FERINJECT

Ferric carboxymaltose is an iron replacement product and, chemically, an iron-carbohydrate complex.

It was FDA approved on

July 25, 2013.

Ferric carboxymaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in patients ≥1 year of age who have an intolerance to, or unsatisfactory response from, oral iron therapy, 2 and in adult patients who have non-dialysis-dependent chronic kidney disease.

It is also indicated to treat iron deficiency and improve exercise capacity in adult patients with NYHA class II or III heart failure.

When measured using positron emission tomography (PET), the red cell uptake of 59-Fe and 52-Fe from INJECTAFER ranged from 61% to 99%.

In patients with iron deficiency, the red cell uptake ranged from 91% to 99%.

In patients with renal anemia, the red cell uptake ranged from 61% to 84%.

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

When a single dose of 100-1000 mg of iron was given to iron-deficient patients, the maximum serum concentration was 37 μg/mL to 333 μg/mL.

These levels were obtained 15 minutes to 1.21 hours post-dose.

The estimated volume of distribution after a single dose was 3 liters.

The terminal half-life of ferric carboxymaltose ranges from 7-12 hours.

The elimination half-life in pediatric patients was approximately 9.7 hours.

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The most common adverse reactions (>2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness.

Uses Stop use and ask a doctor if symptoms persist or worsen If pregnant or breast-feeding ask a health professional before use Keep out of reach of children.

Directions best if used in the morning and just before bed use 5 days per week until symptoms are relieved adults and children 12 years and over 4-5 sprays in mouth twice per day children 2 years to under 12 years 2-3 sprays in mouth twice per day children under 2 years consult a doctor.

Information do not use if plastic seal around cap is broken or missing. store in a cool, dry place.