Brand Name
Monoferric
Generic Name
Derisomaltose
View Brand Information FDA approval date: January 16, 2020
Form: Injection
What is Monoferric (Derisomaltose)?
Monoferric is 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 who have non-hemodialysis dependent chronic kidney disease 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. who have non-hemodialysis dependent chronic kidney disease.
Approved To Treat
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Brand Information
Monoferric (Ferric derisomaltose)
1INDICATIONS 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)
2DOSAGE FORMS AND STRENGTHS
Monoferric is a sterile, dark brown, non-transparent aqueous solution available as:
- Injection: 1,000 mg iron/10 mL (100 mg/mL) single-dose vial
- Injection: 500 mg iron/5 mL (100 mg/mL) single-dose vial
- Injection: 100 mg iron/mL single-dose vial
3CONTRAINDICATIONS
Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity Reactions
- Iron Overload
4.1Clinical 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.
The safety of Monoferric was evaluated in 3008 patients with iron deficiency anemia enrolled in two randomized, actively-controlled trials. Trial 1 enrolled adult patients with iron deficiency anemia with intolerance to oral iron or had an unsatisfactory response to oral iron with a clinical need for repletion of iron stores. Eligible subjects were required to have a baseline hemoglobin of ≤11g/dl, transferrin saturation (TSAT) of less than 20% and serum ferritin level of <100 ng/mL. Trial 2 enrolled adult patients with non-dialysis dependent chronic kidney disease (CKD) with iron deficiency anemia (
4.2Post-marketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been most commonly reported from the post-marketing spontaneous reports with Monoferric:
Cardiac disorders: Tachycardia
Gastrointestinal disorders: Abdominal pain, nausea and vomiting, constipation, diarrhea
General disorders and administration site conditions: Fatigue, pyrexia, chest pain, chills, Fishbane reaction, extravasation, influenza like symptoms, injection site reactions, malaise, pain
Immune System disorders: Anaphylactic/anaphylactoid reaction, hypersensitivity
Investigations: Hepatic enzymes increased
Musculoskeletal and connective tissue disorders: Back pain, muscle spasms, arthralgia, myalgia
Nervous system disorders: Dizziness, headache, paresthesia, dysgeusia, seizure, loss of consciousness, syncope
Psychiatric disorders: Anxiety
Respiratory, thoracic and mediastinal disorders: Dyspnea, cough, bronchospasm
Skin and subcutaneous tissue disorders: Erythema, urticaria, discoloration skin, rash, pruritus, skin exfoliation, angioedema, sweating
Vascular disorders: Hypertension, hypotension, flushing, phlebitis
Extravasation of Monoferric at the injection site that may lead to irritation of the skin and potentially long lasting brown discoloration at the site of injection has also been reported.
5OVERDOSAGE
Excessive dosages of Monoferric may lead to accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Monoferric in patients with iron overload
6DESCRIPTION
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.
Ferric derisomaltose has an average molecular weight of 155,000 Da and has the following empirical formula:
{FeO
(C
X = 0.0311; T = 0.25; R = 0.14; Z = 0.49; Y = 0.14
Iron atoms placed in the electronegative cavities of the 3-D structure between and within the derisomaltose molecules. A schematic representation is presented below
Monoferric is a sterile, dark brown, non-transparent aqueous solution with pH 5.0-7.0, containing ferric derisomaltose dissolved in water for injections and filled into Type I glass vials.
Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection, hydrochloric acid and sodium hydroxide may be used to adjust pH.
7CLINICAL STUDIES
The safety and efficacy of Monoferric for treatment of iron deficiency anemia (IDA) were evaluated in two randomized, open-label, actively-controlled clinical trials performed in a total of 3050 patients with IDA of different etiology. Trial 1 included patients with IDA who had intolerance to oral iron or who had had unsatisfactory response to oral iron or for whom there was a clinical need for rapid repletion of iron stores. Trial 2 included patients with IDA who had non-dialysis dependent chronic kidney disease (NDD-CKD). In these two 8-Week trials, patients were randomized 2:1 to treatment with Monoferric or iron sucrose. Monoferric was intravenously administered as a single dose of 1000 mg.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Box
PHARMACOSMOS
MonoFerric
100 mg / mL
FOR INTRAVENOUS INFUSION AFTER DILUTION
5 x 1 mL Single-Dose Vials
10PRINCIPAL DISPLAY PANEL - 500 mg/5 mL Vial Box
MonoFerric
500 mg / 5 mL
FOR INTRAVENOUS INFUSION
Rx Only
11PRINCIPAL DISPLAY PANEL - 1000 mg/10 mL Vial Box
MonoFerric
1000 mg / 10 mL
FOR INTRAVENOUS INFUSION
Rx Only
