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Study 2 - Injectafer vs IV iron sucrose in NDD-CKD
Study 2 (REPAIR-IDA): Injectafer vs IV iron sucrose in non-dialysis-dependent chronic kidney disease (NDD-CKD)2
A randomized, active-controlled, multicenter, noninferiority, open-label trial comparing the safety and efficacy
of Injectafer with IV iron sucrose in patients with IDA and NDD-CKD.
*14 patients randomized to Injectafer and 9 patients randomized to iron sucrose were withdrawn prior to receiving study drug.
†The efficacy analysis was performed on the modified intent-to-treat (mITT) population, which included all patients who received at least 1 dose of randomized treatment and had at least 1 post-baseline Hb assessment.
‡The safety analysis population comprised all participants who received a randomly assigned treatment dose.
§Included: all-cause death, nonfatal MI, nonfatal stroke, unstable angina requiring hospitalization, chronic HF requiring hospitalization or medical intervention, cardiac arrhythmia, and hyper- or hypotensive events as defined per protocol.
Injectafer demonstrated hemoglobin (Hb) improvement
- Noninferiority of Injectafer compared with iron sucrose was demonstrated in
patients with NDD-CKD3
Greater absolute increase in Hb3
Mean ferritin and TSAT values at each scheduled visit3,4
In a post-hoc analysis, fewer patients taking Injectafer required retreatment5
||Standard deviation.
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Safety Profile from Injectafer Pivotal Trials
EFFICACY & SAFETY: Safety Profile from Injectafer Pivotal Trials
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.