Ferric Derisomaltose (Monograph)

Brand name: Monoferric
Drug class: Iron Preparations

Medically reviewed by Drugs.com on Jun 18, 2023. Written by ASHP.

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Introduction

Iron preparation.

Uses for Ferric Derisomaltose

Iron Deficiency Anemia

Indicated for the treatment of iron deficiency anemia in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron. Also indicated for treatment of iron deficiency anemia in adults who have non-hemodialysis dependent chronic kidney disease (NDD-CKD).

Oral iron supplements generally recommended first-line for management of iron deficiency in these patient populations, with IV formulations reserved for patients who do not respond or are intolerant to oral agents; choice of a specific iron formulation should be based on severity of iron deficiency, venous access, patient-specific factors, compliance, and cost.

Ferric Derisomaltose Dosage and Administration

General

Pretreatment Screening

Evaluate for history of hypersensitivity reactions to ferric derisomaltose or any component prior to administration.

Patient Monitoring

Monitor patients during ferric derisomaltose administration, and for at least 30 minutes following completion of the infusion and until clinically stable, for signs and symptoms of a hypersensitivity reaction.
Monitor patients for hematologic (hemoglobin and hematocrit) and iron (serum ferritin and transferrin saturation) parameters for response to therapy.
Monitor for extravasation. If extravasation occurs, discontinue ferric derisomaltose administration at that site.

Dispensing and Administration Precautions

Only administer ferric derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensivity reactions.

Administration

IV administration

Do not mix with solutions containing other medications.

Extravasation may cause brown discoloration; may be long-lasting. Monitor for extravasation. If extravasation occurs, discontinue administration at the site.

Dilution

Withdraw the appropriate volume of ferric derisomaltose from the single-use vial, and dilute in 100–500 mL of 0.9% sodium chloride injection for a final concentration of at least 1 mg of iron/mL.

Vials of ferric derisomaltose are preservative-free; discard any unused portion of the vial after use.

Rate of Administration

Administer prepared ferric derisomaltose solution via IV infusion over a minimum of 20 minutes.

Dosage

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

Adults

Iron Deficiency Anemia

IV - For patients weighing <50 kg: Administer ferric derisomaltose as 20 mg/kg actual body weight as an IV infusion. Repeat ferric derisomaltose treatment if iron deficiency anemia reoccurs.

IV - For patients weighing ≥50 kg: Administer 1,000 mg of ferric derisomaltose as an IV infusion. Repeat ferric derisomaltose treatment if iron deficiency anemia reoccurs.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Cautions for Ferric Derisomaltose

Contraindications

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, reported. May present as shock, clinically significant hypotension, loss of consciousness, and/or collapse. In clinical studies, serious hypersensitivity occurred in 0.3% (n=6) of treated patients.

Monitor for signs and symptoms of hypersensitivity during and after administration of infusion for at least 30 minutes and until clinically stable. Only administer when personnel and therapies available to treat serious reactions. Use of ferric derisomaltose contraindicated in patients with prior serious hypersensitivity reactions.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor hematologic (hemoglobin and hematocrit) and iron (serum ferritin and transferrin saturation) parameters . Avoid administration in patients with iron overload.

Specific Populations

Pregnancy

No data available in humans, but may cause fetal harm. Based on animal data, teratogenicity and embryo-fetal lethality demonstrated at doses 0.09–0.4 times the maximum recommended human dose of 1000 mg (based on body surface area).

Published data in humans indicate no increased risk of fetal malformations; although, studies were not designed to assess for birth defects.

Untreated iron deficiency anemia in pregnancy has been associated with negative outcomes, including post-partum maternal anemia, an increased risk of preterm delivery, and low birth weight.

Use of parenteral iron products in pregnant women, particularly in the second or third trimester of pregnancy, can cause serious adverse reactions including severe hypotension and shock, which can result in fetal bradycardia.

Lactation

Iron present in breast milk. Effects on breast-fed infants or on the production of milk are not known.

Monitor breastfed infants for gastrointestinal toxicities such as constipation and diarrhea.

Pediatric Use

Safety and effectiveness not established in pediatric patients.

Geriatric Use

In clinical studies, 29% of ferric derisomaltose-treated patients were ≥65 years of age and 13% were ≥ 75 years of age. No overall differences in safety or efficacy observed between these patients and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment

Manufacturer does not provide information on use of ferric derisomaltose in hepatic impairment.

Renal Impairment

Due to the size of the iron complex, likely not excreted via the kidneys. Indicated for use in patients with non-hemodialysis-dependent chronic kidney disease.

Common Adverse Effects

Adverse reactions (incidence ≥1%) include rash and nausea.

Drug Interactions

Formal studies examining compatibility of ferric derisomaltose with other drugs have not been performed to date.

Ferric Derisomaltose Pharmacokinetics

Absorption

After an IV dose, serum ferritin peaks after approximately 7 days, and returns to stable levels after 4 weeks.

Following a single IV infusion, AUC and peak serum concentrations of iron are approximately dose-proportional over a single-dose range of 100–1000 mg.

Distribution

Once reaching circulation, binds to the available protein moieties to form hemosiderin and ferritin for iron storage, and to a lesser extent, transferrin, a transport molecule.

Likely present in breastmilk.

Elimination

Ferric derisomaltose not excreted via kidneys; small quantities of iron excreted in urine and feces.

Half-life

Mean of 27 hours after a single 1000 mg dose.

Stability

Storage

Parenteral

Injection, for IV use

Store at 20–25ºC (excursions permitted between 15–30ºC). Once diluted, solution may be stored at room temperature for up to 8 hours.

Actions

A complex of iron (III) hydroxide and derisomaltose, ferric derisomaltose is an iron carbohydrate oligosaccharide.
Once iron is released from the complex, the binding of iron to transferrin allows for the transport to erythroid precursor cells for incorporation into hemoglobin.

Advice to Patients

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Gather a medical history from the patient regarding any prior history of reactions to parenteral iron products.
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.
Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed. Monitor infants exposed to iron via breast milk for constipation and diarrhea.
Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.
Advise patients of other important precautionary information. (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.