Class: Supportive Care

Generic Name: ferric carboxymaltose (FER-ik kar-box-ee-MAWL-tose) injection

Trade Name: Injectafer®

For which conditions is this drug approved? Injectafer is 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
• Who have non-dialysis dependent chronic kidney disease

What is the mechanism of action? Injectafer is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

How is Injectafer typically given (administered)? Injectafer is given intravenously. Dosage is determined by bodyweight and administered in two doses separated by at least seven days. Total cumulative dosage should not to exceed 1500 mg of iron per course.

How are patients typically monitored?

Though infrequent, serious hypersensitivity reactions—including anaphylactic-type reactions, some of which have been life threatening and fatal—have been reported in patients receiving Injectafer. Symptoms include shock, clinically significant hypotension (low blood pressure), loss of consciousness, and/or collapse. Patients should be monitored for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Patients should also be monitored for signs and symptoms of hypertension following each Injectafer administration. In clinical studies hypertension was reported in less than 4% of subjects and temporary elevations in systolic blood pressure, in 6% of subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes.

What are the common (occur in 30% or more of patients) side effects of treatment with Injectafer?

• None reported

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Injectafer?

• Temporary decrease in laboratory blood phosphorus levels

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)

Are there any special precautions patients should be aware of before starting treatment?

• Question patients regarding any prior history of reactions to parenteral (not orally administered) iron products.
• Advise patients of the risks associated with Injectafer.
• Monitor patients for signs and symptoms of hypertension (high blood pressure) following each administration.
• Advise patients to report any signs and symptoms of hypersensitivity that may develop during and following Injectafer administration, such as rash, itching, dizziness, lightheadedness, swelling, and breathing problems.

When should patients notify their physician?

• If there are signs of hypersensitivity—rash, itching, dizziness, lightheadedness, swelling, breathing problems
• If there are signs of hypertension—nervousness, sweating, difficulty sleeping, facial flushing

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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