IV IRON REPLACEMENT IN
JUST ONE DOSE 1 ,*
Monoferric is FDA approved for 1000 mg in a single , rapid infusion 1
* Intravenous infusion over at least 20 minutes . Repeat dose if iron deficiency anemia reoccurs .
FDA-APPROVED IV IRON REPLACEMENT THAT CAN ADMINISTER UP TO 1000 mg WITH A SINGLE INFUSION IN ≥20 MINUTES 1
VISIT WWW . MONOFERRIC . COM TO LEARN HOW MONOFERRIC PROVIDES A SLOW AND CONTROLLED RELEASE OF IRON FOR PATIENTS WITH IRON DEFICIENCY ANEMIA 1 , 2
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 call 1-800-FDA-1088 .
Please see Brief Summary of Prescribing Information on adjacent pages .
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 .
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