(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 Salt
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 undergoing hemodialysis in conjunction with erythropoietin therapy
Off Label Uses
Data from two prospective, randomized, open-label, multicenter trials supports the use of ferric gluconate in the management of patients with chemotherapy-associated anemia [Pedrazzoli 2008], [Henry 2007].
Known hypersensitivity to ferric gluconate or any component of the formulation
Iron-deficiency anemia, hemodialysis patients: IV: 125 mg elemental iron per dialysis session. Most patients will require a cumulative dose of 1 g elemental iron over approximately 8 sequential dialysis treatments to achieve a favorable response.
Note: A test dose of 2 mL diluted in NS 50 mL administered over 60 minutes was previously recommended (not in current manufacturer labeling). Doses >125 mg are associated with increased adverse events.
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.
Iron-deficiency anemia, hemodialysis patients: Children ≥6 years: IV: 1.5 mg/kg of elemental iron (maximum: 125 mg/dose) per dialysis session. Doses >1.5 mg/kg are associated with increased adverse events.
Dosing: Renal Impairment
No dosage adjustment necessary. The ferric gluconate iron complex is not dialyzable.
Dosing: Hepatic Impairment
No dosage adjustment necessary.
For IV infusion, dilute ferric gluconate in NS (children: 25 mL NS, adults: 100 mL NS).
Children: Administer diluted in 25 mL NS over 1 hour.
Adults: Administer diluted in 100 mL NS over 1 hour or administer undiluted, slowly at a rate of up to 12.5 mg/minute.
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
Bictegravir: Iron Salts may decrease the serum concentration of Bictegravir. Management: Bictegravir, emtricitabine, and tenofovir alafenamide can be administered with iron salts under fed conditions, but coadministration with or 2 hours after an iron salt is not recommended under fasting conditions. Consider therapy modification
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 Salts. 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: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. 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), vasodilatation
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 1-2 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.
Hemoglobin and hematocrit, serum ferritin, iron saturation; vital signs; signs and symptoms of hypersensitivity (monitor for ≥30 minutes following the end of administration and until clinically stable)
NKF K/DOQI guidelines recommend that iron status should be monitored monthly during initiation through the percent transferrin saturation (TSAT) and serum ferritin.
Chemotherapy-associated anemia (off-label use): Iron, total iron-binding capacity, transferrin saturation, or ferritin levels at baseline and periodically (Rizzo, 2011).
Pregnancy Risk Factor
Adverse events were not observed in animal reproduction studies. It is recommended that pregnant women meet the dietary requirements of iron with diet and/or supplements in order to prevent adverse events associated with iron deficiency anemia in pregnancy. Treatment of iron deficiency anemia in pregnant women is the same as in nonpregnant women and in most cases, oral iron preparations may be used. Except in severe cases of maternal anemia, the fetus achieves normal iron stores regardless of maternal concentrations (IOM 2001).
• 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.
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