Феринжект

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Феринжект

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Феринжект

Quick Facts: Феринжект (Ferric Carboxymaltose)

Property Description
Active ingredient Ferric Carboxymaltose
Form Solution for intravenous use
Pharmacological class Iron replacement product (Antianemic)
Common purpose Replenishment of body iron stores
Origin Synthetic (Manufactured complex)

What is Феринжект? Definitional Overview and Classification

Феринжект is a modern, synthetic, single-ingredient medicinal preparation classified as an Iron replacement product within the wider antianemic class. The core active substance is Ferric Carboxymaltose (INN), which is chemically engineered as a stable iron(III)-hydroxide carbohydrate complex. This medication is clinically recognized for its effectiveness in rapidly correcting iron deficits in adult patients when oral supplementation is insufficient. The overarching purpose is to address chronic or severe iron deficiency by efficiently restoring the body's total iron content, thereby supporting the fundamental processes of hemoglobin synthesis required for oxygen transport.

Composition and Pharmaceutical Form

The medicine is formulated exclusively as a colloidal Solution for intravenous use, necessitating parenteral administration directly into a vein. The composition features a polynuclear iron core bound to the polymer Carboxymaltose, a design supported by pharmacological studies investigating safe high-dose iron delivery. This specific form is intended for use in situations requiring quick iron replenishment, such as when significant deficiency is detected, bypassing the unreliable and often slow absorption of oral iron.

Unique Characteristics of Intravenous Iron

Ferric Carboxymaltose is structurally characterized as an advanced non-dextran iron complex, which is a key differentiator from historical intravenous preparations. This macromolecular structure prevents the risk associated with a high bolus dose of "free" iron by maintaining stability. The complex functions as a controlled, slow-release reservoir, a feature designed to facilitate the gradual and safe distribution of iron to storage sites. This unique stability profile is essential for enabling the effective delivery of a therapeutically significant amount of iron in a single administration.

What side effects are possible with Феринжект?

Possible Side Effects and Safety Information

The safety profile of Ferric Carboxymaltose (Феринжект) is defined by officially documented adverse reactions classified by frequency and body system, as established in regulatory documents such as the Summary of Product Characteristics (SmPC) and FDA Prescribing Information.

Adverse effects listed as common (occurring in 1 to 10 out of 100 treated patients) include hypophosphatemia (decreased blood phosphorus), headache, dizziness, nausea, hypertension (high blood pressure), and reactions localized to the injection or infusion site. Effects affecting the vascular and nervous systems, like flushing and vomiting, are also commonly documented.

Serious adverse reactions are classified as rare. The most significant documented risk is serious hypersensitivity reactions, including anaphylactic-type reactions, which have been associated with severe outcomes. These reactions are typically noted to occur during or shortly after administration. Rare cases of severe, symptomatic hypophosphatemia are also documented.

Safety constraints and limitations are explicitly noted in the labeling. The medicine is contraindicated in patients with known hypersensitivity to the complex. It should not be used in individuals with anemia not caused by iron deficiency or those with evidence of iron overload. Specific safety statements regarding use in pregnancy highlight the potential for severe maternal adverse reactions that could lead to fetal bradycardia, limiting its use to cases where the benefit clearly outweighs the risk, generally after the first trimester.

This structure ensures that the officially documented range of common and rare risks is clearly communicated.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with Ferric Carboxymaltose (Феринжект) is formally documented in regulatory sources as the potential for acute iron overload or the chronic condition of haemosiderosis. Iron overload occurs when the administered dose exceeds the body's total iron-binding capacity, leading to the accumulation of excessive iron deposits in the reticuloendothelial system and other organs. Laboratory findings of an overdose include significantly elevated iron status parameters, such as high serum ferritin or transferrin saturation.

Required Emergency Actions

The official regulatory instructions mandate specific actions when an overdose is suspected. The infusion must be discontinued immediately. Patients are required to seek immediate medical attention or call emergency services if severe symptoms or substantial overdose exposure occurs. This level of intervention is required because severe iron poisoning is classified as a potentially life-threatening outcome, particularly in vulnerable populations such as children. Management is officially described as providing symptomatic and supportive treatment to sustain vital functions.

Management and Monitoring

In cases of confirmed acute iron poisoning, the official label specifies that chelating agents (such as Deferoxamine) are the available therapeutic measures. Following an overdose, hospital monitoring is required, including the continuous assessment of iron status parameters to measure the degree of iron accumulation and ensure safe resolution.

Therapeutic Uses of Феринжект

Key Uses and Therapeutic Benefits

Феринжект (Ferinject) is a medicine that supports the management of certain conditions by addressing the need for iron supplementation. Its primary role is in the symptomatic management of iron deficiency, and is considered relevant when short-term symptomatic assistance is needed.

The medication is applied across domains where additional symptomatic support is needed to help patients cope more steadily with difficult episodes. It is relevant for easing symptoms associated with conditions like iron deficiency anemia, chronic kidney disease, and certain heart conditions where iron deficiency is a factor.

Symptom Relief and Functional Support

This treatment helps address symptom clusters that create noticeable functional strain or physical discomfort, such as general fatigue, dizziness, and shortness of breath. This provides support that helps ease the overall symptom burden and contributes to improved comfort during symptomatic periods. It is applied in clinical settings that involve acute or unstable symptom patterns where symptomatic assistance is needed quickly, and is relevant when supportive symptom management is appropriate.

“It assists with maintaining functional stability and supports general well-being during symptomatic phases.”

Quick Fact: Relief for Systemic Imbalance

Regulatory References

  1. NIH MedlinePlus overview of Ferric Carboxymaltose

Eligibility and Restrictions for Use

Who Can and Cannot Use Феринжект? Official Regulatory Information

The use of Феринжект (Ferric Carboxymaltose) is strictly defined by regulatory eligibility criteria, focusing on confirmation of iron status and patient demographics.


Eligibility & Contraindications

Classification Population Rule (As Stated in Official Labeling)
Eligible Populations Adults (18 years and older) and Pediatric Patients (ge 1 year of age) with confirmed Iron Deficiency where oral iron is unsuitable.
Contraindications Patients with known hypersensitivity to the drug. Patients with evidence of iron overload or anaemia not caused by iron deficiency.

Age and Condition-Based Restrictions

Restriction Focus Official Regulatory Statement
Pediatric Use Safety and efficacy are not established in children under 1 year of age.
Pregnancy Contraindicated during the first trimester. May only be used during the second and third trimesters if the benefit outweighs the potential risk.
Conditional Use Use with caution and after a risk assessment in patients with impaired liver function or those with an ongoing acute or chronic infection (treatment should be delayed).

These rules ensure the medicine is reserved for patients whose condition and physiological status align with the official labeled criteria.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The official interaction profile for Ferric Carboxymaltose (Феринжект) is primarily characterized by the effect of its intravenous administration on other iron therapies and specific procedural restrictions, as documented in government regulatory labeling. The medicine's official profile demonstrates a lack of documented interactions with common drug metabolism pathways, such as the cytochrome P450 enzyme system or major drug transporter proteins.


Documented Pharmacodynamic and Procedural Interactions

Category Regulatory Statement Restriction/Rule
Oral Iron Preparations Co-administration results in reduced absorption and decreased efficacy of the oral iron product. Oral iron therapy must not be initiated for at least 5 days following the final administration of Ferric Carboxymaltose.
Physical Incompatibility Must not be mixed or co-infused with other medicinal products or intravenous solutions besides sterile 0.9% sodium chloride solution. Strict use of only the approved diluent is mandatory due to the risk of precipitation and interaction.
Food, Alcohol, Supplements No formal interactions are documented with food, alcohol, or herbal products. No specific regulatory interaction caveats exist for co-administration.

The regulatory structure for this product is defined by functional and procedural constraints, rather than the pharmacokinetic interactions common to many small-molecule drugs. The mandatory timing rule for oral iron is a direct consequence of the intravenous administration suppressing the absorption of the oral therapy.

Mechanism of Action

The mechanism of Ferric Carboxymaltose involves the biological management of iron via the parenteral route, circumventing the absorption limits of the gastrointestinal system.

Stabilization and Controlled Delivery to Macrophages

The Ferric Carboxymaltose complex functions as a specialized, stable, macromolecular transport vehicle. It sequesters the iron(III) core, preventing the rapid release of free, ionic iron ( Fe^3+) into the plasma, thereby minimizing the concentration of non-transferrin-bound iron. This structure allows the entire macromolecule to be specifically taken up by macrophages in the Reticuloendothelial System (RES) via endocytosis. This process ensures the iron dose is channeled into the cellular storage and release infrastructure.

Mobilization of Iron for Hemoglobin Synthesis

Inside the macrophages, the iron core is slowly liberated and exported from the cell, immediately binding to the transport protein Transferrin in the plasma. This Transferrin-bound iron is delivered to the bone marrow, where it is utilized by Erythroid Precursor Cells as the essential raw material for the production of Heme and, subsequently, Hemoglobin. The resulting physiological effect is the increased availability of iron necessary for Hemoglobin synthesis, which contributes to the formation of oxygen-binding molecules.

Dosage and Administration Information

How to use Феринжект: Official Administration Guidelines

Феринжект (Ferric Carboxymaltose) is administered exclusively via the intravenous (IV) route. The medicine may be given as a slow IV injection or an IV infusion after proper preparation, but it must never be administered intramuscularly or subcutaneously.


Standard Dosing and Frequency

Dosage is determined by individual iron needs, typically based on body weight and hemoglobin level. The standard adult course is 1,500 mg of iron, administered as two separate 750 mg doses, separated by a minimum of seven days. Alternatively, a single dose of up to 1,000 mg may be administered for some patients weighing 50 kg or more.

Administration Parameter Official Instruction
Maximum Single Dose Up to 1,000 mg iron, or 20 mg iron/kg body weight, whichever is lower.
Maximum Weekly Dose 1,000 mg of iron.
Pediatric Dosing (1 year) Up to 15 mg iron/kg per dose, not to exceed 750 mg per single administration.

Preparation and Procedural Rules

When administered as an IV infusion, the solution must be diluted only in sterile 0.9% sodium chloride solution. To maintain chemical stability, the final concentration of the infusion must be not less than 2 mg of iron per mL. High doses (e.g., 500 mg to 1,000 mg) must be administered over a minimum of 15 minutes, whether given as an infusion or a slow IV push. Each vial is for single-use only. The treatment course may be repeated only if subsequent laboratory tests confirm the reoccurrence of iron deficiency, with re-assessment performed no sooner than four weeks after the last dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Феринжект

Evidence for Use in Iron Deficiency Anemia (IDA)

Research examined Феринжект (Ferric Carboxymaltose) in patients experiencing Iron Deficiency Anemia (IDA), particularly when oral iron supplements have been ineffective or not tolerated. The evidence base primarily consists of Randomized Controlled Trials (RCTs) and systematic reviews that evaluated the medicine alongside oral iron or other forms of intravenous iron. The core research focused on measurements of hemoglobin concentration and specific biomarkers like ferritin and Transferrin Saturation (TSAT). Findings describe patterns related to the measurement of iron storage markers and a shift in hemoglobin levels in the populations studied. Studies report how symptoms evolved in the observed populations, and findings help contextualize how patients reported their experience over defined time intervals.

Evidence for Use in Iron Deficiency and Chronic Heart Failure (CHF)

Research related to the use of this medicine in adults with Chronic Heart Failure (CHF) and an associated iron deficiency was evaluated in several large-scale, placebo-controlled Randomized Controlled Trials. Research examined changes in the physical and functional outcomes of heart failure patients where iron deficiency was monitored. Studies monitored patient functional capacity, such as walking distance measured by the 6-Minute Walk Test, and patient-reported outcomes (PROs) reflecting daily functioning or activity level. Multiple large trials described patterns related to the measured frequency of heart failure-related hospitalizations. Certainty remains low regarding long-term cardiovascular and mortality outcomes, where findings were mixed across specific trials, and long-term effects beyond two years are not fully characterized.

Evidence for Use in Chronic Kidney Disease (CKD) (Non-Dialysis)

Research was evaluated in the context of Iron Deficiency Anemia (IDA) in adult patients with Chronic Kidney Disease (CKD) who are not on dialysis. The studies included Randomized Controlled Trials that evaluated the intravenous treatment alongside oral iron supplements. Research examined the outcomes related to systemic or functional imbalance by monitoring increases in hemoglobin concentration and the measurement of iron stores (ferritin and TSAT). The follow-up durations were limited in these studies, making long-term effects not fully established for major clinical outcomes like cardiovascular events.

What Research Shows is Still Uncertain About Феринжект

The available research highlights areas where more data are needed. The evidence quality varies across studies, and comparative evidence is lacking to fully determine how this formulation was evaluated against all other modern intravenous iron preparations. Overall, the data for certain long-term outcomes and for some specific subgroups are still emerging, and research is ongoing to fill these existing gaps.

Frequently Asked Questions (FAQ)

Common questions about Феринжект (FAQ)

Q: Does it make you sleepy?

A: Official product information indicates that drowsiness (somnolence) and dizziness are commonly reported side effects. Because of this, activities that require clear judgment, such as operating machinery or driving, may be affected during treatment.

Q: Can I drink alcohol while taking this medication?

A: Official product information suggests that alcohol should be limited or avoided during treatment. This is because alcohol may increase the risk of side effects like drowsiness, dizziness, and difficulty concentrating.

Q: Is it safe to take it for a long period of time?

A: Official documents indicate that if treatment is stopped after long-term use, the dose is generally reduced gradually over at least one week. This gradual reduction helps to manage the potential for withdrawal symptoms. Official information also notes that cases of misuse and dependence have been reported.

Q: Can children 2 years old use it?

A: The age range for which this medication is approved varies based on the condition being treated and the regulatory guidance in different countries. For some medical uses, it is approved for children 1 month of age and older, while for others, approval may begin at 17 or 18 years of age.

How should Феринжект be stored and disposed of?

Storage and Disposal Requirements for Феринжект

The storage and disposal instructions for Феринжект (Ferric Carboxymaltose) are based strictly on regulatory labeling to preserve product integrity.

Mandatory Storage Conditions

Condition Requirement
Temperature Store at a temperature not above 30°C and do not freeze.
Protection Store in the original container to protect from light.
Safety Keep the medicine out of the sight and reach of children.

Stability and Disposal

The unopened product has a shelf-life of 3 years. After dilution, the solution should be used immediately from a microbiological perspective. Any unused medicinal product or waste material must be disposed of in accordance with local requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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