Engflag

Ultrafer

Quick links to important sections

Ultrafer

Ultrafer_LT

Treatment option:

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 Ultrafer

Property Description
Active ingredient Iron(III)-hydroxide polymaltose complex (Ferripolimaltose)
Form Tablets and Oral Solutions (syrups, drops)
Pharmacological class Oral Iron Preparation (Antianemic drug)
Common use Providing iron to the body to correct or prevent deficiency
Origin Synthetic complex

What Type of Medicine Is Ultrafer?

Ultrafer is a common brand name for a medicinal supplement that belongs to the pharmacological class of Oral Iron Preparations. The supplement’s active ingredient is Iron(III)-hydroxide polymaltose complex (IPC), also known by its INN as ferripolimaltose. This is a synthetic compound where iron is held in its trivalent form (Fe^3+) within a large carbohydrate carrier. This specific formulation is recognized for its role in delivering essential iron when the body is confirmed to be experiencing a deficiency.

What Makes Ultrafer's Iron Different?

The differentiating factor for Ultrafer lies in its unique composition, where the iron core is protected within a stable polymaltose complex. This structure means the iron is released gradually in the small intestine, unlike simple ferrous salts which break apart rapidly. This complexed form may cause less direct irritation to the gastrointestinal lining. Therefore, Ultrafer is often seen as a gentler option that may result in better tolerability and fewer side effects like gastric distress.

What Forms Does Ultrafer Come In?

Ultrafer is administered via the oral route (by mouth) and is available as a single-ingredient product in multiple dosage forms to suit different patient needs. The brand typically offers both tablets (e.g., film-coated) and specialized oral liquid solutions (such as drops or syrup). This flexibility in form is a strategic feature that allows for easier and more precise dosing in populations like children, or assists adults who have difficulty swallowing pills.

Regulatory References

  1. Oral Iron Therapy: Current Concepts and Future Prospects
  2. About active and inactive medicine ingredients (Australian Dept. of Health)
  3. Iron (III)-hydroxide Polymaltose Complex in Iron Deficiency Anemia (Meta-Analysis)
  4. ClinicalTrials.gov on Iron Bivalent or Trivalent Oral
  5. Taking iron supplements: MedlinePlus (NIH)
  6. Iron Oral Supplements for Anemia: Side Effects (Cleveland Clinic)
  7. Oral Iron Therapy: Current Concepts and Future Prospects (Mentions Adverse Effects)

What side effects are possible with Ultrafer?

Possible Side Effects and Safety Information

The safety profile for oral Iron(III)-hydroxide polymaltose complex (Ultrafer) is defined by officially documented adverse reactions, predominantly affecting the digestive system, and a specific set of contraindications listed in regulatory documents.

Adverse Reaction Classification

Adverse reactions associated with this medicine are mainly gastrointestinal in nature. Official regulatory labeling classifies these specific effects as occurring Very Rarely.

System-Organ Class Frequency Classification Adverse Reactions (Examples)
Gastrointestinal disorders Very Rarely Nausea, vomiting, diarrhoea, or constipation

It is also noted in regulatory information that a harmless discolouration of faeces is a very common, expected consequence of taking oral iron preparations.

Regulatory Safety Constraints

Official labeling defines specific conditions under which Ultrafer is contraindicated, meaning it must not be used:

  • In individuals with known hypersensitivity to the active ingredient.
  • In cases of existing iron overload (such as haemochromatosis or hemosiderosis) or disturbances in the assimilation of iron.
  • For forms of anaemia that are not caused by iron deficiency, such as megaloblastic or haemolytic anaemia.

Population-Specific Notes

Official safety documents address the use of this medicine in specific populations:

  • Pregnancy and Lactation: Controlled studies conducted after the first trimester of pregnancy have not indicated any undesirable effects. While the exact amount transferred to breast milk is not known, the administration of the medicine is considered unlikely to cause undesirable effects in the nursed child.

This framework establishes that the primary risk area is minor, very rarely occurring gastrointestinal discomfort, while the main safety focus is adherence to the restrictions concerning pre-existing iron-related conditions.

Overdose and Emergency Response

Regulatory documents state that an overdose of Iron(III)-hydroxide polymaltose complex has the potential to cause serious systemic toxicity, necessitating immediate action.

Documented Clinical Manifestations

Overdose may be heralded by severe gastrointestinal effects, including vomiting, diarrhea, abdominal pain, and the presence of hematemesis (vomiting blood). Systemic effects such as lethargy may also be present.

Severe Outcomes and Complications

The official profile addresses the potential for life-threatening manifestations, including circulatory collapse (shock), acute liver failure, metabolic acidosis, convulsions, and coma. Delayed complications such as gastric scarring are also documented.

Mandatory Emergency Actions

Immediate medical attention is required in all cases of suspected overdosage. Regulators mandate that patients must promptly consult a physician or poison control center, with immediate hospital transfer required if severe symptoms occur.

Antidote and Supportive Treatment

The specific antidote required for severe iron poisoning is the chelating agent Desferrioxamine. Treatment involves administering this antidote along with supportive procedures, such as gastric lavage and monitoring of serum iron levels.

Population-Specific Risk

The official labeling includes a strong warning that accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age.

Therapeutic Uses of Ultrafer

Main Uses and Indications

Ultrafer is primarily used for the prevention and treatment of iron deficiency and iron deficiency anemia. It is formulated to address conditions where the body's iron stores are depleted or where the intake of iron is insufficient to meet physiological demands.

Iron Deficiency Anemia

The primary application of Ultrafer is the management of iron deficiency anemia. This condition occurs when the body lacks enough iron to produce adequate amounts of hemoglobin, the protein in red blood cells responsible for transporting oxygen to tissues. By providing a source of supplemental iron, Ultrafer helps to restore hemoglobin levels and replenish internal iron stores.

Latent Iron Deficiency

Ultrafer is also used to treat latent iron deficiency, a state where iron stores (ferritin) are exhausted but hemoglobin levels remain within the normal range. Addressing iron deficiency at this stage can prevent the progression to clinical anemia.

Benefits and Physiological Impact

Iron is an essential trace element required for several vital functions within the human body. The benefits of maintaining adequate iron levels through the use of Ultrafer include:

  • Oxygen Transport: Supporting the production of hemoglobin to ensure efficient oxygen delivery throughout the body.
  • Cellular Energy: Iron is a key component of myoglobin and various enzymes involved in energy metabolism and mitochondrial function.
  • Cognitive Function: Adequate iron levels contribute to normal neurological development and cognitive performance.
  • Immune Support: Iron plays a role in the proper functioning of the immune system.

Targeted Populations

Ultrafer may be used in various clinical scenarios where iron requirements are increased or absorption is compromised, including:

  • Increased physiological demand during pregnancy and breastfeeding.
  • Recovery from blood loss due to surgery or menstruation.
  • Dietary insufficiencies where nutritional intake does not meet the body's requirements.
  • Malabsorption syndromes where the uptake of iron from food is impaired.

Eligibility and Restrictions for Use

Ultrafer (ferric maltol) is intended for use only in adults who require treatment for iron deficiency. Official regulatory documents establish several patient groups for whom the medicine is either strictly prohibited or restricted.

Populations Who Must Not Use Ultrafer (Contraindications)

Ultrafer is contraindicated and must not be used by individuals who have:

  • A known hypersensitivity or history of an allergic reaction to the active substance (ferric maltol) or any other ingredients in the formulation.
  • Hemochromatosis or other conditions that cause an iron overload syndrome (excessive iron accumulation in the body).
  • Are currently receiving repeated blood transfusions, as this treatment can lead to iron overload.

Eligibility Restrictions and Special Populations

The following groups face specific restrictions or eligibility limitations as defined in regulatory labeling:

Population Eligibility Status (Official)
Active Inflammatory Bowel Disease (IBD) Flare Avoid use due to the potential risk of increased inflammation in the gastrointestinal tract.
Pediatric Patients (Under 18) Safety and effectiveness have not been established; use is not authorized.
Pregnancy/Lactation Information is limited. The drug is not absorbed systemically as an intact complex, but there are no adequate studies to determine infant risk during lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The following section outlines documented interactions for Ultrafer (Ferric Carboxymaltose) strictly based on official regulatory labeling.

Pharmacokinetic and Pharmacodynamic Interactions

Oral Iron Preparations: Ultrafer, an intravenous iron product, significantly reduces the absorption of concomitantly administered oral iron. Official documents state that oral iron therapy should not be initiated for at least five days following the last injection of Ultrafer to avoid this interaction and ensure effective therapy.

Other Intravenous Agents: Due to the risk of physical and chemical incompatibility, Ultrafer must not be mixed with any other intravenous solutions or therapeutic agents besides sterile 0.9% sodium chloride solution. Mixing with other agents may lead to precipitation or undesirable interactions.

Interaction with Laboratory Tests

Ultrafer administration causes transient interference with certain laboratory assays for serum iron and transferrin-bound iron. This interference can result in the overestimation of these parameters, and clinicians must be aware of recent administration when interpreting test results.

Indirect Interaction Considerations

Patients who are concurrently or have recently used medications that affect proximal renal tubular function may have an increased risk of developing symptomatic hypophosphatemia, an adverse effect associated with Ultrafer. Regulatory information highlights this specific patient population as having an increased susceptibility.

Mechanism of Action

Ultrafer delivers an iron-polymaltose complex whose structure is analogous to the body’s natural iron storage protein, ferritin. This structural similarity is the basis for its controlled absorption mechanism, which protects the iron core from premature dissociation into free inorganic iron within the gastrointestinal tract and blood plasma.

The complex is taken up by the mucosal cells of the small intestine, primarily via a process of endocytosis or through specific, controlled membrane uptake pathways, a distinct process from the absorption of simple iron salts. Once internalized, the complex is processed in the lysosomes where elemental Fe^3+ is gradually released. This regulated release rate reduces the potential for oxidative stress caused by a surge of uncomplexed iron.

Subsequent to release, the iron is bound to circulating transferrin for transport to target tissues, predominantly the bone marrow, where it is utilized as a substrate for hemoglobin synthesis. Any excess iron is safely sequestered into ferritin stores within the liver and spleen. This entire cascade serves to replenish systemic iron stores and restore the substrate supply necessary for erythropoiesis.

Dosage and Administration Information

How to Use Ultrafer (Ferric Carboxymaltose Injection)

The administration of Ultrafer (Ferric Carboxymaltose) must be performed in accordance with established medical protocols. This medicine is for intravenous use only and must be administered by a healthcare professional.

Official Administration Guidelines

Guideline Element Instruction Summary
Route Intravenous (IV) injection or infusion only.
Dosing Adults ge 50 kg: Two doses of 750 mg of iron, separated by at least 7 days, for a total course dose of 1,500 mg. Alternative single dose of 15 mg/kg (max 1,000 mg).
Pediatric (ge 1 year) 15 mg/kg body weight, administered in two doses separated by ge 7 days.
Dilution May be administered undiluted as a slow IV push or diluted in 0.9% sodium chloride. The final concentration must be not less than 2 mg of iron per mL.
Administration Rate The diluted product must be administered as an infusion over a minimum of 15 minutes. Undiluted 1,000 mg doses also require 15 minutes for administration.

Procedural Context

The required two-dose regimen structures the entire course of treatment, demanding a precise, time-separated administration. Administration requires careful procedural adherence, including proper dilution and a controlled infusion rate to meet required specifications. The single-use vials must be inspected before use, and any unused portion must be discarded.

Recent Clinical Evidence

Ultrafer: Recent Clinical Evidence

The research on the active ingredient in Ultrafer (Iron(III)-hydroxide Polymaltose Complex) was studied for use in people with iron deficiency and research examined its role in prevention. This summary demonstrates that evidence highlights what is known — and what is still uncertain.

Evidence for Treating Iron-Deficiency Anemia (IDA)

Research was studied for its use in people with Iron-Deficiency Anemia (IDA). The primary body of evidence consists of Randomized Controlled Trials (RCTs), often using other oral iron preparations as a comparison. The studies monitored changes in key markers like hemoglobin (Hb) and serum ferritin. The trials reported measurements of changes in these markers during the treatment period. However, the consistency of these findings appears to vary, particularly when examining the restoration of ferritin stores.

Evidence for Iron Deficiency Prevention (Prophylaxis)

The ingredient was evaluated in groups that may have a higher risk of iron deficiency, such as pregnant individuals and young children. The main outcomes studies monitored were the frequency of developing IDA and the biomarker changes over defined time intervals. The data are still emerging, and comparative evidence is lacking for a full assessment against several different iron supplements used for prevention.

Tolerability Patterns Described in Clinical Trials

The research base was studied for patterns related to tolerability of Ultrafer's active ingredient in relation to other iron preparations. Studies research describes differences in outcomes related to physical discomfort. The active ingredient was associated with patterns of lower incidence of self-reported gastrointestinal issues in some observed studies.

Evidence in Special Populations and Uncertainties

Ultrafer’s active ingredient was evaluated in several special populations, including pregnant women and children. Research involving both groups was evaluated in studies with distinct structures tailored to each group. However, the research for children, where the ingredient was studied for use in anemia, findings were mixed and evidence quality varies across studies.

Most research studies explored short-term outcomes. Because the follow-up durations were limited in many key trials, long-term effects are not fully established. The research describes the need for more trials to fully characterize long-term effects and the durability of restored iron levels.

Frequently Asked Questions (FAQ)

Common questions about Ultrafer (FAQ)

Q: What is Ultrafer used for?

According to the official product information, Ultrafer is used to treat iron deficiency anemia. This condition occurs when the body lacks sufficient iron to produce enough healthy red blood cells.

Q: How long does it take for Ultrafer to start working?

Official product information indicates that the body's response to Ultrafer can be measured by an increase in hemoglobin (the protein in red blood cells that carries oxygen) and ferritin (a protein that stores iron). These values typically start to rise after 2–3 weeks of continuous treatment, though individual responses may vary.

Q: Can I take Ultrafer with food or should it be taken on an empty stomach?

Regulatory documents state that Ultrafer is administered by slow intravenous injection or infusion. Since it is not an oral medicine, the official information does not address taking it with or without food. It should only be administered by a healthcare professional.

Q: What is the typical length of treatment with Ultrafer?

The official product information indicates that the treatment duration is tailored to the individual patient's iron deficiency and is determined by a healthcare professional. Treatment is typically continued until the body's iron stores, measured by ferritin and hemoglobin levels, are sufficiently replenished.

Q: Is Ultrafer suitable for pregnant women?

The official product information specifies that Ultrafer is not recommended for use in the first trimester of pregnancy. For the second and third trimesters, the official documents state that a careful benefit-risk assessment should be performed by a healthcare provider before use.

Q: How is Ultrafer administered?

According to the official product information, Ultrafer is a medication for intravenous use only. It must be administered as an intravenous injection or infusion by a trained healthcare professional in a clinical setting. It is not intended to be taken as a tablet or capsule.

How should Ultrafer be stored and disposed of?

How to Store and Dispose of Ultrafer

Storage and disposal of Ultrafer (Iron(III)-hydroxide polymaltose complex) must strictly follow the conditions specified in official regulatory labeling to ensure product integrity and safety.

Storage Requirements

  • Temperature and Environment: The medicine must be stored at controlled room temperature (typically 20^circ to 25 C) and protected from excessive heat and moisture.
  • Container Rules: Ultrafer must be kept in its original container, which should be maintained tightly closed when not in use.
  • Child Safety: It is a mandatory requirement to keep this product out of the reach and sight of children, as accidental overdose of iron-containing products can cause serious poisoning.

Disposal Instructions

Unused or expired Ultrafer should be returned through a designated medicine take-back program or specialized collection point. It must not be disposed of by flushing it down a toilet or pouring it into any drain.

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

Equivalent of Ultrafer found in:

A-Z Index: