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Injectafer vs Oral Iron
Trial 1, Cohort 1: Injectafer vs Oral Iron
Trial 1, Cohort 1, was a randomized, open-label, controlled clinical study in patients with iron deficiency anemia who had an unsatisfactory response to oral iron during the 14-day oral iron run-in period.
- The primary etiologies of iron deficiency anemia were heavy uterine bleeding (47%) and gastrointestinal disorders (17%)
Injectafer demonstrated significant improvement in hemoglobin (Hb) than oral iron
Injectafer provided significantly greater increases in Hb levels than oral iron1*
- The Injectafer arm consisted of patients with iron deficiency anemia who did not have a satisfactory response to oral iron in a 14-day run-in period
Improvement vs oral iron at day 35
*A randomized, open-label, multicenter study evaluated the efficacy and safety of Injectafer in adult patients with IDA of any etiology (N=977). Appropriate candidates received oral iron therapy in a 14-day run-in phase. Patients who responded with an increase in hemoglobin (Hb)≥1 g/dL were not randomized for further treatment. Patients with an increase in Hb <1 g/dL were placed in Cohort 1 and randomized to receive either Injectafer (n=244) or oral iron (n=251) for another 14 days. Dosing for iron replacement agents was:Injectafer- 2 doses of 750 mg, up to 1500 mg; oral iron-325 mg 3x/day. The primary efficacy measure was the mean change in Hb from baseline to highest value between day 0 and day 35 or time of intervention (Cohort 2). 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. Secondary efficacy endpoints included the mean change from baseline to highest observed Hb at any time between baseline and day 35 or time of intervention (Cohort 2), proportion of subjects achieving an Hb level >12 g/dL at any time between baseline and day 35, mean change from baseline to highest ferritin measurement at any time between baseline and day 35, proportion of subjects achieving an Hb level >12 g/dL and an increase in ferritin of at least 160 ng/mL at any time between baseline and day 35, proportion of subjects achieving an increase in Hb level of at least 2 g/dL at any time between baseline and day 35, and mean change from baseline to each scheduled visit for Hb, ferritin, and TSAT levels.
‡Secondary efficacy endpoints were not powered for superiority.
Injectafer Vs Other
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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.