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Injectafer (ferric carboxymaltose injection) is an iron-replacement product administered to adults with anemia. However, recent studies suggest Injectafer is more likely to cause severe hypophosphatemia (dangerously low levels of phosphorous in the blood) compared to other injectable iron supplements.

Injectafer and Iron Deficiency Anemia

The U.S. Food & Drug Administration (FDA) approved Injectafer in 2013 for the treatment of adults with iron deficiency anemia who either:

• Have intolerance to oral iron;
• Experienced an unsatisfactory response to oral iron; or
• Have non-dialysis dependent chronic kidney disease.

Iron deficiency anemia is caused by a shortage of iron and red blood cells in the blood stream. Because this inhibits the body’s ability to transport oxygen to the body’s tissues, patients may experience serious health problems if left untreated.

Symptoms of iron deficiency anemia include:

• Excessive fatigue
• Pale skin
• Muscle weakness
• Cold hands and feet
• Shortness of breath, and lightheadedness
• Unusual cravings for things like dirt and ice

Generally, doctors prescribe oral supplements to treat iron deficiency anemia. But supplements won’t resolve anemia if a patient’s digestive system is unable to absorb iron. Other patients may be unable to tolerate certain side effects associated with oral iron.

Because ferric carboxymaltose and other intravenous anemia medications deliver a higher dose of iron, patients experience faster results and require less frequent treatment.

Patients receive Injectafer in two doses, at least 7 days apart. Following an infusion, patients are observed for 30 minutes for signs of an allergic reaction.

Injectable Safety Concerns Delayed FDA Approval

Injectafer is manufactured by Luitpold Pharmaceuticals, a wholly owned subsidiary of Daiichi Sankyo.

Luitpold Pharmaceuticals initially attempted to bring ferric carboxymaltose injection to market in 2007, when it asked the FDA to approve the drug for iron deficiency anemia associated with heavy uterine bleeding and the postpartum state. In February 2008, an agency advisory panel expressed support for approval, but recommended restricting Injectafer to patients who could not tolerate oral iron supplements.

The FDA ultimately declined to approve the medication, and asked Luitpold for additional data “to address concerns over safety of Injectafer in this population.”  Among other things, the agency noted that patients treated with ferric carboxymaltose experienced higher rates of death, hypophosphatemia, and other adverse events during clinical trials compared to patients treated with  oral iron supplements.

Luitpold Pharmaceuticals tried again in 2011, when it requested that the FDA approve Injectafer to treat iron deficiency anemia. But because an inspection turned up issues Luitpold’s manufacturing facility, the agency decided to withhold approval until the problems were corrected.

The FDA finally approved Injectafer in 2013, but with restrictions. As a result, the drug is only indicated for use in patients with non-dialysis dependent chronic kidney disease, or those unable to take oral iron due to intolerance or previous poor treatment response.

Injectafer Side Effects

The most common side effects associated with ferric carboxymaltose include:

• Nausea
• Hypophosphatemia (low levels of phosphorus in the blood)
• High blood pressure
• Dizziness
• Flushing

Because life-threatening allergic reactions have been reported with Injectafer and other intravenous iron products, patients should tell their doctor if they’ve ever had an unusual or allergic reaction to IV iron.

Symptoms of allergic reaction to ferric carboxymaltose may include:

• Hives
• Feeling light-headed
• Difficult breathing
• Swelling of the face, lips, tongue, or throat

Injectafer patients should contact their doctor right away if they experience any of the following side effects:

• Increased blood pressure– severe headache, pounding in your neck or ears, dizziness, nausea.
• Low levels of phosphorus in the blood– confusion, bone pain, muscle weakness.
• High levels of iron stored in the body– metallic taste in the mouth, bloody or tarry stools, vomiting blood, severe shortness of breath, chest pain, pale skin, blue lips or fingernails, loss of consciousness, or seizure (convulsions).

Injectafer and Severe Hypophosphatemia

As early as 2013, research indicated that ferric carboxmaltose could lower phosphorus levels for as long as three months. Subsequent studies have suggested Injectafer is more likely to cause severe hypophosphatemia compared to its competitors.

In 2016, for example, Austrian researchers reported that 45% of patients treated with ferric carboxymaltose experienced hypophosphatemia, while 32% developed severe hypophosphatemia. However,  just 4% of those treated with isomaltoside (brand name Monofer) developed the condition, and none experienced severe hypophosphatemia

Most recently, a study published in the Journal of Clinical Investigation compared the rate of adverse events among nearly 2,000 patients treated with either Injectafer or Feraheme (ferumoxytol injection).  The findings were disturbing, as over half (50.8%) of the Injectafer patients experienced severe hypophosphatemia, while fewer than 1% of of those receiving Feraheme developed hypophosphatemia.