Ferric Derisomaltose
Generic Name: ferric derisomaltose
Brand Names:
Monoferric
11 DESCRIPTION Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides.
Overview
11 DESCRIPTION Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides.
Uses
1 INDICATIONS AND USAGE 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) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron. ( 1 ) who have non-hemodialysis dependent chronic kidney disease. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric as an intravenous infusion. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight as an intravenous infusion. Repeat Monoferric treatment if iron deficiency anemia reoccurs. ( 2 ) 2.1 Recommended Dosage For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. The dosage of Monoferric is expressed in mg of elemental iron.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions (see Warnings and Precautions (5.1) ) . Iron Overload (see Warnings and Precautions (5.2) ) . Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: 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. ( 5.1 ) Iron Overload: Do not administer Monoferric to patients with iron overload. ( 5.2 ) 5.1 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. 4 CONTRAINDICATIONS Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1) , Description (11) ) . Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. Serious hypersensitivity to Monoferric or any of its components. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on Monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see Data ) .
Storage
16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). See the USP controlled room temperature. Do not freeze. When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored for up to 8 hours at room temperature.
Frequently Asked Questions
What is Ferric Derisomaltose used for?▼
1 INDICATIONS AND USAGE 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) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron. ( 1 ) who have non-hemodialysis dependent chronic kidney disease. ( 1 )
What are the side effects of Ferric Derisomaltose?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions (see Warnings and Precautions (5.1) ) . Iron Overload (see Warnings and Precautions (5.2) ) . Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
Can I take Ferric Derisomaltose during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on Monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see Data ) .
What are the important warnings for Ferric Derisomaltose?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: 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. ( 5.1 ) Iron Overload: Do not administer Monoferric to patients with iron overload. ( 5.2 ) 5.1 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. 4 CONTRAINDICATIONS Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1) , Description (11) ) . Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. Serious hypersensitivity to Monoferric or any of its components. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.