Complete IV iron replacement in just one dose

Only Monoferric is FDA-approved as a single, rapid iron infusion, regardless of patient weight1,a

For patients weighing 50 kg or more: Administer 1000 mg of Monoferric by intravenous infusion ≥20 minutes as a single dose.1

For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion ≥20 minutes as a single dose.1

  • Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reaction1
  • Repeat Monoferric treatment if iron deficiency anemia reoccurs1
  • 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 infusion1
a Monoferric is administered as a single, 1-g IV infusion for patients weighing ≥50 kg, or 20 mg/kg for patients <50 kg, over ≥20 minutes. Repeat dose if iron deficiency anemia reoccurs. Patients should be monitored for an additional 30 minutes post-infusion.

FDA=US Food and Drug Administration.

References: 1. Monoferric (ferric derisomaltose) Prescribing Information; Pharmacosmos Therapeutics Inc., Morristown, NJ: 2022. 2. Data on file. Pharmacosmos Therapeutics Inc. 3. Page RD, Narang M, Polson M. Management of iron deficiency anemia in oncology: intravenous iron discordance in cancer patients. Poster presented at: AMCP 2024; April 15-18, 2024; New Orleans, LA. 4. Upadhyay A, Polson M. Intravenous iron treatment considerations in patients with non-dialysis dependent chronic kidney disease. Poster presented at: AMCP 2024; April 15-18, 2024; New Orleans, LA. 5. Fudim M, Burkle J, Polson M. Managing iron deficiency anemia with heart failure: impact of intravenous iron selection. Poster presented at: ACC 2024; April 6-8, 2024; Atlanta, GA.

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.