Monoferric is used to treat iron deficiency anemia in adults with chronic kidney disease who are not on dialysis.

Monoferric is for people who are unable to take an iron replacement medicine by mouth, or after other medicines have not been effective.

Monoferric is not for use in people who are on kidney dialysis.

It is not known if Monoferric is safe and effective for use in children less than 18 years old.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Monoferric is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 20 minutes to complete.

You will be watched closely for at least 30 minutes to make sure you do not have an allergic reaction.

You will need medical tests to measure the iron in your blood. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

You may need a repeat dose if your iron levels get too low again.

You should not use Monoferric if you are allergic to ferric derisomaltose.

To make sure Monoferric is safe for you, tell your doctor if you have ever had:

• iron overload; or

• an allergic reaction to an iron medication given by intravenous injection.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether ferric derisomaltose will harm an unborn baby. However, having untreated iron deficiency anemia during pregnancy may cause complications such as premature birth, low birth weight, or anemia after delivery. The benefit of treating iron deficiency anemia may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea or constipation in the nursing baby.

Monoferric is not approved for use by anyone younger than 18 years old.

Monoferric is given as a single dose and does not have a daily dosing schedule.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Monoferric: 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 Monoferric 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.

Other drugs may interact with ferric derisomaltose, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.