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EFFICACY & SAFETY
MONOFERRIC VS FERRIC CARBOXYMALTOSE

THE PHOSPHARE TRIALS REPORTED A SIGNIFICANTLY LOWER INCIDENCE OF HYPOPHOSPHATEMIA WITH MONOFERRIC VS FERRIC CARBOXYMALTOSE

Two identical, randomized (1:1), open-label, comparative trials in 245 patients total across two trials 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 was administered at 750 mg on Day 0 and 750 mg on Day 7. See full study design below.

Pooled incidence of hypophosphatemia (<2.0 mg/dL) in the Phosphare Trials (primary endpoint)5

200406080100Patients with Hypophosphatemia, %AnyPostbaselineDay 0Day 1Day 7Day 8Day 14Day 21Day 3541200/1250/1170/1201109Monoferric1000 mg doseFerric carboxymaltose1500 mg total dose10/12587/117381136/11646/1104/1162/1101/11771/10956/11149/114Infusion:Ferric carboxymaltose, 750 mgMonoferric, 100 0 mgInfusion:Ferric carboxymaltose, 750 mg

Percentage of patients with hypophosphatemia from baseline to Day 35:

  • Trial A: 7.9% with Monoferric vs 75.0% with ferric carboxymaltose [adjusted rate difference, –67.0% {95% CI, –77.4% to –51.5%}]
  • Trial B: 8.1% with Monoferric vs 73.7% with ferric carboxymaltose [adjusted rate difference, –65.8% {95% CI, –76.6% to –49.8%}]
  • Pooled Data: 8.0% with Monoferric vs 74.4% with ferric carboxymaltose [adjusted rate difference, –68.3% {95% CI, –76.5% to –56.5%}]

Post Hoc Analysis: Pooled incidence of severe hypophosphatemia (≤1.0 mg/dL)

Post Hoc Analysis:
Pooled incidence
of severe hypophosphatemia (≤1.0 mg/dL)

Percentage of patients
with hypophosphatemia
from baseline to Day 35:

  • Trial A: 7.9% with Monoferric vs 75.0% with ferric carboxymaltose [adjusted rate difference, –67.0% {95% CI, –77.4% to –51.5%}]
  • Trial B: 8.1% with Monoferric vs 73.7% with ferric carboxymaltose [adjusted rate difference, –65.8% {95% CI, –76.6% to –49.8%}]
  • Pooled Data: 8.0% with Monoferric vs 74.4% with ferric carboxymaltose [adjusted rate difference, –68.3% {95% CI, –76.5% to –56.5%}]

Study limitations

The 2 trials enrolled mostly women with iron-deficiency anemia due to gynecological bleeding, who tend to have higher rates of hypophosphatemia. This likely explains the higher than anticipated incidence of hypophosphatemia following ferric carboxymaltose treatment. Trials did not measure clinical outcome.

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PHOSPHARE STUDY

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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.

References:

  1. Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. Am J Hematol. 2019;94(9):1007‐1014.
  2. Data on File. 2021. Pharmacosmos Therapeutics Inc.
  3. Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Nephrol Dial Transplant. 2021;36(1):111-120.
  4. Monoferric (ferric derisomaltose) Prescribing Information; Pharmacosmos Therapeutics Inc., Morristown, NJ: 2022.
  5. Wolf M, Rubin J, Achebe M, et al. JAMA. 2020;323(5):432‐443.

IMPORTANT SAFETY INFORMATION + -

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.

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