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Anemia is prevalent in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD)
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).6
CLINICAL CONSIDERATION IDA is the most common reversible cause of chronic or worsening anemia in CKD patients
other than anemia related directly to CKD.7
Progression of renal dysfunction and anemia can exacerbate chronic heart failure (CHF), which in turn can cause more renal impairment and worsen anemia8
Consider Injectafer as first-line therapy for your patients
with IDA and NDD-CKD4
Consider Injectafer as first-line therapy for your patients with IDA and NDD-CKD4
Review REPAIR-IDA: The first and largest head-to-head IV iron study in patients with IDA and NDD-CKD9
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.6 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.10
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 diagnosis3,10:
- 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 100% dextran-free IV iron indicated for adult IDA patients of various etiologies. It is the only FDA-approved IV iron that delivers up to 1500 mg of iron in 2 administrations, separated by at least 7 days.2,4*
*In Injectafer clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer.4
†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.
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Important Safety Information
Injectafer® (ferric carboxymaltose injection) is 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, or who have 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
Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.
Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.
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 adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria.
CLINICAL CONSIDERATIONS IN PREGNANCY
Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.
Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.
You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.