OVERVIEW, IMPORTANT SAFETY INFORMATION, AND INDICATIONS

CLINICAL DATA OVERVIEW

The approval of Monoferric for treatment of iron deficiency anemia (IDA) was supported by two randomized, open-label, actively-controlled clinical trials (FERWON Trials) performed in a total of 3050 patients with IDA of different etiologies. In FERWON-IDA and FERWON-NEPHRO, Monoferric was shown to be non-inferior to iron sucrose (IS) in Hb change from baseline to Week 8. There were no significant differences in serious or severe hypersensitivity reactions between Monoferric and iron sucrose (co-primary endpoint). Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in FERWON-IDA and FERWON-NEPHRO.

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.

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)

Please see Full Prescribing Information.

US-FDI-2400033