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 | Updating Practices in an Evolving IV Iron and Anemia Environment: Practical Solutions  ANNA 2007 Satellite Symposium Updating Practices... Audience Questions |
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Some points about high ferritins
Answers from PanelMs. Easom: What I tell my doctors as I'm training them is, that if your anemia manager is not bringing you patients to discuss, you need to go and talk to her/him, because when you think of a protocol, we always think of about 20% of our patients who fall out of a protocol and should be looked at individually. When I looked at my data a couple of years ago, when I looked at my above-800s, it was about 20%. When I looked at my 500s - this is ferritins last year - almost 50% of my patients at times were above-500 ferritin. Now that does not really surprise me, because in some of the other studies at other times that I've talked about, I've shown you data where in normal human beings, whatever that means, but healthy human beings with no known disease, you can have ferritins - especially in males - that come up close to 500, and in our patients with all their comorbidities - it's easy to see how the ferritins can be a lot higher than that. So, again, you should be taking those outliers to your dialysis unit.
(Index) (Question) Ms. Easom: The first question is on acute patients. We have a new acute SIG in our ANNA, and a very key thing goes along with those acute nurses - they can make a huge difference. First of all, as a prescriber, if a patient is admitted to the hospital, especially since so many chains own the hospital units, some of those nurses don't have access to EPO and iron or whatever you need to give, and even vitamin D - that you get it from the hospital - so it's very important. And what I suggest to our acute nurses, and that does not always get done, is that you have contact frequently with the outpatient unit - they are owned by the same people - get that dose of EPO that the patient is on and just continue the same dose, but order it subcu, so that the nurse on the floor can get it. And if you stop and think about it, it makes sense, because you get about 30% bigger bang for your buck, subcu versus IV, and the patient is in the hospital, where they kind of leech blood out every time you turn around there, drawing blood, so patients are going to have more blood losses and other things may well be going on with them. So if you go ahead and give them a little bit extra - which you would on the same dose - just giving it subcu, then that would help immensely.
Also, for incident patients, the new patients coming out of the hospital, if I try to order an EPO dose that is appropriate for them, but frequently, acute nurses don't weigh patients - they are so used to the acutely ill. I know if my patient walked into the dialysis unit, they probably were able to stand and weigh in the acute unit. If I have a weight, so I can start a more appropriate ESA dose when I get them, and that is helpful. Frequently, you don't have iron studies when you first are admitting a patient. I go back through - I have access to the university's systems obviously - so I go back and I look for iron indices, to see if I can start them on some iron at the beginning, but frequently I have to wait. If your anemia manager is doing that, and your doctors or your prescribers are not writing when the patients are starting - I probably do about 98% of all initial orders. If you don't get them there, you are delaying treatment another week or two until they get the lab back and the anemia manager has a chance to say, "Oh my gosh, I've got a new patient I need to address this." So the more data you can get at the very beginning, and if you tell or remind your doctors, that is great, because they are so busy with what is going on with that patient they forget that, "Hey, I have not ordered an ESA dose," or I find some programs where doctor "A" will order this huge dose one day and doctor "B" orders none or a really low dose - there's not any stability. So if you just continue the patient on the same EPO dose, but subcu, that would be quite helpful, and it doesn't matter, if they are in the hospital, 1 treatment or 100 treatments - just get that ESA dose in. Some units here actually give them Aranesp® (darbepoetin alfa), a longer acting dose, when they come into the hospital. So talk to your group and you be a partner with that anemia manager in the chronic unit with those facilities to do what's best for those patients.
(Index) (Question) Ms. Easom: In my experience, we have very few patients who are allergic to IV iron, and frequently, if you think a patient is allergic, sometimes it's related to how fast the dose was given. And even if you can push 62.5 mg of ferric gluconate in like, 4-5 minutes, and we push 125 mg in over around 10 minutes, that might be okay for package instructions, but it might be too fast for the patient. So you can put it in and drip it in. If the patient has been pretty cantankerous and actually had an anaphylactic reaction in the unit, I kind of buy into an anaphylactic reaction in the unit, and you may not be able to give iron IV. You may have to give p.o. iron. If you give a blood transfusion, you are giving iron, just as when you lose 1 cc of blood, you lose 1 mg of iron. When you give blood, you are giving a couple hundred mg of iron. In the case of mild reactions that are not anaphylactic, we may premedicate with Benadryl (diphenhydramine), we may premedicate with steroids, and I will turn it over to the panel to see if they have any other ideas on true allergies to IV iron.
Dr. Amerling They are very rare. I also premedicate with either Benadryl or Allegra (fexofenadine) or Claritin (loratadine), and it seems to work very well for patients who have very mild reactions, and we have yet to see a serious reaction with ferric gluconate.
(Index) (Question) Dr. Amerling: The answer is no. I remember the era of transfusions where there was significant iron overload occurring in some patients who were transfusion-dependent; however, with dialysis and EPO, we can burn up iron like you won't believe, so there really is no way that these patients are going to get symptomatic iron overload, unless you dose them for 10 years excessively. So as long as you are monitoring and you are able to hold or cut dosing appropriately, the actual number of 900 ferritin, as we have seen, does not tell you very much about what is going on with the patient's iron stores.
Mr. Juergensen: As was mentioned before, if the ferritin is over 900, you also want to look for other causes as to why the ferritin is high, aside from having gotten a lot of iron theoretically in the past, and it's a workup for inflammation. So as Andrea mentioned before, she had found some patients with cancer or subtle infection. So if you look at high ferritin, it does not mean you don't give the iron, but it also means that if the patient has not been worked up, you may want to.
(Index) (Question) Dr. Amerling: And I think this is a very good point. My philosophy is, that iron and anemia are related, but separate. Both have to be treated. Iron deficiency is bad in and of itself. If the patient is not obviously anemic, though they may be iron-deficient, they will become anemic at some point. They also may have other symptoms related to pure iron-deficiency, so my answer to this is - yes, we treat this independently of the hemoglobin level. If they don't require any EPO, so much the better, but unless they are polycythemic and we have to bleed them, we don't back off on the iron therapy.
(Index) (Question) Ms. Easom: There are lots of things you can do. One of the questions they are asking is, "Can you throw away a circuit of blood?" I know that some people do that. If somebody's hemoglobin was up to 15, or blood pressure was up and I was concerned about it, I have to admit I've done that. I would like to do it in a little bit more organized fashion, and I will just - when you are putting them on and checking their access and you aspirate 20 to 50 cc of blood - I would like to just throw away the 20 to 50 cc of blood, so I would know exactly how much I'm throwing away and can quantify that. It's not something I do automatically above 14, but certainly if I have concerns, and we tried not to get people above 14, but if you settle that infectious process or inflammatory process that is going on with the patients, it happens. So I would like to do mine that way, and I welcome Peter's or Dr. Amerling's comments. Do you do any of that?
Dr. Amerling: If somebody has high hemoglobin and it's affecting them clinically, I do phlebotomy by discarding the blood in the circuit. I tell the nurses to just throw the blood away. If somebody, for example, has severe peripheral gangrene, and they have hemoglobin of 15 or 16 that is really almost limb threatening, we rapidly get the hemoglobin down by discarding blood.
(Index) (Question) Ms. Easom: I have to admit that we're not organized enough to actually stop it most of the time, so obviously if your patient is in your unit and he/she is septic that day and you are getting blood cultures and starting antibiotics and fixing to shift him to the hospital, that's not the day that you really want to give your IV iron. Bbut once they have a couple of doses of antibiotics on the ward, most infections are fine. The only thing that happens is, that iron goes into storage. It does not go into circulation where you can use it as a protective mechanism. Other people may be a little bit more organized or have a protocol that kind of works for that, but unless you are out on the floor, if I'm ordering blood cultures, our nurses know not to give iron on the day that I'm ordering blood cultures or there is suspected sepsis. Any comments on that one?
Mr. Juergensen: One other approach to looking at that - it's sometimes difficult, I mean the patient may suddenly feel septic at the end of the treatment and they got their iron during the dialysis treatment. So, as you said, it's sometimes difficult to decide that in an acute unit. When patients are in the hospital, you can then decide to hold the iron dose, if it's applicable, for whatever period of time. The theory behind this is, that iron may be used by the bacteria, and then in that setting, the sepsis could get worse. But you can always make up for that missed iron dose later on that week or the following week, so that the patients will get the subsequent iron dosing. So if you can get it into your protocol, it's great, but sometimes it's so hard to do in a setting where the patient is acutely ill and the patient may have already received the iron.
(Index) (Question) Ms. Easom: You should be getting the TIBC every time you get transferrin saturation, because that is part of the formula, so we get ours on a monthly basis. It's just that people aren't keyed in to actually look at TIBC. And so that's something you have to put in your protocol. And you actually have to add it and look at it to judge.
(Index) (Question) Mr. Juergensen: Well, the issue is - in that setting, why is that patient's hemoglobin over 14? Is it because they've gotten a fair amount of EPO, or have they suddenly shot out after cure of an acute inflammatory state and they went from 12 to 14? So remember, the patients are always going to need iron everyday making new red cells. So just because their hemoglobin is 14, it isn't necessary that you have to hold the iron in that setting. You can decrease the dose of iron if you have a set protocol - that is an example that we place - and it can be decision of the team also. You can maybe hold it for a week, but I would not hold the iron. You basically hold the iron based on your levels of ferritin and TSAT, based on a standard protocol that you have.
Dr. Amerling: I would agree, but you clearly need to hold the EPO, and I think we have to be extremely aggressive about cutting EPO dosing. With the recent FDA guidelines and in the climate of litigation, we are going to be very vulnerable if we don't follow these recent FDA recommendations. We are really targeting 10-12, and above 12.5, we hold EPO at this point.
(Index) (Question) Dr. Amerling: there's a little case presentation of a patient with sickle cell anemia with increased LFTs. Kidney remains yellow, that is, I guess, bilirubin from the hemolysis - ferritin levels are over 1300, hemoglobin remains under 4.5 despite EPO 10,000 units 3 times a week; given numerous blood transfusions. Unfortunately, I don't know any magic bullets for sickle cell anemia. Patients who are actively hemolyzing are in big trouble, regardless of whether they are on dialysis or not. We obviously don't give these patients iron. The iron that they reclaim from their red cells after hemolysis stays with them, and these are the patients who are really at serious risk of iron overload. Some may respond to EPO, but it has not been my experience that this works very well.
(Index) (Question) Ms. Easom: That's that thing you look at when you are trending. When I went back and I looked at my patients above 800, and I told you that I had 20% that were above 800. I looked at those patients, and 50% of the ones that were above 800 lived there. They fluctuated 200% to 300% so maybe they were 900 that day, they may have been 700 the month before, but they are kind of going like between 700 and 1200 - that neighborhood. That patient probably has an underlying something that is causing inflammation. There's a chance that it could be even infection, especially in patients who have old grafts that may have some occult infection in them, and so you have to treat those patients and look and see. I have one lady - I talk to her, probably, if not monthly, every other month, when I'm rounding - I do lab rounds on everybody, I do what's call the CMEs and then if the doctors get by and do them, we bill it under the doctor; if it's not, it's done and they bill it under me. I really actively look, and I keep thinking I'm going to find something bad and to date I have not. But in looking at other patients, I've found malignancies etc., so something is going on and you don't know. If they are 500 to 600 or under, I just consider that is all the chronicity of what is going on with patients and I don't delve too deeply, but when they start climbing above that, especially above 800, I really start looking and saying, "Is there something I can find? If there's something that that patient's body is telling me that I need to address?"
(Index) (Question) Mr. Juergensen: So for the first part of the question - again your ferritin and TSAT will go up after transfusion. We measure monthly TSATs and ferritins in our patients, so if you can follow it on a monthly basis, that is an adequate thing. You don't need to reassess it anytime sooner.
Would you recommend holding IV iron dosing after receiving a transfusion? No, because the same principle applies here. If you load somebody with iron, that does not mean that you don't start a maintenance dose on that patient. So the same principle applies here. You are giving them red cells. You are giving them some iron with red cells, but for some reason, they were anemic requiring a transfusion, so in essence, you do want to continue iron on that patient.
Dr. Amerling: I will just clarify that the exceptions for that would be the sickle cell type of patients or hemolysis patient. But most people who require transfusions either have very hypoproductive marrow or they have bled, and in those settings, iron should be continued.
(Index) (Question) Dr. Amerling: I think that I presented data that suggest that you indeed not only can give maintenance iron, but you can actually rebolus patients with 1 g and achieve an improved hemoglobin at a lower ESA dose.
Ms. Easom: We are going to have a difference of opinion about where ferritins should be and where you should give iron - I have 8 fellows and about 9 faculty, so I'm dealing with about 17 doctors - and their opinions are all over the place, as opinions of 17 anybody can be - and so, I tease Dan (Coyne) that if he were in the political arena, Dan would be called a liberal when it comes to iron; I believe Dr. Amerling will be too. I'm kind of a moderate, and then the KDOQI guidelines are extremely conservative, and I will tell you that I can't get consensus with my doctors to give a full gram, but if you look at the DRIVE study, some of those patients were actually getting maintenance doses before they got their gram of iron, and so it definitely worked, and if that's what you choose to do, and you may choose to do it on individual patients, I think there's a comfort level that you can do that. But so many patients with numbers like that aren't getting any iron. At least if you give a healthy maintenance dose, you may well see a response. But some of those patients were getting as much as 125, not all of them, but they could get up to 125 a week, and still could have been admitted into the DRIVE study. Just because they could, does not mean they did. Do you remember how many of those patients, Dr. Amerling, may have been on maintenance iron before they started DRIVE?
Dr. Amerling: I don't remember.
(Index) (Question) Dr. Amerling: My understanding is all were predialysis, although some started dialysis during the study. (The question continues): and we have seen that increased risk of death in stage III and IV that may be caused by lack of focus on vitamin D therapy, PTH, etc., and cardiovascular events. Did either of these studies take these into account? All I can tell you is, that both studies were randomized, so that calcium, vitamin D status, all that stuff, evened out in the wash of randomization, which is why they were good studies.
(Index) (Question) Ms. Easom: I tend to do that. I look at patients, especially initial patients whom you are loading, and I look at what their hemoglobin is, so if I'm going to load somebody, if they are low on iron and their hemoglobin is like 10 something, then I know I'm going to load them with iron and start them on an ESA. I'm going to start them on a lower dose than what I would have if I had not been giving the iron. If you go back to the other KDOQI guidelines, the first one is on anemia. They said iron replete before you ever start an ESA, and most of us don't do that, but you certainly have to consider that iron alone is going to bring up your hemoglobin, so if you are choosing to give an ESA and the patient is not on it, like in incident patients, you can choose a lower ESA dose. If they are on a healthy dose, you might well consider decreasing it. It just kind of depends on what that hemoglobin is. And if you don't stop at that, or decrease at that time, you are going to quickly be decreasing the ESA dose as you monitor.
(Index) (Question) Mr. Juergensen: Well there are. The problem is, as we have presented today, that this is a very rapidly changing field right now in the last several months. So KDOQI has protocols published, and we will have ours published. So there are available protocols, but I think it's all changing, as to how we now look at the management of anemia with available old protocols. And I think the protocols will be changed in the near future.
Dr. Amerling: I'd like to also point out, that protocols, I believe, are very good at assuring a basal level of treatment, but you need to go over the individual cases on a regular basis to fine tune based on the protocol. Protocols will miss things - protocols will miss trends; protocols will miss nonresponders in certain cases. So you have to look at individual cases and not rely totally on the protocols.
Ms. Easom: We are actually past our time. We have lots more questions, and I apologize for not getting to all of them. If you have a burning question that we did not get to, I encourage you to come up and we will talk to you individually. And we thank you for your attention. Thank you!
(Index) (Question)
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