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Injectafer restores iron

The evidence for administering 1500 mg of iron per course

Patients with IDA in Injectafer clinical trials were found to
have iron deficits of approximately 1500 mg1

Patients with IDA in Injectafer clinical trials were found to have iron deficits of approximately 1500 mg1

Average calculated iron deficits in Injectafer clinical trials*

Injectafer Iron Deficits Clinical Trials Injectafer Iron Deficits Clinical Trials

Injectafer restores up to 1500 mg of iron in 2 administrations
of 750 mg separated by at least 7 days9

Injectafer restores up to 1500 mg of iron in 2 administrations of 750 mg separated by at least 7 days9

*Calculated iron deficit based on the modified Ganzoni formula: Subject weight in kg x (15 - current hemoglobin g/dL) x 2.4 + 500. If subject TSAT >20% and ferritin >50 ng/mL, the 500-mg constant is not needed.

Reported etiologies included chronic kidney disease, heavy uterine bleeding (now commonly reffered to as abnormal uterine bleeding), GI-related, postpartum, and other/unknown.

Reported etiologies included heavy uterine bleeding (now commonly reffered to as abnormal uterine bleeding), GI disorders, postpartum, nutritional or dietary deficiency, and other.

Injectafer restores iron

When patients fail oral iron, choose Injectafer, the only FDA-approved IV iron that delivers up to 1500 mg in 1 course of therapy. Injectafer is dosed in 2 administrations of 750 mg separated by at least 7 days.With Injectafer, 100% of IV iron is delivered into the patient’s bloodstream. The full dose of IV iron is available to be utilized in hemoglobin production or stored as ferritin for future use as hemoglobin is depleted.

Benefits of Injectafer IV Iron Administration Benefits of Injectafer IV Iron Administration
Injectafer treatment may be repeated if iron deficiency anemia reoccurs. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment (see Important Safety Information)

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.

Over 9 million patient-years of experience worldwide10

  • Studied in more than 40 clinical trials with >8800 patients treated worldwide
  • Approved in more than 75 countries since its initial EU approval in 2007

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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 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 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.

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.

Please see Full Prescribing Information.

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