Aviron

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Aviron

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Medically reviewed

Marina Burgos

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 Aviron

Property Description
Active ingredient Iron Sucrose
Form Injectable Solution / Concentrate for Infusion
Pharmacological class Parenteral Iron Replacement Product
Common use Iron Deficiency Management
Origin Synthetic (Chemically Complexed)
Status Prescription-Only (Rx)

What Type of Medicine is Aviron (Iron Sucrose)?

Aviron is classified as a parenteral iron replacement product, a synthetic, single-ingredient medication designed to correct significant iron deficits in the body. It belongs to the broader pharmacological class of hematinic agents—medicines specifically used to support the production of red blood cells. The active ingredient is Iron Sucrose, which is chemically defined as a polynuclear iron(III)-hydroxide sucrose complex. This confirms the medicine provides an important source of elemental iron needed for the body's vital functions. As a Prescription-Only (Rx) injectable, Aviron is administered only via the intravenous route as a sterile injectable solution, which differentiates it from over-the-counter tablets. It is clinically recognized for use in scenarios where patients have chronic conditions that impair the absorption of oral iron or require rapid replenishment of iron stores.


Aviron’s Composition and General Purpose

The composition of Aviron is a sterile aqueous complex designed for direct, controlled introduction into the bloodstream, bypassing the digestive system entirely. Its high-level mechanism is straightforward: it provides a direct, readily available source of elemental iron to the body's circulation. Intravenous iron preparations are used for increasing hemoglobin levels when oral iron is insufficient. This indicates the therapy's main benefit is its ability to ensure rapid and efficient iron supplementation. The general purpose of this therapy is to rapidly and efficiently replenish iron stores when a patient’s need for iron is urgent or absorption is compromised. By delivering this vital mineral directly, Aviron supports the swift formation of oxygen-carrying red blood cells, which helps to relieve the underlying fatigue and weakness associated with a significant lack of iron.

What side effects are possible with Aviron?

Possible Side Effects and Safety Information

The safety profile of Aviron (Iron Sucrose) is formally documented in government regulatory materials, classifying adverse reactions by frequency and the body system affected. These official documents specifically address high-incidence effects, serious adverse reactions, and safety notes for specific patient populations.

Official Adverse Reaction Categories

Adverse reactions are formally categorized based on the incidence observed in clinical trials (e.g., Common, defined as ge 2%). Common adverse reactions officially listed in regulatory labeling include Hypotension (low blood pressure), Nausea, Headache, Dizziness, Diarrhea, Vomiting, and Injection site reactions.

The official documentation groups effects by System-Organ Class (SOC), covering Vascular disorders (Hypotension, Shock), Gastrointestinal disorders, Nervous System disorders, and Immune system disorders.

Serious Adverse Reactions and Safety Constraints

The safety profile highlights specific, serious adverse reactions, including potentially life-threatening Serious hypersensitivity reactions (anaphylactic-type reactions), Shock, Loss of consciousness, and Clinically significant hypotension. Use is formally restricted and Contraindicated in individuals with a known hypersensitivity to the drug and in those with documented Iron Overload.

Time-related patterns in the safety documentation note that most reactions associated with the intravenous preparation occur within 30 minutes of the completion of the infusion. Specific safety considerations are included for pediatric patients and notes on potential fetal bradycardia during the second and third trimesters of pregnancy.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Iron Sucrose (Aviron) addresses the risks of both chronic iron accumulation and acute administration-related emergencies. The primary documented consequence of excessive parenteral iron therapy is the excessive storage of iron, which can potentially lead to iatrogenic hemosiderosis. This condition is primarily assessed through the periodic monitoring of hematologic parameters, specifically looking for elevated serum ferritin and transferrin saturation (TSAT) values.

Immediate medical attention is required for any acute, severe manifestations that may occur during administration. The regulatory label mandates that the infusion must be stopped immediately if signs of intolerance or life-threatening hypersensitivity reactions develop. These severe manifestations include clinically significant hypotension, fainting, or swelling. Administration is required to occur only in settings where personnel and therapies are immediately available to manage such emergencies.

For confirmed overdose, official guidance states that treatment should be managed with an iron chelating agent as deemed necessary, and according to standard medical practice. Furthermore, regulatory monitoring constraints require clinicians not to perform serum iron measurements for at least 48 hours following administration due to transient, misleading increases in TSAT.

Therapeutic Uses of Aviron

What Aviron Treats: Main Uses and Benefits

Aviron (Iron Sucrose) is considered relevant for managing significant iron deficits, particularly in contexts where oral supplementation may be insufficient or inappropriate. Its therapeutic role is used for managing reliable iron replenishment to address the underlying deficiency and support patient function.

Iron sucrose is indicated for the treatment of Iron Deficiency Anemia (IDA) in patients with Chronic Kidney Disease (CKD). The main clinical applications are commonly used to manage IDA in individuals with CKD (including those on dialysis), in cases where oral iron fails or is not tolerated, and when efficient support for severe deficits is required.


Therapeutic Contexts

This approach may assist with managing patients who have impaired absorption due to chronic conditions like Inflammatory Bowel Disease (IBD) and supports the body in receiving the necessary iron. The therapy can contribute to easing the effects of acute or disruptive episodes associated with severe iron deficiency.

It helps address symptom clusters that interfere with daily functioning, such as chronic fatigue and persistent weakness. This symptomatic relief can contribute to improved comfort and assists with maintaining functional stability for the patient.

Quick Fact: Relief for Chronic Anemia-Related Fatigue
The therapy is relevant when symptoms create noticeable physiological strain and a reliable iron source is commonly used to ease the overall symptom burden.

Eligibility and Restrictions for Use

Who can and cannot use Aviron?

The official eligibility for Aviron (Iron Sucrose) is strictly defined by regulatory authorities based on population group and medical condition.

Contraindicated Use

Aviron is contraindicated and must not be used by patients with a known hypersensitivity to iron sucrose or its components, or by individuals with evidence of iron overload (hemosiderosis). Use is also prohibited for patients whose anemia is not caused by iron deficiency.


Eligible and Restricted Populations

Population Group Regulatory Eligibility Status
Primary Eligible Adults Approved for Iron Deficiency Anemia (IDA) in patients with Chronic Kidney Disease (CKD).
Pediatric Patients Approved for patients 2 years of age and older with Hemodialysis-Dependent CKD. Safety and efficacy are not established in those younger than 2 years.
Pregnancy/Lactation Not recommended during the first trimester. Use is typically confined to the second or third trimester only when clearly necessary.
Hepatic Impairment Use requires caution and careful assessment in patients with liver dysfunction and is avoided in those where iron overload is a factor (e.g., Porphyria Cutanea Tarda).

Administration requires caution in older adults and in patients with a history of severe allergies or active infections, as per official prescribing information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Aviron (Iron Sucrose) as noted in government regulatory sources, without providing clinical advice.

Interaction Scope

Field Official Regulatory Documentation Status
Medicinal product categories with documented interactions: Oral Iron Preparations
Mechanistic basis of interactions: Pharmacokinetic interaction (parenteral iron may reduce the absorption of concomitantly administered oral iron).
Timing-based interaction rules: Oral iron therapy must be started at least 5 days after the last injection of Iron Sucrose.
Interaction-related restrictions: Co-administration with Oral Iron Preparations is prohibited.

Interaction Classifications (High-Level)

Field Official Regulatory Documentation Status
Interaction severity classification: Classified as requiring prohibition of co-administration and a mandatory separation period.
Food, alcohol, herbal product interactions: None documented in regulatory labels.

Resulting Interaction Structure

Official regulatory documents define the product's interaction profile predominantly by a single, mandatory restriction concerning Oral Iron Preparations. This effect—where the intravenous formulation may reduce the absorption of the oral form—mandates a prohibition of simultaneous use and establishes a specific timing separation requirement in the official label. The regulatory documentation also notes the absence of documented interactions with CYP enzymes, drug transporters, food, or alcohol, as formal interaction studies for Aviron have not been conducted.

Mechanism of Action

Aviron (Iron Sucrose) functions by ensuring the controlled release of ferric iron ( Fe^3+) directly into the circulation, bypassing the body's natural absorption limits. The polynuclear iron core is rapidly processed upon uptake by Reticuloendothelial System (RES) Macrophages in tissues like the liver and spleen. The released Fe^3+ immediately binds to the carrier protein Transferrin for transport. This iron-Transferrin complex targets the Transferrin Receptor (TfR1) on erythroid precursor cells in the bone marrow. The resulting receptor-mediated internalization delivers the iron as an essential cofactor needed for the swift incorporation into Heme and the subsequent synthesis of Hemoglobin ( Hb). The core physiological consequence of this cascade is the elevation of the blood's oxygen-carrying capacity. The supplied iron also replenishes iron-dependent enzyme systems critical for cellular energy metabolism throughout the body. However, the mechanism's utility is subject to biological constraints, particularly the regulation by the peptide hepcidin, which can restrict the release of iron from macrophages during inflammatory conditions, contributing to functional iron deficiency.

Dosage and Administration Information

The administration of Aviron (Iron Sucrose) follows specific instructions detailing the route, dosing regimen, and preparation steps.

Administration Protocol

Aviron is a parenteral therapy, meaning its use is restricted to the intravenous (IV) route only, administered either as a slow injection or via infusion. The labeling specifies that it is not for use via the intramuscular or subcutaneous routes. Proper administration requires the dose to be diluted only with sterile 0.9% sodium chloride (NaCl) solution, and it must never be mixed with other therapeutic agents in the same container. The infusion rate is also specified, requiring the dose (e.g., 100 mg) to be administered over a minimum duration (e.g., at least 15 minutes).

Dosing Schedule and Course

The total cumulative dose for a typical course of therapy is 1000 mg of elemental iron, which is administered in divided doses. The schedule is defined by the patient’s clinical context:

  • Patients undergoing hemodialysis-dependent Chronic Kidney Disease (HDD-CKD) typically receive a dose of 100 mg per consecutive dialysis session, often administered early during the session.
  • For patients with non-dialysis dependent CKD (NDD-CKD), the total course is administered as five separate doses of 200 mg over a 14-day period.

The treatment course may be repeated if laboratory criteria confirm the reoccurrence of an iron deficit. Specific dosage rules also apply for pediatric patients 2 years and older, who have a defined maintenance dose of 0.5 mg/kg, not to exceed 100 mg per administration.

Recent Clinical Evidence

Research evidence / Overview of studies

Efficacy in Symptom Management

Studies have explored whether the drug was associated with changes in symptom severity. One large-scale trial examined the effect on patient-reported quality of life. Research has explored whether participants reported changes in pain during acute flare-ups.

A Phase 3, randomized controlled trial (RCT) evaluated the long-term clinical profile on disease activity. Research examined the period of time until participants reported changes in symptoms.


Impact on Inflammatory Markers

Studies evaluated the drug’s effect on inflammatory markers. Outcomes were measured based on changes in C-reactive protein (CRP) levels and erythrocyte sedimentation rate (ESR) over a six-month period. Studies reported mixed findings among different patient populations evaluated.


Drug Interaction and Tolerability Profile

Research explored the drug’s acceptance in study participants who had moderate liver impairment. Participant responses were examined when the drug was administered alongside certain other treatments. Some studies evaluated the drug's effect when administered alongside dietary modifications.


Safety and Long-Term Use

The evidence base for long-term use (beyond three years) remains limited. A retrospective analysis evaluated the potential for serious adverse events over a one-year follow-up period. It is not yet clear whether the long-term safety profile is different from placebo.

Frequently Asked Questions (FAQ)

Common questions about Aviron (FAQ)

Q: Can Aviron be taken at the same time as cold and flu medicine?

Official regulatory information does not list specific interactions with common cold and flu medicines. Drug labels state that Aviron may reduce the absorption of oral iron preparations and should not be mixed with other therapeutic agents in the same container. Information regarding combined use with other medications is best discussed with a healthcare professional.


Q: Does Aviron affect your ability to drive or operate machinery?

Official safety data lists adverse reactions that may affect the nervous system, such as headache and dizziness. The potential for effects like dizziness or headache means that an individual’s reaction to Aviron should be observed before performing tasks that require concentration or coordination.


Q: Is Aviron effective for acute symptoms?

Aviron is officially indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease. Regulatory information indicates its primary use is to replenish iron stores and increase hemoglobin levels over a course of treatment. The medication is not indicated for treating acute, non-anemia-related symptoms.


Q: Why do official documents mention 'risk categories' for Aviron?

Official documents categorize risks to inform healthcare providers about mandatory safety precautions. These categories highlight the potential for serious events, such as hypersensitivity reactions and clinically significant hypotension. Contraindicated use, which means use is prohibited, also establishes specific risk categories.


Q: Does Aviron have a 'Black Box Warning' in the US?

The product label for Aviron (Iron Sucrose) in the US does not contain a Boxed Warning, which is often called a 'Black Box Warning.' Regulatory labels do contain detailed warnings and precautions about the potential for serious adverse reactions, such as anaphylactic-type reactions.


Q: Can Aviron be taken with common pain relievers like ibuprofen or paracetamol?

Official regulatory documents do not list specific interactions with common non-prescription pain relievers like ibuprofen or paracetamol. The label specifies a major interaction only with oral iron preparations. Information regarding combined use with other medications is best discussed with a healthcare professional.


Q: Does Aviron interfere with common diagnostic lab tests?

Yes, official safety information indicates that Aviron can interfere with certain laboratory measurements. Specific laboratory tests, such as those measuring serum iron, may show inaccurate results if performed within 48 hours following administration of Aviron. Laboratory personnel must be informed of the treatment schedule.


Q: What information should I read on the Aviron patient leaflet?

The patient leaflet contains critical information on indications (what the drug treats), how it is administered, and known side effects, both common and serious. It also outlines who should not use the medication (contraindications) and details the known drug interactions, particularly with oral iron preparations.


Q: What should I do if I accidentally used more Aviron than intended?

Official product information advises that overdose may result in excess iron accumulation, known as hemosiderosis. The label directs the use of periodic monitoring of iron parameters to avoid overdose. Immediate medical attention is necessary if there is any suspicion of overdose, which can lead to excess iron accumulation.


Q: Is Aviron effective for preventing recurrences of a condition?

Aviron is indicated for treating existing iron deficiency anemia. The dosing regimen specifies a course of treatment which may be repeated if iron deficiency reoccurs, suggesting its use is primarily therapeutic. Its indication is not specifically for prophylactic (preventative) use.


Q: Why is Aviron sometimes used in combination with other drugs?

Aviron is often studied and indicated for use in patients with Chronic Kidney Disease (CKD) who are receiving erythropoiesis-stimulating agents. This combination is designed to address both the iron deficiency and the underlying anemia management in this specific population.


Q: Does taking Aviron impact fertility?

Regulatory labels contain sections detailing non-clinical studies related to 'Impairment of Fertility.' These sections provide information regarding potential effects observed in animal studies. Specific findings from these non-clinical studies are available in the official prescribing information.

How should Aviron be stored and disposed of?

Storage and Disposal of Aviron (Iron Sucrose)

The storage and handling of Aviron, an injectable solution, must adhere strictly to regulatory requirements to maintain its stability and integrity.

  • Required Temperature: Unopened vials must be stored at Controlled Room Temperature, specifically defined as 20 C to 25 C. Brief temperature excursions between 15 C and 30 C are permitted.
  • Prohibited Storage: It is mandatory not to freeze the solution, and the product should be stored in its original carton.
  • Post-Opening Stability: Because Aviron is preservative-free and supplied in single-dose vials, the solution must be used immediately after opening. It must not be mixed with any other medicinal products.
  • Disposal: Any unused portion of the medicine or related waste materials must be discarded and disposed of strictly in accordance with local requirements for pharmaceutical waste.

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

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