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

Monofar

Active Ingredient:
Ferric Derisomaltose
Origin:
EU

Monofar (Ferric Derisomaltose)

Ferric derisomaltose, the active ingredient in Monofar, is an iron supplement presented as a solution for injection for intravenous use. It treats iron deficiency anemia and related anemic conditions in patients who require parenteral iron therapy.

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

Manufacturer / TM Owner

Pharmacosmos A/S

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Indications & Clinical Uses

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

  • Iron deficiency anemia: restores hemoglobin levels and replenishes body iron stores.
  • Anemia associated with chronic kidney disease: improves iron availability for erythropoiesis in CKD patients.
  • Anemia in inflammatory bowel disease: corrects iron deficiency when oral iron is ineffective.

How It Works

  • Ferric derisomaltose is a stable iron‑carbohydrate complex that is rapidly taken up by the reticuloendothelial system after intravenous administration. The complex releases elemental iron, which is then incorporated into hemoglobin within developing red blood cells, supporting normal erythropoiesis and correcting iron‑deficiency anemia.

Side Effects

Adverse reactions may occur with any intravenous iron product.

Common Side Effects

  • Nausea
  • Headache
  • Infusion‑site pain or erythema
  • Dizziness
  • Transient hypotension
  • Metallic taste in the mouth

Serious or Rare Side Effects

  • Anaphylactic or severe hypersensitivity reactions
  • Acute respiratory distress syndrome
  • Severe hypotension or shock
  • Marked elevation of serum ferritin or iron overload
  • Hemolysis
  • Severe skin rash or urticaria

Precautions & Warnings

When using Monofar, clinicians should observe several safety measures.

  • Assess iron status before administration: confirm diagnosis of iron deficiency anemia.
  • Monitor hemoglobin and ferritin levels: adjust therapy based on laboratory response.
  • Observe for hypersensitivity during infusion: be prepared to manage reactions.
  • Use caution in patients with active infection: iron may promote bacterial growth.
  • Avoid in patients with known hypersensitivity to ferric derisomaltose or its excipients.
  • 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 status.

Major Interactions (Avoid)

  • Concurrent use with other intravenous iron products: risk of iron overload.
  • Co‑administration with erythropoiesis‑stimulating agents: may increase hypertension risk.
  • High‑dose parenteral vitamin C: can increase free iron and oxidative stress.

Moderate Interactions (Monitor Closely)

  • Oral iron supplements given simultaneously: may affect absorption; separate dosing times.
  • Antacids containing aluminum or magnesium: may bind iron and reduce efficacy.

Frequently Asked Questions

Monofar is an intravenous iron formulation containing ferric derisomaltose. It is used to treat iron deficiency anemia, including anemia associated with chronic kidney disease and inflammatory bowel disease, when oral iron therapy is insufficient or not tolerated.

Ferric derisomaltose is a stable iron‑carbohydrate complex that, after intravenous infusion, is taken up by the reticuloendothelial system. The complex releases elemental iron, which is incorporated into hemoglobin during red‑cell production, thereby correcting iron deficiency.

The dose of Monofar is individualized. The prescribing clinician determines the total iron requirement based on the patient’s weight, hemoglobin level, and iron deficit, and then calculates the appropriate infusion volume.

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

To order Monofar, 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 where required) and import documentation.

Monofar (ferric derisomaltose) delivers a high dose of elemental iron in a single infusion with a low incidence of free‑iron reactions, compared with some older iron sucrose or iron dextran formulations that may require multiple administrations or have higher hypersensitivity rates.

Monofar should be stored at 2‑8 °C, protected from light, and must not be frozen or shaken. Keep the vial in its original packaging until use to maintain stability.

Monofar is given as an intravenous infusion. The solution is administered through a suitable IV line over the period recommended by the prescriber, typically ranging from a few minutes to an hour, depending on the total dose.

Serious risks include severe hypersensitivity reactions such as anaphylaxis, acute respiratory distress, and significant hypotension. Clinicians should monitor patients closely during and after the infusion and be prepared to manage these events.

Monofar is contraindicated in patients with known hypersensitivity to ferric derisomaltose or any of its excipients, and it should be used with caution in individuals with active infections, severe cardiac disease, or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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