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IV IRON REPLACEMENT IN
JUST ONE DOSE*

*Intravenous infusion over at least 20 minutes.
    Repeat dose if iron deficiency anemia reoccurs.

Only Monoferric is FDA approved for
a single, 1000 mg, rapid infusion

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients1:

  • Who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • Who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

INNOVATIVE MATRIX CONTROLS BIOAVAILABLE IRON RELEASE

Monoferric is the ONLY 1000 mg IV IRON THAT IS FDA APPROVED FOR ONE INFUSION ≥20 MINUTES* that delivers a slow and controlled release of bioavailable iron for patients with IDA.1,2

*Repeat dose if iron deficiency anemia reoccurs.

MORE THAN 10 YEARS OF INTERNATIONAL EXPERIENCE IN THE HIGH DOSE IV IRON MARKETPLACE

Monoferric was introduced 10 years ago as Monofer® in the EU. Over 16 million doses have been administered ex-US since launch, and it is available in more than 30 countries.

The safety and efficacy of Monoferric for treatment of iron deficiency anemia (IDA) were evaluated in two randomized, open-label, non-inferiority, actively controlled clinical trials performed in a total of 3050 patients with IDA of different etiology.3,4

SEE THE RESULTS

Artist rendition

INNOVATIVE IRON MATRIX STRUCTURE

Monoferric has a complex matrix structure that enables high iron concentrations for a slow and controlled release based on pre-clinical studies.2

LEARN ABOUT CONTROLLED IRON RELEASE

1000 mg IV IRON IN A SINGLE INFUSION IN ≥20 MINUTES*

Monoferric offers iron infusion in one dose in a single 1000 mg vial for patients weighing 50 kg or more.1,3 Monoferric is the only iron infusion that is FDA
approved to administer 1000 mg in ≥20 minutes.

*Repeat dose if iron deficiency amemia reoccurs.

SEE DOSING & ADMINISTRATION

*Repeat dose if iron deficiency amemia reoccurs.

MONOFERRIC PATIENT SOLUTIONS DELIVERS DIVERSE SUPPORT TO HELP ADDRESS IDA TREATMENT NEEDS

Pharmacosmos has a wide range of tools and resources available for you and your patients including:

  • Hub Support
  • Billing and Coding
  • Supplemental Nursing Support
  • Co-pay Assistance
  • Field Support
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. Monoferric (ferric derisomaltose) Prescribing Information; Pharmacosmos Therapeutics Inc., Morristown, NJ: 2020. 2. Jahn MR, Andreasen HB, Fütterer S, et al. Eur J Pharm Biopharm. 2011;78(3):480‐491. 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. 2020 [epub]. doi:10.1093/ndt/gfaa011.

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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