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For your specific specialty, access information below about the patients you're seeing and how to test for, diagnose, and manage iron deficiency anemia (IDA).

Cardiologist

Iron deficiency is a risk for cardiology patients*

30% to 50% of patients with heart failure also have iron deficiency31
Signs and symptoms of anemia and heart failure due to impaired oxygen delivery. For anemia: dyspnea, edema, fatigue, Congitive impairment, and angina pectoris. For heart failure: dyspnea, edema, fatigue, confusion, and angina pectoris. Signs and symptoms of anemia and heart failure due to impaired oxygen delivery. For anemia: dyspnea, edema, fatigue, Congitive impairment, and angina pectoris. For heart failure: dyspnea, edema, fatigue, confusion, and angina pectoris.

The incidence of iron deficiency and anemia was greater among patients with a more severe New York Heart Association (NYHA) functional class38†

Results seen in a study of international pooled cohort comprising 1506 patients with CHF. 30% iron deficiency and anemia in patients with NYHA IV Results seen in a study of international pooled cohort comprising 1506 patients with CHF. 30% iron deficiency and anemia in patients with NYHA IV

*Injectafer is not indicated for the treatment of iron deficiency.

Data were captured from a single measurement in time, and the effects of changes in iron, anemia, or NYHA functional class status over time should not be inferred.

Patients with both iron deficiency and anemia were older and had a higher NYHA functional class, more comorbidities, and higher biomarker levels compared with those with no iron deficiency and no anemia.38

§NYHA IV functional class is defined as being unable to perform any physical activity without discomfort, and having symptoms of CHF present at rest.39

Consider routinely testing your patients with CHF for IDA

Consider routinely testing your patients with CHF for IDA

Injectafer restores iron

Injectafer is a 100% dextran-free IV iron indicated for adult IDA patients of various etiologies, and is the only FDA-approved IV iron that delivers up to 1500 mg of iron in 2 administrations, separated by at least 7 days.2,4||

Take two 750 mg doses of Injectafer 7 days apart for a total course up to 1500 mg. IV infussion over at least 15 minutes or slow IV push over 7.5 minutes Take two 750 mg doses of Injectafer 7 days apart for a total course up to 1500 mg. IV infussion over at least 15 minutes or slow IV push over 7.5 minutes
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).

||In Injectafer clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer.4

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.

Injectafer is not indicated to treat the symptoms of IDA.

Choosing Injectafer: VIDEO LIBRARY

Choosing Injectafer: VIDEO LIBRARY

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.

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.

Please see Full Prescribing Information.

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