Ferric Carboxymaltose

Ferric Carboxymaltose is a iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or those who have non-dialysis dependent chronic kidney disease. (Iron deficiency anemia;)

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.

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferric Carboxymaltose.

Ferric Carboxymaltose should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be closely observed for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following each Ferric Carboxymaltose injection.

Determination of the Cumulative Iron Dose: The cumulative dose for repletion of iron using Ferric Carboxymaltose is determined based on the patient’s body weight and haemoglobin level and must not be exceeded. Table 1 should be used to determine the cumulative iron dose :

Note: A cumulative iron dose of 500 mg should not be exceeded for patients with body weight <35 kg.

For overweight patients, a normal body weight/blood volume relationship should be assumed when determining the iron requirement.

For patients with an Hb value ≥14 g/dL, an initial dose of 500 mg iron should be given and iron parameters should be checked prior to repeat dosing.

Post-repletion, regular assessments should be completed to ensure that iron levels are corrected and maintained.

Maximum Tolerated Single Dose: A single dose of Ferric Carboxymaltose should not exceed 1,000 mg of iron (20 mL/day). Do not administer 1,000 mg of iron (20 mL) more than once a week.

Intravenous Injection:

Intravenous Infusion:

Children: The use of Ferric Carboxymaltose has not been studied in children, and therefore is not recommended in children under 14 years.

Administration: Ferric Carboxymaltose must be administered only by the intravenous route, by bolus injection, or during a haemodialysis session undiluted directly into the venous limb of the dialyser or by infusion. In case of infusion, Ferric Carboxymaltose must be diluted only in sterile 0.9% m/V sodium chloride solution as follows :

Ferric Carboxymaltose must not be administered by the subcutaneous or intramuscular route.

See also:
What is the most important information I should know about Ferric Carboxymaltose?

The use of Ferric Carboxymaltose is contraindicated in cases of: Hypersensitivity to Ferric Carboxymaltose complex, to Ferric Carboxymaltose solution or to any of its excipients in Description.

Anaemia not attributed to iron deficiency eg, other microcytic anaemia.

Evidence of iron overload or disturbances in iron utilisation.

Use Ferric Carboxymaltose as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ferric Carboxymaltose. Talk to your pharmacist if you have questions about this information.
• Ferric Carboxymaltose is administered as an injection at your doctor's office, hospital, or clinic.
• Do not use Ferric Carboxymaltose if it contains particles or is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Ferric Carboxymaltose, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Ferric Carboxymaltose.

Use: Labeled Indications

Iron deficiency anemia: Treatment of iron deficiency anemia (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)

Off Label Uses

Abdominal surgery, major (perioperative anemia management)

Data from a randomized, controlled trial comparing Ferric Carboxymaltose therapy to usual perioperative care (eg, no treatment, continued observation, oral iron recommendations, and allogeneic blood transfusion) in patients with iron deficiency anemia scheduled for abdominal surgery supports the use of Ferric Carboxymaltose in perioperative patients. Results showed a reduced need for blood transfusion in the perioperative period, a shorter hospital stay, enhanced restoration of iron stores, and higher mean hemoglobin concentration 4 weeks after surgery in those receiving intravenous iron.

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What other drugs will affect Ferric Carboxymaltose?

As with all parenteral iron preparations, the absorption of oral iron is reduced when administered concomitantly. Therefore, if required, oral iron therapy should not be started for at least five days after the last injection of Ferric Carboxymaltose.

See also:
What are the possible side effects of Ferric Carboxymaltose?

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Hypersensitivity Reactions
• Hypertension
• Lab test alterations

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. In two randomized clinical studies [Studies 1 and 2, See Clinical Studies], a total of 1,775 patients were exposed to Ferric Carboxymaltose 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1500 mg of iron.

Adverse reactions reported by ≥ 1% of treated patients are shown in the following table.

Table 1: Adverse reactions reported in ≥ 1% of Study Patients in Clinical Trials 1 and 2

Other adverse reactions reported by ≥ 0.5% of treated patients include abdominal pain, diarrhea, gamma glutamyl transferase increased, injection site pain/irritation, rash, paraesthesia, sneezing. Transient decreases in laboratory blood phosphorus levels ( < 2 mg/dL) have been observed in 27% (440/1638) patients in clinical trials.

Post-marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following serious adverse reactions have been most commonly reported from the post-marketing spontaneous reports with Ferric Carboxymaltose: urticaria, dyspnea, pruritis, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia, and syncope. One case of hypophosphatemic osteomalacia was reported in a subject who received 500 mg of Ferric Carboxymaltose every 2 weeks for a total of 16 weeks. Partial recovery followed discontinuation of Ferric Carboxymaltose.

Each mL of solution for injection/infusion contains iron as Ferric Carboxymaltose 50 mg and sodium up to 5.5 mg (0.24 mmol).

Excipients/Inactive Ingredients: Sodium hydroxide and hydrochloric acid for pH adjustment and water for injections.