Brand Name

Monoferric

Generic Name
Derisomaltose
View Brand Information
FDA approval date: January 16, 2020
Form: Injection

What is Monoferric (Derisomaltose)?

Iron deficiency anemia can leave people feeling constantly tired, weak, and unable to keep up with daily life. When oral iron supplements aren’t enough or can’t be tolerated, patients may need a faster and more effective option to restore healthy iron levels. Monoferric (ferric derisomaltose) offers such a solution. 

Monoferric is a prescription intravenous (IV) iron replacement therapy used to treat iron deficiency anemia (IDA) in adults who cannot use or have not responded well to oral iron supplements. It belongs to a class of medications known as parenteral iron preparations, which deliver iron directly into the bloodstream for quick absorption. 

Approved by the U.S. Food and Drug Administration (FDA) in 2020, Monoferric is one of the newer IV iron therapies designed to provide a complete iron repletion in a single treatment session, helping patients restore their energy and quality of life more conveniently than older regimens. 

What does Monoferric do? 

Monoferric is prescribed to treat iron deficiency anemia, a condition that occurs when the body lacks enough iron to produce adequate hemoglobin, the protein in red blood cells responsible for carrying oxygen throughout the body. Without enough iron, tissues and organs don’t receive the oxygen they need, leading to fatigue, shortness of breath, dizziness, and pale skin. 

While oral iron tablets are often the first treatment option, some patients can’t absorb iron properly through the digestive system or experience stomach upset from pills. Monoferric helps by bypassing the digestive tract entirely, delivering iron directly into the bloodstream for immediate use. 

It is typically used for adults with: 

  • Chronic kidney disease (CKD) not on dialysis 
     
  • Gastrointestinal disorders that limit iron absorption 
     
  • Ongoing blood loss 
     
  • Inflammatory conditions like inflammatory bowel disease (IBD) 

Clinical studies have shown that Monoferric effectively raises hemoglobin and ferritin levels after just one infusion, with results comparable or superior to other IV iron products (NIH, 2024). Most patients report feeling stronger and less fatigued within a few weeks. 

How does Monoferric work? 

Monoferric contains ferric derisomaltose, a stable iron–carbohydrate complex. Once injected into the bloodstream, it slowly releases iron (Fe³⁺), which binds to the body’s natural transport protein called transferrin. Transferrin then delivers iron to the bone marrow, where it is used to make new red blood cells. 

This controlled release mechanism is key, it prevents sudden spikes in free iron levels, which could otherwise cause toxicity. Instead, Monoferric provides a steady and safe supply of iron to replenish the body’s stores efficiently. 

Clinically, this matters because iron is vital for oxygen transport, energy metabolism, and cell function. By restoring normal iron and hemoglobin levels, Monoferric helps relieve the hallmark symptoms of anemia such as fatigue, weakness, and lightheadedness allowing patients to return to normal activity and energy levels more quickly. 

Monoferric side effects 

Most people tolerate Monoferric well, but as with any medication, side effects can occur. The majority are mild and temporary. 

Common side effects include: 

  • Nausea 
     
  • Rash or mild itching 
     
  • Headache 
     
  • Dizziness 
     
  • Flushing or warmth at the injection site 

Serious but rare side effects: 

  • Allergic or hypersensitivity reactions, including swelling, wheezing, or difficulty breathing 
     
  • Low blood pressure during or shortly after infusion 
     
  • Dizziness or fainting 

Severe allergic reactions are uncommon but can happen with any IV iron therapy. Therefore, Monoferric infusions are always administered in a clinical setting under medical supervision, allowing immediate treatment if a reaction occurs. 

People who have had previous allergic reactions to IV iron or who have iron overload disorders (such as hemochromatosis) should avoid using Monoferric. Patients with liver disease, infections, or inflammatory conditions should inform their doctor before starting therapy, as iron levels must be carefully balanced. 

If you experience chest pain, severe shortness of breath, swelling of the face or throat, or lightheadedness during treatment, seek emergency care right away. 

Monoferric dosage 

Monoferric is a single-session intravenous iron infusion administered by a healthcare professional, typically taking about 20 minutes. Dosage is individualized based on body weight and iron deficiency, and patients are observed briefly post-infusion for side effects. 

Doctors often monitor: 

  • Hemoglobin and ferritin levels before and after infusion 
     
  • Liver function tests if there are concerns about iron storage 
     
  • Blood pressure and vital signs during administration 

These checks help ensure the treatment is effective and safe. For patients with chronic kidney disease or inflammatory diseases, periodic re-evaluation of iron levels is important to decide if and when another infusion might be needed. 

Does Monoferric have a generic version? 

As of 2025, no generic version of Monoferric (ferric derisomaltose) is available in the United States. It is currently marketed only as the brand-name product Monoferric, developed by Pharmacosmos Therapeutics. However, international versions may exist in other markets. 

Other IV iron formulations like Injectafer, Feraheme, and Venofer are distinct products, not generics of Monoferric. An FDA-approved generic will share the same active ingredient, strength, safety, and effectiveness. Patients should discuss insurance, infusion options, and cost assistance with their healthcare providers. 

Conclusion 

Monoferric (ferric derisomaltose) offers an innovative, single-dose solution for adults struggling with iron deficiency anemia, especially when oral supplements fall short. By delivering iron directly into the bloodstream, it allows the body to rebuild healthy red blood cells efficiently helping restore energy, vitality, and quality of life. 

Monoferric offers a safe and convenient option for anemia, with mild side effects and rare serious reactions. Its benefits include fewer clinic visits and faster symptom relief. Optimal outcomes require patient-provider collaboration, monitoring, and follow-up, helping patients regain strength and resume daily activities. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Monoferric (ferric derisomaltose) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Ferric derisomaltose injection: Uses and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Ferric derisomaltose injection drug information. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). IV iron therapies in the management of iron deficiency anemia. Retrieved from https://www.nih.gov 
     

Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

A Double-blind,Randomized, Placebo-controlled Study to Assess Exercise Tolerance After Iron Repletion With Ferric Derisomaltose (Monoferric®) IV Compared to Placebo in Heart Failure With Preserved Ejection Fraction and With Iron Deficiency.

Summary: The primary objective of this study is to determine if the correction of functional iron deficiency by administering a single dose of intravenous iron (ferric derimaltose or Monoferric®) in participants with heart failure with preserved ejection fraction (HFpEF) will improve exercise capacity as measured by the change in peak oxygen uptake (peak VO2) from baseline to 12 weeks.

Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.

Summary: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortl...

The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial

Summary: The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture The main questions it aims to answer are: It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skelet...

Brand Information

Monoferric (Ferric derisomaltose)
1INDICATIONS AND USAGE
Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:
  • who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)
2DOSAGE FORMS AND STRENGTHS
Monoferric is a sterile, dark brown, non-transparent aqueous solution available as:
  • Injection: 1,000 mg iron/10 mL (100 mg/mL) single-dose vial
  • Injection: 500 mg iron/5 mL (100 mg/mL) single-dose vial
  • Injection: 100 mg iron/mL single-dose vial
3CONTRAINDICATIONS
Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
  • Hypersensitivity Reactions
  • Iron Overload
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
The safety of Monoferric was evaluated in 3008 patients with iron deficiency anemia enrolled in two randomized, actively-controlled trials. Trial 1 enrolled adult patients with iron deficiency anemia with intolerance to oral iron or had an unsatisfactory response to oral iron with a clinical need for repletion of iron stores. Eligible subjects were required to have a baseline hemoglobin of ≤11g/dl, transferrin saturation (TSAT) of less than 20% and serum ferritin level of <100 ng/mL. Trial 2 enrolled adult patients with non-dialysis dependent chronic kidney disease (CKD) with iron deficiency anemia (
4.2Post-marketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been most commonly reported from the post-marketing spontaneous reports with Monoferric:
Cardiac disorders: Tachycardia
Gastrointestinal disorders: Abdominal pain, nausea and vomiting, constipation, diarrhea
General disorders and administration site conditions: Fatigue, pyrexia, chest pain, chills, Fishbane reaction, extravasation, influenza like symptoms, injection site reactions, malaise, pain
Immune System disorders: Anaphylactic/anaphylactoid reaction, hypersensitivity
Investigations: Hepatic enzymes increased
Musculoskeletal and connective tissue disorders: Back pain, muscle spasms, arthralgia, myalgia
Nervous system disorders: Dizziness, headache, paresthesia, dysgeusia, seizure, loss of consciousness, syncope
Psychiatric disorders: Anxiety
Respiratory, thoracic and mediastinal disorders: Dyspnea, cough, bronchospasm
Skin and subcutaneous tissue disorders: Erythema, urticaria, discoloration skin, rash, pruritus, skin exfoliation, angioedema, sweating
Vascular disorders: Hypertension, hypotension, flushing, phlebitis
Extravasation of Monoferric at the injection site that may lead to irritation of the skin and potentially long lasting brown discoloration at the site of injection has also been reported.
5OVERDOSAGE
Excessive dosages of Monoferric may lead to accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Monoferric in patients with iron overload
6DESCRIPTION
Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides.
Ferric derisomaltose has an average molecular weight of 155,000 Da and has the following empirical formula:
{FeO
(C
X = 0.0311; T = 0.25; R = 0.14; Z = 0.49; Y = 0.14
Iron atoms placed in the electronegative cavities of the 3-D structure between and within the derisomaltose molecules. A schematic representation is presented below
Image
Monoferric is a sterile, dark brown, non-transparent aqueous solution with pH 5.0-7.0, containing ferric derisomaltose dissolved in water for injections and filled into Type I glass vials.
Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection, hydrochloric acid and sodium hydroxide may be used to adjust pH.
7CLINICAL STUDIES
The safety and efficacy of Monoferric for treatment of iron deficiency anemia (IDA) were evaluated in two randomized, open-label, actively-controlled clinical trials performed in a total of 3050 patients with IDA of different etiology. Trial 1 included patients with IDA who had intolerance to oral iron or who had had unsatisfactory response to oral iron or for whom there was a clinical need for rapid repletion of iron stores. Trial 2 included patients with IDA who had non-dialysis dependent chronic kidney disease (NDD-CKD). In these two 8-Week trials, patients were randomized 2:1 to treatment with Monoferric or iron sucrose. Monoferric was intravenously administered as a single dose of 1000 mg.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Box
PHARMACOSMOS
MonoFerric
100 mg / mL
FOR INTRAVENOUS INFUSION AFTER DILUTION
5 x 1 mL Single-Dose Vials
PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Box
10PRINCIPAL DISPLAY PANEL - 500 mg/5 mL Vial Box
MonoFerric
500 mg / 5 mL
FOR INTRAVENOUS INFUSION
Rx Only
PRINCIPAL DISPLAY PANEL - 500 mg/5 mL Vial Box
11PRINCIPAL DISPLAY PANEL - 1000 mg/10 mL Vial Box
MonoFerric
1000 mg / 10 mL
FOR INTRAVENOUS INFUSION
Rx Only
PRINCIPAL DISPLAY PANEL - 1000 mg/10 mL Vial Box
12PRINCIPAL DISPLAY PANEL- 10 mL Vial Single Dose
MonoFerric®
1000 mg / 10 mL
FOR INTRAVENOUS INFUSION
Rx Only
PRINCIPAL DISPLAY PANEL - 1000 mg/10 mL Vial  label