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
sodium ferric gluconate complex in sucrose intravenous
-
62.5 mg/5 mL vial
sodium ferric gluconate complex in sucrose intravenous
-
62.5 mg/5 mL vial
sodium ferric gluconate complex in sucrose intravenous
-
62.5 mg/5 mL vial
Ferrlecit intravenous
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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

SODIUM FERRIC GLUCONATE COMPLEX - INJECTION

(SOE-dee-um FER-ik GLOO-koe-nate)

COMMON BRAND NAME(S): Ferrlecit

USES: This medication is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease and using a certain class of drug (man-made form of erythropoietin). You may need extra iron because of blood loss during kidney dialysis. Your body may also need more iron to help erythropoietin make new red blood cells.Iron is an important part of your red blood cells and is needed to transport oxygen in the body. Many people with kidney disease cannot get enough iron from food and require injections.

HOW TO USE: This medication is given by injection slowly into a vein or into your dialysis line by a health care professional.Severe dizziness or fainting (hypotension) may occur while you are receiving iron given by injection. This may be helped by giving the medication more slowly or at a lower dose. Follow your doctor's directions carefully.The dosage is based on your medical condition, response to treatment, and lab tests.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

SIDE EFFECTS: Nausea, vomiting, flushing, headache, diarrhea, cramps, or discomfort at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: dizziness/lightheadedness, muscle pain (especially in the lower back/buttocks/legs), tingling of hands/feet, unusual weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, certain metabolic disorders (such as hemochromatosis, hemosiderosis), previous reactions to other iron products given by injection.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant before using this medication.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: iron supplements taken by mouth.

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. Symptoms of overdose may include: severe stomach pain, vomiting, pale/bluish skin (especially the lips/fingers/toes), rapid breathing.

NOTES: Lab tests (such as complete blood count, ferritin levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.Remember that it is best to get your vitamins and minerals from food whenever possible. Maintain a well-balanced diet, and follow any dietary guidelines as directed by your doctor. Foods rich in iron include meats (especially liver), eggs, raisins, figs, broccoli, brussels sprouts, beans, lentils, and iron-fortified or enriched cereals.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.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.

Information last revised August 2021. 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

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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.