FERRIC DERISOMALTOSE

Other

Brand names: Monoferric

Intravenous

Mechanism of Action

12.1 Mechanism of Action Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1)
• Description (11) ) . Reactions have included shock
• clinically significant hypotension
• loss of consciousness
• and/or collapse. Serious hypersensitivity to Monoferric or any of its components. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion
1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric
Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions
Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components ( see Contraindications (4) )

Known Side Effects

11 documented side effects by frequency

Nausea

>10%

Shortness of Breath

1-10%

Vomiting

1-10%

Diarrhea

1-10%

Dizziness

1-10%

Abdominal Pain

1-10%

Headache

1-10%

Itching

1-10%

Constipation

1-10%

Rash

0.1-1%

Back Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous