Banner - About IDA- Detecting and diagnosing IDA

Common signs and symptoms of IDA include

The symptoms of IDA are often nonspecific and can be underreported. Some patients may also be asymptomatic1

Common signs and symptoms of IDA may include6*:

IDA in Women Icon

Headache

IDA in Women Icon

Chest Pain

IDA in Women Icon

Pale or
yellow skin

IDA in Women Icon

Fatigue

IDA in Women Icon

Pale or
yellow skin

IDA in Women Icon

Shortness
of breath

Other signs and symptoms may include1,7

  • Weakness
  • Arrhythmia
  • Coldness in extremities
  • Dizziness, lightheadedness
  • Brittle nails or spooning of the nails
  • Pica (craving nonfood items such as clay or paper)

The signs and symptoms of IDA can overlap with those of other conditions1,8-10

It is important to routinely test patients who are at risk for
IDA for low iron stores, even when they aren’t exhibiting symptoms1

It is important to routinely test patients who are at risk for IDA for low iron stores, even when they aren’t exhibiting symptoms1

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

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

IDA Laboratory Markers 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.13

An additional test for total iron binding capacity (TIBC) values may be required to diagnose IDA.6 Normal values for TIBC range from 240 to 450 µg/dL in healthy patients.14 Please note that TIBC values were not measured in Injectafer clinical trials.

Consider testing patients who are at risk for IDA,
including patients who are already on oral iron therapy

Consider testing patients who are at risk for IDA, including patients who are already on oral iron therapy

There's more to evaluating IDA than hemoglobin levels

3 key indices for evaluating IDA

The Injectafer clinical trials looked at absolute change in Hb as the primary
endpoint—and also assessed changes in ferritin and TSAT as secondary endpoints.17,18

SEE THE DATA

A wide variety of patient types should be tested for IDA

A wide variety of patient types should be tested for IDA

A wide variety of patient types should be tested for IDA

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

There is a 36% to 76% prevalence of IDA in patients with inflammatory bowel disease (IBD).19

IDA and Heart Failure Icon IDA and heart failure§

17% of patients with chronic heart failure (CHF) have iron deficiency and anemia.20

IDA in Women Icon IDA in women||

In the United States, 1 in 5 women of childbearing age have IDA.21

IDA and Cancer Icon IDA and cancer

There is a 44% to 50% prevalence of IDA across tumor types, including hematological malignancies.22

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

There is a 58% to 73% prevalence of low iron tests in patients with NDD-CKD.23¶ Injectafer may be used as first-line therapy in adult patients with NDD-CKD.24

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

There is a 58% to 73% prevalence of low iron tests in patients with NDD-CKD.23¶ Injectafer may be used as first-line therapy in adult patients with NDD-CKD.24

§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.

Defined in reference as a serum ferritin <100 ng/mL or TSAT <20%. Authors concluded this remarkably high prevalence might indicate these indices may not be specific enough and may falsely identify too many patients as iron deficient.

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

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