Medically reviewed by Drugs.com. Last updated on Jul 9, 2019.
(FER ik GLOO koe nate)
- Sodium Ferric Gluconate
- Sodium Ferric Gluconate Complex
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ferrlecit: 12.5 mg/mL (5 mL) [contains benzyl alcohol, sucrose]
Generic: 12.5 mg/mL (5 mL)
Brand Names: U.S.
- Iron Preparations
Supplies a source to elemental iron necessary to the function of hemoglobin, myoglobin and specific enzyme systems; allows transport of oxygen via hemoglobin
Bound iron: 1 hour
Use: Labeled Indications
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
Off Label Uses
Iron deficiency anemia (in nondialysis patients unresponsive to or poorly tolerant of oral iron therapy)
Clinical experience supports the use of IV iron preparations, including ferric gluconate, for the treatment of iron deficiency anemia in patients who are not responding to or do not tolerate oral iron therapy [DeLoughery 2017]. A meta-analysis supports the use of ferric gluconate in patients with chronic kidney disease (CKD) not on dialysis; randomized controlled trials of oral versus intravenous iron in patients with CKD (dialysis and nondialysis dependent) were analyzed and found that patients receiving IV iron products were more likely to reach desired hemoglobin levels with an associated slightly higher risk of hypotension and fewer gastrointestinal side effects [Shepshelovich 2016]. Data from two randomized, multicenter trials support the use of ferric gluconate in the management of chemotherapy-associated anemia in patients with cancer [Henry 2007], [Pedrazzoli 2008]. IV ferric gluconate may be of benefit in patients whose absorption of oral iron may be impaired (eg, inflammatory bowel disease [IBD]) or in patients in whom IV iron therapy may provide more expeditious improvement in hematologic parameters [Gomollón 2013], [Reed 2015].
Known hypersensitivity to ferric gluconate or any component of the formulation
Note: A test dose of 2 mL diluted in NS 50 mL administered over 60 minutes was previously recommended (not in current manufacturer labeling [consider a test dose in patients with a history of drug allergies]).
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 (Folkert 2003; Pandey 2016).
Iron-deficiency anemia (in nondialysis patients unresponsive to or poorly tolerant of oral iron therapy) (off-label use): IV: 125 to 250 mg elemental iron per dose; repeated until hematologic parameters or total iron requirements are met (DeLoughery 2017; Gomollón 2013; Reed 2015)
Chemotherapy-associated anemia (off-label use): IV infusion: 125 mg once every week for 6 doses (Pedrazzoli 2008) or for 8 doses (Henry 2007)
Refer to adult dosing.
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 (Warady 2004).
For IV infusion, dilute ferric gluconate in NS 100 mL.
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 (Folkert 2003; Reed 2015).
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze. Use immediately after dilution in NS.
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification
Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Ferric Gluconate. Monitor therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Avoid combination
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Avoid combination
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy
Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy
Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. 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. Consider therapy modification
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Serum or transferrin bound iron levels may be falsely elevated if assessed within 24 hours of ferric gluconate administration. Serum ferritin levels may be falsely elevated for 5 days after ferric gluconate administration.
Percentages reported in adults unless otherwise noted.
Cardiovascular: Hypotension (children: 35%; adults: 29%), hypertension (children: 23%; adults: 13%), tachycardia (children: 17%; adults: 5%)
Central nervous system: Headache (children: 24%; adults: 7%), dizziness (13%)
Gastrointestinal: Vomiting (adults: ≤35%; children: 11%), nausea (adults: ≤35%; children: 9%), diarrhea (adults: ≤35%; children: 8%)
Hematologic & oncologic: Abnormal erythrocytes (11%; changes in color, morphology, or number)
Local: Injection site reaction (33%)
Neuromuscular & skeletal: Muscle cramps (25%)
Respiratory: Dyspnea (11%)
1% to 10%:
Cardiovascular: Chest pain (10%), syncope (6%), thrombosis (children: 6%), edema (5%), angina pectoris, bradycardia, myocardial infarction, peripheral edema (including leg edema), vasodilation
Central nervous system: Pain (10%), fatigue (6%), paresthesia (6%), agitation, chills, drowsiness, impaired consciousness, malaise, rigors
Dermatologic: Pruritus (6%), diaphoresis, skin rash
Endocrine & metabolic: Hyperkalemia (6%), hypermenorrhea, hypervolemia, hypoglycemia, hypokalemia
Gastrointestinal: Abdominal pain (children: 9%; adults: 6%), anorexia, dyspepsia, eructation, flatulence, gastrointestinal disease, melena, rectal disease
Genitourinary: Urinary tract infection
Hematologic & oncologic: Anemia, carcinoma, leukocytosis, lymphadenopathy
Infection: Abscess, infection, sepsis
Neuromuscular & skeletal: Leg cramps (10%), weakness (7%), arm pain, arthralgia, back pain, myalgia
Ophthalmic: Conjunctivitis, corneal changes (arcus senilis), diplopia, eye redness, eyelid edema, nystagmus, watery eyes
Respiratory: Pharyngitis (children: 9%), cough (6%), rhinitis (children: 6%), upper respiratory tract infection (6%), flu-like symptoms, pneumonia, pulmonary edema
Miscellaneous: Fever (children: 9%; adults: 5%)
<1%, postmarketing, and/or case reports: Anaphylaxis, convulsions, dysgeusia, facial flushing, hemorrhage, hypersensitivity reaction, hypertonia, hypoesthesia, loss of consciousness, nervousness, pallor, phlebitis, shock, skin discoloration, xerostomia
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. Monitor during administration and for ≥30 minutes after administration and until clinically stable after infusion. Avoid rapid administration. Equipment for resuscitation and trained personnel experienced in handling medical emergencies should always be immediately available.
• Elderly: Use with caution in the elderly.
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.
• Appropriate use: Use only in patients with documented iron deficiency; caution with hemoglobinopathies or other refractory anemias as iron overload may occur.
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)
Pregnancy Risk Factor
Adverse events were not observed in animal reproduction studies.
Maternal iron requirements increase during pregnancy. Adequate iron concentrations to the fetus can be maintained regardless of maternal iron status, except in severe cases of anemia (IOM 2001). Untreated iron deficiency and iron deficiency anemia (IDA) in a pregnant female may be associated with adverse events, including low birth weight, preterm birth, or increased perinatal mortality (ACOG 95 2008; IOM 2001; Pavord 2012).
In general, treatment of iron deficiency or IDA in pregnancy is the same as in non-pregnant females. The majority of studies note iron therapy improves maternal hematologic parameters; however, information related to clinical outcomes in the mother and neonate is limited (Siu 2015).
Oral preparations are generally sufficient; however, parenteral iron therapy may be used in females who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008; Pavord 2012). Due to limited safety data in early pregnancy, use of intravenous iron is generally not started until the second or third trimester. Information related to the use of ferric gluconate in pregnancy is limited (Breymann 2017; Pavord 2012)
Preparations may contain benzyl alcohol (avoid in pregnant women due to association with gasping syndrome in premature infants).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea, cramps, abdominal pain, lack of appetite, or injection site irritation. Have patient report immediately to prescriber signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, numbness or tingling feeling), angina, severe dizziness, passing out, burning or numbness feeling, cough, tachycardia, edema, chills, flushing, severe back pain, severe groin pain, severe thigh pain, sweating a lot, severe nausea, severe vomiting, severe headache, shortness of breath, or severe loss of strength and energy (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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