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

Ferric derisomaltose is for people who are unable to take an iron replacement medicine by mouth, or after other medicines have not been effective. ferric derisomaltose is not for use in people who are on kidney dialysis.

Ferric derisomaltose may also be used for purposes not listed in this medication guide.

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.

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

ferric derisomaltose 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.

Usual Adult Dose for Iron Deficiency Anemia:

Patients weighing 50 kg or more: 1000 mg elemental iron intravenously over at least 20 minutes as a single dose
-Repeat if iron deficiency anemia reoccurs.

Patients weighing under 50 kg: 20 mg/kg (actual body weight) elemental iron intravenously over at least 20 minutes as a single dose
-Repeat if iron deficiency anemia reoccurs.


Comments:
-Only administer when personnel and therapies for serious hypersensitivity reactions are immediately available.
-Dosing is expressed in elemental iron; each mL of Monoferric(R) contains 100 mg elemental iron.

Uses: Iron deficiency in patients intolerant to, or with an unsatisfactory response to, oral iron, and non-hemodialysis dependent chronic kidney disease (NDD-CKD)

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

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.

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

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

Since ferric derisomaltose 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: 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 of ferric derisomaltose 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 affect 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.