Ferric Derisomaltose

Ferric Derisomaltose is an iron replacement product indicated for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose.

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.

• Iron Deficiency Anemia: Used for treatment of IDA in adults who have intolerance or unsatisfactory response to oral iron; also for IDA in adults with non-hemodialysis dependent CKD.

Parenteral Iron Preparations

Iron Replacement (IV)

Ferric Derisomaltose is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides.

Ferric Derisomaltose replenishes iron stores in the body which helps in the formation of new red blood cells and hemoglobin.

Adult Dose (IV):

• >=50 kg: Administer 1,000 mg IV infusion over at least 20 minutes as a single dose; repeat if IDA reoccurs.
• <50 kg: Administer 20 mg/kg actual body weight IV infusion over at least 20 minutes as a single dose; repeat if IDA reoccurs.

For IV administration only. Each vial is single-dose only. Dilute in 100-500 mL of 0.9% Sodium Chloride Injection; final concentration should be more than 1 mg iron/mL; administer via IV infusion over at least 20 minutes.

If you miss a dose of Ferric Derisomaltose, please consult your doctor.

Common Side Effects (>=1%):

• Rash
• Nausea

Others: Headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, fever, fatigue, hypotension, muscle spasms, back pain, dyspnea.

Precautions:

• Serious hypersensitivity reactions (anaphylactic-type) reported; monitor for 30 minutes.
• Iron overload: Excessive therapy may lead to hemosiderosis or hemochromatosis; monitor iron parameters.
• Extravasation: May cause brown discoloration; discontinue if extravasation occurs.

Contraindications:

• Hypersensitivity
• Iron overload

Drug Interactions: Formal drug interaction studies have not been performed.

Food Interactions: No interactions with food.

Use in Pregnancy: No data on use in pregnant women; caution required.

Use in Lactation: Iron is present in breast milk; caution required.

Pediatric Use: Safety and efficacy not established.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: No specific dosage adjustment is necessary.

Hepatic Impairment: No specific dosage adjustment is necessary.

Overdose: Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis; avoid use in patients with iron overload.

Storage: Store at 20-25 degree C; excursions permitted to 15-30 degree C. Do not freeze.

Ferric Derisomaltose