ferric gluconate (Rx)

Brand and Other Names:Ferrlecit, Nulecit
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 12.5mg elemental Fe/mL; 10 mL ampules

Iron Deficiency Anemia

Indicated for treatment of iron deficiency anemia in adults and in children aged ≥6 years with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy

125 mg IV infusion over 1 hr; not to exceed 250 mg/infusion for 8 hemodialysis sessions

May dilute in 100 mL 0.9% NaCl and administer over 1 hr

May administer undiluted; not to exceed administration rate of 12.5 mg/min

Dosage Forms & Strengths

injectable solution

  • 12.5mg elemental Fe/mL

Iron Deficiency Anemia

Indicated for treatment of iron deficiency anemia in adults and in children aged ≥6 years with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy

<6 years: Safety and efficacy not established

≥6 years: 1.5 mg/kg elemental Fe IV infusion over 1 hr for 8 hemodialysis sessions

Not to exceed 125 mg/dose

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Adverse Effects

>10%

Diarrhea (35%)

Nausea (35%)

Vomiting (35%)

Injection site reaction (33%)

Hypotension (29%)

Cramps (25%)

Dizziness (13%)

Hypertension (13%)

Dyspnea (11%)

Chest pain (10%)

1-10%

Asthenia

Headache

Syncope

Fatigue

Fever

Edema

Cough

Upper respiratory tract infection

Abdominal pain

Hyperkalemia

Electrolyte abnormalities

Pruritus

Leg cramps

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Warnings

Contraindications

Hemochromatosis, hemosiderosis, hemolytic anemia, PUD, ulcerative colitis; hypersensitivity to drug or excipients

Cautions

DO NOT mix Ferrlecit with other meds or add to TPN; compatibility has not been established

Significant hypotension may occur following administration; may resolve within 1-2hr

Contains benzyl alcohol, which is associated with gasping syndrome in neonates (not for use in neonates)

Iron overload may occur in patients with hemoglobinopathies or other refractory anemias

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Pregnancy & Lactation

Pregnancy

Parenteral iron administration may be associated with hypersensitivity reactions, which may have serious consequences, such as fetal bradycardia

Advise pregnant women of potential risk to fetus; available data from postmarketing reports with Ferrlecit use in pregnancy are insufficient to assess risk of major birth defects and miscarriage

Ferrlecit contains benzyl alcohol as a preservative; because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs

Consider alternative iron replacement therapies without benzyl alcohol

There are risks to mother and fetus associated with untreated iron deficiency anemia in pregnancy

In absence of maternal toxicity, Ferrlecit was not teratogenic to offspring of pregnant mice or rats at clinically relevant exposures

Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with intravenous iron administration which may have serious consequences on fetus such as fetal bradycardia, especially during second and third trimester

Lactation

Drug contains benzyl alcohol; because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in breastfed infant is unlikely; however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs; consider alternative iron replacement therapies without benzyl alcohol for use during lactation

There are no available data on presence of Ferrlecit in human or animal milk, effects on milk production, or on breastfed child

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin

Pharmacokinetics

Half-Life: 1 hr

Vd: 6 L

Clearance: 3.02-5.35 L/hr

Excretion: urine, 0.5-1 mg/day

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Administration

IV Compatibilities

Solution: 0.9% NaCl

IV Incompatibilities

All other medications, parenteral nutrition solutions

IV Preparation

Dilute 10 mL Ferrlecit (125 mg Fe) in 100 mL 0.9% NaCl

IV Administration

Infuse IV over 1 hr

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Ferrlecit intravenous
-
62.5 mg/5 mL vial
sodium ferric gluconate complex in sucrose intravenous
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62.5 mg/5 mL vial
sodium ferric gluconate complex in sucrose intravenous
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62.5 mg/5 mL vial
sodium ferric gluconate complex in sucrose intravenous
-
62.5 mg/5 mL vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
sodium ferric gluconate complex in sucrose intravenous

NO MONOGRAPH AVAILABLE AT THIS TIME

USES: Consult your pharmacist.

HOW TO USE: Consult your pharmacist.

SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.

DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: No monograph available at this time.

MISSED DOSE: Consult your pharmacist.

STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.