Dosing & Uses
Dosage Forms & Strengths
injection (Ferrlecit, generic)
- 12.5mg/mL (5-mL vials)
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
For repletion treatment most patients may require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions
Dosing considerations
- Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events
- Treatment may be repeated if iron deficiency reoccurs
Dosage Forms & Strengths
injection (Ferrlecit, generic)
- 12.5mg/mL (5-mL vials)
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
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
Postmarketing Reports
Cardiovascular System: Shock, fetal bradycardia, injection site superficial thrombophlebitis, phlebitis, acute myocardial ischemia with or without myocardial infarction with in-stent thrombosis in the context of hypersensitivity reaction.
Gastrointestinal System: Dysgeusia.
Immune System: Anaphylactic-type reactions.
Nervous System: Loss of consciousness, generalized convulsion, hypoesthesia. Skin and Appendages: skin discoloration, pallor
Warnings
Contraindications
Hypersensitivity to drug or excipients
Cautions
DO NOT mix Ferrlecit with other meds or add to TPN; compatibility has not been established
Excessive therapy with parenteral iron can lead to excess storage of iron with possibility of iatrogenic hemosiderosis; patients receiving therapy require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation)
Adverse effects due to benzyl alcohol
- Not approved for use in neonates or infants; serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs
- The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations; minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known
Hypersensitivity
- Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, reported in patients receiving drug in postmarketing experience
- Patients may present with shock, clinically significant hypotension, loss of consciousness, or collapse
- Monitor patients for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of the infusion
- Only administer drug when personnel and therapies are immediately available for treatment of anaphylaxis and other hypersensitivity reactions
Hypotension
- Therapy may cause clinically significant hypotension
- Hypotension associated with lightheadedness, malaise, fatigue, weakness or severe pain in the chest, back, flanks, or groin reported
- Hypotensive reactions may or may not be associated with signs and symptoms of hypersensitivity reactions and usually resolve within one to two hours
- Transient hypotension may occur during dialysis; administration may augment hypotension caused by dialysis; monitor patients for signs and symptoms of hypotension during and following administration
Drug interactions overview
- Drug-drug interactions not studied; drug may reduce absorption of concomitantly administered oral iron preparations
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.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
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
Do not mix with other medications or add to parenteral nutrition solutions for intravenous infusion
The compatibility with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit
If diluted, use immediately
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Ferrlecit intravenous - | 62.5 mg/5 mL vial |  | |
| sodium ferric gluconate complex in sucrose intravenous - | 62.5 mg/5 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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, chest pain.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.
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 March 2022. Copyright(c) 2023 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.
Formulary
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.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
