Monoferric

Last updated on RxList: 1/22/2021
Monoferric Side Effects Center

What Is Monoferric?

Monoferric (ferric derisomaltose) is an iron replacement product used to treat iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and/or who have non-hemodialysis dependent chronic kidney disease.

What Are Side Effects of Monoferric?

Side effects of Monoferric include:

  • rash and
  • nausea

Dosage for Monoferric

The dose of Monoferric for patients weighing 50 kg or more is 1,000 mg administered as an intravenous infusion. The dose of Monoferric for patients weighing less than 50 kg is 20 mg/kg actual body weight administered as an intravenous infusion.

Monoferric In Children

The safety and effectiveness of Monoferric have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Monoferric?

Monoferric may interact with other medicines.

Tell your doctor all medications and supplements you use.

Monoferric During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Monoferric; it is unknown how it would affect a fetus. Iron is present in breast milk but it is unknown how Monoferric may affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Monoferric (ferric derisomaltose) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Monoferric Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, or have a skin rash, swelling, or trouble breathing.

Common side effects may include:

  • rash; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Monoferric (Ferric Derisomaltose Injection)

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Monoferric Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS].
  • Iron Overload [see WARNINGS AND PRECAUTIONS].

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.

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 [see Clinical Studies]. Eligible subjects also had to have serum ferritin ≤200 μg/L or ≤300 ng/mL if TSAT ≤30%.

Trial 1 And Trial 2

In the two randomized, actively-controlled clinical trials, Trials 1 and Trial 2 [see Clinical Studies], patients were randomized in a 2: 1 ratio to intravenous Monoferric (n = 2008) or intravenous iron sucrose (n = 1000) respectively. Monoferric was administered as a single intravenous infusion of 1000 mg diluted in 100 mL 0.9 % sodium chloride and given over approximately 20 minutes (approximately 50 mg iron/min). Iron sucrose was administered as 200 mg undiluted intravenous injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times (1000 mg) within the first two weeks starting at baseline.

The data described below reflect exposure to Monoferric in 2008 patients exposed to a 1000 mg single intravenous dose of Monoferric. The mean cumulative intravenous Iron exposure was 984 mg.

Trial 1 included 1483 patients with iron deficiency anemia in the safety analysis that had intolerance to oral iron or have had unsatisfactory response to oral iron or with a clinical need for rapid repletion of iron stores. Trial 2 included 1525 patients in the safety analysis who had non-dialysis dependent CKD. The mean (SD) age of the combined study population was 56.4 (18.3) years. The majority of patients were women (75.7%).

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 in the combined analysis of Trial 1 and 2 are listed in Table 1.

Table 1. Adverse Reactions (≥ 1 %) in Patients Receiving Monoferric in Clinical Trials 1 and 2

Monoferric (N = 2008)
N (%)
Iron sucrose (N = 1000)
N (%)
Adverse Reaction
Nausea24 (1.2)11 (1.1)
Rash21 (1)1 (0.1)

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.

Post-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

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

Skin and subcutaneous tissue disorders: Erythema, urticaria, discoloration skin, rash, pruritus, 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.

Read the entire FDA prescribing information for Monoferric (Ferric Derisomaltose Injection)

© Monoferric Patient Information is supplied by Cerner Multum, Inc. and Monoferric Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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