Product image of Monofer (Ferric Derisomaltose) supplied by GNH India

Monofer

Active Ingredient:
Ferric Derisomaltose
Origin:
EU

Monofer (Ferric Derisomaltose)

Ferric derisomaltose, the active ingredient in Monofer, is an iron supplement presented as an intravenous solution for intravenous administration. It provides bioavailable iron for patients with iron deficiency anemia, including those with chronic kidney disease or postoperative blood loss, enabling rapid restoration of hemoglobin levels.

GNH India supplies Monofer as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, ensuring consistent quality, regulatory compliance, and patient safety through rigorous quality control across global markets.

Manufacturer / TM Owner

Pharmacosmos A/S

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Monofer is used to treat iron deficiency anemia by replenishing iron stores via the intravenous route.

  • Iron deficiency anemia: rapid correction of hemoglobin and replenishment of iron stores.
  • Chronic kidney disease‑related anemia: provides intravenous iron for patients on dialysis or with reduced oral absorption.
  • Peri‑operative or postpartum anemia: restores iron levels when rapid repletion is required.

How It Works

  • Ferric derisomaltose forms a stable iron‑carbohydrate complex that remains bound in the plasma until cellular uptake. The complex is endocytosed by reticulo‑endothelial macrophages, where iron is released and transferred to transferrin for delivery to the bone marrow and other iron‑dependent tissues, supporting hemoglobin synthesis.

Side Effects

Monofer may cause adverse reactions ranging from mild to severe.

Common Side Effects

  • Nausea: mild gastrointestinal discomfort.
  • Headache: transient cranial pain.
  • Injection site reactions: erythema, pain or swelling at the infusion site.
  • Hypotension: transient drop in blood pressure during infusion.

Serious or Rare Side Effects

  • Anaphylactic reaction: severe allergic response requiring emergency treatment.
  • Hypersensitivity syndrome: rash, fever, eosinophilia.
  • Acute iron overload: signs of organ toxicity due to excess iron.
  • Thromboembolic events: rare clot formation.

Precautions & Warnings

Before using Monofer, consider the following precautions to ensure safe administration.

  • Assess iron status: confirm iron deficiency anemia and evaluate ferritin and transferrin saturation.
  • Monitor hemoglobin: check baseline and follow‑up levels to avoid excessive rise.
  • Screen for hypersensitivity: avoid use in patients with known allergy to ferric derisomaltose or other IV iron products.
  • Use with caution in cardiac disease: monitor for hypotension or arrhythmias during infusion.
  • Avoid in active infection: defer infusion until infection is controlled.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Monofer can interact with certain medicines, affecting iron metabolism or infusion safety.

Major Interactions (Avoid)

  • Erythropoiesis‑stimulating agents (ESAs): concurrent use may increase risk of hypertension and cardiovascular events.
  • High‑dose vitamin C: may enhance free iron release, increasing oxidative stress.

Moderate Interactions (Monitor Closely)

  • Oral iron supplements: may reduce absorption of ferric derisomaltose if given concurrently; separate administration times.
  • Antacids containing aluminum or magnesium: can affect iron complex stability; schedule apart from infusion.
  • Certain antibiotics (e.g., tetracyclines, fluoroquinolones): may chelate iron and reduce efficacy.

Frequently Asked Questions

Monofer is an intravenous iron preparation indicated for the treatment of iron deficiency anemia, especially in patients who cannot tolerate or have not responded to oral iron therapy. It is commonly used in chronic kidney disease, postoperative settings, and other conditions requiring rapid iron repletion.

Ferric derisomaltose delivers iron in a stable carbohydrate complex that circulates in the bloodstream. The complex is taken up by macrophages, where iron is released and bound to transferrin, the transport protein that delivers iron to the bone marrow for hemoglobin synthesis and to other iron‑dependent tissues.

The prescribed dose of Monofer is individualized by the treating clinician based on the patient’s total iron deficit, body weight, hemoglobin level, and clinical condition. The prescriber calculates the required amount of iron to safely correct the deficiency and monitors response during therapy.

Safety data for ferric derisomaltose in pregnancy and lactation are limited. The product should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To order Monofer, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling if needed), and necessary import documentation.

Monofer delivers a large, single‑dose infusion of iron with a stable iron‑carbohydrate complex, allowing rapid repletion with fewer administrations compared with some older IV iron formulations. Its low‑reactivity profile reduces the risk of acute reactions, but clinicians still consider patient‑specific factors when selecting an IV iron product.

Monofer should be stored at 2 °C to 8 °C (refrigerated). Keep the vial in its original packaging, protect it from light, and do not freeze or shake the solution. If the product reaches room temperature, it should be used promptly and not returned to refrigeration.

Monofer is given as an intravenous infusion. The vial is diluted with an appropriate compatible solution and administered through a peripheral or central line over a period determined by the prescriber, typically ranging from a few minutes to an hour, while monitoring the patient for any adverse reactions.

The most serious risks include severe hypersensitivity reactions such as anaphylaxis, acute iron overload leading to organ toxicity, and rare thromboembolic events. Immediate medical attention is required if signs of an allergic reaction, sudden hypotension, or unexplained chest pain occur during or after infusion.

Monofer is contraindicated in patients with known hypersensitivity to ferric derisomaltose or any component of the formulation. It should also be avoided in individuals with active severe infections, uncontrolled cardiac disease, or those who have experienced previous severe reactions to other intravenous iron products.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.