Ferrlecit

Iron Deficiency Anemia, Chemotherapy, Iron Deficiency Anemia + 2 more
Treatment
4 FDA approvals
20 Active Studies for Ferrlecit

What is Ferrlecit

Sodium ferric gluconate complexThe Generic name of this drug
Treatment SummarySodium ferric gluconate complex is an iron-based medication used to treat iron deficiency anemia. It is composed of iron oxide hydrate, sucrose, and gluconate molecules with a ratio of two iron molecules to one gluconate molecule. It is prescribed to adult and pediatric patients over the age of 6 years with chronic kidney disease who are receiving hemodialysis and supplemental epoetin therapy.
Ferrlecitis the brand name
image of different drug pills on a surface
Ferrlecit Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Ferrlecit
Sodium ferric gluconate complex
1999
8

Approved as Treatment by the FDA

Sodium ferric gluconate complex, otherwise known as Ferrlecit, is approved by the FDA for 4 uses including Iron Deficiency Anemia (IDA) and Epoetin Treatment .
Iron Deficiency Anemia (IDA)
Epoetin Treatment
Iron Deficiency Anemia
Chronic Hemodialysis (ESRD)

Effectiveness

How Ferrlecit Affects PatientsSodium ferric gluconate complex is a drug that helps the body to get more iron. Iron is necessary for the body to make hemoglobin which carries oxygen, as well as for certain chemical reactions in the body. Taking this drug can increase the number of red blood cells and help the body use iron better.
How Ferrlecit works in the bodyMacrophages in the body take up sodium ferric gluconate and break it down. The iron from this complex is then used to make ferritin, transferrin or hemoglobin. Sodium ferric gluconate also helps create more red blood cells by binding with hemoglobin.

When to interrupt dosage

The proposed amount of Ferrlecit is contingent upon the diagnosed situation, including Iron deficiency anemia, Chemotherapy and Iron Deficiency Anemia. The dosage fluctuates as per the method of delivery mentioned in the table underneath.
Condition
Dosage
Administration
Iron Deficiency Anemia
, 12.5 mg/mL, 12.5 mg
, Intravenous, Injection, Injection - Intravenous, Liquid, Solution, Solution - Intravenous, Liquid - Intravenous
Chemotherapy
, 12.5 mg/mL, 12.5 mg
, Intravenous, Injection, Injection - Intravenous, Liquid, Solution, Solution - Intravenous, Liquid - Intravenous
Iron Deficiency Anemia
, 12.5 mg/mL, 12.5 mg
, Intravenous, Injection, Injection - Intravenous, Liquid, Solution, Solution - Intravenous, Liquid - Intravenous
Epoetin Treatment
, 12.5 mg/mL, 12.5 mg
, Intravenous, Injection, Injection - Intravenous, Liquid, Solution, Solution - Intravenous, Liquid - Intravenous
Chronic Hemodialysis (ESRD)
, 12.5 mg/mL, 12.5 mg
, Intravenous, Injection, Injection - Intravenous, Liquid, Solution, Solution - Intravenous, Liquid - Intravenous

Warnings

Ferrlecit Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Sodium Ferric Gluconate Complex may interact with Pulse Frequency
There are 20 known major drug interactions with Ferrlecit.
Common Ferrlecit Drug Interactions
Drug Name
Risk Level
Description
Acebutolol
Moderate
The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Acebutolol.
Aldesleukin
Moderate
The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Aldesleukin.
Aliskiren
Moderate
The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Aliskiren.
Alprenolol
Moderate
The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Alprenolol.
Ambrisentan
Moderate
The risk or severity of hypotension can be increased when Sodium ferric gluconate complex is combined with Ambrisentan.
Ferrlecit Toxicity & Overdose RiskFerrlecit is not removable through dialysis. There is no known information on Ferrlecit overdose in humans, however it can lead to the build-up of iron in the body, which can cause harm. Taking more than 125 mg of Ferrlecit can increase the risk of adverse side effects. In animal studies, doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg, and 250 mg/kg of Ferrlecit have been found to cause death. Signs of acute toxicity may include a decrease in activity, unsteady walking, faster breathing, shaking, and seizures.

Ferrlecit Novel Uses: Which Conditions Have a Clinical Trial Featuring Ferrlecit?

Currently, 219 active clinical trials are investigating the potential of Ferrlecit to treat Iron deficiency anemia, Iron Deficiency Anemia induced by Chemotherapy.
Condition
Clinical Trials
Trial Phases
Chronic Hemodialysis (ESRD)
0 Actively Recruiting
Chemotherapy
4 Actively Recruiting
Phase 1, Phase 3, Not Applicable
Epoetin Treatment
0 Actively Recruiting
Iron Deficiency Anemia
7 Actively Recruiting
Phase 3, Phase 4, Phase 2, Not Applicable
Iron Deficiency Anemia
21 Actively Recruiting
Phase 3, Not Applicable, Phase 2, Phase 1, Phase 4

Ferrlecit Reviews: What are patients saying about Ferrlecit?

5Patient Review
11/17/2016
Ferrlecit for Anemia from Inadequate Iron
I didn't experience any negative effects from taking Benedryl.
3.7Patient Review
7/1/2013
Ferrlecit for Anemia from Inadequate Iron
I get iron infusions every 6 months, and this is the product my MD has had me on since 2007. No reactions to it, except for post-infusion edema twice last year. I needed Lasix after those two treatments, but otherwise no problems.
3.7Patient Review
2/17/2011
Ferrlecit for Anemia from Inadequate Iron
The only downside to Ferrlecit is that I've started constantly tasting metal. But other than that, it's much improved my quality of life.
3.3Patient Review
4/10/2011
Ferrlecit for Anemia from Inadequate Iron
I've been getting IV infusions for two years now, ever since my Feritin level hit zero. I initially had a bad reaction to the treatment, but we halved the dosage and added saline before doubling the infusion time. That worked for a while, but I had another bad reaction this week. I'm still ill after two more infusions, and I have six more scheduled. Recently found out I had Caliac so I am hopeful this may all end but I have been told I may have to be "filled-up" for the rest of my life.
3Patient Review
4/24/2011
Ferrlecit for Anemia from Inadequate Iron
I've completed five treatments and have yet to feel any benefits. I'm seven years post-gastric bypass surgery and recently fell off my nutritional diet, so I'm now iron deficient. Yesterday and today were very active days for me, and now my feet, calves, and back are killing me. I took some Aleve a little while ago, but it hasn't kicked in yet. If this doesn't work soon, I won't be getting any sleep tonight.
3Patient Review
7/31/2011
Ferrlecit for Anemia from Inadequate Iron
I completed an eight-week treatment plan of weekly infusions and began to feel more energetic after the third week. I did have some joint pain, sleepiness, and intense cravings for meat after the first treatment, but nothing unmanageable. However, my fifth infusion was delivered too quickly and I developed intense joint pain (worse than week one), dizziness, and fatigue immediately. Overall, I'm pleased with the results; though not all of my iron numbers increased as a result of this treatment, most did.
3Patient Review
6/12/2014
Ferrlecit for Anemia from Inadequate Iron
I've now completed 3/8 of my treatments. Unfortunately, each time I get an infusion I also experience some nasty side effects including a headache, nausea, and fatigue that last for about 24 hours. Additionally, the joint pain I was hoping to alleviate with these treatments has only gotten worse in the days following each treatment.
3Patient Review
1/7/2014
Ferrlecit for Anemia from Inadequate Iron
Yesterday was my third treatment and I got a steroid and Benadryl as well. Unfortunately, I had an awful headache afterward that has lingered into today a bit. On top of that, last night I had terrible sweats that soaked my sheets! Although I'm feeling tired, it's not as bad as it was before the IV.
2.7Patient Review
8/12/2015
Ferrlecit for Anemia from Inadequate Iron
The concentration of benzyl alcohol in Ferrlicet is WAY too high. This prevents us from getting the required dose. Our prescribing doctors have brought this problem up with the company, but they have NO explanation for the extremely high amount of this preservative. We must infuse this at a rate no higher than 42 ml/hour or our pediatric patient will experience severe headache and other symptoms. Our pharmacists say the amount of benzyl alcohol is orders of magnitude higher than it should be.
2.7Patient Review
11/15/2011
Ferrlecit for Anemia from Inadequate Iron
I experienced nausea and dizziness. I felt very weak afterwards.
1Patient Review
10/12/2011
Ferrlecit for Anemia from Inadequate Iron
I had a really severe reaction to this Ferrlecit infusion, despite the fact that they gave me steroids and benadryl beforehand. My heart rate dropped, I had chest pain, and blisters all over my body. It was awful.
1Patient Review
10/24/2016
Ferrlecit for Anemia due to Kidney Failure
After the three hour infusion, I had a severe reaction. Hives, high heart rate, and difficulty breathing. My hip also started hurting really badly. went to the ER and they said it was anaphylactic shock.
1Patient Review
1/21/2012
Ferrlecit for Anemia from Inadequate Iron
I am so exhausted and feeble before I get treatment...it takes too long before I feel normal again. This happens one month out of every three, and it's really frustrating.
1Patient Review
4/23/2012
Ferrlecit for Anemia from Inadequate Iron
I had a severe reaction to this medication and it was honestly the worst experience of my life. I hope that nobody else has to go through what I did.
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Patient Q&A Section about ferrlecit

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Ferrlecit used for?

"This medication is used to treat anemia in people with long-term kidney disease who are using a certain class of drug. You may need extra iron because you lose blood during kidney dialysis."

Answered by AI

What is the cost of Ferrlecit?

"The price of Ferrlecit intravenous solution (12.5 mg/mL) is approximately $344 for 50 milliliters, depending on the pharmacy you visit. The price is for cash paying customers only and is not valid with insurance plans."

Answered by AI

How do you administer Ferrlecit?

"Ferrlecit should be diluted in 100 mL of 0.9% sodium chloride and given by intravenous infusion over the course of one hour per dialysis session. It can also be given undiluted as a slow intravenous injection over the course of one hour per dialysis session."

Answered by AI

What type of drug is Ferrlecit?

"Ferrlecit is a type of iron replacement product used to treat iron deficiency anemia in adults and children 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy."

Answered by AI

Clinical Trials for Ferrlecit

Image of UPMC Hillman Cancer Center in Pittsburgh, United States.

Mobile App for Cancer

18+
All Sexes
Pittsburgh, PA
The goal of this study is to determine whether a mobile application that combines real-time sensor data and patient-reported symptoms to trigger care-team contact recommendations is feasible and beneficial for patients receiving chemotherapy. The main questions it aims to answer are: * Is the mobile application feasible and acceptable to patients? * Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment? Participants will: * Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study. * Complete daily symptom ratings via study application. * Wear a Fitbit activity tracker for 90 days. * At the end of the study, complete a semi-structured interview to provide feedback on the study. * Optional: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).
Waitlist Available
Has No Placebo
UPMC Hillman Cancer CenterCarissa A Low
Image of Centre hospitalier affilié universitaire régional de Trois-Rivières in Trois-Rivières, Canada.

Endoscopic Evaluation for Iron-Deficiency Anemia

18 - 90
All Sexes
Trois-Rivières, Canada
This is a single-center, randomized pilot study evaluating the feasibility and safety of two management strategies for patients on antithrombotic therapy who present with obscure gastrointestinal bleeding (OGIB). Participants will be randomized to either repeated endoscopic evaluations or a conservative medical approach with limited testing. The study aims to assess whether conservative management yields similar clinical outcomes and quality of life compared to standard repeated endoscopic procedures. Results will inform the design of a larger trial and address the current lack of guidelines for managing recurrent iron-deficiency anemia in this patient population.
Recruiting
Has No Placebo
Centre hospitalier affilié universitaire régional de Trois-RivièresÉva Mathieu, PhD
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Mitapivat for Anemia

18+
All Sexes
Toronto, Canada
This is a prospective exploratory phase 2 study designed to evaluate the safety and efficacy of mitapivat in RBC membranopathies and CDAII, a rare sub type of anemia. Nine patients from Princess Margaret who are diagnosed with CDAII will be enrolled to the study. Patients will be in the trial for 57 weeks treatment weeks and a safety follow up week after 30 days from last dose. First 8 weeks will be dose escalating period followed by 48 weeks of fixed dose period. 57th week will be dose tapering week. Data collected from Princes Margaret will be incorporated to the main study conducted in EU for analysis. Overall, approximately 25 patients are expected to be enrolled: Approximately 16 patients at sites in the EU and approximately 9 patients in Canada.
Phase 2
Recruiting
University Health Network (UHN)Agios Pharmaceuticals, Inc.
Have you considered Ferrlecit clinical trials? We made a collection of clinical trials featuring Ferrlecit, we think they might fit your search criteria.Go to Trials
Image of Weill Cornell Medical College in New York, United States.

Luspatercept for Clonal Cytopenia

18+
All Sexes
New York, NY
The purpose of this clinical trial is to test how well the drug luspatercept works in improving low blood cell counts in people with clonal cytopenias of uncertain significance (CCUS). The main questions the study seeks to answer include: * How many patients experience improvements in their low blood counts (red cells, platelets, or white cells) within 24 weeks, based on specific criteria for blood conditions like myelodysplastic syndromes (MDS)? * How long these improvements last before the condition worsens or changes. * The percentage of participants showing improvements at 12, 24, and 48 weeks. * How long it takes for the condition to progress to more severe diseases like myeloid disorders. * How long red blood cell responses last and how quickly these responses are seen. * The average change in hemoglobin levels over 24 weeks. * How many patients need blood transfusions during the study and how soon transfusions are required. * Changes in participants' well-being and energy levels based on a standardized questionnaire. * Monitoring for any side effects, including progression to MDS or leukemia, heart-related issues, or sudden increases in hemoglobin. Participants will: * Receive luspatercept as an injection every three weeks. * Visit the clinic every three weeks for treatment and monitoring.
Phase 2
Recruiting
Weill Cornell Medical CollegePinkal Desai, MDBristol-Myers Squibb
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Choline for Iron Deficiency

5 - 7
All Sexes
Minneapolis, MN
BACKGROUND: Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations. GAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development. HYPOTHESIS: Infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo. METHODS: This randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months. RESULTS: Pending IMPACT: If our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.
Phase 2 & 3
Recruiting
University of MinnesotaSarah Cusick
Image of Columbia University Medical Center in New York, United States.

Iron Supplementation for Scoliosis

10 - 26
All Sexes
New York, NY
This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary * Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion. Secondary * Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. * Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.
Recruiting
Paid Trial
Columbia University Medical CenterLisa D Eisler, MD
Have you considered Ferrlecit clinical trials? We made a collection of clinical trials featuring Ferrlecit, we think they might fit your search criteria.Go to Trials
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Iron Replacement Therapy for Iron-Deficiency Anemia

16 - 60
Female
Duarte, CA
This is a trial with an observational and an interventional arm, in patients with moderate to severe anemia and control subjects. The main purposes of this study is to phenotype the scope of neurocognitive deficits from iron deficiency anemia (IDA) in adult women, determine derangements in cerebral perfusion, vascular reactivity, functional connectivity, and blood brain barrier permeability in adult-onset IDA and relate them to neurocognitive deficits, as well as determine the reversibility and durability of both the physiologic and neurocognitive derangements by iron replacement therapy. All eligible subjects will be asked to provide informed consent before participating in the study.
Phase 4
Recruiting
City of Hope Blood Donor Center (+3 Sites)John Wood, MD, PhD
Have you considered Ferrlecit clinical trials? We made a collection of clinical trials featuring Ferrlecit, we think they might fit your search criteria.Go to Trials
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