Венофер

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Венофер

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Medically reviewed

Laura Arias

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 Венофер

What Type of Medicine is Venofer (Iron Sucrose)?

Venofer is a parenteral iron replacement product belonging to the therapeutic class of hematinic agents. Its active ingredient is iron sucrose (ferric hydroxide sucrose complex), a synthetic complex of polynuclear iron(III)-hydroxide in sucrose. This formulation is a prescription-only (Rx) medication designed for intravenous administration, typically utilized in cases where oral iron preparations are inadequate or cannot be used. It provides a direct method for addressing mineral deficits through a stabilized chemical structure suitable for systemic delivery.

Composition and Form: An Intravenous Iron Complex

The medication is supplied as a sterile, non-pyrogenic aqueous solution intended for intravenous injection or intravenous infusion. Its composition consists of the iron sucrose active ingredient dissolved in water for injection. The sucrose stabilization of the complex is a key characteristic, ensuring the iron remains controlled for systemic delivery without requiring gastrointestinal absorption. This structure is designed to facilitate introduction into the venous system, distinguishing it from other types of injectable iron preparations.

General Purpose: Replenishing Iron Stores

The primary purpose of Venofer is to restore the body’s iron stores. It provides a source of elemental iron that the body utilizes for the synthesis of essential proteins, most notably hemoglobin. This method of replacement is frequently employed for patients with chronic conditions, such as certain stages of chronic kidney disease, who require predictable iron replacement. It serves as a direct intervention to address physiological iron deficiency when there is a confirmed need for iron that cannot be effectively managed through the digestive system.

What side effects are possible with Венофер?

Possible Side Effects and Safety Information

Venofer (Iron Sucrose) has an officially documented safety profile, with potential adverse reactions classified by frequency and affected body system, as detailed in regulatory documents.

Frequency-Classified Adverse Reactions

Adverse effects are formally grouped according to their documented incidence from clinical trials and post-marketing data:

  • Common Reactions (ge 1/100 to < 1/10): These typically involve hypotension (low blood pressure), headache, dizziness, dysgeusia (taste disturbance), and gastrointestinal effects (such as nausea and vomiting). Injection site reactions, including pain or swelling, are also common.

  • Uncommon/Rare Reactions: These categories include less frequent events such as severe hypersensitivity or anaphylactoid reactions, which are officially documented as serious due to the potential for fatality and circulatory collapse.


System and Timing Safety Patterns

The label specifies that reactions are grouped into System-Organ Classes, covering the Immune System, Vascular System, Nervous System, and Gastrointestinal System. Many observed adverse effects are temporally linked, with reactions often occurring shortly after the completion of the infusion or being related to the rate of administration.

Safety Constraints and Special Populations

Official prescribing information includes specific limitations on use. The medicine is contraindicated in patients with known hypersensitivity to iron sucrose, and in individuals with evidence of iron overload or certain forms of severe hepatic impairment. Use during the first trimester of pregnancy should be avoided unless clearly necessary, based on regulatory statements regarding fetal safety.

Overdose and Emergency Response

Overdose and When to Seek Help

The information provided outlines the officially documented overdose profile for Venofer (Iron Sucrose), based strictly on government regulatory documents.

Documented Overdose Manifestations

Acute overdose or excessive administration may lead to hypotension (abnormally low blood pressure), nausea, vomiting, dizziness, headache, and potential signs of circulatory collapse. Overdose occurring through the chronic administration of excessive iron may result in iron overload (Hemosiderosis), which is diagnosed by laboratory findings such as highly elevated serum ferritin and Transferrin Saturation (TSAT).

Required Emergency Actions

Regulators mandate that immediate medical attention must be sought upon suspicion of overdose or if severe acute symptoms, such as significant hypotension or circulatory instability, are observed. The official labeling states that Venofer administration must be stopped immediately in such events.

Management is primarily symptomatic and supportive treatment. While no specific antidote is known, the official procedure for managing severe iron overload involves the use of iron chelating agents, such as Deferoxamine. Monitoring of vital signs and iron status parameters is required during management. Population-specific considerations note that severe reactions, including circulatory failure, may occur in pregnant women, potentially causing fetal bradycardia.

Therapeutic Uses of Венофер

What Venofer Treats: Main Uses and Benefits

Venofer is an approved treatment indicated for addressing iron deficiency anemia (IDA) that is associated with chronic kidney disease (CKD). This therapy is used in adults and children aged 2 years and older, covering patients who are on hemodialysis, peritoneal dialysis, or who are not yet on dialysis. The medicine provides a source of iron to help contribute to the maintenance of the body's iron supply.

The goal of this treatment is to help manage IDA and its common associated symptoms, such as generalized fatigue and weakness. When managed appropriately, this intervention can support the patient’s overall well-being related to their iron status. The treatment is intended to contribute to the maintenance of iron status.


Quick Fact: Support for Iron Deficiency Anemia

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Венофер (Iron Sucrose) — Official Regulatory Information


Populations for whom use is allowed (as stated in label):

  • Adult patients with Iron Deficiency Anemia (IDA) associated with Chronic Kidney Disease (CKD) (including all dialysis types).
  • Pediatric patients 2 years of age and older with IDA associated with CKD.

Populations for whom use is contraindicated:

  • Patients with known serious hypersensitivity to iron sucrose or other injectable iron products.
  • Patients with evidence of iron overload (e.g., hemochromatosis).
  • Patients with anemias not attributed to iron deficiency.

Age-related eligibility rules:

  • Use is not approved for pediatric patients under 2 years of age.
  • Geriatric patients may require caution due to the greater frequency of decreased organ function.

Pregnancy and lactation eligibility status:

  • Pregnancy: Use is not recommended in the first trimester. Conditional use is permitted only during the second and third trimesters when the potential benefit is determined to outweigh the potential risk, as severe reactions can occur.
  • Lactation: Use during breastfeeding should be assessed on a case-by-case basis.

Eligibility-related restrictions:

  • Use is restricted in patients with severe hepatic impairment (decompensated cirrhosis or active hepatitis).
  • Caution is required for patients with a history of asthma, eczema, or other atopic allergies.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Венофер (iron sucrose) is an intravenous iron replacement therapy, and its documented interactions primarily relate to the management of iron levels in the body.

Product Class / Category Interaction Mechanism Management / Condition
Oral Iron Preparations May reduce the absorption of the oral iron preparation. Concomitant administration must be avoided.

The main interaction-related constraint established in regulatory documents involves the simultaneous use of this intravenous iron product with medicines containing iron taken by mouth. Administering Венофер may reduce the body's absorption of any oral iron preparation given at the same time. To manage this potential reduction in effectiveness, the intravenous iron product and oral iron preparations should not be used concurrently.

Furthermore, official prescribing information advises a specific timing rule for switching treatment. If a patient is to start oral iron therapy after a course of Венофер, it is generally recommended that the oral iron treatment begin at least 5 days after the last injection of Венофер. This restriction helps ensure that the body can fully utilize the oral iron without interference from the prior intravenous treatment. Aside from oral iron, there is limited clinical data regarding other systematic drug-drug interactions with iron sucrose.

Mechanism of Action

The mechanism of Венофер (Iron Sucrose) is a process of controlled intravenous iron delivery centered on utilization and storage pathways. The iron sucrose complex is primarily recognized and processed by macrophages of the Reticuloendothelial System (RES). Inside these cells, the complex undergoes controlled dissociation, releasing Iron(III) at a measured rate. This release ensures the iron immediately binds to the plasma protein transferrin, the body's iron transport shuttle, thus preventing rapid saturation of transferrin.

This iron-transferrin complex travels to the bone marrow where it is internalized by erythroid precursor cells via transferrin receptors. Once inside, the iron is channeled into the mitochondria to complete the heme synthesis pathway and form hemoglobin. This process directly fuels the final stages of red blood cell maturation, resulting in an increase in the blood's oxygen-carrying capacity. Iron not immediately used for hemoglobin is incorporated into the storage protein ferritin in the RES and liver, contributing to the total inventory of iron homeostasis. However, this process is subject to regulation by hepcidin, an inflammatory mediator that can restrict the release of stored iron from the macrophages, limiting its availability for the erythropoiesis pathway.

Dosage and Administration Information

Official Administration Guidelines

Венофер (iron sucrose) is administered exclusively via the intravenous (IV) route, either by slow injection or, most often, as an infusion. This medicine requires administration within a clinical setting under medical supervision.

Dosing and Frequency Patterns

The total amount of iron needed, known as the Total Cumulative Dose (TCD), is calculated first based on the patient's body weight and hemoglobin levels. This TCD is then divided and administered over multiple treatment sessions.

Patient Population Single Dose Regimen Frequency and Course Duration
Adults (Hemodialysis-Dependent) 100 mg elemental iron (in 5 mL) Up to three times per week during consecutive dialysis sessions until the TCD (typically 1,000 mg) is reached.
Adults (Non-Dialysis Dependent) 200 mg elemental iron Administered over five separate occasions within a 14-day period to complete the 1,000 mg course.
Pediatric Patients (≥ 2 years) 0.5 mg/kg (not to exceed 100 mg) Every two or four weeks for a total of 12 weeks for iron maintenance treatment, depending on dialysis status.

Preparation and Procedural Conditions

For administration as an infusion, the medicine must be immediately diluted in a 0.9% Sodium Chloride Injection (normal saline) solution before use. The infusion rate is precisely regulated: a 100 mg dose must be administered over a minimum of 15 minutes. Larger doses, such as 200 mg, require a minimum infusion time of 30 minutes, and doses up to 500 mg may require a minimum of 3½ hours to administer.

The medicine is designed to be administered as an intermittent course of therapy, meaning treatment cycles are initiated and concluded when the total calculated iron replacement need is met.

Recent Clinical Evidence

Research evidence / Overview of studies for Venofer (Iron Sucrose)


Evidence for Iron Deficiency Anemia in Hemodialysis Patients

The research base for Venofer includes Randomized Controlled Trials (RCTs) and systematic reviews that examined the medicine's use in adults with iron deficiency anemia (IDA) who are undergoing maintenance hemodialysis. These studies were used in research exploring how blood markers related to anemia and iron storage change over defined time intervals.

Studies monitored key outcomes such as the shifts in Hemoglobin (Hb) levels and indicators of iron status, specifically Serum Ferritin and Transferrin Saturation (TSAT). Research also monitored changes in Erythropoiesis-Stimulating Agent (ESA) dosing requirements. Findings described patterns observed in the studies related to these laboratory markers. Systematic reviews and large observational evidence derived from settings with varying symptom burdens also contributed to understanding symptom patterns and the frequency of interventions over time.

A limitation noted in the research is the focus of most controlled trials on short-term follow-up and surrogate laboratory measures. Therefore, long-term effects are not fully established by the shorter duration of most controlled studies, and there is limited information for long-term outcomes that reflect physical discomfort or systemic or functional imbalance over many years.


Evidence for Iron Deficiency Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Research for Venofer in patients with chronic kidney disease (CKD) who are not yet on dialysis includes comparative studies against oral iron supplements or other intravenous iron products. These studies evaluated changes in symptoms during short-term observation. The study populations were adults with stages of CKD who were not receiving maintenance dialysis.

Research examined the proportion of patients who achieved a specific goal related to increased Hemoglobin (Hb) levels. Studies also monitored changes in iron storage levels (Ferritin and TSAT). Findings described group patterns related to changes measured during the study period. The reported outcomes were primarily related to short-term laboratory markers used in the management of anemia.


Gaps in the Research: What Remains Uncertain

Certainty remains low in several areas because research has mainly concentrated on short-term laboratory markers rather than sustained, long-term outcomes. There is limited information for long-term outcomes related to functional capacity and quality of life across the entire spectrum of the studied conditions.

Data for certain groups remain insufficient, particularly regarding the long-term follow-up of non-dialysis dependent patients and those on peritoneal dialysis. Research highlights what is known—and what is still uncertain—but does not determine whether an individual will respond similarly.

Key Studies & References

  1. Venofer (iron sucrose) injection, USP Prescribing Information
  2. Intravenous versus oral iron supplementation for the treatment of anemia in CKD: systematic review and meta-analysis
  3. Evidence reviews for managing anaemia with IV iron in people with GFR category G5 who are on dialysis (NICE Guideline Background)

Frequently Asked Questions (FAQ)

Common questions about Венофер (FAQ)

Q: How quickly can someone expect to see iron level changes after getting Венофер?

According to official product information, laboratory markers such as transferrin saturation are seen to increase rapidly after the administration of this medicine. For reliable monitoring of changes to serum iron levels after treatment, official documents indicate it is generally observed to wait at least 48 hours.


Q: How long does the effect of a Венофер infusion typically last?

Studies focusing on this medicine have primarily concentrated on short-term laboratory markers to manage iron status. Because of the shorter duration of most controlled studies, the long-term effects or the duration of action after a full course is not fully established by the research evidence.


Q: Is Венофер approved for use during pregnancy?

Regulatory documents state that use is not recommended during the first trimester of pregnancy. Conditional use is described as permissible only during the second and third trimesters when the potential benefit is assessed by a healthcare provider to outweigh the potential risks.


Q: Can taking other vitamins interfere with Венофер?

The primary interaction established in official documents is that this intravenous medicine may reduce the absorption of oral iron preparations taken at the same time. Aside from oral iron, there is limited clinical data regarding other systematic drug-drug interactions with this medicine, including most vitamins and supplements.


Q: What is the typical time frame between separate Венофер treatments?

The time frame between treatments is based on the specific regimen described in the official product information. For patients undergoing hemodialysis, treatment can be administered up to three times per week. For non-dialysis patients, a standard course is often administered over five separate occasions within a 14-day period.


Q: Is Венофер safe for older adults (seniors)?

Official documents advise that caution may be required for geriatric patients. This is due to the general understanding that older adults may experience a greater frequency of decreased organ function, which may require consideration during administration.


Q: Is a fever after the infusion considered a serious side effect?

Fever (pyrexia) is a documented adverse event that has been reported in clinical trials and post-marketing experience. While it can be reported as a common side effect, it is also listed as a potential sign of a serious allergic reaction, and, if experienced, is a finding that warrants professional monitoring.


Q: Can Венофер be used while breastfeeding?

Official documents indicate that the use of this medicine during breastfeeding should be assessed on a case-by-case basis. Studies suggest that the non-metabolized iron sucrose complex is unlikely to pass into the mother's milk.


Q: What is the main difference between Венофер and other iron infusions?

Official administration protocols note that this medicine (iron sucrose) is typically administered as a divided dose given over multiple sessions. In contrast, certain other intravenous iron preparations can sometimes be administered as a total single-dose infusion.


Q: Is Венофер the same as iron dextran?

No, they are different preparations. Regulatory documents list iron sucrose (Венофер) and iron dextran as separate, distinct intravenous iron products with different chemical compositions and administration requirements.


Q: Can Венофер cause my urine to change color?

Changes to the color of urine (chromaturia) have been mentioned in official post-marketing reports associated with the medicine. This is a documented side effect, although the exact frequency is not known.


Q: Is it common to feel tired right after a Венофер treatment?

Yes, fatigue and asthenia (unusual weakness or lack of energy) are listed in the official safety profile as common reported adverse events in clinical trials. These effects can occur after administration.


Q: Can people with kidney problems use Венофер?

Yes. Official documents state that one of the medicine's main indications is for the treatment of iron deficiency anemia specifically in patients with Chronic Kidney Disease (CKD). This includes patients on dialysis and those who are not.


Q: What are the most common reported side effects from Венофер?

The most common reported adverse reactions documented in clinical trials include hypotension (low blood pressure), headache, dizziness, taste disturbance (dysgeusia), nausea, vomiting, and reactions at the injection site such as pain or swelling.


Q: Does Венофер cause an allergic reaction often?

Official documents classify serious allergic reactions, including anaphylaxis, as uncommon or rare adverse reactions. The medicine is administered in a supervised clinical setting due to the potential for this type of reaction.


Q: Why do official documents mention the risk of low blood pressure with Венофер?

The risk of low blood pressure (hypotension) is mentioned because official information indicates this effect may be related to the rate at which the medicine is administered and/or the total dose delivered during a treatment session.


Q: Is it possible to receive too much Венофер?

Yes. Official documents warn that excessive therapy with intravenous iron can lead to excess iron storage in tissues, which is known as iatrogenic hemosiderosis or iron overload. For this reason, official protocols specify periodic monitoring of iron levels.


Q: How does Венофер help with anemia associated with chronic kidney disease?

The medicine is designed to replenish iron stores by delivering iron directly into the bloodstream. This iron is then utilized to fuel the synthesis of hemoglobin, which is essential for forming red blood cells and improving the blood's oxygen-carrying capacity in patients with chronic kidney disease.


Q: What does the research say about Венофер's effectiveness in non-dialysis patients?

Studies have examined the use of the medicine in non-dialysis dependent patients with chronic kidney disease. Research described group patterns related to changes in key iron storage and hemoglobin levels, and evaluated the proportion of patients who achieved specific hemoglobin goals.


Q: Are there any long-term effects associated with repeated Венофер use?

Regulatory documents note that research has mainly concentrated on short-term laboratory markers. Therefore, official documents state that long-term effects are not fully established by the shorter duration of most controlled studies.


Q: Can children or teenagers be treated with Венофер?

Official regulatory documents indicate that the medicine is approved for use in pediatric patients who are 2 years of age and older. This use is specifically for iron deficiency anemia associated with chronic kidney disease.


Q: Why is it necessary to monitor iron levels after a Венофер infusion?

Patients require periodic monitoring of iron parameters to assess the effect of the treatment and manage the overall regimen. Monitoring is necessary to ensure there is no evidence of excess iron storage, which is known as iron overload.


Q: Is it normal to feel a metallic taste during or after the infusion?

Yes, dysgeusia (a change or disturbance in taste) is listed in the official safety profile as a common adverse reaction associated with the medicine. This is frequently described by users as a metallic taste.


Q: How is the need for Венофер determined by healthcare professionals?

The decision to use this medicine is typically based on the patient having a defined need for iron replacement that cannot be met by oral iron. This includes circumstances such as documented intolerance to oral iron or a clinical need to rapidly deliver iron to replenish stores.


Q: Are there any specific laboratory tests required before starting Венофер?

Official protocols for intravenous iron treatment may require specific laboratory investigations before starting. These often include standard iron profile tests, blood cell counts, and measures of inflammation.


Q: Is Венофер commonly used in cancer patients with anemia?

Guidance from certain medical compendia and drug policies recognizes the use of parenteral iron products like this one in certain patients with chemotherapy-induced anemia. This is provided they meet specific criteria for hemoglobin and iron levels.


Q: Why do some people experience headaches after their infusion?

Headache is listed as a common adverse reaction in the official safety profile. Some official information indicates that certain adverse effects, including headache, may be associated with the total dose or infusing the medicine too rapidly.


Q: Does the brand of intravenous iron matter, or are they all the same?

No. The various intravenous iron preparations are not the same. They are different products with distinct chemical compositions and administration requirements, such as whether they are given as a single dose or divided dose. This influences the choice of treatment.


Q: What evidence supports the use of Венофер in post-operative patients?

Research has examined the medicine's use in related non-CKD populations, such as postpartum patients. In these studies, a measurable increase in hemoglobin levels was observed within two weeks of treatment.


Q: Can Венофер be administered at home?

No. Official administration guidelines state that the medicine is administered exclusively via the intravenous route. This procedure requires administration within a clinical setting under medical supervision.


Q: What information is available about the risk of iron overload with Венофер?

Official documents warn that excessive therapy with intravenous iron can lead to excess iron storage, which is known as iatrogenic hemosiderosis or iron overload. The medicine is contraindicated in patients who already have evidence of iron overload.


Q: Is Венофер used to treat all types of anemia?

No. Official prescribing information states the medicine is contraindicated in patients with anemias not attributed to iron deficiency. It is intended specifically for iron deficiency anemia.


Q: What is the purpose of the test dose sometimes mentioned for iron infusions?

Official protocols may require a test dose during the first infusion. This procedure is performed to monitor the patient for any immediate adverse events or signs of intolerance before administering the full therapeutic dose.


Q: Is Венофер's safety profile different from oral iron supplements?

Yes, the safety profile is different primarily due to the route of administration. The intravenous route avoids gastrointestinal side effects commonly associated with oral iron, and intolerance to oral iron is one clinical indication for using the intravenous medicine.

How should Венофер be stored and disposed of?

Official Storage and Disposal Requirements for Venofer (Iron Sucrose) Injection

Venofer must be stored in the original carton to protect the contents and must be kept at Controlled Room Temperature (20 to 25 C / 68 to 77 F). It is a mandatory requirement to Do not freeze the product.

Handling & Stability Rule Requirement
Container Status Single-use vial; contains no preservatives.
Immediate Use Must be used immediately after first opening or dilution.
Extended Stability Dilutions to 1 to 2 mg/mL in 0.9% NaCl are stable for 7 days when refrigerated or at room temperature.
Disposal Discard any unused portion and dispose of all waste material according to local requirements.

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

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