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Injectafer® (ferric carboxymaltose injection) video Click on the video below to learn more about Injectafer.
Injectafer®
(ferric carboxymaltose injection) video Click on the video below to learn more about Injectafer.
NOW PLAYING: The Mechanism of Action of Injectafer
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 or have had unsatisfactory response to oral iron or who have non-dialysis-dependent chronic kidney disease (NDD-CKD).
Injectafer or ferric carboxymaltose injection is a dextran-free iron formulation for intravenous use.
It has a shell made of a carbohydrate polymer called carboxymaltose, that is tightly bound around a colloidal iron (III) hydroxide core.
It has a neutral pH and physiologic osmolarity.
Its structure is similar to that of physiologic ferritin, the body's iron storage protein.
Together, the chemical characteristics of this molecular structure may enable Injectafer to deliver a large amount of iron in a controlled fashion.
After administration, enzymes in the blood partially degrade the Injectafer carbohydrate shell but no iron is released.
It is likely then taken up by macrophages of the reticuloendothelial system or RES.
Inside the macrophages, enzymes gradually break down the carbohydrate shell that is tightly bound to the iron core.
Iron is released slowly and may be stored mainly in the liver as ferritin, the storage protein.
Alternatively, it may be exported to the plasma. In the plasma, iron is bound by transferrin, the transport protein.
Transferrin delivers iron to cells in the liver and spleen or to the bone marrow, where it can be used for hemoglobin synthesis and red blood cell formation.
The chemical characteristic of the iron carbohydrate complex means that iron is released slowly.
As a result, the transferrin available for uptake does not become fully saturated with iron. This entire process results in a controlled release of iron into the bloodstream.
The number one IV iron in oncology clinics and fastest growing IV iron in the United States is Injectafer. A dextran-free iron carbohydrate complex with a controlled release of iron.
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Choosing Injectafer:FAQ
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Important Safety Information
INDICATIONS
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
CONTRAINDICATIONS
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.
ADVERSE REACTIONS
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.