Europe — EMA
Monofar (Ferric Derisomaltose)
GNH USA supplies Monofar (Ferric derisomaltose), an iron supplement for iron deficiency anemia, anemia of chronic kidney disease, and anemia in inflammatory
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What is 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 USA supplies Monofar as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.
What is Ferric Derisomaltose used for?
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.
What are the side effects of Ferric Derisomaltose?
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
What precautions apply to Ferric Derisomaltose?
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.
What does Ferric Derisomaltose interact with?
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.



