Ferric Carboxymaltose

Ferric Carboxymaltose is an iron replacement medicine. It is used to treat a type of anemia where you have fewer amount of red blood cells due to insufficient iron in your body (iron-deficiency anemia). Iron is needed to produce the red blood cells that carry oxygen around your body.

Ferric Carboxymaltose is an anti-anemic medication. It replenishes the iron stores in your body. Iron is vital for the formation of new red blood cells and 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-dialysis dependent CKD.

Parenteral Iron Preparations

Iron Replacement (IV)

Ferric Carboxymaltose is a colloidal iron (III) hydroxide in complex with Carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin.

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

Adult Dose (IV):

• >50 kg: 750 mg IV once, follow 7 days later with second 750 mg dose; not to exceed cumulative dose of 1500 mg per course.
• <50 kg: 15 mg/kg IV once, follow 7 days later with second dose; not to exceed 1500 cumulative dose per course.
• Single administration: 15 mg iron/kg (IV injection) or 20 mg/kg (IV infusion); max 1000 mg; max 1000 mg per week.

Your doctor or nurse will give you this medicine. Administered as IV injection or infusion. You will be observed for at least 30 minutes after each injection (risk of allergic reaction).

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

Common Side Effects:

• Injection site reactions (pain, swelling, redness)
• Nausea
• Vomiting
• Dark colored stool
• Headache
• Dizziness
• Flushing
• Hypertension
• Aminotransferase increased
• Hypophosphataemia

Precautions:

• Ferric Carboxymaltose does not usually affect your ability to drive.
• Observed for at least 30 minutes after each injection due to risk of allergic reaction.
• Blood pressure and blood iron levels will be regularly monitored during treatment.
• Inform doctor if taking any oral iron-containing products.
• Avoid alcohol (may worsen side effects).
• Stools may become black or dark in color (normal and harmless).

Contraindications:

• Hypersensitivity
• Anemia not attributed to iron deficiency
• Iron overload or disturbances in utilisation of iron

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

Food Interactions: It is not known whether it is safe to consume alcohol with Ferric Carboxymaltose; consult your doctor.

Use in Pregnancy: Ferric Carboxymaltose may be unsafe; animal studies suggest effects on fetal skeletal development; should be confined to second and third trimester if benefit outweighs risk.

Use in Lactation: Ferric Carboxymaltose is safe during breastfeeding; limited data suggests no significant risk to the baby.

Pediatric Use: Not recommended for use in children under 14 years.

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

Renal Impairment: Probably safe; dose adjustment may not be needed; hemodialysis-dependent CKD patients should not exceed 200 mg iron per injection.

Hepatic Impairment: Use with caution; dose adjustment may be needed.

Overdose: Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis; monitor serum ferritin and transferrin saturation; consider use of iron chelator.

Storage: Store below 30 degree C in a cool and dry place, away from light. Do not freeze. Keep out of reach of children.

Ferric Carboxymaltose