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Study 1: Injectafer vs oral iron and vs IV iron Standard of Care

Study 1: Injectafer vs oral iron and vs IV iron Standard of Care (SoC)1

Study 1:
Injectafer vs oral iron
and vs IV iron Standard of
Care (SoC)1

A randomized, open-label, multicenter study evaluating the efficacy and safety of Injectafer in adult patients with IDA of any etiology.

Injectafer vs. Oral Iron vs. IV Iron SoC Clinical Trial Injectafer vs. Oral Iron vs. IV Iron SoC Clinical Trial

*Participants who responded adequately to oral iron during run-in (Hb increase ≥1 g/dL) were not randomized.

Subjects inappropriate for oral iron were defined as either those who were intolerant of oral iron during the run-in phase or those in whom the baseline Hb measurement was sufficiently low as to require rapid repletion of iron stores to minimize the risk of eventual blood transfusion. These patients were not included in the indication for Injectafer.

The efficacy analyses were 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 Population consisted of all subjects who received a dose of randomized treatment. All safety analyses were performed with the Safety Population.

Study 1, Cohort 1

Injectafer provided significantly greater increase
in hemoglobin (Hb) than oral iron

Injectafer provided
significantly greater
increase in hemoglobin
(Hb) than oral iron

  • Cohort 1 consisted of patients with iron deficiency anemia who did not have a satisfactory response to oral iron in a 14-day run-in period1

Greater absolute increase in Hb1

Injectafer vs. Oral Iron Hemoglobin Greater Increase Clinical Study 1, Cohort 1 Injectafer vs. Oral Iron Hemoglobin Greater Increase Clinical Study 1, Cohort 1

 

Proportion of patients achieving Hb target of >12 g/dL1

Injectafer vs. Oral Iron Hemoglobin Target Increase Clinical Study 1, Cohort 1 Injectafer vs. Oral Iron Hemoglobin Target Increase Clinical Study 1, Cohort 1

 

Improvements in ferritin and TSAT1

Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 1 Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 1

 

Primary composite safety endpoint

Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 1 Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 1

  • The most commonly observed components of the composite safety endpoint were protocol-defined hypertension (4 participants in Cohort 1, Injectafer arm; 7 participants in Cohort 2, Injectafer arm; and 6 participants in Cohort 2, SoC IV iron arm) and death due to any cause (2 participants in Cohort 1, oral iron arm).1

|| Standard deviation.

Post-hoc comparison.

Study 1, Cohort 2

Injectafer 1500 mg provided greater increase
in Hb than IV iron Standard of Care (SoC)

  • Cohort 2 consisted of patients who tolerated oral iron poorly or were inappropriate for treatment with oral iron
  • 90% of patients randomized to IV iron SoC received iron sucrose1

Greater absolute increase in Hb1

Injectafer vs. Oral Iron Hemoglobin Greater Increase Clinical Study 1, Cohort 2 Injectafer vs. Oral Iron Hemoglobin Greater Increase Clinical Study 1, Cohort 2

 

Proportion of patients achieving Hb target of >12 g/dL1

Injectafer vs. Oral Iron Hemoglobin Target Increase Clinical Study 1, Cohort 2 Injectafer vs. Oral Iron Hemoglobin Target Increase Clinical Study 1, Cohort 2

 

Improvements in ferritin and TSAT1

Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 2 Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 2

 

Primary composite safety endpoint

Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 1 Injectafer vs. Oral Iron Ferritin TSAT Improvement Clinical Study 1, Cohort 1

  • The most commonly observed components of the composite safety endpoint were protocol-defined hypertension (4 participants in Cohort 1, Injectafer arm; 7 participants in Cohort 2, Injectafer arm; and 6 participants in Cohort 2, SoC IV iron arm) and death due to any cause (2 participants in Cohort 1, oral iron arm).1

#Standard deviation.

**Post-hoc comparison.

Gradient Bar links - EFFICACY

EFFICACY & SAFETY: Study 2 (REPAIR-IDA): Injectafer vs IV iron sucrose in NDD-CKD

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.

Please see Full Prescribing Information.

Reference - Efficacy and Saftey