ferrlecit
Pharmaranks rates Ferrlecit 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ferrlecit (Sodium Ferric Gluconate Complex) is a parenteral iron replacement used to treat Hematologic Pregnancy Complications, Iron-Deficiency Anemia.
Sodium Ferric Gluconate Complex · by Sanofi Aventis US
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Sodium Ferric Gluconate Complex
- Drug class
- Parenteral Iron Replacement
- Form
- Injectable
- Strength
- Sodium Ferric Gluconate Complex EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Sanofi Aventis US
- FDA application
- NDA020955
What is Ferrlecit?
From the FDA label: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.
How to use
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 ) 2.1 Important 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. 2.2 Adult Dosage and Administration The…
Side effects
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. 6.1 Clinical 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…
Warnings
Important safety information
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 ) 5.1 Hypersensitivity 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. 5.2 Hypotension 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) ] . 5.3 Iron 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). 5.4 Risk 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 benzyl alcohol per mL) [see Use in Specific Populations (8.4) ] .
Who should not take Ferrlecit
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 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Drug-drug interactions involving Ferrlecit have not been studied. Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations.
Drug class
How this class works, per Iron Dextran - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Ferrlecit ranks — best-rated parenteral iron replacement for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Ferrlecit treat?
- Ferrlecit (Sodium Ferric Gluconate Complex) may be used to treat hematologic pregnancy complications, iron-deficiency anemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Ferrlecit work?
- Ferrlecit is a parenteral iron replacement. Given by injection or IV, these supply iron directly into the bloodstream wrapped in a protective carbohydrate shell. The iron is gradually released, picked up by the protein transferrin, and delivered to the bone marrow, where it is used to build hemoglobin and treat iron-deficiency anemia.
- How is Ferrlecit rated?
- pharmaranks gives Ferrlecit a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Ferrlecit?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ferrlecit. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ferrlecit?
- Ferrlecit is marketed by Sanofi Aventis US. You can see Sanofi Aventis US's full profile, rating, and other products on pharmaranks.
- Is Ferrlecit a brand-name or generic drug?
- Ferrlecit is a brand-name product with the active ingredient Sodium Ferric Gluconate Complex.
- Is Ferrlecit available over the counter?
- No. Ferrlecit is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ferrlecit come in?
- Ferrlecit is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Ferrlecit?
- Ferrlecit is classified as parenteral iron replacement, phosphate binder, per the FDA's Established Pharmacologic Class.
- Is Ferrlecit FDA-registered?
- Ferrlecit is on record with the U.S. FDA under application number NDA020955. You can verify this on its official FDA label.
- Has Ferrlecit been recalled by the FDA?
- Ferrlecit has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Ferrlecit safe?
- There's no single safe-or-not verdict. pharmaranks gives Ferrlecit a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ferrlecit?
- Ferrlecit's side effects are taken directly from its FDA label. From the label: 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 (≥… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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ferrlecit
70/100