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Ferric Gluconate

Pronunciation

(FER ik GLOO koe nate)

Index Terms

  • Sodium Ferric Gluconate
  • Sodium Ferric Gluconate Complex

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)

Brand Names: U.S.

  • Ferrlecit

Pharmacologic Category

  • Iron Salt

Pharmacology

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

Use: Labeled Indications

Iron deficiency anemia: Treatment of iron-deficiency anemia in patients undergoing hemodialysis in conjunction with erythropoietin therapy

Use: Unlabeled

Chemotherapy-associated anemia

Contraindications

Known hypersensitivity to ferric gluconate or any component of the formulation

Dosing: Adult

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)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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.

Reconstitution

For IV infusion, dilute ferric gluconate in NS (children: 25 mL NS, adults: 100 mL NS).

Administration

IV

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.

Compatibility

Stable in NS. Do not mix with parenteral nutrition solutions or other medications.

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

ACE Inhibitors: May enhance the adverse/toxic effect of Ferric Gluconate. Monitor therapy

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

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

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

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

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

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 adults 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%), 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: Arcus senilis, conjunctivitis, diplopia, eye redness, eye rolling, eyelid edema, watery eyes

Otic: Deafness

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% (Limited to important or life-threatening): Anaphylaxis, convulsions, facial flushing, hemorrhage, hypersensitivity reaction, hypertonia, hypoesthesia, loss of consciousness, shock, skin discoloration

Warnings/Precautions

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.

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

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

B

Pregnancy Considerations

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.

Patient Education

• 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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