FERRIC CARBOXYMALTOSE

Background and Date of Approval

Ferric carboxymaltose is a prescription iron replacement medicine approved for medical use on 26 July 2013.

Uses

Ferric Carboxymaltose Injection has been developed to treat iron deficiency anaemia in adult and paediatric patients who have not responded well to oral iron treatment. This injection also treats iron deficiency anaemia in adult patients with chronic kidney disease who are not dependent on dialysis.

How is it administered?

Ferric Carboxymaltose is available as 2ml, 10ml and 20ml vials of injection in the doses 100mg, 500mg and 1000mg. Your healthcare provider will calculate the accurate dose and inject this medicine into your vein. The usual recommended dose for patients weighing more than 50kg is 15mg/kg of body weight or two 750mg injections separated by at least 7 days, thus forming a cumulative dose of 1500mg iron per course. The recommended dose for patients weighing less than 50 kg is 15mg/kg body weight in two doses separated by at least 7 days per course.

Side Effects

The common side effects that are likely to occur while you are on the treatment with Ferric Carboxymaltose Injection are nausea, hypertension, flushing, injection site reactions, dizziness, stomach pain, indigestion, vomiting, high heart rate, back pain and hypophosphatemia. If you experience any symptoms like allergic reactions, inflammation of veins, low blood pressure and breathing difficulty, report to your doctor immediately.

Warnings

Your healthcare provider will observe for at least 30 minutes for signs and symptoms of hypersensitivity during and after injecting Ferric Carboxymaltose injection. you will also be monitored for changes in blood phosphate levels and blood pressure. Report to your doctor if you have had a history of heart failure, high blood pressure, liver problem, systemic lupus erythematosus or arthritis. Get immediate medical attention if you have breathlessness or lightheadedness.

Precautions

Ferric Carboxymaltose injection is not recommended for use during pregnancy because the risk of hypersensitivity reactions can have serious consequences on the foetus. Ferric Carboxymaltose passes into the breast milk. However, it is not known whether this medicine would pose a risk to your baby. Tell your Healthcare provider before taking this injection if you are pregnant, think you could be pregnant, breastfeeding or planning to have a baby.

Word of Advice

Ferric Carboxymaltose injection may cause dizziness. Patients should avoid driving and operating machinery during treatment.

References

American Regent Inc., U.S. Food & Drug Administration, [Revised on Feb 2022] [Accessed on 23rd Aug 2022], https://daiichisankyo.us/prescribing-information-portlet/getDocument?product=IF&inline=true Charmila et al., Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India, Journal of Blood Medicine, Published on 8th June 2022, :13 303–313, [Accessed on 24th Aug 2022], https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9189149/pdf/jbm-13-303.pdf

Frequently Asked Questions

What is Ferric Carboxymaltose injection used for?

Ferric Carboxymaltose injection is used for treating moderate to severe iron deficiency anaemia. oral medicines will not be adequate to achieve desired improvement in haemoglobin and iron levels within a short time. Hence, doctors prescribe parenteral iron preparations to achieve faster improvement.

Is it safe for women of reproductive potential to use Ferric Carboxymaltose Injection?

Ferric Carboxymaltose injection is not recommended for use during pregnancy because the risk of hypersensitivity reactions can have serious consequences on the foetus. Ferric Carboxymaltose passes into the breast milk. However, it is not known whether this medicine would pose a risk to your baby. Tell your Healthcare provider before taking this injection if you are pregnant, think you could be pregnant, breastfeeding or planning to have a baby.

Will you be monitored during this treatment?

Yes, you will be monitored for 30 minutes for signs of allergic reaction after injecting Ferric Carboxymaltose. Your healthcare provider will also monitor your blood pressure and blood phosphate levels during this treatment.

What are the side effects of Ferric Carboxymaltose Injection?

Nausea, hypertension, flushing, injection site reactions, dizziness, stomach pain, indigestion, vomiting, high heart rate, back pain and hypophosphatemia are some of the most common side effects of Ferric Carboxymaltose treatment.

How is Ferric Carboxymaltose Injection administered?

Ferric Carboxymaltose Injection is given intravenously and the dose will be measured based on your body weight.

How to store Ferric Carboxymaltose injection?

Ferric Carboxymaltose injection at 20-25°C without freezing.

Who should not take Ferric Carboxymaltose injection?

Ferric Carboxymaltose injection not recommended for patients who are hypersensitive to Ferric Carboxymaltose or its excipients. this injection is also not intended to treat anaemia that is not due to iron deficiency.

How would you know if you are allergic to Ferric Carboxymaltose?

Symptoms like itching, hives, wheezing and skin reactions indicate that you could be allergic to Ferric Carboxymaltose. Tell your healthcare provider if you have experienced any of the above reactions after taking this injection.

Available Brands 71

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS