Monoferric (ferric derisomaltose)

Monoferric is a prescription iron replacement medicine used to treat iron deficiency anemia in adults who have:

• intolerance to oral iron or who have not responded well to treatment with oral iron
• non-dialysis dependent chronic kidney disease

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

Monoferric may cause serious side effects, including:

• Allergic (hypersensitivity) reactions. Serious life-threatening allergic reactions have happened in people who receive Monoferric. Symptoms of an allergic reaction including rash, itching, hives, dizziness, lightheadedness, breathing problems and low blood pressure have also happened during treatment with Monoferric. Tell your healthcare provider right away if you develop any of the above symptoms of a serious allergic reaction or if you have ever had any unusual or allergic reaction to any IV iron in the past.
• Too much iron stored in your body (iron overload). Your healthcare provider should check the iron level in your blood before you start and during treatment with Monoferric.

The most common side effects of Monoferric include rash and nausea.

These are not all the possible side effects of Monoferric.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Recommended Dosage

For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron.

Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Preparation And Administration

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives.

Each vial of Monoferric is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Monoferric with other drugs has not been established. Monoferric should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored at room temperature for up to 8 hours.
• Extravasation of Monoferric may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Monoferric administration at that site.

No information provided

Before receiving Monoferric, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Monoferric will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Monoferric passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Monoferric.