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Condition and patient type1
Iron deficiency and iron deficiency-associated anemia are common complications in cancer patients, and the prevalence of anemia in patients with cancer is remarkably high. In these patients, iron regulation and homeostasis often are distorted. This may result in insufficient iron supply to erythroblasts with clinical sequelae of iron deficiency such as weakness, fatigue, and impaired physical fitness and wellbeing as well as anemia.
In your practice, you are commonly seeing patients that are also being treated by a gastroenterologist and/or an OB/GYN. It’s important to ask what they are experiencing and hearing from other doctors to get a full picture of their health and treatment journey. To learn more about what these other doctors may be reviewing with these particular patients, visit the gastroenterologist section and the OB/GYN section of this site.
Diagnosing and managing IDA2
One of the most common laboratory test used to diagnose IDA is of serum ferritin, which generally reflects the status of iron stores. Transferrin saturation (TSAT), the percentage of hypochromic red cells (%HYPO), and the hemoglobin (Hb) content of reticulocytes (CHr) reveal the availability of iron.
Since serum ferritin, an acute-phase protein, can be elevated due to inflammation and liver cell damage, normal or elevated ferritin levels do not necessarily indicate sufficient iron stores, particularly in cancer patients. Therefore other routine blood tests may include C-reactive protein (CRP) and alanine aminotransferase (ALT) to check for inflammation and assess liver function.
See below for typical lab markers of the above-mentioned tests used to monitor IDA. Keep in mind that this chart displays normal values that could change in different patient types for a variety of reasons.
Laboratory markers used to monitor IDA3-5
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.
†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.
One potential limitation to the use of IV iron in cancer patients might be the interaction of iron with certain chemotherapies, in particular anthracyclines and platinum-based therapies.2 Formal drug interaction studies have not been performed with Injectafer.
Injectafer is not indicated to treat the symptoms of IDA.
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.