Treating Side Effects of IVIG and Subcutaneous IG (SCIG)

Listen to the episode Treating Side Effects of Intravenous and Subcutaneous Immune Globulin hosted by patient advocate Abbie Cornett. In this episode, we’ll be exploring what the side effects of IG treatment are and how to manage them. Our guest today, Michelle Greer, RN, is executive vice president of sales at Nufactor, a specialty infusion company. Michelle has had years of experience working with both patients and clinicians to help people manage IG therapy safely and effectively. 

Transcript

Welcome to today’s podcast! My name is Abbie Cornett, and I am the patient advocate for IG Living magazine. This podcast is brought to you by IG Living to give readers the chance to hear directly from healthcare experts on topics that matter to them most. 

Abbie: Today we’re talking about something nearly every patient receiving immune globulin (IG) therapy has experienced at some point, and that’s side effects. Our topic today is Treating Side Effects of Intravenous and Subcutaneous Immune Globulin. And joining me is Michelle Greer, RN, executive vice president of sales at NuFactor, a specialty infusion company. Michelle has had years of experience working with both patients and clinicians helping people manage IG therapy safely and effectively. 

Michelle, I want to thank you so much for being here today. Before we get started, can you tell our listeners a little bit about yourself and your experience? How did you get started working in infusion therapy? And what led you to focus so much on patient safety and comfort with IG treatments?

Michelle: So, thanks for having me, Abbie. I am an RN for almost 40 years now. Right out of college, I really took an interest in IV therapy in general. So I got an IV certification, and I was working in home care at the time. And I really sought out all the home infusion patients. A few years later, I got into IVIG. (SCIG, also known as Sub-Q was not really a thing at the time.) And I was administering that. And then I got into nurse management, and then I ventured over into sales, but still stayed very close to the clinical aspects of IG therapy.

Abbie: That’s great. Like I said, we’ve been doing this for a while now. For listeners who may be new to the treatment, can you explain what intravenous immune globulin, also known as IVIG, and subcutaneous immune globulin, also known as SCIG, therapies are and why they sometimes cause side effects? Can you give them a little idea about what’s happening in their bodies during these treatments and what can make some people react differently than others?

Michelle: Sure. Well, IG stands for immune globulin, which is essentially antibodies. And IVIG and SCIG are made from donors, thousands of donors, that go into each batch and dose of IG. So you’re getting an array of all different antibodies. So when those are infused into the system, IV or sub-Q, it is going to stir up an immune response of some sort. And that can range just from mild flu-like symptoms to more severe headaches, nausea, vomiting. And then the most severe adverse reactions with IVIG would be a thrombotic event where you actually have a blood clot that forms, or anaphylaxis, an allergic reaction, which can occur with any medications that are infused.

Aseptic meningitis is another side effect that can happen where you can get a headache, but this would be like a severe light-sensitive debilitating headache. And then, lastly, renal failure, which over the years with the stabilizers moving away from sucrose and more into other forms of sugars or amino acids, that side effect is really not a huge concern anymore, but it’s still something to consider.

Abbie: I was going to say, years and years ago, I got aseptic meningitis and it is rough. Rough. With that being said, though, IVIG is known for being life-changing, but a lot of patients do encounter those mild side effects like headaches and body aches and fatigue. From your experience, what are the most common side effects that you see with IVIG and are there any specific factors that trigger those?

Michelle: Well, everybody’s different, and everybody’s immune system is different. Although IVIG is very similar across the board, each product has various characteristics. There are things that we can do that make it more tolerable in general. And then it’s really going to be just how does the patient receive it? We look at the package insert that lists a maximum infusion rates that we should not exceed. During clinical trials, they didn’t go over a certain rate, and we would not exceed that. And in fact, in the home, we’re probably a little more conservative than that as well, because like you said, it is life-changing. And with the potential for symptoms, we want to minimize those as much as possible so that every patient can get the chance to tolerate it and see that it would work for them and make a change in whatever their condition is. The biggest thing that we look at upfront is hydration — patients who are well-hydrated. We encourage patients to drink a lot, and in some cases, we’ll even give them pre- or post-hydration or both.

The rate, hand in hand, is really going slow. You start out slow, and then you see how the patient does. You’re monitoring vital signs the whole time because blood pressure changes are another side effect that can occur. So you’re starting out slow and if they tolerate it, then you can increase the rate. And we do that every half hour until we get to what the pharmacist would determine the maximum rate should be for that patient. 

Abbie: And you change the maximum rate from patient to patient depending on how well they tolerate it.

Michelle: It can change from patient to patient, yep. And, you know, the pharmacist will look at all sorts of things for that particular patient as well. Like, do they have a history of migraines? Because that can maybe increase the potential for aseptic meningitis. And, do they already have impaired kidney function? Do they have a history of blood clotting? Have they tolerated IVIG in the past? Have they had reactions in the past? Are they diabetic?

There are all kinds of things that they look at. What medications they’re on. If they had a history of allergic reactions to medications in the past. And, they’ll want to take all that into consideration to tailor the infusion to the patient.

Abbie: Now you kind of touched on my next question. What are some of the ways patients can address side effects before their infusion? Can you walk us through some of the best practices patients can follow beforehand? And you mentioned hydration, which is always something that I tell everyone: Hydrate, hydrate, hydrate. There are also pre-medications and other things. So what would you recommend prior to the infusion, and then maybe some tips after the infusion that they can do to help mitigate some of those side effects?

Michelle: Yes. So the biggest thing that someone getting IVIG can do is to follow the nurse’s instructions to a T and take the pre-medications like you say. Patients should get some sort of antihistamine like Benadryl or loratadine. And they’ll get a Tylenol. Those would hopefully offset some of the reactions.

Abbie: And some patients I’ve even heard of getting steroids ahead of time.

Michelle: That can be a pre-medication too. If patients get migraines, they could take their migraine medication as a pre-medication. And then if things happen during the infusion, the nurse should be well-versed in administering IG. It is a very different treatment, and they should have been trained ahead of time on all of the nuances like the side effects and managing them. So it would be the hydration, it would be the pre-meds, it would be the nurse knowing what they’re doing to follow the infusion protocol that’s laid out by the pharmacist and not exceed that. And the patient should make themselves familiar with what their infusion rates should be. And they should pay attention to the pump to make sure that it’s all, you know, a double checked.

Abbie: When someone’s first diagnosed, patients often wonder what they can do. I said, well, the first thing you have to do is educate yourself about your disease. And you have to know what your medications are and what your dosage is,  and if you’re on an infusion, what’s your radius? The nurse is supposed to be there, but it’s your body. You need to make sure of those things too. That brings me to the fourth question.

We touched on the mild side effects, and they may seem pretty awful when you have them — like the headache and the nausea and some of those. And they are; they're significant to you. But there are worse side effects that can occur. And they are more rare, definitely. But can you go over a little bit of some of the serious reactions like the severe headaches and blood clots and kidney issues? And you have mentioned that the kidney issues are less common than they used to be. But what causes those severe side effects? And, is there any way to tell ahead of time which patients are more at risk for them? And is there any way to reduce those risks?

Michelle: Yes. So the biggies are, let’s go through them. Anaphylaxis. So we're going to want to know, does the patient have allergies? Have they had any sort of anaphylactic reaction in the past? And every patient gets an anaphylaxis kit in the home that has epinephrine or adrenaline and some other medications and fluids so that if the patient does have a true anaphylaxis response to the therapy, then the nurse would break open that kit and follow the anaphylaxis protocol that’s written out in the orders. That is so rare, because we do really take the time to screen the patients up front. And if there’s any concern that the patient might be at risk for that type of reaction, we would ask that the patient get the first dose in a controlled setting, like an outpatient infusion center or physician’s office.

Abbie: I was going to say, the people who are really at risk for anaphylaxis, they probably are in an outpatient setting more likely, even inpatient. I have one patient who’s actually in an inpatient setting for their treatments.

Michelle: Yeah, if it’s that bad. So, that takes care of anaphylaxis. Then we go to renal failure. Well, that is product selection, and the product was the reason for that black box warning. That product is not even on the market anymore. That product contains sucrose, and that was what was tied to renal failure. But we still look at it because it can be taxing to the kidney. So we do look at whether they have any sort of renal impairment. Are they a diabetic? Things that might put them at risk for renal impairment like diabetes. And then we would maybe select a product that doesn’t even have a sugar derivative to stabilize the problem. They’re coming out more and more. 

And then there’s the thrombotic event that’s also now a boxed warning. And that is just because of the viscosity of the IVIG when it hits the bloodstream. If you know you’re at risk for a clot formation, then that could be a problem. If you’re not, typically that’s not something that you see. So if you’ve had a previous heart attack, stroke, deep vein thrombosis, we would want to know. Some patients are already on blood thinners, so that’s great. If they are, that should take care of it. And just sticking with the rate and making sure that you follow all the instructions. 

And then the last one is aseptic meningitis syndrome, which is not a black box warning, but it is a potential side effect that can happen. I mean it could happen with anybody, but it’s more prevalent when IVIG is given in very large doses, because IVIG is dosed by disease state and by weight. So if you have an autoimmune condition, your doses are going to be higher. If you have an immune deficiency, your doses are going to be on the lower side, and then again it’s still dosed by your weight. But it’s the high doses that have been a little more prevalent.

We also look at whether there is a migraine history. Do they get headaches now? What do they take for them? Should that be included as part of their pre-med protocol? And just taking it easy on those days.

Abbie: The one thing I recommend is just don’t plan to run a marathon when you get done with treatment. Take it easy on yourself.

Michelle: Yeah. So, you know, we try to make, obviously we’re home infusion, but any infusion center is going to try to make a patient as relaxed as possible and comfortable. If it’s a first dose, we’re going to take even more precautions by making sure that somebody else is in the home with them, and things like that to make sure that they do OK.

Abbie: So you touched briefly on the formulation of different products when you were talking about the sucrose. But some patients who do have trouble with IVIG do find relief when they either switch products or they switch to SCIG. What are the differences between the two treatments, and how does SCIG reduce the risk of some of the side effects we’ve talked about?

Michelle: So IVIG is going into a vein. So the effect on the system is going to be more immediate, and the reactions are going to be more systemic. SCIG goes into the subcutaneous tissue, so it’s absorbed more slowly, and it's not in the venous system or going right into your circulation, so the effects occur over time. And you know, the infusion rate and things like that aren’t going to make an impact. You could get a headache, but it would be more mild and over time. The reactions are less systemic and more localized. 

With SCIG, where the needle insertion site is, that’s what you would look at: irritation, redness and how severe that is. For that, we look at needle placement, we look at needle length, we look at the height and weight of the patient and the location where they want to infuse, like in their abdomen or their thighs. And then we’ll make recommendations for needle length. And there’s tips and tricks that you could do. Like we always say, don’t prime the tubing all the way out so that the medication actually drips out the needle. Stop it right before so it’s a dry stick so there’s not medication irritating your skin as you insert the needle.

Abbie: That’s actually a really good tip. You know, just briefly, you explained it a little bit before. But, going back to IVIG real quick, why do some people tolerate one IVIG brand more than the others? It’s funny: You explain to people that they’re biologics. So, none of them are formulated exactly the same. But why would one product affect a patient more than another?

Michelle: Mostly they don’t, honestly. But there are patients who don’t do well with one and then we try another and they do OK with that one. And that could be the product. It could be that particular batch, like that antibody mixture. It could be the characteristics of what the formulation and the stabilizer and the pH and a host of things.

But mostly people can tolerate changing a brand. But if you have somebody who had difficulty up front and then finally got stable, you wouldn’t want to change. You wouldn’t want to rock that boat. So you would want to leave them on that brand. But the brands are similar. They are. They have some differences, but there are similarities as well.

Abbie: So if a patient continues to struggle with side effects, even with what you’ve recommended, and even after slowing the infusion rate or trying pre-medications, what should that patient do? And what would a conversation with their doctors look like about changing the product or the dose or even the delivery method? So if they’re still not doing well on IVIG, do they go to SCIG? What are those conversations? 

Michelle: Honestly, I would say the majority of IVIG side effects and reactions are really manageable. It’s just a matter of the pre-meds, the rest, the hydration, maintaining the proper infusion rate that works for that patient, repeating any pre-meds, getting the right brand, all of that stuff. It’s pretty manageable. But if there are some patients who are going to, no matter what, have horrible reactions to IVIG, in that case, sub-Q would be a good option to look at. If you’ve tried, you know, brand changes and pre-meds and steroids and all the host of things that you would do to manage reactions, then sub-Q would be a good next option to explore. And that’s just talking with your physician first to see that they are on board with prescribing that.

Abbie: And that it’s a good option for you.

Michelle: And then you need to make sure because if you are on it for an autoimmune condition and you’re on a higher dose, you want to make sure that that’s something that is manageable. And there are, you know, the different concentrations. So the IV products are typically 10% and the sub-Q products are mostly 20% and then one of the sub-Q brands is 16.5%.

And so you’re going to have less volume and more drug. So it's a little bit easier to infuse. But still, you know, you’re going to need a certain number of insertion sites. It’s very rare that somebody just needs one insertion site to infuse all of the monthly dose, whatever that dose is. You would  break it up into weekly infusions or even twice a week depending on how big your dose is. 

Abbie:  There are some lifestyle considerations too.

Michelle: Absolutely. So what we like to do if somebody is interested in exploring that as an option is we will take their dose and calculate the fluid. And then we would kind of go, OK, that patient would need four insertion sites and they’d need to infuse twice a week. And then we’d talk to the patient about that. Is that something that you’re up for? And, we have patients who do that because they need their IG and they didn’t tolerate IV and that’s what they commit to. And it’s a shorter infusion; it’s one to two hours as opposed to four or five in one sitting. But yeah, everything should kind of be laid out. I’m a big believer in laying out options for patients, for people. 

Abbie:  I was going to say, for me, I use the word communication. Communication is so important between you and your doctor, between the patient and the doctor and the doctor and the nurse and the nurse and the patient. It’s got to be open communication. 

Before we wrap up, what advice would you give to patients and caregivers who are new to IG therapy in general, and who are feeling a little bit overwhelmed by side effects or anxiety about treatment? Because a lot of the times when I talk to patients who are just diagnosed, they’re scared. They read about the side effects, and they have a lot of anxiety or fear going into that first couple of treatments. What would your advice be?

Michelle: My advice would be that most patients do really well without any reactions, but the potential is there. And again, it’s about infusing it correctly and effectively. And so, if you do what you’re supposed to do in terms of hydration and the pre-meds and just relaxing and just understanding that if they feel like, I'm starting to get a headache, you don't wait; you tell the nurse. And they’re going to be monitoring you as well to make sure your vital signs are stable. Most patients do well with very minor side effects or none at all. So don’t get overwhelmed by all the information that could happen. We have to tell you about them because there are those potentials. And it is a lot of information, but most patients do fine.

Abbie:  You touched briefly on this. I’ve had two or three patients come back and go, well, I felt really awful during the infusion. I had this, that. And then I'm like, well, what did your nurse say? Well, I didn’t tell them. I didn’t want to bother them. I’m like, no, no, no, no. You have to talk to people and say, this isn’t working. And don’t wait until you’re actually not feeling well. That’s really important.

Michelle: You have to talk to us.

Abbie:  Well, Michelle, I want to thank you for sharing your expertise and your insight today on managing side effects. It is one of the bigger challenges for our community. And it’s been so helpful to hear that there are practical ways to make therapy more comfortable and successful.

Michelle: Thank you.

Thank you again for joining us today. Additional information regarding this podcast can be found on our website at www.igliving.com. If you have a question that was not answered, please contact me at acornet@igliving.com. 

Look for the next IG Living podcast announcement on our website for the opportunity to submit your questions. 

IG Living Advocate is a copyright production of IG Living magazine, published by FFF Enterprises — the only magazine for the immune globulin community, comprised of patients who suffer from chronic illness, and their caregivers.

Disclaimer: The views and opinions expressed by the guest speaker are their own and do not necessarily reflect the views of IG Living magazine, FFF Enterprises or its affiliates.