Banner - About IDA

Common symptoms of IDA include

Common symptoms of IDA include1,5*:

Headache, especially with activity

Dyspnea or chest pain,
especially with activity

Pallor

Unexplained fatigue or
lack of energy

Symptoms could be indicative of another disease or condition, and some patients with IDA
are asymptomatic.

*Injectafer is not indicated to treat the symptoms of IDA.

Patients with a wide range of underlying conditions are at risk for IDA

Patients with a wide range of underlying conditions are at risk for IDA

Patients with a wide range
of underlying conditions
are at risk for IDA

IDA Gastrointestinal Disease Icon IDA and gastrointestinal (GI) diseases and conditions

Approximately 36%-76% of patients with inflammatory bowel disease (IBD) had IDA in a 2010 systematic review of studies evaluating the prevalence of IDA in IBD patients.6

IDA and Heart Failure Icon IDA and heart failure

17% of chronic heart failure (HF) patients had IDA according to a 2011 prospective study of 157 patients with chronic HF.7

IDA in Women Icon IDA in women

Approximately 3.3 million women in the United States have IDA according to a 1997 analysis of data from the third National Health and Nutrition Examination Survey (NHANES)—including 24,894 people.8

IDA and Cancer Icon IDA and cancer

33% of patients with solid tumors were reported to have IDA in a 2011 review looking at iron deficiency anemia in cancer patients.9

IDA and Kidney Disease Icon IDA and non-dialysis-dependent chronic kidney disease (NDD-CKD)10
IDA and Kidney Disease Icon
IDA and non-dialysis-dependent chronic kidney disease (NDD-CKD)10

Based on a prospective assessment of clinical and iron indexes in 157 consecutively eligible patients with chronic heart failure at dedicated heart failure clinics at 2 UK hospitals and 22 control subjects with no known medical problems or regular medications. Chronic heart failure was defined based on a >6-month history of appropriate symptoms and signs and a left ventricular ejection fraction ≤45%. Anemia was defined as Hb <13 g/dL in men and <12 g/dL in women, and iron deficiency was principally defined as TSAT <20%.

Injectafer has not been studied in pregnant women. Injectafer should be prescribed during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Symptoms of IDA may be nonspecific and are frequently unreported, so laboratory markers are key to evaluation

Symptoms of IDA may be nonspecific and are frequently unreported, so laboratory markers are key to evaluation

IDA Laboratory Markers

§Normal lab values may vary based on patient characteristics/comorbidities and by laboratory.

||For patients with chronic kidney disease, guidelines issued by the National Kidney Foundation define TSAT of 30% as a lower limit to begin treatment. Please consult the NKF guidelines for a complete list of recommendations for IDA lab values when starting treatment.10

Learn more about the 3 key indices for evaluating IDA.

ABOUT IDA: TREATING AND MANAGING IDA

ABOUT IDA: TREATING AND MANAGING IDA

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.

References - About IDA