Europe — EMA
Monofer (Ferric Derisomaltose)
GNH USA supplies Monofer (Ferric Derisomaltose), an IV iron supplement for iron deficiency anemia in adults, including CKD cases. Request a quote for supply.
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What is 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 USA 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.
What is Ferric Derisomaltose used for?
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.
What are the side effects of Ferric Derisomaltose?
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.
What precautions apply to Ferric Derisomaltose?
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.
What does Ferric Derisomaltose interact with?
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.



