INJECTAFER is the #1 IV iron used in oncology clinics (mg volume)*
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Patients with iron deficiency anemia (IDA) in INJECTAFER clinical trials were found to have iron deficits of approximately 1500 mg.1†

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INJECTAFER is the only IV iron that delivers up to 1500 mg of iron in 2 administrations of 750 mg, separated by at least 7 days.‡§

Chart presenting data related to 7 INJECTAFER clinical trials
*
Based on Symphony Health Solutions PHAST Non-retail Mg Administration Volume Data (February 2018-January 2019).
Based on a retrospective analysis of 7 INJECTAFER clinical trials of patients with IDA of various etiologies. Calculated iron deficit was based on the modified Ganzoni formula.
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.
a
Studies 1-5 utilized a modified Ganzoni formula to determine dose requirements, while Studies 6 and 7 (2 larger pivotal studies) used 1500 mg IV iron per study protocol and calculated iron deficits as a post hoc analysis. Calculated iron deficit based on the modified Ganzoni formula: subject weight in kg x (15 - current Hb g/dL) x 2.4 + 500. If subject TSAT >20% and ferritin >50 ng/mL, the 500-mg constant is not needed.1
b
Reported etiologies included heavy uterine bleeding,d GI disorders, postpartum, nutritional or dietary deficiency, and other.2
c
Reported etiologies included CKD, heavy uterine bleeding,d GI related, postpartum, and other/unknown.3,4
d
Now commonly referred to as abnormal uterine bleeding.
Please see Important Safety Information for INJECTAFER.
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 Important Safety Information and full Prescribing Information for INJECTAFER at www.injectafer.com/pdf/pi.pdf.
References: 1. Koch TA, Myers J, Goodnough LT. Intravenous iron therapy in patients with iron deficiency anemia: dosing considerations. Anemia. 2015;2015:763576. doi:10.1155/2015/763576 2. Onken JE, Bregman DB, Harrington RA, et al. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia. Transfusion. 2014;54(2):306-315. 3. Barish CF, Koch T, Butcher A, Morris D, Bregman DB. Safety and efficacy of intravenous ferric carboxymaltose (750 mg) in the treatment of iron deficiency anemia: two randomized, controlled trials. Anemia. 2012;2012:172104. doi:10.1155/2012/172104 4. Hussain I, Bhoyroo J, Butcher A, Koch TA, He A, Bregman DB. Direct comparison of the safety and efficacy of ferric caboxymaltose versus iron dextran in patients with iron deficiency anemia. Anemia. 2013;2013:169107. doi:10.1155/2013/169107

American Regent, Inc. is a member of the Daiichi Sankyo Group.

INJECTAFER® and the INJECTAFER® logo are trademarks of Vifor (International), Inc., Switzerland.

INJECTAFER® is manufactured under license from Vifor (International), Inc., Switzerland.

Trademarks not owned by American Regent, Inc. or Vifor (International) are the property of their respective owners.

©2019 Daiichi Sankyo, Inc. All Rights Reserved. PP-US-IN-1205 08/19

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