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MONOFERRIC MOMENTS

HEAR FROM
HEALTHCARE PROVIDERS
TREATING IDA

ON WHY THEY
CHOOSE MONOFERRIC
FOR THEIR PATIENTS

INTRODUCING
DR. HUZEFA BAHRAIN

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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

INTRODUCING
REGISTERED NURSE CARRIE SMITH

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I’m Carrie Smith, welcome to Monoferric Moments.

I’m a registered nurse and director of research with a focus in oncology. My clinical site participated in the Monoferric registration trials.

The fact that Monoferric is just 1, 1000 milligram dose, administered typically in at least 20 minutes, is a great feature. It can help to lessen the burden of repeated office visits for patients.

For more information, explore Monoferric.com

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DR. BAHRAIN DISCUSSES
EFFICACY AND SAFETY

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I’m Dr. Huzefa Bahrain, welcome to Monoferric Moments.

In my experience, we find that for most patients, just 1 dose of 1000 milligrams of Monoferric is sufficient to replenish iron stores.

Looking at all the intravenous iron infusions we’ve administered through clinical trials and commercial patients, Monoferric is observed as having a solid safety profile that is comparable to iron sucrose and is generally well tolerated by the vast majority of patients.

Monoferric has been evaluated in two clinical trials with a total of 3050 patients.

When looking at safety, there was no significant differences in adjudicated serious or severe hypersensitivity reactions between Monoferric and iron sucrose.

Only 0.3 percent of patients reported adjudicated serious or severe hypersensitivity reactions.

Monoferric was also evaluated in the PHOSPHARE study, which was two identical safety trials that were pooled to compare the incidence of hypophosphatemia with Monoferric vs ferric carboxymaltose.

Monoferric demonstrated significantly fewer incidences of hypophosphatemia than ferric carboxymaltose from baseline to day 35.

In the PHOSPHARE study, pooled results, only 8.0% of patients treated with Monoferric versus 74.4% of those treated with ferric carboxymaltose were noted to have hypophosphatemia.

For more information, explore Monoferric.com

CARRIE SMITH, RN, DISCUSSES
EFFICACY AND SAFETY

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Hello, my name is Carrie Smith. Welcome to Monoferric Moments.

As a prescriber you have to take many things into consideration when recommending iron replacement. Even though they are all iron, some things I consider are the safety of the IV iron product, as well how it will affect my patients in terms of the adherence and accessibility.

There is a risk of infusion reactions with all IV iron therapies. In my experience, Monoferric is well tolerated by most patients.

Monoferric was tolerated well during the clinical trials, without any pre-medication.

The clinical trials reported that only 0.3 percent of patients experienced adjudicated serious or severe hypersensitivity reactions.

Patients with iron deficiency anemia experience fatigue and tiredness because of the decrease in hemoglobin and red blood cell production. But for many patients, once we infuse them with just 1 dose of Monoferric, their symptoms gradually improve.

In the FERWON trials, patients receiving Monoferric experienced improvement in their FACIT fatigue score above 30.

In my experience, some patients say how much better they feel after 1 dose of Monoferric when they come back to their follow-up appointment, typically in about a month.

For more information, explore Monoferric.com

EXPLORE THE MONOFERRIC EFFICACY AND SAFETY TRIALS


CARRIE SMITH, RN, DISCUSSES DOSING

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I was the first nurse to administer Monoferric in the United States after it was commercially available in 2020. I’ve administered various iron preparations, but this one is unique.

You can administer just 1, 1000-milligram dose of Monoferric typically in at least 20 minutes.

I was initially not familiar with a single high dose, but Monoferric was well tolerated by our patients. It was a positive experience for me, just the way that it's administered.

1 dose is important to my patients. When speaking with them, they found the one dose to be convenient and were able to easily fit it into their normal activities.

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DR. BAHRAIN DISCUSSES
THE MONOFERRIC PATIENT
SOLUTIONS™ PROGRAM

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The Monoferric Patient Solutions™ Program has been helpful to those who have trouble accessing intravenous iron. The program is well coordinated and supportive to the patients and their needs.

There is also the availability of Nurse Educators for infusion staff.

CARRIE SMITH, RN, DISCUSSES
THE MONOFERRIC PATIENT
SOLUTIONS™ PROGRAM

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The Monoferric Patient Solutions™ Program is set up for patient support. The team is easily accessible online and provides resources that can enhance that patient’s Monoferric treatment journey.

The patient support team responds promptly, so whether patients have financial burdens or other specific needs, the support team is accessible and available to help.

LEARN ABOUT THE MONOFERRIC PATIENT SOLUTIONS™ PROGRAM


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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.

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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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