Dosage Forms
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)
Pharmacology
Mechanism of Action
Supplies a source to elemental iron necessary to the function of hemoglobin, myoglobin and specific enzyme systems; allows transport of oxygen via hemoglobin
Pharmacokinetics/Pharmacodynamics
Half-Life Elimination
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
Use: Off Label
Iron deficiency anemia (in nondialysis patients unresponsive to or poorly tolerant of oral iron therapy)a
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.
Contraindications
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.
Dosage and Administration
Dosing: Adult
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)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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).
Reconstitution
For IV infusion, dilute ferric gluconate in NS 100 mL.
Administration
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).
Storage
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.
Drug Interactions
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: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. 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
Test Interactions
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.
Adverse Reactions
Percentages reported in adult patients unless otherwise noted.
>10%:
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%)
Central nervous system: Pain (10%), fatigue (6%), paresthesia (6%)
Dermatologic: Pruritus (6%)
Endocrine & metabolic: Hyperkalemia (6%)
Gastrointestinal: Abdominal pain (children: 9%; adults: 6%)
Infection: Infection (8%)
Neuromuscular & skeletal: Lower limb cramp (10%), asthenia (7%)
Respiratory: Pharyngitis (children: 9%), cough (6%), rhinitis (children: 6%), upper respiratory tract infection (6%)
Miscellaneous: Fever (children: 9%; adults: 5%)
<1%: Facial flushing, hemorrhage, hypersensitivity reaction, hypertonia, nervousness, xerostomia
Frequency not defined:
Cardiovascular: Acute myocardial infarction, angina pectoris, bradycardia, peripheral edema, vasodilation
Central nervous system: Agitation, chills, drowsiness, impaired consciousness, malaise, rigors
Dermatologic: Diaphoresis, skin rash
Endocrine & metabolic: Heavy menstrual bleeding, hypervolemia, hypoglycemia, hypokalemia
Gastrointestinal: Anorexia, dyspepsia, eructation, flatulence, gastrointestinal disease, melena, rectal disease
Genitourinary: Urinary tract infection
Hematologic & oncologic: Anemia, carcinoma, leukocytosis, lymphadenopathy
Infection: Abscess, sepsis
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: Anaphylaxis, dysgeusia, hypoesthesia, loss of consciousness, pallor, phlebitis, seizure, severe hypersensitivity reaction, shock, skin discoloration, superficial thrombophlebitis (injection site)
Warnings/Precautions
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.
Special populations:
- 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.
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.
Monitoring Parameters
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
Pregnancy Risk Factor
B
Pregnancy Considerations
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 2019).
In general, treatment of iron deficiency or IDA in pregnancy is the same as in nonpregnant 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 2019). Due to limited safety data in early pregnancy, use of IV 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 2019). Fetal monitoring is recommended during maternal IV ferric gluconate administration due to risk of severe adverse reactions (eg, hypotension, anaphylaxis) that may be harmful to fetus, especially during the second and third trimester.
Preparations may contain benzyl alcohol (avoid in pregnant women due to association with gasping syndrome in premature infants).
Patient Education
What is this drug used for?
- It is used to treat anemia.
Frequently reported side effects of this drug
- Diarrhea
- Cramps
- Abdominal pain
- Lack of appetite
- Fatigue
- Injection site irritation
- Common cold symptoms
- Nausea
- Vomiting
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- High potassium like abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, numbness or tingling feeling
- Chest pain
- Severe dizziness
- Passing out
- Vision changes
- Burning or numbness feeling
- Cough
- Fast heartbeat
- Swelling
- Chills
- Flushing
- Severe back pain
- Severe groin pain
- Severe thigh pain
- Severe headache
- Shortness of breath
- Severe loss of strength and energy
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
