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 a solution for injection for intravenous use. It treats iron deficiency anemia in adults, including cases related to chronic kidney disease, inflammatory bowel disease, and post‑operative or postpartum blood loss.

GNH India supplies Monofer as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, with distribution networks across Europe, Asia, the Middle East and Africa, ensuring timely delivery.

Manufacturer / TM Owner

Pharmacosmos A/S

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Indications & Clinical Uses

Monofer is used to treat iron deficiency anemia by providing intravenous iron to patients who cannot receive or absorb oral iron.

  • Iron deficiency anemia in adults: restores hemoglobin levels and replenishes iron stores.
  • Anemia of chronic kidney disease: improves iron availability for erythropoiesis in CKD patients.
  • Anemia related to inflammatory bowel disease: corrects iron loss and malabsorption associated with IBD.
  • Post‑operative or postpartum anemia: rapidly repletes iron after surgical blood loss or childbirth.

How It Works

  • Ferric derisomaltose is a stable iron‑carbohydrate complex that, after intravenous infusion through the bloodstream, is rapidly taken up by the reticuloendothelial system. Within macrophages the complex releases bioavailable iron in a controlled manner, avoiding free labile iron. The iron then binds to transferrin and is incorporated into hemoglobin and other iron‑dependent proteins, supporting erythropoiesis and cellular metabolism while bypassing gastrointestinal absorption.

Side Effects

Ferric derisomaltose may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate feeling of sickness.
  • Headache: transient cranial discomfort.
  • Injection site reactions: pain, erythema or swelling at the infusion site.
  • Transient hypotension: temporary drop in blood pressure during or shortly after infusion.

Serious or Rare Side Effects

  • Anaphylactic reaction: severe allergic response requiring immediate medical attention.
  • Hypophosphatemia: significant drop in serum phosphate levels that may cause muscle weakness or cardiac issues.

Precautions & Warnings

When using Monofer, clinicians should observe several precautionary measures to ensure patient safety and product integrity.

  • Assess iron status: confirm iron deficiency and evaluate ferritin and transferrin saturation before administration.
  • Monitor for hypersensitivity: observe patients during infusion for signs of allergic reaction.
  • Check renal function: adjust use in patients with severe renal impairment.
  • Avoid rapid infusion: administer at recommended rate to reduce risk of hypotension.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ferric derisomaltose can interact with certain medicines, influencing iron availability or increasing adverse reaction risk.

Major Interactions (Avoid)

  • Concurrent IV iron products: may cause iron overload.
  • Erythropoiesis‑stimulating agents: combined use can exacerbate hypertension.

Moderate Interactions (Monitor Closely)

  • Oral phosphate binders: may reduce iron absorption if given shortly after infusion.
  • Antacids containing magnesium or aluminum: can affect serum iron measurements.
  • Certain antibiotics (e.g., tetracyclines, fluoroquinolones): iron can chelate and reduce antibiotic efficacy.

Frequently Asked Questions

Monofer is an intravenous iron formulation indicated for the treatment of iron deficiency anemia in adults, including anemia associated with chronic kidney disease, inflammatory bowel disease, and anemia that occurs after surgery or childbirth.

Ferric derisomaltose is a stable iron‑carbohydrate complex that, after IV infusion, is taken up by the reticuloendothelial system. It releases bioavailable iron that binds to transferrin, allowing incorporation into hemoglobin and other iron‑dependent proteins to support red blood cell production.

The dose of Monofer is individualized by the prescribing clinician based on the patient’s iron deficiency severity, body weight, hemoglobin level, and calculated iron deficit. No fixed regimen is provided; the prescriber calculates the appropriate total iron requirement.

Safety data for ferric derisomaltose in pregnancy and lactation are limited. It should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and after careful consideration by the treating physician.

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, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and import documentation.

Monofer delivers a large iron dose in a single infusion, similar to ferric carboxymaltose, but uses a distinct iron‑carbohydrate complex that releases iron more gradually. Compared with iron sucrose, Monofer requires fewer administrations, which can improve convenience and reduce infusion‑related discomfort.

Monofer should be stored refrigerated between 2 °C and 8 °C. Keep the vial in its original packaging, protect it from light, and do not freeze or shake the solution. If temperature excursions occur, discard the product according to local regulations.

Monofer is given as an intravenous infusion. The recommended infusion rate is typically 0.5 mg of iron per kilogram of body weight per minute, but the exact rate should follow the prescribing information and be adjusted for patient tolerance.

The most serious adverse events include anaphylactic or severe hypersensitivity reactions, profound hypotension during infusion, and clinically significant hypophosphatemia, which may lead to muscle weakness or cardiac complications. Immediate medical intervention is required if these occur.

Monofer is contraindicated in patients with known hypersensitivity to ferric derisomaltose or any component of the formulation, as well as in individuals with active severe infections or uncontrolled hypertension. Caution is also advised for patients with severe renal impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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