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Condition and patient type
IDA is common in chronic kidney disease (CKD) patients.3 Main causes of IDA in CKD patients include impaired intestinal absorption of dietary iron, blood loss, chronic inflammation, and increased iron requirements during therapy with erythropoiesis-stimulating agents (ESAs).4
Injectafer is indicated for the treatment of IDA in adult patients who have non-dialysis-dependent chronic kidney disease (NDD-CKD). Injectafer is also indicated for the treatment of IDA in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron.
Review REPAIR-IDA: The first and largest head-to-head IV iron study in patients with IDA and NDD-CKD5
Diagnosing and managing IDA
A prevalent complication of CKD, IDA remains underdiagnosed and undertreated. Both early-stage CKD and anemia can be asymptomatic, so renal and hematologic laboratory values should be monitored annually in at-risk patients.4 The Kidney Disease Outcomes Quality Initiative (K/DOQI) concluded that serum ferritin and transferrin saturation (TSAT) levels should be the primary indicators for assessing iron management in patients with anemia and CKD.6
The increasing prevalence of multiple comorbidities among anemic patients with CKD has made the use of serum ferritin and transferrin saturation more challenging in diagnosing iron deficiency. Here are other common laboratory tests taken to confirm an IDA diagnosis3,6:
- Serum creatinine
- Iron studies
- Serum iron
- Serum ferritin
- Total iron binding capacity (TIBC)
Injectafer restores iron—indicated for first-line use in NDD-CKD patients with IDA
Injectafer is a dextran-free IV iron indicated for adult IDA patients of various etiologies. It is the only IV iron that delivers up to 1500 mg of iron in just 2 administrations, separated by at least 7 days.
*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.
Injectafer is indicated for the treatment of IDA in adult patients who have NDD-CKD. Injectafer is also indicated for the treatment of IDA in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron.
Injectafer is not indicated to treat the symptoms of IDA.
Gradient Bar links- Choosing Injectafer
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.