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Condition and patient type 30,31
IDA is prevalent in both men and women, being more common in women, and remains a frequently underdiagnosed and underappreciated
women's health issue.
About 1 in 5 women of childbearing age has IDA32Women of childbearing age are at higher risk for IDA because of blood loss during their monthly periods
IDA is a risk for OB/GYN patients*
Relevant diagnoses among OB/GYN patients
who received IV iron†
Relevant diagnoses among
OB/GYN patients who
received IV iron†
†Based on Projected IMS Medical (Dx) Claims (July 2017-September 2017) of approximately 4000 patients. HUB identified as a relevant diagnosis for the most relevant procedure.
‡Abnormal uterine bleeding (AUB) has previously been referred to as heavy uterine bleeding (HUB).
§Includes 17% of the total claims submitted without a diagnosis code (left blank).
*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.
47% of patients
in a pivotal Injectafer study had AUB33
Women that are at a particularly higher risk for IDA include31:
- Women with AUB such as abnormal menstrual periods
- Women who are pregnant or breastfeeding or those who have recently given birth
- Many women lack the sufficient amount of iron needed for the second and third trimesters
Women become at a higher risk for IDA during pregnancy if they31:
- Have two pregnancies close together
- Are pregnant with more than one child
- Are vomiting frequently due to morning sickness
- Do not consume enough iron through their diet
- Have an abnormal pre-pregnancy menstrual flow
Diagnosing and managing IDA30,34-36
Being that IDA is as common as it is in women, testing is critical in order to identify and treat it. Three of the most common tests for diagnosing IDA are:
- Hemoglobin (Hb)
- Serum ferritin
- Transferrin saturation (TSAT)
There are several indicators that can help understand if someone is at risk for IDA. The initial diagnosis is defined as hemoglobin less than 12 g/dL in nonpregnant women.
Injectafer restores iron
Injectafer is a dextran-free IV iron indicated for adult IDA patients of various etiologies, and only Injectafer provides 1500 mg of iron in just 2 administrations, up to 750 mg each, separated by at least 7 days.
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.
||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.
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.