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Injectafer is the #1 IV Iron administered by gastroenterologists*
*Based on Symphony Health PHAST Non-retail Mg Administration Volume Data (May 2017-April 2018).
Bleeding lesions in the gastrointestinal (GI) tract are identified in about 50% of patients with IDA7
Condition and patient type8
As a gastroenterologist, your patients with IDA may present with diverse etiologies, including those of which are not known. In fact, patients with IDA of unknown etiology are frequently referred to a gastroenterologist because, in the majority of cases, the condition has a GI origin. Causes of IDA include malabsorption and gastrointestinal causes. Click on both to learn more:
- Celiac disease
- Duodenal resection/gastric bypass surgery
- Inflammatory bowel disease (ileal-jejunal disease and/or anemia of chronic disease)
- Helicobacter pylori gastritis
- Autoimmune gastritis
- Upper gastrointestinal blood loss
- Gastric/duodenal ulcer
- Variceal bleeding
- Esophagitis, erosive gastritis
- Mallory-Weiss syndrome
- Angiodysplasia, vascular ectasia
- Dieulafoy lesions
- Rare: Meckel diverticula, Cameron lesions
- Lower gastrointestinal blood loss
- Hemorrhoids, anal fissures, rectal ulcers
- Inflammatory bowel disease (IBD)
- Infectious colitis
IDA is a risk for gastroenterology patients
Absorption is impaired in many patients with GI conditions, limiting the efficacy of oral iron therapy.8
† Study conducted in Italy and included only Italian study subjects.
A wide variety of inflammatory conditions can elevate hepcidin, hindering oral iron absorption and reducing serum iron levels21
- Concomitant therapies such as acid suppressants can also impair oral iron absorption
Symptoms and diagnosis7
Patients with mild IDA are most likely asymptomatic and certain patients may present with nonspecific symptoms such as fatigue, pallor, and dyspnea on exertion. Behavioral changes such as pica (the craving and consumption of nonfood items) and restless legs syndrome may also be observed. Patients with GI causes of IDA may experience symptoms such as a change in stool caliber, epigastric pain, and alterations in bowel habits, weight loss, early satiety, and poor appetite.
IDA is diagnosed through several laboratory tests. Since IDA often arises from bleeding gastrointestinal lesions, many of which are malignant, establishment of a firm diagnosis usually obligates an endoscopic evaluation of the lower and upper GI tract. Many practitioners now regard colonoscopy as an essential component of the anemia evaluation. Other tests include:
- Serum ferritin—this is the single best laboratory test for the diagnosis of iron deficiency
- The serum transferrin receptors (sTfR) test, similar to serum ferritin, can be used to estimate body iron stores
- An erythrocyte zinc protoporphyrin assay (ZnPP) is another laboratory screening method used to assess iron status
- Fecal occult blood testing (FOBT) detects blood loss from the GI tract
As recommended by the American Gastroenterological Association (AGA), patients who have persistent or recurrent IDA after negative esophagogastroduodenoscopy (EGD) and colonoscopy should undergo small-bowel evaluation.
Three of the most common tests used to diagnose IDA are hemoglobin (Hb), ferritin, and TSAT.See the common laboratory markers used to monitor IDA.
Injectafer restores iron
Injectafer is a dextran-free IV iron indicated for adult IDA patients of various etiologies, and is the only IV iron that delivers up to 1500 mg of iron in just 2 administrations, separated by at least 7 days.
‡ 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.
Intravenous iron is an effective treatment of iron deficiency anemia and should be considered when oral iron is inadequate or cannot be tolerated. The efficacy of oral iron is limited in certain gastrointestinal conditions, such as inflammatory bowel disease, celiac disease, and autoimmune gastritis.8
Adult patients may fail oral iron for a number of reasons, and IDA patients in Injectafer clinical trials were found to have iron deficits of approximately
- Data reveals that the adherence rate for oral iron therapy is 40%-60%23
- Adherence may be affected by side effects7
||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.
Gradient Bar links- Choosing Injectafer
Important Safety Information
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
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.
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.