Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease.

First and only high dose IV iron approved for Pediatric Patients (1 year of age and older)

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Injectafer® (ferric carboxymaltose injection) videos

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Challenging Current Beliefs Around Iron Deficits

INDICATIONS

Injectafer® (ferric carboxymaltose injection) is 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, or who have 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

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

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 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. 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

Adults

In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single 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 (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

Pediatric

The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

CLINICAL CONSIDERATIONS IN PREGNANCY

Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.

You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

View transcript

[Voice Over]

At a recent conference, gastroenterologists from across the United States gathered at a national conference to share groundbreaking therapeutic methods and best practices in the field of inflammatory bowel disease, as well as clinical information about iron deficiency anemia or IDA.

[Neil Nandi]

IDA is the most common form of anemia. Certain patients are at a higher risk of developing IDA, including those with chronic heart failure, cancer, abnormal uterine bleeding, and non–dialysis-dependent chronic kidney disease. Patients with gastrointestinal diseases and conditions are also at greater risk for IDA. In fact, 36 to 76% of patients with inflammatory bowel disease have IDA.

Oral iron tablets are commonly used to treat IDA, but even in healthy patients, less than 10% of oral iron is absorbed into the bloodstream. Certain medications and inflammatory conditions can further limit iron absorption. In some cases, iron losses can outpace oral iron absorption. It’s important to make sure that patients are getting the correct dosage and delivery necessary to restore their iron supply.

When patients cannot tolerate oral iron or they do not have an adequate response. IV iron therapy (such as ferric carboxymaltose, commercially known as Injectafer®) delivers 100% of the iron into the patient’s bloodstream.

[Voice Over]

Greater than or equal to 2% of patients experienced common adverse reactions when using Injectafer. Of these patients, 7.2% complained of nausea, 4.0% experienced hypertension, 4.0 % experienced flushing, 3.0% experienced injection site reactions, 3.0% experienced erythema, 2.1% had hypophosphatemia, 2.1% experienced dizziness and 2.0% experienced vomiting. The control release of Injectafer allows the body to slowly absorb what it needs, while storing the remainder.

[Voice Over]

We asked event attendees what they believed was the average iron deficit found in the 7 Injectafer clinical studies. They used dots to mark their predictions on an interactive wall.

[Neil Nandi]

Labs like hemoglobin, transferrin saturation, and ferritin not only help diagnose IDA but can also guide providers when making treatment decisions.

[Voice Over]

After marking their predictions on the wall, attendees found out the actual average iron deficits from the Injectafer clinical studies. In those clinical trials, the average iron deficit was 1500 mg.

[Neil Nandi]

One of the major issues related to treating patients with IDA is that healthcare providers may underestimate their patients’ iron deficit. The reality is that many patients do not respond to or tolerate oral iron. And often, their iron deficit may be greater than what some IV therapies deliver in a single course.

[Voice Over]

The interactive iron deficit wall at the conference helped healthcare providers visualize the misconception about iron deficit levels.

Providers walked away from the experience armed with pertinent information about iron deficits in patients with IDA, which can help inform future treatment decisions.

Injectafer is the only FDA-approved IV iron that delivers up to 1500 milligrams of iron in 1 course of treatment. The #1 IV iron among gastroenterologists and oncologists in the US and most studied IV iron in the world is dextran-free Injectafer.

The Mechanism of Action of Injectafer

INDICATIONS

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have 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

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

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 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. 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

Adults

In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single 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 (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

Pediatric

The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

CLINICAL CONSIDERATIONS IN PREGNANCY

Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.

You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

View transcript

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease.

Injectafer, or ferric carboxymaltose injection, is a dextran-free iron formulation for Intravenous use.

It has a shell made of a carbohydrate polymer, called carboxymaltose, that is tightly bound around a colloidal iron-3 hydroxide core.

It has a neutral pH and physiologic osmolarity. Its structure is similar to that of physiologic ferritin, the body’s iron storage protein.

Together, the chemical characteristics of this molecular structure may enable Injectafer to deliver a large amount of iron in a controlled fashion.

After administration, enzymes in the blood partially degrade the Injectafer carbohydrate shell, but no iron is released.

It is likely taken up by macrophages of the reticuloendothelial system, or RES.

Inside the macrophages, enzymes gradually break down the carbohydrate shell that is tightly bound to the iron core.

Iron is released slowly and may be stored mainly in the liver as ferritin, the storage protein.

Alternatively, it may be exported to the plasma.

In the plasma, iron is bound by transferrin, the transport protein.

Transferrin delivers iron to cells in the liver and spleen or to the bone marrow where it can be used for hemoglobin synthesis and red blood cell formation.

The chemical characteristic of the iron-carbohydrate complex means that iron is released slowly.

As a result, the transferrin available for uptake does not become fully saturated with iron. This entire process results in a controlled release of iron into the bloodstream.

The #1 IV iron among gastroenterologists and oncologists in the United States and most studied IV iron in the world is Injectafer — a dextran-free, iron-carbohydrate complex with a controlled release of iron.

Gastroenterology Educational Video

INDICATIONS

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have 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

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

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 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. 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

Adults

In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single 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 (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

Pediatric

The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

CLINICAL CONSIDERATIONS IN PREGNANCY

Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.

You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

View transcript

Voice Over: Hi there. I’m Dr. Rahul Dixit, a practicing gastroenterologist based out of Santa Monica, California.

At my single-specialty practice, I see a lot of young, adult patients with a wide variety of pathology. During my experience, I’ve come across many patients who have developed iron deficiency anemia as a result of their gastrointestinal (GI) conditions. Let’s begin our discussion today with the identification and diagnosis of iron deficiency anemia.

Identification and Diagnosis

What is iron deficiency anemia, or IDA?

IDA occurs when the balance of iron intake, existing iron stores, and iron depletion cannot fully support the production of erythrocytes. There are three main causes of IDA: blood loss, insufficient absorption of iron, and insufficient intake of iron.

Some examples of these causes include: peptic ulcers, colon cancer, Crohn’s disease, celiac disease, and decreased absorption after intestinal surgeries, such as bariatric surgery.

Because anemia can often be found in patients with a variety of GI conditions, your patients may be at high risk of developing IDA. For instance, IDA is particularly prevalent in patients with celiac disease, gastrointestinal bleeding, inflammatory bowel disease (IBD), and patients who have had bariatric surgery. For instance, bariatric gastric bypass surgery disrupts the physiological absorption of iron in the duodenum by decreasing the area available to absorb iron.

There are 2 types of iron deficiency: absolute and functional. Absolute iron deficiency occurs when the body’s iron stores are depleted due to low dietary iron intake, impaired iron absorption, or excessive iron loss. Functional iron deficiency occurs when there are adequate iron stores, but insufficient mobilization of iron in the body.

Hepcidin is a protein that serves as a regulator of the entry of iron into the circulatory system. In functional iron deficiency, iron release and absorption are blocked by high hepcidin levels. In patients with IDA, hepcidin suppression may also be an early sign of absolute iron deficiency along with decreased TSAT and ferritin.

IDA may be difficult to spot in your practice because the symptoms aren’t ones patients normally report to a gastroenterologist. Some patients with mild to moderate IDA may exhibit non-specific symptoms, or may even be completely asymptomatic. In more severe cases, you may see patients who experience signs and symptoms that include: weakness, fatigue, pica, shortness of breath, arrhythmia, pale skin, sore tongue, tinnitus, brittle nails, hair loss, headache, chest pain, coldness in the hands and feet, and dizziness.

IDA is frequently under-reported, so to prevent misdiagnosis, I tend to ask my patients about specific symptoms that can be caused by IDA. If your patients have any of the previously mentioned conditions that contribute to IDA risk, it is important to routinely test their iron levels, even when your patients aren’t exhibiting symptoms.

There are three key indices for evaluating IDA: hemoglobin, transferrin saturation or TSAT, and ferritin.

Normal hemoglobin values are 13.5-17.5 g/dL for men and 12.0-15.5 g/dL for women. Ferritin levels range from 12-300 ng/mL for men and 12-150 ng/mL for women. Normal levels for TSAT are from 20%-50%.

I believe that IDA screening is an important part of care for my patients.

However, current screening and management practices may be suboptimal.

A study of 836 patients who were newly diagnosed with ulcerative colitis was conducted to assess frequency of iron deficiency screening and treatment in patients who developed anemia. This analysis showed that of the 585 patients who developed anemia, nearly 1/3 went unscreened for an iron study evaluation.

This study also showed that of those patients who were diagnosed, nearly 25% did not receive oral iron supplementation.

Furthermore, none of the patients treated for IDA received IV iron.

Let’s examine a hypothetical case for a patient with IDA.

Meet Sara. Sara is 26 years old and has been struggling with ulcerative colitis. She is currently being treated with a corticosteroid and she was shown to be intolerant to oral iron in the past. In addition to having 4-5 episodes of bloody diarrhea per day, Sara also reported generalized malaise and mild dyspnea on exertion. Lab testing shows that her hemoglobin level is 10.5 g/dL, which falls below the lower threshold of normal.

Let’s explore potential treatment options for patients like Sara whom you might see in your practice.

Treatment goals and options

The optimal outcome of treatment for IDA is iron repletion above the lower threshold of normal. This means that the patient’s TSAT, ferritin, and hemoglobin must be within normal ranges.

There are two treatment options for patients diagnosed with IDA. Oral iron and Intravenous (IV) iron. Both forms of treatment have pros and cons to consider for your patients’ individual needs.

I usually start with oral iron for all of my patients with IDA as first-line therapy.

It is obtainable without a prescription, can be readily found at a pharmacy, and has a dosage of 1-3 times a day. However, oral iron absorption can be inhibited due to a variety of conditions, which can interfere with digestive processes and compromise its efficacy.

Even in healthy patients, less than 10% of oral iron is absorbed due to the fact that the duodenum can maximally absorb only 10-20 mg daily. That means nearly 90% of oral iron may be going to waste.

Additionally, reports indicate that adherence rates range from 40%-60% for oral iron therapy. This may be due to the side effects of oral iron, which include epigastric discomfort, nausea, vomiting, diarrhea, and constipation. If patients in my practice are 4-8 weeks into treatment and their iron levels are still not within normal limits, oral iron may be the wrong option for them.

IV iron may be an option for your patients if oral iron fails. 100% of IV iron is delivered into the bloodstream, so your patients can restore their iron in less time. As IV iron may only be administered in an infusion center by a healthcare professional, it may be less convenient for some patients.

Although every infusion experience is different, some of your patients may be more familiar with infusions due to other conditions for which they already receive similar treatment. Whether you infuse in your office or not, it is important to monitor your patients’ labs throughout their treatment journey to see if their therapy is working.

Some side effects for IV iron include nausea, hypertension, injection site reactions, hypotension, and headache. Serious hypersensitivity reactions may also occur. If you are unfamiliar with IV iron treatment options, it is important to note that dextran-free IV iron options are now available.

Let’s revisit Sara, the hypothetical patient with ulcerative colitis who showed low hemoglobin levels. In order to assess whether Sara has developed IDA, Sara’s doctor ordered tests for her ferritin and TSAT levels. These results showed that Sara is low across all three indices, confirming that she does, in fact, have IDA.

Given what we already know about Sara’s previously reported intolerance to oral iron, how would you proceed with her care? Next, we will explore an IV iron treatment option that may be appropriate for a patient like Sara.

Treating with Injectafer

Injectafer is an iron replacement product indicated for the treatment of IDA in adult patients who have intolerance or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease. Injectafer is a dextran-free IV iron.

Injectafer has a carbohydrate shell that is tightly bound around a colloidal iron (III) hydroxide core. This molecular structure was designed for the controlled release of iron to deliver 1500 mg in 2 administrations of 750 mg separated by at least 7 days. Let’s examine the efficacy and safety data for Injectafer in adult patients with IDA when compared to oral iron and iron sucrose.

This study was designed as a randomized open-label active controlled multicenter trial with 1011 adult subject randomized at 84 US centers.

Inclusion criteria for the study were that patients had to have hemoglobin levels of ≤11.0 g/dL, ferritin levels ≤100 ng/mL or ≤300 ng/mL when TSAT ≤30%, and IDA of any etiology, including heavy uterine bleeding; GI disorders; postpartum, nutritional, or dietary deficiency; and others. Patients with a history of iron intolerance and a history of drug allergy were also included.

After a 14-day run-in period of oral ferrous sulfate dosed at 325 mg, 3 times daily, eligible patients with hemoglobin <12 g/dL who had an inadequate response to oral iron were randomized to receive ferric carboxymaltose or to continue oral iron therapy. These patients formed Cohort 1. Those who were unable to tolerate or were inappropriate for oral iron (subjects inappropriate for oral iron were not included in the indication for Injectafer) during the run-in period were randomized to receive ferric carboxymaltose or standard of care IV iron treatment, thus forming Cohort 2.

The primary endpoint of the study was mean change to highest observed hemoglobin from baseline to Day 35 or time of intervention for subjects in Cohort 1. The same measurement was a secondary endpoint in Cohort 2.

In Cohort 1, results showed that Injectafer provided significantly greater increases in hemoglobin levels vs oral iron to Day 35, and improvements in hemoglobin were greater with Injectafer vs oral iron (1.6 vs 0.8 respectively). Also, the mean change in iron indices was greater with Injectafer vs oral iron from baseline to Day 35 or time of intervention.

One other point of note is that by the end of the study, patients supplemented with oral iron demonstrated diminished iron stores, as seen by the Ferritin and TSAT levels, compared to their baseline levels, suggesting that iron losses outpaced oral iron supplementation.

In Cohort 2, the mean change in hemoglobin from baseline to highest value between baseline and Day 35 or time of intervention was greater with Injectafer vs iron sucrose. Furthermore, the mean change in ferritin and TSAT was greater with Injectafer vs iron sucrose during that time period. The composite safety endpoint for Cohorts 1 and 2 included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization, congestive heart failure, arrhythmias, and protocol-defined hypotension or hypertension. 

Seven participants (2.9%) in Group A (Injectafer), 4 (1.6%) in Group B (oral iron), 10 (4%) in Group C (Injectafer), and 12 (4.9%) in Group D (iron sucrose) met the primary composite safety endpoint.  The most commonly observed components of the composite safety endpoint were protocol-defined hypertension and death due to any cause.

Injectafer has real-world experience that supports its use for patients with IDA. Injectafer is approved in 75 countries, with a total global exposure of approximately 7.5 million patient years. Injectafer is also the #1 selling IV iron in the US with more than 680,000 patients treated to date.

Let’s wrap up our conversation with Sara, the hypothetical patient we have previously spoken about. Sara’s labs showed that her hemoglobin, ferritin, and TSAT levels were all below normal. Because Sara is also oral-iron intolerant, she was prescribed Injectafer.

Approximately 4 weeks after her infusion, her doctor ordered another round of labs which showed that Sara’s hemoglobin had risen from 10.5 mg/dL to a normal level of 12.1 mg/dL. Her TSAT and ferritin levels had also risen (21% and 20 ng/mL, respectively). If you see patients like Sara in your practice, you might want to consider Injectafer.

To learn more about Injectafer, including the full Prescribing Information, patient savings offerings, and more, visit injectaferhcp.com.

OB/GYN Patient Exam Room Video

INDICATIONS

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have 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

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

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 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. 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

Adults

In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single 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 (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

Pediatric

The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

CLINICAL CONSIDERATIONS IN PREGNANCY

Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.

You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

View transcript

[KOL Voiceover:]

The video you are about to view depicts a hypothetical physician/patient interaction. This video is for your education and not intended to replace your clinical judgement. 

[KOL:]

Hello, my name is Dr. Mark Martens. And I am at the Reading Hospital in West Reading, Pennsylvania. I am a Professor of Obstetrics and Gynecology, and also Vice President and Chief Academic Officer for the Tower Hill System.

[KOL Voiceover:]

In a moment, we’ll meet Jessica, age 31. Diagnosed with abnormal uterine bleeding (or AUB) at age 30, Jessica was originally placed on a nonsteroidal anti-inflammatory drug, ibuprofen, 400 mg three times a day for 4 days, starting on day 1 of her menses, which provided partial improvement. Last year, she was also put on a triphasic combination oral contraceptive—ethinyl estradiol with norgestimate. 

Based on Jessica's continued presentation with AUB at her last visit one month ago, iron deficiency anemia (or IDA) was suspected. Laboratory tests carried out one month ago revealed that Jessica had low hemoglobin, ferritin, and transferrin saturation (or TSAT) levels, as shown here.

She was diagnosed with IDA secondary to abnormal uterine bleeding, and initiated on oral iron therapy, 325 mg ferrous sulfate three times a day, which she has been on for the past month.

Jessica returns to her OB/GYN for a follow-up visit. Let’s join Jessica and her physician in the exam room.

[Dialogue:]

[Physician enters room.]

[Physician:] Hi, Jessica. How are you?

[Jessica:] Hi, Dr. Stevens.

[Physician:] What brings you in here today?

Jessica:] I came in so we can follow up with the lab panel you suggested as part of the treatment plan.

[Physician:] OK…so, how have you been feeling overall?

[Jessica:] Not great. I’ve been feeling perpetually tired and short of breath. On top of that, I’m still getting headaches. I’ve even had to skip work some days. 

[Physician:] What type of work do you do?

[Jessica:] I’m a microbiologist. We are currently in a critical phase with some important projects, and I really can’t afford to miss work. 

[Physician:] I see…and are you still taking the oral iron? 

[Jessica:] Yes, I’ve been on oral iron now for 1 month, since I was diagnosed with IDA. I’m taking 325 mg of ferrous sulfate 3 times a day.

[Physician:] OK.

Now as we had discussed, the symptoms you’re experiencing may be related to IDA, but we’ll do some lab work to make sure your oral iron is working. 

[KOL Voiceover:]

Jessica’s lab results reveal little improvement in her hemoglobin, ferritin, and TSAT levels compared with her lab results prior to initiating oral therapy.

Calculation of Jessica’s iron deficit is based on the modified Ganzoni formula, which we see onscreen. 

Her iron deficit remains at 1446.4 mg.

[KOL:]

Let’s now take a moment to review the physiology of iron storage, as it is the key to understanding the evaluation of IDA. 

As free iron is toxic to cells, it’s bound to transferrin, the main transport molecule for iron, which facilitates iron uptake and transport to red blood cell precursors in the bone marrow. An indirect measure of the amount of circulating unbound transferrin is referred to as the total iron binding capacity (TIBC). Transferrin saturation (TSAT) is the ratio of serum iron to TIBC, calculated using the formula shown onscreen. IDA is characterized by depleted or absent iron stores and an increase in TIBC, resulting in a lower TSAT. A TSAT value of less than 18% suggests that the iron supply is inadequate for normal erythropoiesis. [Auerbach 2016/p32]

Ferritin is a circulating iron storage protein that increases in proportion to body iron stores. Low serum ferritin with values less than 15 to 25 ng/L, in combination with a low TSAT, is considered to confirm the diagnosis of iron deficiency. [Auerbach 2016/p32]

Onscreen, we see the normal values of ferritin in women. [Camaschella 2015/p1838]

Although evaluation of ferritin status is considered the most sensitive and specific test for the identification of iron deficiency, the entire clinical picture should be considered when deciding which tests to order and when evaluating test results. [Camaschella 2015/p1837]

Hemoglobin is a commonly used lab marker in the evaluation of IDA. Sufficient levels of stored iron and adequate transferrin saturation are needed for hemoglobin production. In addition to correcting the hemoglobin deficit in an iron deficiency anemia patient, enough iron must also be provided for measurable storage iron as reflected by the serum ferritin.  [Auerbach 2016/p37]

As seen onscreen, in addition to assessing hemoglobin levels, the 2 other key indices that should be assessed in the evaluation of IDA are ferritin and TSAT levels.

Let’s review the indication for Injectafer.

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.

Please see Important Safety Information below and full Prescribing Information for INJECTAFER by clicking the link at the top of this video player.

[KOL:]

Let’s now briefly review some of the evidence supporting the use of Injectafer in IDA, and why Injectafer may be appropriate for a patient such as Jessica. 

[KOL Voiceover:]

The standard dosing for Injectafer is 750 mg administered at least 7 days apart, for a total of 1500 mg. When administered via IV infusion, the iron is diluted such that the concentration of the infusion is not less than 2 mg of iron per mL and is administered over at least 15 minutes. When administered as a slow IV push, it is administered at a rate of approximately 100 mg (or 2 mL) per minute.

For adult patients weighing less than 50 kg (which is equivalent to 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.

Now, let’s review data from an Injectafer clinical trial.

A randomized, open-label, multicenter study was conducted to evaluate the efficacy and safety of Injectafer in adult patients with IDA of various etiologies. 

Patients not appropriate for or intolerant of oral iron (cohort 2) were assigned to treatment with Injectafer or standard-of-care IV iron.

The primary efficacy endpoint was the mean change from baseline to day 35 in the highest observed hemoglobin level in cohort 1. 

Secondary efficacy endpoints included:

  • Mean change from baseline to highest observed hemoglobin any time between baseline and Day 35 or time of intervention for subjects in Cohort 2.
  • The proportion of participants achieving a hemoglobin level of more than 12 g/dL any time between baseline and day 35, and
  • Mean change from baseline to each scheduled visit for hemoglobin, ferritin, and TSAT levels.

The composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, heart failure, arrhythmias, and hyper- or hypotensive events.

Here we see the efficacy data from cohort 1. The increase in hemoglobin levels from baseline to the highest observed value over 35 days was significantly greater with Injectafer than with oral iron. 

In addition, more patients receiving Injectafer than oral iron achieved a hemoglobin level of greater than 12 g/dL. 

Both serum ferritin and TSAT levels were also increased to a greater level with Injectafer than with oral iron. 

A total of 7 participants (2.9%) in the Injectafer group and 4 (1.6%) in the oral iron group met the primary composite safety endpoint. 

In cohort 2, the increase in hemoglobin levels from baseline to the highest observed value over 35 days was greater with Injectafer than with standard-of-care IV iron. 

Significantly more patients receiving Injectafer than standard-of-care IV iron achieved a hemoglobin level of greater than 12 g/dL.

Both serum ferritin and TSAT levels were also increased to a significantly greater level with Injectafer than with standard-of-care IV iron.

A total of 10 participants (4%) in the Injectafer group and 12 (4.9%) in the standard-of-care IV iron group met the primary composite safety endpoint. 

The most commonly observed components of the composite safety endpoint were protocol-defined hypertension (4 participants in cohort 1, Injectafer arm, 7 in cohort 2, Injectafer arm, and 6 in cohort 2, standard-of-care IV iron arm) and death due to any cause (2 participants in cohort 1, oral iron arm).

This table summarizes the most common adverse events from the clinical trial that was reviewed and from REPAIR-IDA—a randomized, active-controlled, multicenter, noninferiority, open-label trial that compared the safety and efficacy of Injectafer with IV iron sucrose in 2561 adult patients with IDA and non–dialysis-dependent chronic kidney disease.

[KOL:]

Now let’s join Jessica and her physician again in the exam room.

[Dialogue:]

[Physician:] So Jessica, we’ve tried oral iron and your iron levels are still low. I have discussed with you the option of switching from oral to an IV administration of iron. 

Does Injectafer sound like an option you’d like to try?

[Jessica:] Yes, that sounds good to me. 

Since my iron levels are still low, let’s change treatments and try Injectafer.

[KOL:]

Let’s now review some selected Important Safety Information for Injectafer.

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.  In summary, Injectafer could be an appropriate treatment option for patients like Jessica, who have had an unsatisfactory response to oral iron.

Let’s briefly summarize some key takeaways from this clinical case presentation. 

There are 3 key indices for evaluating IDA— hemoglobin, ferritin, and TSAT levels.

Injectafer is the only IV iron that delivers up to 1500 mg in just 2 administrations separated by at least 7 days. Injectafer demonstrated improvements in hemoglobin, ferritin, and TSAT levels compared with both oral iron and standard-of-care IV iron. 

Now, let’s review some additional Important Safety Information for Injectafer.

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 at least 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.

  • IMPORTANT SAFETY INFORMATION


    INDICATIONS

    Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have 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

    Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

    Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

    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 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. 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

    Adults

    In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single 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 (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

    The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

    Pediatric

    The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

    CLINICAL CONSIDERATIONS IN PREGNANCY

    Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

    Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.


    Please see Full Prescribing Information

IMPORTANT SAFETY INFORMATION


INDICATIONS

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have 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

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

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 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. 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

Adults

In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single 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 (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

Pediatric

The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

CLINICAL CONSIDERATIONS IN PREGNANCY

Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.


Please see Full Prescribing Information

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