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Ferric Derisomaltose

Ferric Derisomaltose, also known as iron isomaltoside 1000 or Monofer, is an intravenous iron formulation being studied in clinical trials for treating iron deficiency and anemia across various medical conditions. This article summarizes key findings from recent trials investigating its efficacy and safety in patients with heart failure, gynecologic cancer, pediatric anemia, and other conditions.

Table of Contents

What is Ferric Derisomaltose?

Ferric derisomaltose is an intravenous (IV) iron treatment used to address iron deficiency anemia. It’s also known by several other names, including:

  • Iron isomaltoside
  • Monofer®
  • Monoferric®
  • Monover®
  • Monofar®
  • Monoferro®
This medication belongs to a class of drugs called third-generation iron preparations, which allow for higher doses of iron to be given in a shorter time compared to older iron treatments[1].

What Conditions Does Ferric Derisomaltose Treat?

Ferric derisomaltose is primarily used to treat iron deficiency anemia, a condition where the body doesn’t have enough healthy red blood cells to carry oxygen effectively. This medication is being studied for use in various situations, including:

  • Chronic Heart Failure: Patients with heart failure often have iron deficiency, which can worsen their condition. Ferric derisomaltose is being investigated to improve exercise capacity and quality of life in these patients[2][3].
  • Perioperative Anemia: This refers to low blood counts before, during, or after surgery. Studies are looking at how ferric derisomaltose might help patients undergoing spinal deformity surgery[4].
  • Gynecologic Cancer Surgery: Researchers are examining if this treatment can improve anemia in patients undergoing surgery for gynecologic cancers[5].
  • Prenatal Iron Deficiency: Pregnant women with iron deficiency anemia are being studied to see if ferric derisomaltose can help improve their condition[6].
  • Pediatric Iron Deficiency Anemia: The medication is being investigated for use in children with iron deficiency anemia[7].

How Does Ferric Derisomaltose Work?

Ferric derisomaltose works by providing iron directly into the bloodstream. Iron is an essential component of hemoglobin, the protein in red blood cells that carries oxygen throughout the body. When you have iron deficiency anemia, your body doesn’t have enough iron to produce adequate hemoglobin, leading to symptoms like fatigue and weakness. By delivering iron intravenously, ferric derisomaltose bypasses the digestive system, allowing for faster and more effective iron supplementation compared to oral iron treatments[1].

How is Ferric Derisomaltose Administered?

Ferric derisomaltose is given as an intravenous infusion, which means it’s delivered directly into your vein. The dosage and administration schedule can vary depending on your specific condition and body weight. Generally:

  • It’s often given as a single dose, which can range from 500 mg to 2000 mg of iron.
  • The infusion typically takes about 15-30 minutes for doses up to 1000 mg, and about 30-60 minutes for higher doses.
  • Your healthcare provider will determine the appropriate dose based on your weight and hemoglobin levels[4][1].

Benefits of Ferric Derisomaltose

Ferric derisomaltose offers several potential benefits:

  • Rapid Iron Repletion: It can quickly increase iron levels in the body, potentially leading to faster improvement in anemia symptoms[1].
  • Single-Dose Administration: Many patients can receive their full iron dose in a single infusion, which can be more convenient than multiple treatments or daily oral iron supplements[6].
  • Improved Exercise Capacity: In heart failure patients, it may help improve the ability to exercise and perform daily activities[2].
  • Better Quality of Life: By addressing iron deficiency, it may help improve overall quality of life and reduce fatigue[4].
  • Reduced Need for Blood Transfusions: In surgical patients, it may help reduce the need for blood transfusions[5].

Potential Side Effects

While ferric derisomaltose is generally well-tolerated, it can cause side effects in some people. Potential side effects may include:

  • Hypophosphatemia: This is a condition where phosphate levels in the blood become too low. It’s being closely studied as a potential side effect of intravenous iron treatments[1].
  • Hypersensitivity Reactions: In rare cases, some patients may experience allergic reactions. These can range from mild (like rash or itching) to severe (like difficulty breathing)[1].
  • Other Possible Side Effects: These may include nausea, headache, or changes in blood pressure. Your healthcare provider will monitor you closely during and after the infusion[4].
It’s important to discuss potential side effects with your healthcare provider before starting treatment.

Ongoing Research and Future Applications

Ferric derisomaltose is the subject of ongoing research to explore its potential benefits in various conditions:

  • Heart Failure: Studies are investigating whether it can improve exercise capacity and quality of life in patients with different types of heart failure[2][3].
  • Surgical Outcomes: Researchers are examining its potential to improve outcomes in patients undergoing various types of surgery, including spinal and gynecologic procedures[4][5].
  • Pediatric Use: Studies are looking at its safety and effectiveness in children with iron deficiency anemia[7].
  • Pregnancy: Its potential use in pregnant women with iron deficiency is being investigated[6].
These ongoing studies may lead to expanded use of ferric derisomaltose in the future, potentially benefiting a wider range of patients with iron deficiency.

Condition Key Findings Outcome Measures
Chronic Heart Failure Investigating effects on exercise capacity, quality of life, and cardiovascular events Peak VO2, 6-minute walk test, KCCQ scores, hospitalizations, mortality
Acute Heart Failure Studying impact on exercise capacity and recovery after hospitalization 6-minute walk distance, quality of life measures, NT-proBNP levels
Gynecologic Cancer Assessing efficacy in correcting preoperative anemia and reducing transfusion needs Hemoglobin levels, transfusion rates, quality of life scores
Pediatric Iron Deficiency Anemia Evaluating safety and efficacy in children aged 0 to <18 years Hemoglobin increase, ferritin levels, TSAT percentage
Prenatal Iron Deficiency Studying safety and efficacy in pregnant women with oral iron intolerance Resolution of iron deficiency anemia, hemoglobin levels
Perioperative Anemia in Spinal Surgery Comparing intravenous ferric derisomaltose to oral iron for postoperative anemia Changes in hemoglobin, iron indicators, quality of life measures

FAQ

  • What is Ferric Derisomaltose? Ferric Derisomaltose is an intravenous iron formulation used to treat iron deficiency and anemia. It's also known as iron isomaltoside 1000 or Monofer. It allows for rapid infusion of large doses of iron, potentially improving patient outcomes more quickly than oral iron supplements.
  • What medical conditions are being studied with Ferric Derisomaltose? Clinical trials are investigating Ferric Derisomaltose in various conditions including chronic heart failure, acute heart failure, gynecologic cancer, pediatric iron deficiency anemia, prenatal iron deficiency, and perioperative anemia in spinal surgery patients.
  • How is Ferric Derisomaltose administered? Ferric Derisomaltose is administered intravenously. The dose is typically calculated based on the patient's body weight and hemoglobin levels. It can be given as a single dose or repeated doses, usually infused over 15-60 minutes depending on the total dose.
  • What are some potential benefits of Ferric Derisomaltose? Potential benefits being studied include improved exercise capacity, quality of life, and cardiac function in heart failure patients; correction of anemia and reduced need for blood transfusions in cancer patients; and faster recovery from perioperative anemia in surgical patients.
  • Are there any side effects or risks associated with Ferric Derisomaltose? While generally well-tolerated, potential side effects being monitored in trials include hypersensitivity reactions, changes in blood pressure, and gastrointestinal symptoms. The trials are assessing both the efficacy and safety profile of Ferric Derisomaltose compared to placebo or standard treatments.

Ongoing Clinical Trials on Ferric Derisomaltose

  • Study on Ferric Derisomaltose for Patients with Iron Deficiency and Chronic Heart Failure

    Recruiting

    1 1 1 1
    Investigated drugs:
    Bulgaria Croatia Czechia Denmark Hungary Latvia +6

  • Study on the Effects of Ferric Derisomaltose on Mobility in Elderly Patients After Hip Fracture Surgery

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Treating Postoperative Anemia in Older Cardiac Surgery Patients with Ferric Derisomaltose and Sodium Chloride

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effects of Intravenous Ferric Derisomaltose in Non-Anemic Iron Deficient Patients with Colorectal Cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Testing Personalized Drug Combination Treatment to Reduce Deaths in Patients with Severe Acute Infections

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on the Effects of Ferric Derisomaltose on Cognitive Function in Heart Failure Patients with Iron Deficiency

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effects of Ferric Derisomaltose and Dopaminergic Therapy for Patients with Restless Legs Syndrome

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Austria

Glossary

  • Ferric Derisomaltose: An intravenous iron formulation used to treat iron deficiency and anemia, also known as iron isomaltoside 1000 or Monofer.
  • Anemia: A condition in which you lack enough healthy red blood cells to carry adequate oxygen to your body's tissues.
  • Iron Deficiency: A condition in which your body doesn't have enough iron to produce hemoglobin, the protein in red blood cells that carries oxygen.
  • Hemoglobin (Hb): A protein in red blood cells that carries oxygen throughout the body. It's measured in grams per deciliter (g/dL) of blood.
  • Transferrin Saturation (TSAT): A measure of how much iron is bound to transferrin, a protein that transports iron in the blood. It's expressed as a percentage.
  • Ferritin: A blood protein that contains iron and is the primary form of iron stored inside cells.
  • NT-proBNP: N-terminal pro-brain natriuretic peptide, a hormone released by the heart in response to pressure and stretching. It's used as a marker for heart failure.
  • NYHA Functional Class: New York Heart Association Functional Classification, a system used to classify the extent of heart failure based on symptoms and physical limitations.
  • KCCQ: Kansas City Cardiomyopathy Questionnaire, a tool used to measure quality of life in heart failure patients.
  • VO2: Oxygen consumption, often measured during exercise tests to assess cardiovascular fitness and heart function.

References

  1. https://clinicaltrials.gov/study/NCT03238911
  2. https://clinicaltrials.gov/study/NCT05971732
  3. https://clinicaltrials.gov/study/NCT06427343
  4. https://clinicaltrials.gov/study/NCT05714007
  5. https://clinicaltrials.gov/study/NCT05407987
  6. https://clinicaltrials.gov/study/NCT05763043
  7. https://clinicaltrials.gov/study/NCT05179226