Version May 2024
Note: Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, poor GI absorption, lack of response to or poor tolerability of oral iron, need for rapid repletion, chronic kidney disease, active inflammatory bowel disease, cancer, chronic or extensive blood loss) (Ref). Dosage expression: Dose is expressed in mg of elemental iron. Test dose: A test dose typically is not required.
Iron-deficiency anemia, hemodialysis patients: IV: 125 mg (elemental iron) per dialysis session. For repletion treatment, most patients may require a cumulative dose of 1,000 mg (elemental iron) over ~8 dialysis sessions.
Off-label dosing (based on limited data): After establishing tolerance of the 125 mg dose (elemental iron), single doses of up to 250 mg (elemental iron) have been reported to be safe and well-tolerated in hemodialysis patients (Ref).
Iron-deficiency anemia, treatment, nonhemodialysis patients (off-label use):
IV: 125 mg per dose is typically used, but may administer up to 250 mg per dose; repeat doses may be given until total iron requirements are met (Ref). Dosing schedule depends on iron deficit and ease of scheduling. Cumulative doses >1 g generally are not required during a single treatment course unless there is ongoing blood loss (Ref).
There are no dosage adjustments provided in the manufacturer's labeling. The ferric gluconate iron complex is not dialyzable.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing. Use with caution and consider initiation at the low end of the dosing range.
(For additional information see "Ferric gluconate: Pediatric drug information")
Multiple forms for parenteral iron exist; close attention must be paid to the specific product when ordering and administering; incorrect selection or substitution of one form for another without proper dosage adjustment may result in serious over- or under-dosing; test doses are recommended before starting therapy. Note: Per National Kidney Foundation DOQI Guidelines, initiation of iron therapy, determination of dose, and duration of therapy should be guided by results of iron status tests combined with the Hb level and the dose of the erythropoietin stimulating agent. There is insufficient evidence to recommend IV iron if ferritin level >500 ng/mL. Dosage expressed in mg elemental iron:
Iron-deficiency anemia, hemodialysis patients, repletion: Children ≥6 years and Adolescents: IV: 1.5 mg/kg (0.12 mL/kg) repeated at each of 8 sequential dialysis sessions; maximum dose: 125 mg/dose
Iron-deficiency anemia, hemodialysis patients, maintenance: Limited data available: Children ≥6 years and Adolescents <17 years: Initial: 1 mg/kg/dose once weekly during dialysis session. Adjust dose to desired iron indices (reported range: 0.75 to 1.5 mg/kg/dose); maximum dose: 125 mg/dose. Dosing based on a study of 35 iron-replete patients (ages 6 to 16 years) on hemodialysis receiving ferric gluconate as maintenance therapy for iron deficiency anemia. Patients were able to maintain targeted iron indices and tolerated the medication (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Percentages reported in adult patients unless otherwise noted.
>10%:
Cardiovascular: Hypertension (children, adolescents, adults: 13% to 23%), hypotension (children, adolescents, adults: 28% to 29%), tachycardia (children, adolescents, adults: 5% to 13%)
Gastrointestinal: Diarrhea (children, adolescents: 8%; adults: ≤35%), nausea (children, adolescents: 6%; adults: ≤35%), vomiting (children, adolescents: 9%; adults: ≤35%)
Hematologic & oncologic: Abnormal erythrocytes (11%; changes in color, morphology, or number)
Local: Injection-site reaction (33%)
Nervous system: Dizziness (13%), headache (children, adolescents, adults: 7% to 19%)
Neuromuscular & skeletal: Muscle cramps (25%)
Respiratory: Dyspnea (11%)
1% to 10%:
Cardiovascular: Chest pain (10%), edema (5%), syncope (6%), thrombosis (children, adolescents: 6%)
Dermatologic: Pruritus (6%)
Endocrine & metabolic: Hyperkalemia (6%)
Gastrointestinal: Abdominal pain (children, adolescents, adults: 3% to 6%)
Infection: Infection (children, adolescents: 8%)
Nervous system: Asthenia (7%), fatigue (6%), pain (10%), paresthesia (6%)
Neuromuscular & skeletal: Lower limb cramp (10%)
Respiratory: Cough (6%), pharyngitis (children, adolescents: 6%), rhinitis (children, adolescents: 3%), upper respiratory tract infection (6%)
Miscellaneous: Fever (children, adolescents, adults: 3% to 5%)
Frequency not defined:
Cardiovascular: Acute coronary syndrome (Kounis syndrome), acute myocardial infarction, angina pectoris, bradycardia, lower extremity edema, peripheral edema, vasodilation
Dermatologic: Diaphoresis, skin rash
Endocrine & metabolic: Heavy menstrual bleeding, hypervolemia, hypoglycemia, hypokalemia
Gastrointestinal: Anorexia, dyspepsia, eructation, flatulence, melena, rectal disease
Genitourinary: Urinary tract infection
Hematologic & oncologic: Anemia, carcinoma, leukocytosis, lymphadenopathy
Infection: Abscess, sepsis
Nervous system: Agitation, chills, drowsiness, impaired consciousness, malaise, rigors
Neuromuscular & skeletal: Arm and/or wrist pain, arthralgia, back pain, myalgia
Ophthalmic: Conjunctivitis, corneal deposits (arcus senilis), diplopia, eye redness, eyelid edema, nystagmus disorder, watery eyes
Otic: Deafness
Respiratory: Flu-like symptoms, pneumonia, pulmonary edema
Postmarketing:
Cardiovascular: Facial flushing, ischemic heart disease (acute; with or without infarction), phlebitis, shock
Dermatologic: Pallor, skin discoloration
Gastrointestinal: Dysgeusia, xerostomia
Hematologic & oncologic: Hemorrhage
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis and severe hypersensitivity reaction)
Local: Inflammation at injection site
Nervous system: Hypertonia, hypoesthesia, loss of consciousness, nervousness, seizure
Hypersensitivity to ferric gluconate or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Anemias not associated with iron deficiency and where there is evidence of iron overload (eg, hemochromatosis, chronic hemolysis) or iron utilization disorders (eg, sideroblastic anemia, lead anemia); serious hypersensitivity to other parenteral iron products; severe inflammatory diseases of the liver or kidneys.
Concerns related to adverse effects:
• Hypotension: Clinically significant hypotension may occur; usually resolves within 1 to 2 hours. May augment hemodialysis-induced hypotension.
• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, have occurred (may be life-threatening). May present with shock, clinically significant hypotension, loss of consciousness, or collapse. Avoid rapid administration. Equipment for resuscitation and trained personnel experienced in handling medical emergencies should always be immediately available.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
Other warnings/precautions:
• Appropriate use: Use only in patients with documented iron deficiency; caution with hemoglobinopathies or other refractory anemias as iron overload may occur.
Strength of ferric gluconate injection is expressed as elemental iron.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Ferrlecit: 12.5 mg/mL (5 mL) [contains benzyl alcohol, sucrose]
Generic: 12.5 mg/mL (5 mL)
Yes
Solution (Ferrlecit Intravenous)
12.5 mg/mL (per mL): $7.63
Solution (Na Ferric Gluc Cplx in Sucrose Intravenous)
12.5 mg/mL (per mL): $1.97 - $7.63
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Ferrlecit: 12.5 mg/mL (5 mL) [contains benzyl alcohol, sucrose]
IV: Administer diluted over 1 hour or undiluted (slowly) at a rate of up to 12.5 mg/minute per dialysis session. The 250 mg dose (off-label) has been infused (diluted) over 1 to 2 hours (Ref).
Parenteral: IV infusion: Children and Adolescents: Administer diluted over 1 hour
Iron deficiency anemia: Treatment of iron-deficiency anemia in patients 6 years and older with chronic kidney disease undergoing hemodialysis in conjunction with supplemental erythropoietin therapy
Iron deficiency anemia, treatment, nondialysis patients
Ferric gluconate may be confused with ferric carboxymaltose, ferumoxytol
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification
Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Ferric Gluconate. Risk C: Monitor therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy
Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: Avoid combination
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy
Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy
Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Iron transfer to the fetus is regulated by the placenta (BSH [Pavord 2020]; NAS 2020).
There is a risk of adverse maternal reactions (eg, anaphylaxis, hypotension, shock) following use of parenteral iron, which may result in fetal bradycardia, especially during the second and third trimesters. An immediate hypersensitivity reaction has been reported in a pregnant patient (Cuciti 2005). Although the risk is rare, immediate treatment for anaphylactoid and/or hypersensitivity reactions should be available (BSH [Pavord 2020]).
Maternal iron requirements increase during pregnancy. Untreated iron deficiency and iron-deficiency anemia (IDA) in pregnant patients are associated with adverse pregnancy outcomes, including low birth weight, preterm birth, and increased perinatal mortality (ACOG 2021; BSH [Pavord 2020]). Maternal iron deficiency is also associated with fatigue, increased risk of postpartum depression, and possibly postpartum hemorrhage (BSH [Pavord 2020]).
Oral and parenteral iron are effective at replacing iron stores in pregnant patients (ACOG 2021). Most studies note iron therapy improves maternal hematologic parameters, however, data related to clinical outcomes in the mother and neonate are limited (FIGO 2019; NAS 2020; USPSTF [Siu 2015]). Parenteral iron therapy may be used in pregnant patients who cannot tolerate or respond to oral iron, when iron deficiency occurs later in pregnancy, or when malabsorption is present (ACOG 2021; BSH [Pavord 2020]). However, due to limited safety data in early pregnancy, use of intravenous iron is generally not started until the second or third trimester (ACOG 2021; BSH [Pavord 2020]; FIGO 2019).
Ferric gluconate preparations contain benzyl alcohol; avoid use in pregnant patients due to association with gasping syndrome in premature infants.
Iron is present in breast milk.
Endogenous iron concentrations in breast milk vary by postpartum age and are lower than concentrations in the maternal plasma (Dorea 2000; Emmett 1997). Breast milk concentrations of iron are maintained in lactating patients with mild to moderate iron-deficiency anemia (IDA), but concentrations decrease if IDA is moderate to severe (El-Farrash 2012) or severe (Kumar 2008).
Iron deficiency and IDA are associated with adverse effects in postpartum patients (eg, altered cognition, depression, fatigue) that may influence interactions with the infant. Iron supplementation in the postpartum patient should be initiated as soon as possible following delivery when gestational anemia is a concern (WHO 2016).
Parenteral iron therapy may be used in postpartum patients with uncorrected anemia at delivery who cannot tolerate, do not respond to, or are noncompliant with oral iron therapy, or the severity of anemia requires prompt management (BSH [Pavord 2020]). However, because ferric gluconate preparations contain benzyl alcohol as a preservative, the manufacturer recommends considering use of other products during lactation.
Monitor hemoglobin and hematocrit, serum ferritin, iron saturation; vital signs; monitor for signs and symptoms of hypersensitivity (monitor for at least 30 minutes following the end of administration and until clinically stable)
Chronic kidney disease: Monitor transferrin saturation and ferritin more frequently following a course of IV iron (KDIGO 2013)
Chemotherapy-associated anemia (off-label use): Iron, total iron-binding capacity, transferrin saturation, or ferritin levels at baseline and periodically (Rizzo 2010)
Anemia:
Hemoglobin, whole blood:
Female: 12 to16 g/dL (SI: 120 to 160 g/L) (ABIM 2023).
Male: 13 to 18 g/dL (SI: 130 to 180 g/L) (ABIM 2023; WHO 2011).
Iron deficiency (ABIM 2023):
Ferritin, serum: Note: Ferritin is an acute phase reactant; levels may be elevated in the presence of inflammation or infection which is independent of iron status (WHO 2020).
Female: 24 to 307 ng/mL (SI: 53.9 to 689.8 picomole/L).
Male: 24 to 336 ng/mL (SI: 53.9 to 755 picomole/L).
Iron, serum: 50 to 150 mcg/dL (SI: 9 to 26.9 micromole/L).
Total iron binding capacity, serum: 250 to 310 mcg/dL (SI: 44.8 to 55.5 micromole/L).
Transferrin saturation: 20% to 50%.
Transferrin, serum: 200 to 400 mg/dL (SI: 24.6 to 49.2 micromole/L).
Chronic kidney disease-associated anemia: To achieve and maintain target hemoglobin for patients with nondialysis-dependent chronic kidney disease, patients with a transferrin saturation (TSAT) ≤30% and a serum ferritin level ≤500 ng/mL (SI: 1,123.5 picomole/L) will often respond to iron supplementation (Gutiérrez 2021; KDIGO 2012).
Supplies a source to elemental iron necessary to the function of hemoglobin, myoglobin and specific enzyme systems; allows transport of oxygen via hemoglobin
Half-life elimination: Bound iron: 1 hour
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