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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.
Patients in this study received Injectafer by IV push
Injectafer trials included patients with iron intolerance, drug allergy, and hypotension1,2
Injectafer trials included patients with iron intolerance, drug allergy, and hypotension1,2
*14 patients randomized to Injectafer and 9 patients randomized to iron sucrose were withdrawn prior to receiving study drug.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.
STUDY 2 (REPAIR-IDA): INJECTAFER VS IV IRON SUCROSE IN NDD-CKD
Injectafer demonstrated hemoglobin (Hb) improvement
- Noninferiority of Injectafer compared with iron sucrose was demonstrated in
patients with NDD-CKD2
Greater absolute increase in Hb2
No significant difference was shown at the primary composite safety endpoint2
In Injectafer clinical trials, serious anaphylactic/anaphylactoid reactions were
reported in 0.1% (2/1775) of subjects receiving Injectafer3
In Injectafer clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer3
Injectafer showed greater improvements in ferritin and TSAT
Mean ferritin and TSAT values at each scheduled visit2,4
Mean ferritin and TSAT values at each
scheduled visit2,4
In a post-hoc analysis, fewer patients taking Injectafer required retreatment5¶
||Standard deviation.
¶Please note that this was a post-hoc analysis; therefore, the limitations of the data must be considered, and the results should be interpreted with caution and in the context of the overall trial results.
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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 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
CONTRAINDICATIONS
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 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. 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 [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single 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 (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); dizziness (2.1%); and vomiting (2%).
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; pregnancy: fetal bradycardia.
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.
