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Injectafer restores iron
The evidence for administering 1500 mg of iron per course
Patients with IDA in Injectafer clinical trials were found to
have iron deficits of approximately 1500 mg1
Patients with IDA in Injectafer clinical trials were found to have iron deficits of approximately 1500 mg1
Average calculated iron deficits in Injectafer clinical trials*
of 750 mg separated by at least 7 days9
Injectafer restores up to 1500 mg of iron in 2 administrations of 750 mg separated by at least 7 days9
*Calculated iron deficit based on the modified Ganzoni formula: Subject weight in kg x (15 - current hemoglobin g/dL) x 2.4 + 500. If subject TSAT >20% and ferritin >50 ng/mL, the 500-mg constant is not needed.
†Reported etiologies included chronic kidney disease, heavy uterine bleeding (now commonly reffered to as abnormal uterine bleeding), GI-related, postpartum, and other/unknown.
‡Reported etiologies included heavy uterine bleeding (now commonly reffered to as abnormal uterine bleeding), GI disorders, postpartum, nutritional or dietary deficiency, and other.
Injectafer restores iron
When patients fail oral iron, choose Injectafer, the only FDA-approved IV iron that delivers up to 1500 mg in 1 course of therapy. Injectafer is dosed in 2 administrations of 750 mg separated by at least 7 days.9 With Injectafer, 100% of IV iron is delivered into the patient’s bloodstream. The full dose of IV iron is available to be utilized in hemoglobin production or stored as ferritin for future use as hemoglobin is depleted.
¶For adult patients weighing less than 50 kg (110 lb), give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course of treatment.
§When administered via IV infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not <2 mg of iron per mL and administer over at least 15 minutes. When administered as a slow IV push, give at the rate of approximately 100 mg (2 mL) per minute.
Over 9 million patient-years of experience worldwide10
- Studied in more than 40 clinical trials with >8800 patients treated worldwide
- Approved in more than 75 countries since its initial EU approval in 2007
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Important Safety Information
Injectafer® (ferric carboxymaltose injection) is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and in adult patients with non-dialysis dependent chronic kidney disease.
IMPORTANT SAFETY INFORMATION
Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer 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. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
In clinical studies, hypertension was reported in 3.8% (67/1775) of subjects. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration.
In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer.
In two randomized clinical studies, a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a single maximum 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 ≥2% of Injectafer-treated patients were nausea (7.2%); hypertension (3.8%); flushing/hot flush (3.6%); blood phosphorus decrease (2.1%); and dizziness (2.0%).
The following serious adverse reactions have been most commonly reported from the post-marketing spontaneous reports: urticaria, dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia, and syncope.
To report adverse events, please contact American Regent at 1-800-734-9236. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.