Injectafer

Injectafer Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Injectafer (ferric carboxymaltose) injection is an iron carbohydrate complex used to treat iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease. Common side effects include nausea, high blood pressure (hypertension), flushing, dizziness, vomiting, injection site reactions, and headache.

For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course. For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course. Injectafer may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Injectafer should be used only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Injectafer (ferric carboxymaltose) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Injectafer FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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 Injectafer 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

Term Injectafer
(N=1775)
%
Pooled Comparatorsa
(N=1783)
%
Oral iron
(N=253)
%
Nausea 7.2 1.8 1.2
Hypertension 3.8 1.9 0.4
Flushing/Hot Flush 3.6 0.2 0.0
Blood Phosphorus Decrease 2.1 0.1 0.0
Dizziness 2.0 1.2 0.0
Vomiting 1.7 0.5 0.4
Injection Site Discoloration 1.4 0.3 0.0
Headache 1.2 0.9 0.0
Alanine Aminotransferase Increase 1.1 0.2 0.0
Dysgeusia 1.1 2.1 0.0
Hypotension 1.0 1.9 0.0
Constipation 0.5 0.9 3.2
a Includes oral iron and all formulations of IV iron other than Injectafer

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 Injectafer: 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 Injectafer every 2 weeks for a total of 16 weeks. Partial recovery followed discontinuation of Injectafer.

Read the entire FDA prescribing information for Injectafer (Ferric carboxymaltose Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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