No significant differences in serious or severe hypersensitivity reactions between Monoferric and iron sucrose

Serious or severe hypersensitivity reactions associated with Monoferric were uncommon (0.3%) and were comparable to those with iron sucrose (0.2%) in the FERWON clinical trials2

Incidence of serious or severe hypersensitivity reactions between Monoferric and iron sucrose (co-primary endpoint)3,4

  • Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components1
  • 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 collapse1

FERWON-IDA

Monoferric vs iron sucrose evaluated at 114 US sites3

Randomized, open-label, noninferiority actively controlled pivotal trial in 1512 patients with IDA who had documented intolerance or lack of response to oral iron.3

1512 adult patients with IDA
Selected inclusion criteria

  • Age ≥18 years
  • Hb ≤11 g/dL
  • TSAT <20%
  • s-ferritin <100 ng/mL

Selected baseline demographics

  • Median age, 44 years (range, 18-91)
  • 89% were women
  • Mean Hb level
    • 9.25 g/dL in the Monoferric arm
    • 9.17 g/dL in the iron sucrose arm

1009 randomized to Monoferric

  • 989 received Monoferric
  • One 1000-mg dose
  • IV infusion over at least 20 minutes

Randomized 2:1
503 randomized to iron sucrose

  • 494 received iron sucrose
  • 200 mg per dose
  • Up to 5 doses
  • Iron sucrose was administered as 200-mg undiluted IV injections over approximately 2 to 5 minutes and repeated according to standard practice or physician’s choice up to a maximum of 5 times within the first 2 weeks starting at baseline. A cumulative dose of 1000 mg was recommended

Co-primary endpoints1

  • Incidence of adjudicated serious or severe hypersensitivity reactions from baseline to Week 8
  • Change in Hb from baseline to Week 8

Selected secondary endpoints3

  • Change in Hb from baseline to weeks 1, 2, and 4
  • Change in ferritin and TSAT from baseline to weeks 1, 2, 4, and 8
  • Hb increase ≥2 g/dL
  • Change in fatigue symptoms measured by FACIT–Fatigue Scale from baseline to Week 8

FACIT=Functional Assessment of Chronic Illness Therapy; IDA=iron deficiency anemia; IV=intravenous; s-ferritin=serum ferritin; TSAT=transferrin saturation.

FERWON-NEPHRO

Monoferric vs iron sucrose evaluated at 143 US sites4

Randomized, open-label, noninferiority, actively controlled pivotal trial in 1538 patients with IDA and NDD-CKD (eGFR <60 mL/min).4

1538 adult patients with IDA and NDD-CKD

Selected inclusion criteria

  • Age ≥18 years
  • Hb ≤11 g/dL
  • s-ferritin ≤100 ng/mL (or ≤300 ng/mL if TSAT ≤30%)
  • Chronic renal impairment defined as either:
    • eGFR <60 mL/min/1.73 m2
    • eGFR <90 mL/min/1.73 m2 at screening and kidney damage and/or immediate/high risk of CVD
  • Either no ESAs or ESAs at a stable dose (±20%) for 4 weeks before randomization

Selected baseline characteristics

  • Median age, 69 years (range, 25-97)
  • 63% were women
  • Mean Hb level
    • 9.66 g/dL in the Monoferric arm
    • 9.71 g/dL in the iron sucrose arm

Randomized 2:1
511 randomized to iron sucrose

  • 506 received iron sucrose
  • 200 mg per dose
  • Up to 5 doses
  • Iron sucrose was administered as 200-mg undiluted IV injections over approximately 2 to 5 minutes and repeated according to standard practice or physician’s choice up to a maximum of 5 times within the first 2 weeks starting at baseline. A cumulative dose of 1000 mg was recommended

1027 randomized to Monoferric

  • 1019 received Monoferric
  • One 1000-mg dose
  • IV infusion over at least 20 minutes

Co-primary endpoints4

  • Incidence of adjudicated serious or severe hypersensitivity reactions from baseline to Week 8
  • Change in Hb from baseline to Week 8

Selected secondary endpoints4

  • Change in Hb from baseline to weeks 1, 2, and 4
  • Change in ferritin and TSAT from baseline to weeks 1, 2, 4, and 8
  • Hb increase ≥1 g/dL from baseline to weeks 1, 2, 4, and 8

CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; ESA=erythropoiesis-stimulating agent; IDA=iron deficiency anemia; IV=intravenous; NDD-CKD=nondialysis-dependent chronic kidney disease; s-ferritin=serum ferritin; TSAT=transferrin saturation.

Previous
Safety|Hypophosphatemia in IDA

IDA=iron deficiency anemia.

References: 1. Monoferric (ferric derisomaltose) Prescribing Information; Pharmacosmos Therapeutics Inc., Morristown, NJ: 2022. 2. Data on file. Pharmacosmos Therapeutics Inc. 3. Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. Am J Hematol. 2019;94(9):1007-1014. 4. Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Nephrol Dial Transplant. 2021;36(1):111-120. 5. Wolf M, Rubin J, Achebe M, et al. JAMA. 2020;323(5):432-443. 6. Kaur J, Castro D. Hypophosphatemia. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025. Accessed March 5, 2026. https://www.ncbi.nlm.nih.gov/books/NBK493172/ 7. Zoller H, Wolf M, Blumenstein I, et al. Gut. 2023;72(4):644-653. 8. Ozer NT, Can Sezgin G, Sahin Ergul S, et al. J Gastrointestin Liver Dis. 33(3):323-329.

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.