Ferric Derisomaltose Injection

(fer′ ik der eye″ soe mawl′ tose)

Brand Name(s): Monoferric^®

WHY is this medicine prescribed?

Ferric derisomaltose is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to not enough iron in the body). Ferric derisomaltose is in a class of medications called iron replacement products. It works by providing iron so that the body can make more red blood cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ferric derisomaltose comes as a solution (liquid) to be given intravenously (into a vein) by a healthcare provider. It is usually given as a single dose. Ferric derisomaltose may be given again, if needed for your condition.

Ferric derisomaltose injection may cause severe or life-threatening reactions during and shortly after you receive the medication. Your doctor will watch you carefully while you receive each dose and for at least 30 minutes afterwards. Tell your doctor if you experience any of the following symptoms during or after your injection: shortness of breath; wheezing; difficulty swallowing or breathing; hoarseness; swelling of the face, throat, tongue, lips, or eyes; hives; rash; itching; fainting; lightheadedness; dizziness; flushing of the face; nausea; cold, clammy skin; rapid, weak pulse; chest pain; or loss of consciousness. If you experience a severe reaction, your doctor will stop your infusion immediately and provide emergency medical treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ferric derisomaltose,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had any medical conditions.

• tell your doctor if you are pregnant or are breast-feeding.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Ferric derisomaltose may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• rash

Ferric derisomaltose may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ferric derisomaltose.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2025.