HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------------WARNINGS AND PRECAUTIONS--------------------------

These highlights do not include all the information needed to use DESFERAL • Hypersensitivity Reactions: More common with rapid intravenous
safely and effectively. See full prescribing information for DESFERAL. infusion. Administer intramuscularly or by slow subcutaneous or
intravenous infusion. (5.1)
DESFERAL® (deferoxamine mesylate) for injection, for intramuscular,
intravenous, or subcutaneous use • Auditory and Ocular Toxicity: Have been reported when administered
Initial U.S. Approval: 1968 over prolonged periods of time, at high doses, or in patients with low
ferritin levels. (5.2)
---------------------------------INDICATIONS AND USAGE---------------------------- • Renal Toxicity: Cases of acute renal failure, renal tubular disorders and
DESFERAL is an iron-chelating agent indicated: increase in serum creatinine have occurred. Monitor patients for changes
• As an adjunct to standard measures for the treatment of acute iron in renal function. (5.3)
intoxication. (1.1) • Respiratory Toxicity: Acute respiratory distress syndrome has occurred.
• For the treatment of transfusional iron overload in patients with chronic Risk increased with high intravenous doses. Recommended daily dose
anemia. (1.2) should not be exceeded. (5.4)
• Growth Suppression: Has occurred in pediatric patients treated with high
Limitations of Use (1.3)
doses and concomitant low ferritin levels. Dose reduction may partially
Desferal is not indicated for the treatment of primary hemochromatosis (since
resume growth velocity to pre-treatment rates. (5.5)
phlebotomy is the method of choice for removing excess iron in this disorder).
• Serious Infections: Cases of mucormycosis and Yersinia infections, some
--------------------------DOSAGE AND ADMINISTRATION------------------------- fatal, have occurred. Discontinue Desferal and initiate appropriate
Acute Iron Intoxication: (2.1) treatment immediately. (5.6)
• Intramuscular Administration: Use for patients not in shock. Initial dose is • Cardiac Dysfunction with Concomitant Use of Vitamin C: Avoid
1,000 mg. Depending upon the clinical response, subsequent doses of 500 mg coadministration in patients with cardiac failure. Delay Vitamin C for one
may be administered every 4 hours to 12 hours. Maximum dose is 6,000 mg month after start of Desferal. Avoid exceeding 200 mg daily in adults.
in 24 hours. Monitor cardiac function with combined treatment. (5.7)
• Intravenous Administration: Only for patients in a state of cardiovascular • Risks of Desferal Treatment in Patients with Aluminum Overload: Risks
collapse. Initial dose is 1,000 mg at a rate not to exceed 15 mg/kg/hr. include neurological dysfunction (including seizures), dialysis dementia,
Depending upon the clinical response, subsequent doses of 500 mg may be and aggravation of hyperparathyroidism. (5.8)
administered every 4 hours to 12 hours at a rate of up to 125 mg/hr. Maximum • Effects on Ability to Drive and Use Machines: May cause dizziness. (5.9)
dose is 6,000 mg in 24 hours. • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of
Chronic Iron Overload: (2.2) reproductive potential of the potential risk to a fetus and use effective
• Subcutaneous Infusion: Average daily dose is between 20 and 60 mg/kg. In contraception. (5.10, 8.1, 8.3)
patients with serum ferritin level below 2,000 ng/mL require about 25 ---------------------------------ADVERSE REACTIONS---------------------------------
mg/kg/day. Patients with serum ferritin level between 2,000 and 3,000 ng/mL Most common adverse reactions are injection reactions (local and systemic),
require about 35 mg/kg/day. Patients with higher serum ferritin may require hypersensitivity reactions, infections with Yersinia and Mucormycosis,
up to 55 mg/kg/day. cardiovascular, gastrointestinal, hematologic, hepatic, musculoskeletal,
• Intravenous Administration: 20 mg/kg/day to 40 mg/kg/day for pediatric urogenital, nervous, respiratory, ocular and hearing. (6)
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 To report SUSPECTED ADVERSE REACTIONS, contact Novartis
should not exceed 40 mg/kg/day and 60 mg/kg/day, respectively. Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-
• Intramuscular Administration: 500 mg to maximum daily dose of 1,000 mg. 1088 or www.fda.gov/medwatch.

See Full Prescribing Information for instructions on preparation of Desferal for -----------------------------------DRUG INTERACTIONS-------------------------------
administration. (2.3) • Concurrent treatment with prochlorperazine may lead to temporary
impairment of consciousness. (7.1)
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) • Imaging results may be distorted due to rapid urinary excretion of
Desferal bound gallium-67. Discontinue Desferal 48 hours prior to
-------------------------DOSAGE FORMS AND STRENGTHS------------------------ scintigraphy. (7.2)
For injection: 500 mg of deferoxamine mesylate as a lyophilized powder in single-
------------------------------USE IN SPECIFIC POPULATIONS----------------------
dose vial for reconstitution. (3)
• Lactation: Advise not to breastfeed (8.2)
----------------------------------CONTRAINDICATIONS-------------------------------- • Geriatric Use: Increased risk of ocular disorders (8.5)
• Known hypersensitivity to the active substance. (4)
See 17 for PATIENT COUNSELING INFORMATION.
• Patients with severe renal disease or anuria. (4)
Revised: 9/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 6 ADVERSE REACTIONS
1.1 Acute Iron Intoxication 6.1 Clinical Trials Experience
1.2 Chronic Iron Overload 7 DRUG INTERACTIONS
1.3 Limitations of Use 7.1 Prochlorperazine
2 DOSAGE AND ADMINISTRATION 7.2 Gallium-67
2.1 Recommended Dosage for Treatment of Acute Iron Intoxication 8 USE IN SPECIFIC POPULATIONS
for Adults and Pediatric Patients 8.1 Pregnancy
2.2 Recommended Dosage for Treatment of Chronic Iron Overload 8.2 Lactation
for Adults and Pediatric Patients 8.3 Females and Males of Reproductive Potential
2.3 Preparation 8.4 Pediatric Use
2.4 Management of Vitamin C Deficiency 8.5 Geriatric Use
3 DOSAGE FORMS AND STRENGTHS 8.6 Renal Impairment
4 CONTRAINDICATIONS 8.7 Hepatic Impairment
5 WARNINGS AND PRECAUTIONS 10 OVERDOSAGE
5.1 Hypersensitivity Reactions 11 DESCRIPTION
5.2 Auditory and Ocular Toxicity 12 CLINICAL PHARMACOLOGY
5.3 Renal Toxicity 12.1 Mechanism of Action
5.4 Respiratory Toxicity 12.3 Pharmacokinetics
5.5 Growth Suppression 13 NONCLINICAL TOXICOLOGY
5.6 Serious Infections 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
5.7 Cardiac Dysfunction With Concomitant Use of Vitamin C 16 HOW SUPPLIED/STORAGE AND HANDLING
5.8 Risks of Desferal Treatment in Patients With Aluminum 17 PATIENT COUNSELING INFORMATION
Overload *Sections or subsections omitted from the full prescribing information are not
5.9 Effects on Ability to Drive and Use Machines listed.
5.10 Embryo-Fetal Toxicity
FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Acute Iron Intoxication
DESFERAL is indicated as an adjunct to standard measures for the treatment of acute iron intoxication.
1.2 Chronic Iron Overload
DESFERAL is indicated for the treatment of transfusional iron overload in patients with chronic anemia.
1.3 Limitations of Use
Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for
removing excess iron in this disorder).

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 Desferal 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.
2.1 Recommended Dosage for Treatment of Acute Iron Intoxication for Adults and Pediatric Patients
Intramuscular Administration
Use for all patients not in shock.
The initial recommended dose of Desferal is 1,000 mg intramuscularly 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 Administration
Administer Desferal intravenously 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 Desferal 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.
2.2 Recommended Dosage for Treatment of Chronic Iron Overload for Adults and Pediatric Patients
Subcutaneous Infusion Administration
The average daily dose of Desferal 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 Desferal toxicity increases; it is important to
monitor these patients particularly carefully and perhaps to consider lowering the total weekly dose. The doses specified
here are the average daily doses. Since most patients use Desferal less than 7 days a week, the actual dose per infusion
usually differs from the average daily dose; e.g., if an average daily dose of 40 mg/kg/day is required and the patient
wears the pump 5 nights a week, each infusion should contain 56 mg/kg.
Slow subcutaneous infusion using a portable, light-weight infusion pump over a period of 8 to 12 hours is regarded as
effective and especially convenient for ambulatory patients but may also be given over a 24-hour period. Desferal should
normally be used with the pump 5 to 7 times a week. Desferal is not formulated to support subcutaneous bolus injection.
Intravenous Administration
Desferal can be administered intravenously if needed in patients with intravenous access.
The recommended dose of Desferal in adults is 40 mg/kg/day to 50 mg/kg/day over 8 hours to 12 hours at a rate of up to
15 mg/kg/hour for 5 days to 7 days per week. Maximum dose is 60 mg/kg/day.
The recommended dose of Desferal in pediatric patients is 20 mg/kg/day to 40 mg/kg/day over 8 hours to 12 hours for 5
days to 7 days per week. The maximum recommended daily dose is 40 mg/kg/day until growth (body weight and linear
growth) has ceased.
In case of missed doses, Desferal 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. Desferal 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
If given intramuscularly, the recommended dose of Desferal is 500 mg to 1,000 mg per day. The maximum recommended
daily dose is 1,000 mg per day.
2.3 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.
Table 1. Preparation of Desferal Prior to Administration
Vial size Route of administration Amount of Sterile Water Concentration after
for Injection, USP for reconstitution
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
*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.
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.
2.4 Management of Vitamin C Deficiency
Patients with iron overload usually become vitamin C deficient, probably because iron oxidizes the vitamin. As an
adjuvant to iron chelation therapy, vitamin C in doses up to 200 mg for adults may be given in divided doses, starting after
an initial month of regular treatment with Desferal [see Warnings and Precautions (5.7)]. Vitamin C increases availability
of iron for chelation. In general, 50 mg daily suffices for pediatric patients under 10 years old and 100 mg daily for older
pediatric patients. Larger doses of vitamin C fail to produce any additional increase in excretion of iron complex.

3 DOSAGE FORMS AND STRENGTHS

For injection: 500 mg of deferoxamine mesylate (corresponding to 426.82 mg of deferoxamine as free base) as a white to
almost white lyophilized powder in a single-dose vial for reconstitution.

4 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)].
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, have occurred in Desferal-treated patients. Reactions have included
flushing of the skin, urticaria, hypotension, and shock. These reactions typically occur when Desferal was administered by
rapid intravenous injection. Therefore, administer Desferal intramuscularly or by slow subcutaneous or intravenous
infusion.
5.2 Auditory and Ocular Toxicity
Ocular and auditory toxicities have been reported in Desferal-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.
5.3 Renal Toxicity
Renal toxicity, including increases in serum creatinine (possibly dose-related), acute renal failure and renal tubular
disorders has occurred in Desferal-treated patients. Desferal is contraindicated in patients with severe renal disease [see
Contraindications (4)]. Monitor serum creatinine to assess for changes in renal function.
5.4 Respiratory Toxicity
Acute respiratory distress syndrome has occurred in Desferal-treated patients following treatment with excessively high
intravenous doses of Desferal in patients with acute iron intoxication or thalassemia. The recommended daily doses
should therefore not be exceeded.
5.5 Growth Suppression
High doses of Desferal and concomitant low ferritin levels have also been associated with growth suppression in pediatric
patients. After reduction of Desferal dose, growth velocity may partially resume to pre-treatment rates. Monitor growth
(weight and height) in pediatric patients treated with Desferal every 3 months.
5.6 Serious Infections
Yersinia Infections
Desferal may increase the risk of Yersinia enterocolitica and Yersinia pseudotuberculosis infections. Avoid starting
Desferal treatment in patients with active Yersinia infections. Should Yersinia infection develop, interrupt Desferal
treatment until the infection is resolved.
Mucormycosis
Cases of mucormycosis, some with a fatal outcome, have occurred in Desferal-treated patients. Signs or symptoms are
specific to the site of infection. If mucormycosis is suspected, discontinue Desferal, conduct mycological testing, and treat
immediately.
5.7 Cardiac Dysfunction With Concomitant Use of Vitamin C
Cardiac dysfunction has occurred in Desferal-treated patients with severe chronic iron overload following concomitant
treatment with 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:
• Vitamin C supplements should not be given to patients with cardiac failure.
• Start supplemental vitamin C only after an initial month of regular treatment with Desferal.
• Give vitamin C only if the patient is receiving Desferal regularly, ideally soon after setting up the infusion pump.
• Do not exceed a daily vitamin C dose of 200 mg in adults, given in divided doses. In general, 50 mg daily suffices
for pediatric patients under 10 years old and 100 mg for older pediatric patients.
 • Clinical monitoring of cardiac function is advisable during such combined therapy.
5.8 Risks of Desferal Treatment in Patients With Aluminum Overload
Desferal may cause neurological dysfunction (including seizures) in patients with aluminum-related encephalopathy and
receiving dialysis, possibly due to an acute increase in circulating aluminum [see Adverse Reactions (6)].
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.
5.9 Effects on Ability to Drive and Use Machines
Desferal may cause dizziness, which may impair the ability to drive a car or operate machinery. Patients should not drive
or operate machinery until they know how Desferal will affect their ability to engage in these activities.
5.10 Embryo-Fetal Toxicity
Based on findings in animals, Desferal can cause fetal harm when administered to a pregnant woman. In animal
reproduction studies, administration of deferoxamine to pregnant mice and rabbits during the period of organogenesis
caused adverse developmental outcomes including decreased fetal body weights and malformations at maternal doses less
than those in patients at maximum recommended human dose (MRHD). Advise pregnant women of the potential risk to a
fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective
contraception during treatment with Desferal and for one month after the last dose [see Use in Specific Populations (8.1,
8.3), Nonclinical Toxicology (13.1)].

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 Desferal 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)]
6.1 Clinical Trials Experience
The following adverse reactions associated with the use of Desferal 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, leucopenia)
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

7 DRUG INTERACTIONS
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.

8 USE IN SPECIFIC POPULATIONS

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).
8.2 Lactation
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 Desferal, and for one week after the last dose.
8.3 Females and Males of Reproductive Potential
Based on animal data, Desferal can cause malformations at doses less than the human dose [see Use in Specific
Populations (8.1)].
Contraception
Females
Desferal 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 Desferal and for one
month after the last dose.
8.4 Pediatric 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 Desferal is relatively poor in patients under the age of 3 years with relatively little iron overload.
Desferal 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 Desferal and concomitant low ferritin levels have been associated with growth suppression in pediatric
patients. Monitor weight and height in pediatric patients receiving Desferal every 3 months [see Warnings and
Precautions (5.5), Adverse Reactions (6.1)].
8.5 Geriatric Use
Clinical Studies of Desferal 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 Desferal. 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.
8.6 Renal Impairment
Desferal is contraindicated in patients with severe renal disease [see Contraindications (4)].
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 (5.3)]. Monitor patients for changes in renal function.
8.7 Hepatic Impairment
For patients with hepatic impairment, dose selection should usually start at the low end of the dosing range.

10 OVERDOSAGE
Acute Toxicity
Intravenous LD50s (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
Desferal in patients with acute iron intoxication and in patients with thalassemia.
There is no specific antidote for Desferal overdose. In case of overdose, discontinue Desferal and provide symptomatic
supportive care.
Desferal is readily dialyzable.

11 DESCRIPTION
Desferal, deferoxamine mesylate, is an iron-chelating agent, available in vials for injection via intramuscular,
subcutaneous, and intravenous administration. Desferal is supplied as vials containing 500 mg of deferoxamine mesylate
USP (corresponding to 426.82 mg 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 USP 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.

12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
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.
12.3 Pharmacokinetics
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.

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been performed with Desferal. Cytotoxicity may occur, since
Desferal has been shown to inhibit DNA synthesis in vitro.
Desferal was not mutagenic when tested in an in vitro bacterial reverse mutation (Ames) and was not genotoxic in an
in vivo micronucleus assay in rats.
Animal studies to assess fertility effects have not been conducted.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied
Desferal is supplied in single-dose vials containing 500 mg of deferoxamine mesylate (corresponding to 426.82 mg of
deferoxamine as free base) as a sterile, white to almost white lyophilized powder. Desferal is supplied in cartons of 4 vials
(NDC 0078-0467-91).
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).

17 PATIENT COUNSELING INFORMATION

Caution patients about the potential allergic reactions associated with rapid intravenous administration of Desferal 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 Desferal, 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 Desferal 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
Desferal [see Warnings and Precautions (5.4)].
Caution pediatric patients and their caregivers that child treated with Desferal 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 Desferal 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 (Mucormycosis) when receiving Desferal 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 Desferal 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 Desferal [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 Desferal 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 Desferal 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 Desferal 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 potential of the potential risk to a fetus. Advise females of
reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and
Precautions (5.10), Use in Specific Populations (8.1, 8.3)].
Advise females of reproductive potential to use effective contraceptive during treatment with Desferal and for one month
after the last dose [see Use in Specific Populations (8.3)].
Lactation
Advise patients to avoid breastfeeding while taking Desferal and for one week after the final dose [see Use in Specific
Populations (8.2)].

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