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 intravenous iron supplement presented as an injection solution for intravenous use. It is used to treat iron deficiency anemia in adults, including patients with chronic kidney disease or those requiring rapid iron repletion.
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

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Indications & Clinical Uses

Monofer is an intravenous iron formulation indicated for conditions involving iron deficiency and related anemia.

  • Iron deficiency anemia: restores hemoglobin levels and replenishes depleted iron stores.
  • Chronic kidney disease‑associated anemia: provides intravenous iron when oral supplementation is ineffective or not tolerated.
  • Perioperative anemia: rapidly corrects iron deficiency before surgery to reduce transfusion requirements.

How It Works

  • Ferric derisomaltose delivers a stable ferric iron complex that is taken up by the reticuloendothelial system. Within macrophages, the complex releases iron, which is then transferred to transferrin for incorporation into hemoglobin synthesis, thereby correcting iron deficiency and supporting erythropoiesis.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset after infusion.
  • Headache: transient headache during or shortly after administration.
  • Dizziness: feeling light‑headed, especially with rapid infusion.
  • Injection site reactions: pain, erythema, or swelling at the infusion site.
  • Transient hypotension: temporary drop in blood pressure during infusion.
  • Metallic taste: brief metallic sensation in the mouth.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Severe hypotension: marked blood pressure decline that may need intervention.
  • Iron overload: excessive iron accumulation leading to organ toxicity.
  • Acute respiratory distress: sudden breathing difficulty post‑infusion.
  • Cardiac arrest: rare but life‑threatening cardiac event.
  • Stevens‑Johnson syndrome: severe skin and mucous membrane reaction.

Precautions & Warnings

Monofer should be administered only after confirming iron deficiency and evaluating the need for intravenous iron.

  • Assess iron status: verify ferritin and transferrin saturation before infusion.
  • Monitor hemoglobin: check levels during treatment to avoid excess iron.
  • Caution in hypersensitivity: avoid in patients with known allergy to ferric derisomaltose or other IV iron products.
  • Avoid during active infection: defer treatment if the patient has uncontrolled infection.
  • Observe during infusion: monitor blood pressure and signs of reaction throughout the administration.
  • 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 cause additive adverse effects.

Major Interactions (Avoid)

  • Concurrent IV iron products: increases risk of iron overload and severe reactions.
  • Known severe allergy to ferric derisomaltose or iron dextran: may precipitate anaphylaxis.
  • High‑dose vitamin C administered intravenously: can increase free iron and oxidative stress.

Moderate Interactions (Monitor Closely)

  • Erythropoiesis‑stimulating agents: may amplify blood pressure elevation.
  • Antihypertensive drugs: monitor for additive hypotensive effects during infusion.
  • Oral iron supplements: stagger dosing to prevent gastrointestinal irritation.

Frequently Asked Questions

Monofer is an intravenous iron formulation used to treat iron deficiency anemia in adults, including patients with chronic kidney disease or those who need rapid iron repletion before surgery.

Ferric derisomaltose delivers a stable ferric iron complex to the reticuloendothelial system, where it releases iron for binding to transferrin and incorporation into hemoglobin, thereby correcting iron deficiency.

The prescribed dose of Monofer is determined by the treating physician based on the patient’s iron deficit, body weight, and clinical condition. The regimen is individualized and not standardized.

The safety of Monofer in pregnancy and lactation has not been fully established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and under medical supervision.

To order Monofer, submit an enquiry on the product page at gnhindia.com with 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 if needed) and import documentation.

Monofer (ferric derisomaltose) offers a high‑dose, single‑visit administration option, reducing the number of infusions compared with some older IV iron formulations that require multiple smaller doses.

Monofer must be stored at 2‑8 °C, kept refrigerated, protected from light, and must not be frozen or shaken. Use aseptic technique when preparing the injection solution.

Monofer is given as an intravenous infusion. The infusion rate and total dose are set by the prescribing clinician and administered by qualified healthcare personnel in a controlled setting.

Serious risks include anaphylaxis, severe hypotension, iron overload, acute respiratory distress, and rare severe skin reactions such as Stevens‑Johnson syndrome. Immediate medical attention is required if these occur.

Monofer should not be used in patients with known hypersensitivity to ferric derisomaltose or other intravenous iron products, in those with active uncontrolled infections, or in individuals with severe anemia due to causes other than iron deficiency without appropriate evaluation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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