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 injectable solution for intravenous use. It treats iron deficiency anemia by providing elemental iron for incorporation into hemoglobin in patients with insufficient iron stores.

GNH India supplies Monofer as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

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 an intravenous iron preparation used to correct iron deficiency in several clinical settings.

  • Iron deficiency anemia (IDA): restores hemoglobin levels and replenishes iron stores in patients with insufficient iron.
  • Chronic kidney disease‑related anemia: provides intravenous iron to support erythropoiesis when oral iron is ineffective.
  • Pre‑operative anemia: corrects iron deficiency before surgery to reduce the need for blood transfusion.

How It Works

  • Ferric derisomaltose forms a stable iron‑carbohydrate complex that is taken up by the reticuloendothelial system after intravenous infusion. The complex is processed within macrophages, releasing elemental iron that binds to transferrin and becomes available for incorporation into hemoglobin during erythropoiesis, thereby correcting iron deficiency.

Side Effects

Common Side Effects

  • Nausea: mild to moderate feeling of stomach upset.
  • Headache: transient headache occurring during or shortly after infusion.
  • Injection site reactions: redness, swelling, or discomfort at the infusion site.
  • Dizziness: temporary light‑headedness during administration.
  • Mild hypotension: slight drop in blood pressure, usually self‑limiting.
  • Flushing: brief warmth or reddening of the skin.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Severe hypotension: marked blood pressure drop that may need intervention.
  • Hypersensitivity reactions: rash, bronchospasm, or angioedema.
  • Iron overload: excessive iron accumulation with potential organ damage.
  • Acute respiratory distress: difficulty breathing during or after infusion.

Precautions & Warnings

Monofer should be administered only after confirming iron deficiency and evaluating the patient’s overall clinical status.

  • Assess iron status before administration: confirm diagnosis of iron deficiency anemia.
  • Monitor for hypersensitivity: observe the patient during and after infusion for allergic reactions.
  • Avoid rapid infusion rates: follow recommended infusion guidelines to reduce hypotension risk.
  • Use with caution in patients with cardiac disease: monitor cardiovascular status closely.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ferric derisomaltose may interact with other agents that affect iron metabolism or cardiovascular stability.

Major Interactions (Avoid)

  • Concurrent use of other IV iron products: increases risk of iron overload.
  • Co‑administration with erythropoiesis‑stimulating agents without iron monitoring: may exacerbate hypertension.
  • High‑dose vitamin C: enhances free iron levels, raising oxidative stress risk.

Moderate Interactions (Monitor Closely)

  • Oral iron supplements: can interfere with laboratory assessment of iron parameters.
  • Antihypertensive drugs: monitor blood pressure as infusion may cause transient hypotension.

Frequently Asked Questions

Monofer is an intravenous iron formulation used to treat iron deficiency anemia, including cases related to chronic kidney disease, pre‑operative anemia, or intolerance to oral iron. It provides elemental iron directly into the bloodstream, allowing rapid replenishment of iron stores and support of hemoglobin synthesis.

Ferric derisomaltose is a stable iron‑carbohydrate complex that, after intravenous infusion, is taken up by the reticuloendothelial system. Inside macrophages the complex releases elemental iron, which binds to transferrin and becomes available for incorporation into hemoglobin, thereby correcting iron deficiency.

The dose of Monofer is individualized by the prescribing clinician based on the patient’s iron deficit, body weight, and clinical condition. The prescriber determines the total iron amount required and the infusion rate according to approved guidelines and the product’s prescribing information.

Safety data for ferric derisomaltose in pregnancy and lactation are limited. The product should be used only if the potential benefit justifies any potential risk to the fetus or infant, and the decision should be made by the treating physician after careful assessment.

To order Monofer, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain if needed), and import documentation.

Monofer (ferric derisomaltose) delivers a high dose of elemental iron in a single infusion, reducing the number of administrations compared with some older IV iron formulations. Its stable complex allows controlled release, which may lower the incidence of acute reactions relative to less stable iron dextran products.

Monofer must be stored at 2‑8 °C (refrigerated). Keep the vial in its original packaging, protect it from light, and do not freeze or shake the solution. Before use, inspect the product for particulate matter or discoloration and discard if any abnormalities are observed.

Monofer is administered as an intravenous infusion by a qualified healthcare professional. The vial is diluted according to the prescribing information and infused over the recommended time period, typically ranging from a few minutes to an hour, depending on the total iron dose prescribed.

Serious risks include anaphylactic or severe hypersensitivity reactions, marked hypotension, and iron overload if excessive doses are given. Patients should be monitored during and after infusion for signs of allergic response, blood pressure changes, and any unexpected symptoms.

Monofer should not be used in patients with known hypersensitivity to ferric derisomaltose or any component of the formulation, and it is contraindicated in individuals with active systemic infections where iron could exacerbate bacterial growth. Caution is also advised in patients with uncontrolled cardiac disease.

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.