Ferric derisomaltose

What it is used for

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

• who have intolerance to oral iron or have had unsatisfactory response to oral iron
• who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Side effects, and when to stop

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• Hypersensitivity Reactions (see Warnings and Precautions ).
• Iron Overload (see Warnings and Precautions ).

Who should not take it

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions, Description (11) ). Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

Storing it

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). See the USP controlled room temperature.

Do not freeze.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored for up to 8 hours at room temperature.