Ferrlecit sodium ferric gluconate complex 12.5 mg/mL Injection
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
- When you're on hemodialysis for kidney disease, your body often can't absorb enough iron from pills to keep up with demand — especially while you're also on a medicine like epoetin...
- Why do I need an iron IV instead of just taking iron pills?
- The biggest things to watch for are signs of an allergic reaction — things like trouble breathing, wheezing, dizziness, chest tightness, or feeling like you might pass out. These c...
- What should I watch out for during or after my infusion?
Patient education
Supplement & herbal interactions
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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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9 mg / 1 mL
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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195 mg / 1 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $4.61 | $46.09 / 10 vials |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2916 | $2.197 / J2916 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ferrlecit 12.5 mg/mLthis 00024-2792-10 | sanofi-aventis | 10 vials | — | AB | FDA listed | — |
| Ferrlecit 12.5 mg/mL 00024-2794-10 | sanofi-aventis | 10 vials | — | AB | FDA listed | — |
| Sodium Ferric Gluconate Complex in Sucrose 12.5 mg/mL 00143-9298-10 | Hikma | 10 vials | — | AB | FDA listed | — |
| Sodium Ferric Gluconate Complex in Sucrose 12.5 mg/mL 00143-9570-10 | Hikma | 10 vials | — | AB | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00024-2792-10 You're viewing this | 10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01) | 2011-03-01 | Active |
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| 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) | ✓ 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 |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adult Patients - The recommended adult dosage is 10 mL (125 mg of elemental iron) diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session or undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session. ( 2.2 ) Pediatric Patients - The recommended pediatric dosage is 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session.
( 2.3 ) Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion. Administer in 0.9% saline. ( 2 )
2.1Important Administration Instructions The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-dose vial contains 62.5 mg of elemental iron (12.5 mg/mL). Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion.
The compatibility of Ferrlecit with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately.
Ferrlecit treatment may be repeated if iron deficiency reoccurs.
2.2Adult Dosage and Administration The recommended dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of Ferrlecit (125 mg of elemental iron). Ferrlecit may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session. Ferrlecit may also be administered undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session.
For repletion treatment most patients may require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions. Ferrlecit has been administered at sequential dialysis sessions by infusion or by slow intravenous injection during the dialysis session itself. Data from Ferrlecit postmarketing spontaneous reports indicate that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see Adverse Reactions (6.2) ] .
2.3Pediatric Dosage and Administration The recommended pediatric dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg Ferrlecit (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session. The maximum dosage should not exceed 125 mg per dose.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 62.5 mg/5 mL (12.5 mg/mL) clear, dark brown liquid in single-dose vial Injection: 62.5 mg/5 mL (12.5 mg/mL) in single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . Known hypersensitivity to sodium ferric gluconate or any of its inactive components. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. ( 5.1 ) Hypotension: Ferrlecit may cause hypotension.
Monitor patients for signs and symptoms of hypotension during and following each Ferrlecit dose. ( 5.2 ) Iron Overload: Regularly monitor hematologic responses during Ferrlecit therapy. Do not administer Ferrlecit to patients with iron overload.
( 5.3 ) Benzyl Alcohol Toxicity: Premature and low-birth-weight infants may be more likely to develop toxicity. ( 5.4 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferrlecit in postmarketing experience. Patients may present with shock, clinically significant hypotension, loss of consciousness, or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion.
Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Adverse Reactions (6) ] . In the single-dose, postmarketing safety study one patient experienced a life-threatening hypersensitivity reaction (diaphoresis, nausea, vomiting, severe lower back pain, dyspnea, and wheezing for 20 minutes) following Ferrlecit administration. Among 1,097 patients who received Ferrlecit in this study, there were 9 patients (0.8%) who had an adverse reaction that, in the view of the investigator, precluded further Ferrlecit administration.
These included one life-threatening reaction, six allergic reactions (including pruritus, facial flushing, chills, dyspnea/chest pain, and rash), and two other reactions (hypotension and nausea). Another 2 patients experienced (0.2%) allergic reactions not deemed to represent drug intolerance (nausea/malaise and nausea/dizziness) following Ferrlecit administration.
5.2Hypotension Ferrlecit may cause clinically significant hypotension. Hypotension associated with lightheadedness, malaise, fatigue, weakness or severe pain in the chest, back, flanks, or groin has been reported. These hypotensive reactions may or may not be associated with signs and symptoms of hypersensitivity reactions and usually resolve within one to two hours.
In the single-dose safety study, postadministration hypotensive events were observed in 22/1,097 patients (2%) following Ferrlecit administration. Transient hypotension may occur during dialysis. Administration of Ferrlecit may augment hypotension caused by dialysis.
Monitor patients for signs and symptoms of hypotension during and following Ferrlecit administration [see Adverse Reactions (6.1) ] .
5.3Iron Overload Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients receiving Ferrlecit require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation).
5.4Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative Ferrlecit is not approved for use in neonates or infants. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including Ferrlecit. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.
The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known (Ferrlecit contains 9 mg of ben…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.1) ] Hypotension [see Warnings and Precautions (5.2) ] The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps, and pain. In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most commonly reported adverse reactions (≥10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (e.g., changes in morphology, color, or number of red blood cells), dyspnea, chest pain, leg cramps and pain.
In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting. Studies A and B In multiple dose Studies A and B (total 126 adult patients), the most frequent treatment emergent adverse reactions following Ferrlecit were: Body as a Whole: injection site reaction (33%), chest pain (10%), pain (10%), asthenia (7%), headache (7%), fatigue (6%), fever (5%), malaise, infection, abscess, chills, rigors, carcinoma, flu-like syndrome, sepsis, lightheadedness, weakness.
Nervous System: cramps (25%), dizziness (13%), paresthesias (6%), agitation, somnolence, decreased level of consciousness. Respiratory System: dyspnea (11%), coughing (6%), upper respiratory infections (6%), rhinitis, pneumonia. Cardiovascular System: hypotension (29%), hypertension (13%), syncope (6%), tachycardia (5%), bradycardia, vasodilatation, angina pectoris, myocardial infarction, pulmonary edema.
Gastrointestinal System: nausea, vomiting and/or diarrhea (35%), anorexia, abdominal pain (6%), rectal disorder, dyspepsia, eructation, flatulence, gastrointestinal disorder, melena. Musculoskeletal System: leg cramps (10%), myalgia, arthralgia, back pain, arm pain. Skin and Appendages: pruritus (6%), rash, increased sweating.
Genitourinary System: urinary tract infection, and menorrhagia. Special Senses: conjunctivitis, rolling of the eyes, watery eyes, puffy eye lids, arcus senilis, redness of the eye, diplopia, and deafness. Metabolic and Nutritional Disorders: hyperkalemia (6%), generalized edema (5%), leg edema, peripheral edema, hypoglycemia, edema, hypervolemia, hypokalemia.
Hematologic System: abnormal erythrocytes (11%) (changes in morphology, color, or number of red blood cells), anemia, leukocytosis, lymphadenopathy. Study C – Pediatric Pediatric Patients: In a clinical trial of 66 iron-deficient pediatric hemodialysis patients, 6 to 15 years of age, inclusive, who were receiving a stable erythropoietin dosing regimen, the most common adverse reactions, occurring in ≥5%, regardless of treatment dosage, were: hypotension (35%), headache (24%), hypertension (23%), tachycardia (17%), vomiting (11%), fever (9%), nausea (9%), abdominal pain (9%), pharyngitis (9%), diarrhea (8%), infection (8%), rhinitis (6%), and thrombosis (6%).
More patients in the higher dose group (3.0 mg/kg) than in the lower dose group (1.5 mg/kg) experienced the following adverse events: hypotension (41% vs. 28%), tachycardia (21% vs. 13%), fever (15% vs.
3%), headache (29% vs. 19%), abdominal pain (15% vs. 3%), nausea (12% vs.
6%), vomiting (12…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drug-drug interactions involving Ferrlecit have not been studied. Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Risk of hypersensitivity reaction which may have serious consequences for the fetus. Use only if clearly needed (contains benzyl alcohol). ( 8.1 ) Lactation: Not recommended when breastfeeding. ( 8.2 ) Pediatric Use: Safety and effectiveness have not been established in pediatric patients <6 years of age. ( 8.4 )
8.1Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1) ] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations ) . Advise pregnant women of the potential risk to the fetus. Available data from postmarketing reports with Ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage.
Ferrlecit contains benzyl alcohol as a preservative. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low-birth-weight infants who received intravenously administered benzyl alcohol–containing drugs [see Warnings and Precautions (5.4) and Use in Specific Populations (8.4) ] .
Consider alternative iron replacement therapies without benzyl alcohol. There are risks to the mother and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations ) . In the absence of maternal toxicity, Ferrlecit was not teratogenic to offspring of pregnant mice or rats at clinically relevant exposures (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, 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%–4% and 15%–20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with intravenous iron administration, which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimesters.
Data Animal data Ferrlecit was administered intravenously to pregnant mice during gestation days 6 to 15 at doses of 5, 30, and 100 mg Fe/kg/day to assess embryofetal development. No teratogenic effects were seen in offspring at the highest dose, representing maternal exposure of approximately 4 times maximum human exposure based on body surface area. There were increased fetal resorptions and decreased fetal weights at doses that caused maternal toxicity as evidenced by decreased body-weight gain and decreased food consumption.
Ferrlecit was administered intravenously to pregnant rats during gestation days 6 to 15 at doses of 4 and 20 mg Fe/kg/day to assess embryofetal development. No teratogenic effects were seen in offspring at the highest dose, representing maternal exposure of approximately 1.5 times maximum human exposure based on body surface area. There were decreases in gestation index and litter size, increased fetal resorptions, and decreased fetal weights at doses that caused maternal toxicity as evidenced by decreased body-weight gain and decreased food consumption.
8.2Lactation Risk Summary Ferrlecit contains benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely. However, adverse reactions have occurred in premature neonates and low-birth-weight inf…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1) ] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations ) . Advise pregnant women of the potential risk to the fetus. Available data from postmarketing reports with Ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage.
Ferrlecit contains benzyl alcohol as a preservative. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low-birth-weight infants who received intravenously administered benzyl alcohol–containing drugs [see Warnings and Precautions (5.4) and Use in Specific Populations (8.4) ] .
Consider alternative iron replacement therapies without benzyl alcohol. There are risks to the mother and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations ) . In the absence of maternal toxicity, Ferrlecit was not teratogenic to offspring of pregnant mice or rats at clinically relevant exposures (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, 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%–4% and 15%–20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with intravenous iron administration, which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimesters.
Data Animal data Ferrlecit was administered intravenously to pregnant mice during gestation days 6 to 15 at doses of 5, 30, and 100 mg Fe/kg/day to assess embryofetal development. No teratogenic effects were seen in offspring at the highest dose, representing maternal exposure of approximately 4 times maximum human exposure based on body surface area. There were increased fetal resorptions and decreased fetal weights at doses that caused maternal toxicity as evidenced by decreased body-weight gain and decreased food consumption.
Ferrlecit was administered intravenously to pregnant rats during gestation days 6 to 15 at doses of 4 and 20 mg Fe/kg/day to assess embryofetal development. No teratogenic effects were seen in offspring at the highest dose, representing maternal exposure of approximately 1.5 times maximum human exposure based on body surface area. There were decreases in gestation index and litter size, increased fetal resorptions, and decreased fetal weights at doses that caused maternal toxicity as evidenced by decreased body-weight gain and decreased food consumption.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Ferrlecit have been established in pediatric patients 6 to 15 years of age [see Dosage and Administration (2.3) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] . Safety and effectiveness in pediatric patients younger than 6 years of age have not been established. Benzyl Alcohol Toxicity and Pediatrics Ferrlecit is not approved for use in neonates or infants.
Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and low-birth-weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
Benzyl alcohol contained in Ferrlecit may cause serious and anaphylactoid reactions in infants and children up to 3 years old. The administration of medications containing benzyl alcohol to newborns or premature neonates has been associated with a fatal "gasping syndrome" (symptoms include a striking onset of gasping syndrome, hypotension, bradycardia, and cardiovascular collapse). Preterm, low-birth-weight infants may be more likely to develop these reactions because they could be less able to metabolize benzyl alcohol.
The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known (Ferrlecit contains 9 mg of benzyl alcohol per mL) [see Warnings and Precautions (5.4) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Ferrlecit did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 The Ferrlecit iron complex is not dialyzable. No data is available regarding overdose of Ferrlecit in humans. Excessive dosages of Ferrlecit may lead to accumulation of iron in storage sites potentially leading to hemosiderosis.
Do not administer Ferrlecit to patients with iron overload [see Warnings and Precautions (5.3) ] . Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see Adverse Reactions (6.2) ] . Ferrlecit at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg and 250 mg/kg caused deaths in mice, rats, rabbits, and dogs respectively.
The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in the respiratory rate, tremor, and convulsions.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ferrlecit is used to replete the body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and various enzymatic processes.
12.3Pharmacokinetics Multiple sequential single-dose intravenous pharmacokinetic studies were performed on 14 healthy iron-deficient volunteers. Entry criteria included hemoglobin ≥10.5 gm/dL and transferrin saturation ≤15% (TSAT) or serum ferritin value ≤20 ng/mL. In the first stage, each subject was randomized 1:1 to undiluted Ferrlecit injection of either 125 mg/hr or 62.5 mg/0.5 hr (2.1 mg/min).
Five days after the first stage, each subject was re-randomized 1:1 to undiluted Ferrlecit injection of either 125 mg/7 min or 62.5 mg/4 min (>15.5 mg/min). Peak drug levels (C max ) varied significantly by dosage and by rate of administration with the highest C max observed in the regimen in which 125 mg was administered in 7 minutes (19.0 mg/L). The terminal elimination half-life for drug bound iron was approximately 1 hour.
Half-life varied by dose but not by rate of administration. Half-life values were 0.85 and 1.45 hours for the 62.5 mg/4 min and 125 mg/7 min regimens, respectively. Total clearance of Ferrlecit was 3.02 to
5.35L/h. The AUC for Ferrlecit bound iron varied by dose from 17.5 mg-h/L (62.5 mg) to 35.6 mg-h/L (125 mg). Approximately 80% of drug bound iron was delivered to transferrin as a mononuclear ionic iron species within 24 hours of administration in each dosage regimen.
Direct movement of iron from Ferrlecit to transferrin was not observed. Mean peak transferrin saturation returned to near baseline by 40 hours after administration of each dosage regimen. Pediatrics: Single-dose intravenous pharmacokinetic analyses were performed on 48 iron-deficient pediatric hemodialysis patients.
Twenty-two patients received 1.5 mg/kg Ferrlecit and 26 patients received 3.0 mg/kg Ferrlecit (maximum dose 125 mg). The mean C max , AUC 0–∞ , and terminal elimination half-life values following a 1.5 mg/kg dose were 12.9 mg/L, 95.0 mg∙hr/L, and 2.0 hours, respectively. The mean C max , AUC 0–∞ , and terminal elimination half-life values following a 3.0 mg/kg dose were 22.8 mg/L, 170.9 mg∙hr/L, and 2.5 hours, respectively.
In vitro experiments have shown that less than 1% of the iron species within Ferrlecit can be dialyzed through membranes with pore sizes corresponding to 12,000 to 14,000 daltons over a period of up to 270 minutes. Human studies in renally competent patients suggest the clinical insignificance of urinary excretion.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ferrlecit is used to replete the body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and various enzymatic processes.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ferrlecit is a clear, dark brown liquid supplied in colorless glass vials. Each sterile, single-dose vial contains 62.5 mg of elemental iron in 5 mL for intravenous use. Discard unused portion.
Carton containing 10 vials: NDC 0024-2792-10 Storage Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F). See USP Controlled Room Temperature. Do not freeze.
Keep out of the reach of children.
📦 Storage and Handling ▾
Storage Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Ferrlecit ® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages.
The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe 2 O 3 (C 6 H 11 O 7 )(C 12 H 22 0 11 )5] n≈200• Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7.
Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Prior to Ferrlecit administration: Question patients regarding any prior history of reactions to parenteral iron products. Advise patients of the risks associated with Ferrlecit. Advise patients to report adverse reactions associated with the use of Ferrlecit, including hypersensitivity, allergic reactions, chest pain, dizziness, lightheadedness, swelling, and breathing problems [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1 , 6.2) ] .
Advise patients that Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations [see Drug Interactions (7) ] . Pregnancy Advise pregnant women about the risk of hypersensitivity reactions which may have serious consequences for the fetus. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy (contains benzyl alcohol) [see Use in Specific Populations (8.1) ] .
Lactation Advise patients that treatment with Ferrlecit is not recommended for use while breastfeeding [see Use in Specific Populations (8.2) ] .