Ferric carboxymaltose

Dosage Forms & Strengths

injectable solution

• 50mg/mL (as 750mg/15mL vial)

Iron Deficiency Anemia

Indicated for treatment of iron deficiency anemia (IDA) in adults who have intolerance or an unsatisfactory response to oral iron; also indicated for IDA in adults with nondialysis dependent chronic kidney disease

≥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

Safety and efficacy not established

Ferric Carboxymaltose is part of the drug classes:

• Iron in combination with folic acid

• Iron trivalent, oral preparations

• Iron trivalent, parenteral preparations

Ferric carboxymaltose is an iron replacement product. You normally get iron from the foods you eat. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and organs.

Ferric carboxymaltose is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body).

Ferric carboxymaltose is usually given after oral (taken by mouth) iron replacement medicines have been tried without success.

Ferric carboxymaltose may also be used for purposes not listed in this medication guide.

You should not use ferric carboxymaltose if you have iron overload disorder, or anemia that is not caused by iron deficiency.

Ferric carboxymaltose is injected into a vein through an IV. A healthcare provider will give you this injection.

Ferric carboxymaltose is usually given in two doses, 7 days apart. Your doctor will determine whether you need a repeat course of these two doses.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when ferric carboxymaltose is injected.

You will be watched closely for at least 30 minutes after receiving ferric carboxymaltose, to make sure you do not have an allergic reaction to the medication.

Tell your doctor if you have any changes in weight. Ferric carboxymaltose doses are based on weight, and any changes may affect the dose.

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with ferric carboxymaltose.

Iron is contained in many vitamin or mineral supplements. Taking certain products together can cause you to get too much iron. Avoid taking any vitamin or mineral supplement your doctor has not recommended.

Usual Adult Dose for Iron Deficiency Anemia:

Patients weighing 50 kg or more: Two doses of 750 mg via slow IV push or infusion separated by at least 7 days
Patients weighing less than 50 kg: Two doses of 15 mg/kg via slow IV push or infusion separated by at least 7 days
Maximum dose: Total cumulative dose should not exceed 1500 mg of iron per course

Comments:
-The dosage is expressed in mg of elemental iron.
-Treatment may be repeated if iron deficiency anemia recurs

Use: Treatment of iron deficiency anemia in adults with an intolerance or unsatisfactory response to oral iron and in adults with non-dialysis dependent chronic kidney disease

Iron Deficiency Anemia Not Amenable to Oral Iron Therapy

Treatment of iron deficiency anemia in adults who are intolerant of or have had an unsatisfactory response to oral iron preparations.1 2 5

Iron Deficiency Anemia in Patients with Non-Dialysis-Dependent Chronic Kidney Disease

Treatment of iron deficiency anemia in adults with non-dialysis-dependent chronic kidney disease.1 3 4 5

Absorption

Bioavailability

Rapid, dose-dependent increase in total serum iron concentrations observed following single IV doses of 0.1–1 g.6

Peak iron concentrations of 37–333 mcg/mL observed 0.25–1.21 hours following IV injection or infusion of a single dose of 0.1–1 g in patients with iron deficiency.1 8

Distribution

Extent

Iron administered as ferric carboxymaltose rapidly distributed to bone marrow, liver, and spleen; estimated distribution volume 3 L.1 6 7

RBC iron uptake of 61–99% following administration of radiolabeled ferric carboxymaltose.1

RBC iron uptake of 91–99% reported 24 days following administration of radiolabeled ferric carboxymaltose in patients with iron deficiency.1

Special Populations

RBC iron uptake of 61–84% reported 24 days following administration of radiolabeled ferric carboxymaltose in patients with renal anemia.1

Elimination

Elimination Route

Negligible renal elimination.1

Half-life

7–12 hours.1 6

Maximum iron levels (37-333 mcg/mL): 0.25-1.2 hours

Half-Life Elimination

7-12 hours

Iron-deficiency anemia (IDA): Treatment of IDA in adults with intolerance to oral iron or unsatisfactory response to oral iron; treatment of IDA in adults with nondialysis-dependent chronic kidney disease (ND-CKD)

Refer to adult dosing.

Chronic kidney disease, nondialysis dependent: No dosage adjustment necessary (indicated for use in nondialysis CKD)

Data not available