IV IRON REPLACEMENT IN
JUST ONE DOSE*
*Intravenous infusion over at least 20 minutes.
Repeat dose if iron deficiency anemia reoccurs.
Monoferric is FDA approved as a
single, 1000 mg, rapid infusion.1,*
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)
Ferric derisomaltose is a recommended option by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
Details below
HEAR FROM DR. HUZEFA BAHRAIN,
AN IDA HEALTHCARE PROVIDER
Dr. Bahrain explains why he uses Monoferric to treat his IDA patients.
I’m Dr. Huzefa Bahrain, welcome to Monoferric Moments.
I practice hematology and oncology in Baltimore. We operate an erythropoiesis center where we treat a wide variety of patients with various iron deficiency anemia etiologies. They can range from bariatric surgery patients to heart failure, to pregnancy.
Monoferric is an intravenous iron replacement therapy that can be given in just 1 single dose, delivering 1000 milligrams.
In my experience, we find that for most patients, just 1 dose of 1000 milligrams of Monoferric is sufficient to replace iron stores. If iron deficiency anemia reoccurs, a repeat dose would be necessary.
I use Monoferric in my practice because of its overall combination of 1-dose administration, efficacy, tolerability, and patient support services.
For more information, explore Monoferric.com
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Artist rendition
INNOVATIVE MATRIX CONTROLS BIOAVAILABLE IRON RELEASE
Monoferric 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.
LEARN ABOUT CONTROLLED IRON RELEASE
MORE THAN 10 YEARS OF INTERNATIONAL EXPERIENCE IN THE HIGH DOSE IV IRON MARKETPLACE
Monoferric was introduced more than 10 years ago as Monofer® in the EU. Over 20 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 etiologies.3,4
SEE THE RESULTS
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 Monoferric is FDA approved to administer 1000 mg in ≥20 minutes.
*Repeat dose if iron deficiency anemia reoccurs.
SEE DOSING & ADMINISTRATION
*Repeat dose if iron deficiency anemia reoccurs.
FERRIC DERISOMALTOSE (MONOFERRIC) IS A RECOMMENDED PARENTERAL IRON PREPARATION BY THE NCCN GUIDELINES®†
†Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors, V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed February 6, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
MONOFERRIC PATIENT SOLUTIONS® DELIVERS MULTIFACETED 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
- Nurse Educator Team
- Co-pay Assistance
- Field Support and Reimbursement
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.
References:
- Monoferric (ferric derisomaltose) Prescribing Information; Pharmacosmos Therapeutics Inc., Morristown, NJ: 2022.
- Jahn MR, Andreasen HB, Fütterer S, et al. Eur J Pharm Biopharm. 2011;78(3):480-491.
- Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. Am J Hematol. 2019;94(9):1007-1014.
- Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Nephrol Dial Transplant. 2021;36(1):111-120.
