GNH USA

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.

Request sourcing

1
Pack/s

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.

Frequently asked questions

What is Monofer used for?+
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.
How does ferric derisomaltose work?+
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.
What determines the dose of Monofer?+
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.
Is Monofer safe in pregnancy or breastfeeding?+
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.
How do I order Monofer from GNH USA?+
To order Monofer, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Monofer compare with other IV iron products?+
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.
What are the storage and handling requirements for Monofer?+
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.
How is Monofer administered?+
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.
What are the most serious risks associated with Monofer?+
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.
Who should not receive Monofer?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Ferric Derisomaltose
Route
Intravenous Use
Manufacturer
Pharmacosmos A/S
Origin
EU

Related products