PHOSPHARE-IDA trials: Significantly lower incidence of hypophosphatemia with Monoferric vs FCM

Two identical, randomized (1:1) open-label comparative trials in 245 patients with IDA and intolerance or unresponsiveness to oral iron. Monoferric was administered as a single dose of 1000 mg infused over 20 minutes on Day 0. Ferric carboxymaltose (FCM) was administered at 750 mg on Day 0 and 750 mg on Day 7.5 See full study design below.

Pooled incidence of hypophosphatemia (<2.0 mg/dL) in the PHOSPHARE-IDA trials (primary endpoint)5

PHOSPHARE-IDA

Monoferric vs FCM evaluated at 30 US sites5

Two identical, randomized open-label clinical trials in 245 patients with IDA and intolerance or unresponsiveness to oral iron.5

245 adult patients with IDA

Trial A: 123 patients with IDA
Trial B: 122 patients with IDA

Selected inclusion criteria

  • Age ≥18 years
  • Hb ≤11 g/dL
  • s-ferritin <100 ng/mL
  • A history of intolerance or unresponsiveness to 1 month or more of oral iron

Selected baseline demographics

Trial A: mean age, 45.1 years; 95.9% women
Trial B: mean age, 42.6 years; 94.1% women

Selected exclusion criteria

  • Patients with reduced kidney function

Randomized 1:1
117 in the pooled FCM group

Trial A: 60
Trial B: 57

  • 750 mg per dose on day 0 and day 7
  • 2 doses (1500 mg total)

125 in the pooled Monoferric group

Trial A: 63
Trial B: 62

  • One 1000-mg dose at day 0
  • IV infusion over at least 20 minutes

Co-primary endpoints1

  • Incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) between baseline and day 35

FCM=ferric carboxymaltose; IDA=iron deficiency anemia; IV=intravenous; s-ferritin=serum ferritin.

Percentage of patients with hypophosphatemia from baseline to day 35: Pooled data: 8.0% with Monoferric vs 74.4% with FCM (adjusted rate difference, -68.3% [95% CI: -76.5% to -56.5%])1

Post hoc analysis: Pooled incidence of severe hypophosphatemia (≤1.0 mg/dL)5

1 infusion of Monoferric can provide a full course of therapy compared to 2 infusions of FCM and resulted in a significantly lower incidence of hypophosphatemia in the PHOSPHARE-IDA trials5,a

A serum phosphate level ≤1 mg/dL constitutes severe hypophosphatemia and requires urgent medical attention. This condition may result in respiratory failure, cardiac dysfunction, neurologic complications, and muscle weakness; hospitalization and IV phosphate replacement are advised.6

Study limitations: The two trials enrolled mostly women with IDA due to gynecologic bleeding, who tend to have higher rates of hypophosphatemia. This likely explains the higher than anticipated incidence of hypophosphatemia following FCM treatment. Trials did not measure clinical outcome.

See the full PHOSPHARE Study

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FCM=ferric carboxymaltose; IDA=iron deficiency anemia.

a The PHOSPHARE-IDA clinical trials compared the incidence of hypophosphatemia with Monoferric vs that with FCM. Efficacy and anemia outcomes were not evaluated. Repeat the dose of Monoferric if IDA reoccurs.

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.