Pharmacosmos has a long history of innovation

  • Global, family-owned company focused on innovation in iron metabolism & blood-related disorders
  • Expertise in carbohydrate chemistry & cell cycle biology used to address unmet patient needs
  • 700+ employees worldwide committed to scientific excellence, patient care, and collaborative partnerships

More than 1 billion people live with IDA, making it one of the largest global health challenges of our time1

Monoferric was introduced more than 10 years ago as Monofer in the EU. Monofer is the tradename of Monoferric in most countries outside the US.

Outside the US, Monoferric is measured in 100-mg doses, as it is dosed per body weight. Within the US, Monoferric is measured in 1000-mg vials.

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1 dose of Monoferric vs up to 5 doses of iron sucrose

Safety and efficacy evaluated in two randomized, open-label, noninferiority comparative pivotal trials.2,3

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Complete IV iron replacement in as little as 20 minutes4,a

See dosing & administration

a Intravenous infusion over at least 20 minutes. 
Repeat dose if IDA reoccurs.
Previous
Global Use|Worldwide Experience

IDA=iron deficiency anemia.

References: 1. Pharmacosmos Therapeutics. Our aspiration and values. Accessed October 22, 2025. https://pharmacosmos.us/who-we-are-2/aspiration-and-values 2. Auerbach M, Henry D, Derman RJ, et al. Am J Hematol. 2019;94(9):1007-1014. 3. Bhandari S, Kalra PA, Berkowitz M, et al. Nephrol Dial Transplant. 2021;36:111-120. 4. Monoferric (ferric derisomaltose) Prescribing Information; Pharmacosmos Therapeutics Inc., Morristown, NJ: 2022. 5. Kalra PA. NDT Plus. 2011;4(suppl 1):i10-i13. 6. Data on file. Pharmacosmos Therapeutics, Inc. 7. Wolf M, Rubin J, Achebe M, et al. JAMA. 2020;323(5):432-443. 8. Derman R, Roman E, Modiano MR, et al. Am J Hematol. 2017;92:286-291.

IMPORTANT SAFETY INFORMATION

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

INDICATIONS

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.

ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information.