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Ferric Derisomaltose

Class: Iron Preparations
Chemical Name: (1→6)-α-d-Glucopyranan-(1→6)-d-glucitol iron(III) complex
Molecular Formula: C6H14O5(C6H10O5)nFe
CAS Number: 1345510-43-1
Brands: Monoferric

Medically reviewed by Drugs.com on Feb 17, 2020. Written by ASHP.

Introduction

Ferric derisomaltose is an iron preparation.

Uses for Ferric Derisomaltose

Ferric derisomaltose has the following uses:

Ferric derisomaltose 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.

Ferric derisomaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have non-hemodialysis dependent chronic kidney disease.

Ferric Derisomaltose Dosage and Administration

General

Ferric derisomaltose is available in the following dosage form(s) and strength(s):

  • 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.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration
  • Dosage of ferric derisomaltose is expressed in mg of elemental iron. Each mL of ferric derisomaltose contains 100 mg of elemental iron.

  • For patients weighing 50 kg or more: Administer 1,000 mg of ferric derisomaltose as an intravenous infusion.

  • For patients weighing less than 50 kg: Administer ferric derisomaltose as 20 mg/kg actual body weight as an intravenous infusion.

  • Repeat ferric derisomaltose treatment if iron deficiency anemia reoccurs.

Cautions for Ferric Derisomaltose

Contraindications

Serious hypersensitivity to ferric derisomaltose or any of its components.

Warnings/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 ferric derisomaltose. 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 ferric derisomaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer ferric derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Ferric derisomaltose is contraindicated in patients with prior serious hypersensitivity reactions to ferric derisomaltose 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 ferric derisomaltose 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 ferric derisomaltose to patients with iron overload.

Specific Populations

Pregnancy

Risk Summary: There are no available data on ferric derisomaltose 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. There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy. Iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. The findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency. Animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (MRHD) of 1000 mg, respectively, based on body surface area.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations: Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Animal Data: Iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals at single doses above 125 mg iron/kg body weight. The highest recommended dose in human clinical use is 20 mg iron/kg body weight.

In a combined fertility and embryo-fetal development study in rats, ferric derisomaltose was administered intravenously to female rats 14 days prior to cohabitation and through gestation day (GD) 17 at doses of 3, 11, and 32 mg Fe/kg/day. The doses of 11 and 32 mg Fe/kg/day (approximately 0.1 and 0.3 times the MRHD of 1000 mg, based on body surface area (BSA)) resulted in an increase in the incidence of skeletal developmental delays.

Ferric derisomaltose was administered intravenously to pregnant rabbits during organogenesis, from GD7 to GD20, at doses of 11, 25 and 43 mg Fe/kg/day. The dose of 43 mg Fe/kg/day (approximately 0.8 times the MRHD of 1000 mg, based on BSA) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss. Adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, macroglossia, hydrocephaly, small brain). Fetal malformations and reduced fetal weights were also noted in the 25 mg Fe/kg/day group (approximately 0.5 times the MRHD based on BSA).

Lactation

Risk Summary: The available data on the use of ferric derisomaltose in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ferric derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Clinical Considerations: Monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea).

Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

Geriatric Use

Of the 3934 patients in clinical studies of ferric derisomaltose, 29% were 65 years and over, while 13% were 75 years and over. No overall differences in safety or effectiveness were observed between these patients and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Common Adverse Effects

Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

Advice to Patients

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Prior History of Allergies to Parenteral Iron Products

Question patients regarding any prior history of reactions to parenteral iron products.

Hypersensitivity Reactions

Advise patients to report any signs and symptoms of hypersensitivity that may develop during and following ferric derisomaltose administration, such as rash, itching, dizziness, lightheadedness, swelling, and breathing problems.

Additional Information

AHFSfirstRelease. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ferric Derisomaltose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use

equivalent to 100 mg of elemental iron per mL

Monoferric

Pharmacosmos A/S

AHFS Drug Information. © Copyright 2021, Selected Revisions February 17, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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