferoxamine Mesylate for Injection and the need for kidney function test to monitor for increase in serum creatinine [see Warnings and Precautions ( 5.3 )] . Inform patients that if they have difficulty in breathing during treatment, they should inform the health care provider as this is a symptom of acute respiratory distress syndrome which can occur with excessively high intravenous doses of Deferoxamine Mesylate for Injection [see Warnings and Precautions ( 5.4 )] .
Caution pediatric patients and their caregivers that child treated with Deferoxamine Mesylate for Injection could have slower than normal growth and the need to monitor for body weight and height every 3 months [see Warnings and Precautions ( 5.5 )] . Caution patients about the increased risk of bacterial infections ( Yersinia enterocolitica and Yersinia pseudotuberculosis ) with Deferoxamine Mesylate for Injection treatment and the need for treatment discontinuation until the infection is resolved [see Warnings and Precautions ( 5.6 )] .
Caution patients about the potential risk of fungal infections (M ucormycosis ) when receiving Deferoxamine Mesylate for Injection treatment and the need for treatment discontinuation, mycological tests and required treatment for treating the infection [see Warnings and Precautions ( 5.6 )] . Caution patients about the potential impairment of cardiac function when taking Deferoxamine Mesylate for Injection concomitantly with high doses of Vitamin C (more than 500 mg daily in adults). Inform adult patients not to exceed a daily Vitamin C dose of 200 mg given in divided doses.
Inform pediatric patients under 10 years of age and older pediatric patients or their care takers not to exceed a daily Vitamin C of 50 mg and 100 mg, respectively. [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.7 )] . Inform patients with cardiac failure not to take Vitamin C supplements when on treatment with Deferoxamine Mesylate for Injection [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.7 )] . Caution patients with aluminum-related encephalopathy and receiving dialysis about potential neurological dysfunction [see Warnings and Precautions ( 5.8 )] .
Cautions patients that treatment with Deferoxamine Mesylate for Injection in the presence of aluminum overload may result in decreased serum calcium and aggravation of hyperparathyroidism [see Warnings and Precautions ( 5.8 )] . Inform patients that they should refrain from driving or operating potentially hazardous machines if they experience dizziness or other nervous system disturbances, or impairment of vision or hearing [see Warnings and Precautions ( 5.9 )] . Advise patients to inform the healthcare provider if they have received prochlorperazine prior to Deferoxamine Mesylate for Injection treatment as this may lead to temporary impairment of consciousness [see Drug Interactions ( 7.1 )] .
Inform patients that if they are going for any imaging tests while receiving Gallium-67 and Deferoxamine Mesylate for Injection concomitantly it can result in reports with distorted images [see Drug Interactions ( 7.2 )] . Inform patients that their urine may occasionally show a reddish discoloration. Embryo-fetal Toxicity: Advise pregnant women and females of reproductive…