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Grandpa's Garage
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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 or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. Injectafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
WARNINGS AND PRECAUTIONS
Symptomatic Hypophosphatemia
Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). In most cases, hypophosphatemia resolved within three months.
Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated.
Hypersensitivity Reactions
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.
Hypertension
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.
Laboratory Test Alterations
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%).
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 (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%).
Patients with Iron Deficiency and Heart Failure
The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications
Post-Marketing Experience
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; nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.
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.
GRANDPA'S GARAGE
[The JINGLE music begins]
If iron deficiency has gotten you sicker,
let's go ahead and give your ticker a kicker!
Join the Injectafer entourage and step on into Grandpa's Garage!
Let's go ahead and give your ticker a kicker!
[The JINGLE music ends]
GRANDPA:
Hello everyone and welcome to the Injectafer production of Grandpa's Garage! You've probably already guessed that I'm Grandpa. My friends call me OTTO, so you can call me OTTO or CAR GRANDPA, dealer's choice.
What a crowd. What a crowd. What's your name here in the tan sports jacket?MAN IN AUDIENCE:
Vaughn
GRANDPA:
Vaughn. Nice to meet you. And the one in the blue cardigan outfit all the way over there. Yes, yes. Your name?
WOMAN IN AUDIENCE:
Jamie
GRANDPA:
Nice to meet you, Vaughn and Jamie. Thanks for coming, it's great seeing your smiling faces front and center!
Welcome to my show! I’m coming to you live right here in beautiful Philadelphia and I'm going to talk about 3 things near and dear to my heart: brake fluid, 4-wheel drive, and spark plugs.
[Audience laughs]
GRANDPA:
No, not really, I’m just pulling your seat belts. Well actually, we’ll be talking about heart failure and iron deficiency, and Injectafer--an IV iron treatment.
And I know what you're thinking, "What could a stylish vintage car person possibly have to say at a medical conference?" Well, I've learned a great deal about my health conditions this year, and I'm revved up to share what my cardiologist has taught me about iron deficiency and heart failure. We have a lot to cover today, and we even have a special guest joining us for a drive-thru interview with yours truly. So, let's get the show on the road. Welcome to Grandpa's Garage: Live & Fueled Up!
[The JINGLE music plays.]
GRANDPA:
I’ve always been a fan of road trips, especially the trips I get to take with my family. How about you all? Has anyone here taken a big road trip? Let me hear some of your favorite destinations.
WOMAN IN AUDIENCE:
Colorado
GRANDPA:
I heard Colorado and-?
MAN IN AUDIENCE:
Chicago!
GRANDPA:
Chicago! Yes, Chicago. Very nice. I'm a big fan of Rt. 66 myself. But there is one journey I never like to reminisce about, and that's the time when I was diagnosed with iron deficiency. When my cardiologist looked under my hood and found out I had heart failure, I took it pretty hard, and it was a lot to deal with, especially on top of my kidney issues. And if that wasn't enough, I started to slow down even more. And I mean like Sunday Driver slow.
I felt fatigued and weak. I had difficulty concentrating, chest pains, an irregular heartbeat--I mean, even breathing felt like hard work. And exercise? forget about it. Is this story sounding familiar?
AUDIENCE:
Yea!
GRANDPA:
Uh-huh. I thought it might. Basically, it seemed like all my service lights were flashing on at once.
At first, I thought it was related to heart failure. Then I read about iron deficiency and how the symptoms can overlap. My wife, CARLITA, also known as CAR GRANDMA, encouraged me to keep a log of how I was feeling and she pushed me to eventually talk to my cardiologist about the worsening symptoms.
After some testing, my cardiologist diagnosed me with iron deficiency, which she told me is common for patients with heart failure. She said that about 50% of people with heart failure also have iron deficiency. But for me, it felt like my open road got narrowed down to one little old dirt lane.
AUDIENCE:
Awww
GRANDPA:
Don't feel too bad for me just yet, my story gets better from here. My cardiologist started me on Injectafer, an IV iron treatment. It's indicated for patients like me with iron deficiency and heart failure and New York Heart Association class II or III to improve exercise capacity. I’m class II by the way!
To get my Injectafer infusion, it was a quick couple of trips to the station to get my fill of iron.
And now, I’m replenished talking to you today. Which brings me to our next segment! I'm feeling a bit rusty from all this talking. It's dance time!
[Music starts for ROBOT DANCE BREAK]
GRANDPA:
Alright, alright, alright. Let's settle down and get back to business before I break a hubcap. I think you'll be relieved to hear that this next segment is a bit more professional, as we've got cardiologist, Dr. Jeff Mandak here for a drive-thru interview. Let's bring him out, everyone please put your hands together for Dr. Mandak!
DR. MANDAK:
Hi everybody. Thank you. Thanks for having me.
GRANDPA:
Hey Dr. Mandak, I'm Car Grandpa but my friends call me OTTO. It's great to meet you!
DR. MANDAK:
Hey OTTO. It's great to meet you too. Thanks for having me everybody!
GRANDPA:
Thanks for being here! Now Dr. Mandak, let's get started. Can you give our audience members some information on your background?
DR. MANDAK:
Sure can. I’m Jeff Mandak and I’m a Car-diologist from Fulton County Medical Center in Central Pennsylvania. I actually train right down the road here at University of Pennsylvania in Philadelphia. I’ve been in practice almost 30 years, and I’ve always had a professional interest in the care of patients with heart failure and in fact, the majority of my research has been in addressing the issue of exercise tolerance in our patients with heart failure.
GRANDPA:
That's great, thank you. And thank you for your work. Now for some questions! So as a car person, I reference a lot of manuals. As a cardiologist, do you have something like that?
DR. MANDAK:
Yea, OTTO. I think the word you're looking for is "guidelines". And yes, the newest AHA/ACC/HFSA guidelines regarding the standards of treatment for patients with heart failure was just released last year in 2022.
GRANDPA:
Guidelines, right, of course. What were your key takeaways from the Guidelines regarding iron deficiency and heart failure?
DR. MANDAK:
Good question, Otto. One of the updates focused on the significant concomitant incidence of iron deficiency in our patients with heart failure. Specifically, they put forward a class 1 indication for the assessment of anemia and iron deficiency in our patients with chronic heart failure. They also extended a class 2a recommendation for treating patients with heart failure with reduced ejection fraction and iron deficiency with or without anemia, with an IV iron therapy. They went further to clarify that oral iron supplementation is not effective in chronic HF patients.
GRANDPA:
And how did this impact your practice? Do you see a lot of patients for whom these updates would be relevant?
DR. MANDAK:
Well, something that I learned, OTTO, when I started to dig into this was that approximately half of our patients with heart failure also have iron deficiency. And to tell you the truth that was a much larger number than I would have expected. As I started to apply these recommendations to my own patient population, I found that this was true.
GRANDPA:
So, how do you go about determining which patients in your practice have iron deficiency?
DR. MANDAK:
Well that can be tricky, OTTO, because some of the symptoms of iron deficiency and heart failure may overlap. You see fatigue, shortness of breath, and even heart palpitations can be found across both conditions. So it really does come down to screening.
GRANDPA:
Can you tell me why this is important for patients with heart failure?
DR. MANDAK:
Well, there are a few reasons, OTTO. With heart failure, as we all know, there are a lot of things that we just can’t fix. So we have to look for the things that we are able to fix. Iron deficiency can aggravate heart failure, impacting exercise capacity.
From the cardiologist's perspective, exercise capacity is also fairly easy and inexpensive to assess with a simple 6- minute walk test. Studies have shown that treating our heart failure patients with iron deficiency with an IV iron preparation can improve their performance on a 6-minute walk test by about 25 meters versus placebo at 24 weeks. Now that may not sound like a dramatic change, but I tell you it may be enough to allow a patient to walk the distance to their grandchild’s soccer field to see them play.
GRANDPA:
Yes, my granddaughter, Car Girl plays soccer actually. Thank you for sharing that, doctor.
DR. MANDAK:
You’re welcome.
GRANDPA:
And can you tell us about improvements you've seen in your patients who have undergone treatment with Injectafer?
DR. MANDAK:
Yes, well I mentioned earlier one of my interests is in exercise capacity in patients with chronic heart failure. After treating HF patients with IV iron treatment like Injectafer, my patients demonstrate an improved exercise capacity. And biochemically, I’m seeing improvements in hemoglobin, transferrin saturation, and ferritin.
GRANDPA:
That's great. It must be a relief to see exercise capacity improve. Alright, this is my last question for you, doctor. Can you tell me a bit more about why you choose Injectafer specifically when it comes to selecting an IV iron treatment?
DR. MANDAK:
Well OTTO, like you said, it’s absolutely rewarding to see an improvement in outcomes in our patients. That’s why we do what we do. But outside of that, Injectafer is the first and only scientifically proven and FDA- approved IV iron therapy for treatment of iron deficiency in patients with heart failure. It’s also the most-studied IV iron preparation, with over 40 clinical trials. And then, OTTO, there’s a convenience factor as well with regards to delivery–it’s the only high-dose IV iron preparation that can be administered either through IV infusion or as an undiluted slow IV push. Now personally, as you can tell from my gray hair, I’ve been around long enough to have seen the evolution of iron products to now seeing Injectafer come out with a really unobtrusive dosing schedule for our patients.
GRANDPA:
Awesome! Awesome! Thank you so much for joining us today.
DR. MANDAK:
Thanks for having me, OTTO. And thanks everybody for being here.
[Applause; Jingle music plays]
GRANDPA:
So this segment is all about a little something my cardiologist calls the 6-minute walk test.
Now my wife is always asking me to take a quick cruise around our neighborhood with our dog FEFE.
AUDIENCE:
Awwww
GRANDPA:
Yes, yes, yes. Anyway, now that I'm in my "golden years," the walk between our couch and the fridge is my preferred cardio.
[Audience laughs]
GRANDPA:
Outside of that, it's really my cardiologist who gets me moving. To track how I’m doing with my heart failure and iron deficiency, she had me do this 6-minute walk test. Have any of you heard of this?
AUDIENCE:
Yea!
GRANDPA:
Of course, you have, this is AHA.
You know how it goes, she had me walk back and forth between 2 points to see how far I could travel in 6 minutes. Don't let the 60s upholstery fool you--I can still get some mileage these days all things considered.
[Audience laughs]
GRANDPA:
After my Injectafer treatment, I was able to go about 82 feet further than I could before, which is about the length of a tennis court, or 3 quarters of a city block, for all of you trivia- lovers. Imagine how many more ice cream cones I can get from the freezer with that kind of action?
[Audience laughs]
GRANDPA:
No I'm just kidding, don't tell Car Grandma I said that. As a matter of fact, don't tell my cardiologist I said that either.
[Audience laughs; JINGLE music plays]
GRANDPA:
OK this segment is about an important one. It's all about the quality of fuel and why it matters what form of iron you put in your tank.
When I was first diagnosed with iron deficiency, I tried oral iron, but it didn't work for me. A study found that oral iron wasn't effective in iron repletion and it didn't improve exercise capacity in patients like me, with iron deficiency and heart failure. You already know that exercise capacity is the top of the mind for me--and for FEFE, who loves a nice long spin around the block.
Anyway, on the other hand, IV iron, like Injectafer, delivers 100% of iron right into the bloodstream. Or the oil stream, as I like to call it.
[Audience laughs]
Well, folks, our time here is coming to an end. Yes, I'll miss you all, too. But before we go, I want to give a sincere thank you to all of you in the healthcare field. I can tell you from personal experience that you're making a difference in heart failure when you screen and treat iron deficiency. And I know that my wife and family would like to thank you as well!
That's our show! Thanks for coming to Grandpa's Garage, sponsored by Injectafer--the first and only FDA- approved IV iron for heart failure!
Have a good night and as always, stay fueled up!
[Music plays while ISI and references scroll]
-
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 or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. Injectafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
WARNINGS AND PRECAUTIONS
Symptomatic Hypophosphatemia
Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). In most cases, hypophosphatemia resolved within three months.
Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated.
Hypersensitivity Reactions
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.
Hypertension
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.
Laboratory Test Alterations
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%).
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 (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%).
Patients with Iron Deficiency and Heart Failure
The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications.
Post-Marketing Experience
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; nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.
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.
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 or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. Injectafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
WARNINGS AND PRECAUTIONS
Symptomatic Hypophosphatemia
Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). In most cases, hypophosphatemia resolved within three months.
Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated.
Hypersensitivity Reactions
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.
Hypertension
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.
Laboratory Test Alterations
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%).
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 (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%).
Patients with Iron Deficiency and Heart Failure
The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications.
Post-Marketing Experience
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; nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.
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.
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