What is FERRIC DERISOMALTOSE used for?

FERRIC DERISOMALTOSE (brand name Monoferric) is a Other indicated for See full prescribing information.

What are the most common side effects of FERRIC DERISOMALTOSE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for FERRIC DERISOMALTOSE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is FERRIC DERISOMALTOSE the same as Monoferric?

Monoferric is a brand name for FERRIC DERISOMALTOSE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

FERRIC DERISOMALTOSE

Q: How does FERRIC DERISOMALTOSE work?

FERRIC DERISOMALTOSE works through the following mechanism: 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..

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%

Community Discussions

No community discussions found for FERRIC DERISOMALTOSE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → FERRIC DERISOMALTOSE openFDA label JSON → FERRIC DERISOMALTOSE FAERS adverse-event reports → FERRIC DERISOMALTOSE ClinicalTrials.gov → completed Phase 2+ trials of FERRIC DERISOMALTOSE

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Formulations

Dosage Forms

Tablet

Route

Intravenous