Starting on the Comeback Trail

Click here for the Prescribing Information and Medication Guide for the treatment option described in this podcast: bit.ly/4wKpGmO. Three vibrant and resilient women living with Cold Agglutinin Disease (CAD) talk to host Elin Lantz Lesser to give their firsthand accounts about how their disease has changed their lives and what led to their decisions to start treatment. Elin also sits down with a hematologist to get a crash course in the science behind the treatment. A podcast from Recordati Rare Diseases.

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SPEAKER_03 0:04

Yeah, get those veins pumped up.

SPEAKER_00 0:06

I drank a lot of water this morning to get ready for you. Also had some coffee. Which is probably not the best, right? Right.

SPEAKER_04 0:14

This is the sound of a patient, Duffy, getting set up for an infusion of her medication. You're hearing her nurse, Lori, too. She's trying to find a vein. There we go.

SPEAKER_03 0:28

Yeah, that one looks good too. That's good and juicy. There we go. Alright. Painless. Duffy didn't think this day would come. Painless. Good job, Lori. Thank you. Just give it a flush. Alright. Okay.

SPEAKER_04 0:46

Then again, she didn't think she'd be diagnosed with a rare disease.

SPEAKER_03 0:50

And just priming the line here. There we go.

SPEAKER_04 0:54

At the time, no drug had been developed to treat her condition.

SPEAKER_03 0:58

Okay, right now. I'm gonna hook you up and grab your vital signs.

SPEAKER_04 1:02

Then a drug became available. And we'll turn the pump on.

SPEAKER_00 1:07

Sounds like a new pump to me. Yes.

SPEAKER_04 1:11

But Duffy wasn't sure she wanted to take it.

SPEAKER_03 1:14

We're up and running.

SPEAKER_04 1:15

And yet here she finds herself, sitting down at her dining room table. I'm being infused. So we can get started. Duffy's condition is called cold agglutinin disease, or CAD. It's a form of autoimmune hemolytic anemia, meaning that the body mistakenly attacks and destroys its own red blood cells. Patients with CAD like Duffy often experience profound fatigue. Some feel pain or heart palpitations, and some get strange symptoms, like their hands or feet turning blue. For a long time, there was no treatment specifically for CAD. Patients were often told to keep warm or offer treatments that weren't developed for CAD. But today, Duffy is being infused with a drug that didn't exist when she was first diagnosed. It changed the way she faces her life with CAD. This is part one of Comebacks from the Cold, an original podcast from Sanafi. I'm Aileen Lance-Lesser. I don't have CAD myself, and in fact, I hadn't heard of it before starting this journey. But the moment I heard about this project, I knew I wanted to help tell these patients' stories. And that's because I know what it's like to experience symptoms you can't explain and have to go looking for answers. I went through this myself when I was diagnosed with a different autoimmune condition, multiple sclerosis, a couple of years ago. It's a frustrating and scary journey to find yourself suddenly pulled from your normal life into a medical mystery. That was the experience of Duffy, who you heard from before. And Gloria, a retired nurse practitioner with a great sense of humor. In her career, she'd seen a lot of patients, but never had one with cold agglutin disease.

SPEAKER_06 3:17

He said, Do you know about cold aggluten disease? And I said, Not really. I said I've heard of it, but that's literally it. I've heard the name. But I never saw a patient with it. I never heard of anybody with it, so I never looked into it.

SPEAKER_04 3:32

And Nancy, a Californian who'd retired after a career as a laboratory manager at a medical center.

SPEAKER_05 3:39

So I knew the disease. I had seen a couple of patients in my experience that also had cold agglutinants, but I certainly didn't expect to ever get cold agglutinant disease.

SPEAKER_04 3:52

The voices you'll hear from are all patients who actually have cold agglutinin disease. Patients and physicians participating are being compensated by Sanafi for sharing their stories. I should mention, this podcast is not intended to give you medical advice, but what you will hear are the stories of patients who have found themselves suddenly dealing with symptoms they didn't understand. People who went looking for answers and eventually found a reason to be optimistic. Duffy is one of those people. Before CAD, she was always super active.

SPEAKER_00 4:26

I run half marathons, I walk every day, I exercise, I lift weights. But at age 68, something changed. And I said to my husband that I had just not been feeling right. I was breathless walking up a flight of stairs. I was just tired. And at night, I felt these unbelievable heart palpitations in my chest, and it scared me that maybe I was about to have a heart attack. And I would reach over and my husband would take my pulse and he'd say, Boy, it's racing. Your pulse is racing. And I would stay awake in bed wondering if I was going to make it till the morning.

SPEAKER_04 5:10

She was scared, but she tried to explain it away.

SPEAKER_00 5:13

And I thought, maybe it's my age. Maybe I'm just working out too hard. Maybe I need to slow it down. But the fact that I was breathless walking up the second floor stairs, it was just weird. Something wasn't right.

SPEAKER_04 5:32

She went skiing with her family, trying to put it out of her mind, but she found things got even worse at the higher altitude.

SPEAKER_00 5:40

My absolute favorite pastime is snow skiing, and I couldn't catch my breath in the high altitude. And I said to my husband, just send me home because I'm scared to death. I was just gasping for air. I was just like, I couldn't catch my breath to get a big gulp of air. And that was a real turning point because I haven't been skiing since.

SPEAKER_04 6:09

She took her concerns to her doctor who ordered some tests. But as far as Duffy was concerned, this was not the time for worrying. She was at a really important moment in her life. One of her daughters had just given birth, and she was excited to be a grandmother. But as she was driving to visit the new baby, her doctor called with some news.

SPEAKER_00 6:28

And I was driving down the highway when the doctor called and she said, I think you need to pull over. And I said, What's wrong? And she said, It's not good. Duffy, something is seriously wrong. And I was just holding my breath. She said, I think you either have lymphoma or liver cancer. And I just couldn't believe it. And I said to myself in the car, I am not gonna go in and tell my daughter, who had just had a baby, that I was sick. So I kind of tried to put myself together. And the minute I walked into her apartment, I just burst into tears. And I told her how scared I was that I didn't know um what was going on, and I told her what my doctor had said, and you know, we just hugged, and it was a very, very scary time for me personally, because the joy of having a new grandchild was right there, and here I was getting sick. God, it's bringing back memories. Terrible memories. Sorry.

SPEAKER_04 7:48

No, don't be sorry. Duffy's doctor sent her for further testing to get an official diagnosis, and after a few more difficult months of waiting, Duffy got her answer. It wasn't cancer, but it was still scary. She had cold, aggluten, and disease. Gloria was just approaching her retirement from nursing when her symptoms suddenly appeared on a walk.

SPEAKER_06 8:16

We have a little dog, and I would take him out to go to the restroom first thing in the morning, and he always went up this little hill. And mind you, little is the operative word there. We had been doing that for a long time, and then all of a sudden I'd stop halfway and I'd have to be trying to catch my breath. And then by the time we got to the top, which believe me was not long at all, sometimes I would literally have to bend over double, put my hands on my knees, and start taking deep breaths. And my heart would beat really fast. And I remember one time thinking, gosh, I wonder if my heart could just rupture right here because it was just pounding.

SPEAKER_04 9:02

At the time, Gloria blamed her symptoms on stress. She was working full-time as a nurse, and her husband had been diagnosed with Parkinson's and dementia. She couldn't handle one more worry on her plate.

SPEAKER_06 9:14

So I had diagnosed myself it was stress related, and I was gonna retire the very next month, and so I just knew it'd get better. But unfortunately, it didn't.

SPEAKER_04 9:27

At a routine checkup with her doctor, she mentioned how exhausted she'd been feeling.

SPEAKER_06 9:31

And he goes, Okay, well, let's just check a CBC. And I thought that's a complete blood count. So I was like, gosh, what if it is something medically wrong with me?

SPEAKER_04 9:43

Like Duffy, Gloria tried to push the worries out of her mind.

SPEAKER_06 9:46

I was just like, oh no, I've got too much stuff going on. And I really couldn't let my thoughts go there because I couldn't think of anything happening to me while my husband was still alive. I couldn't imagine what would happen.

SPEAKER_04 10:02

And then there's Nancy. After a routine knee replacement surgery, she just wasn't feeling like herself.

SPEAKER_05 10:09

And the morning after surgery, I was in pain because of the surgery, but they got me up to walk, and I was just so weak. That morning, her doctor checks in on her. And he says, Got your lab results. So, how am I doing? He's well, I don't know what's going on with you, but you lost two grams of hemoglobin.

SPEAKER_04 10:31

Hemoglobin is the protein in the blood that transports oxygen around the body. If you don't have enough hemoglobin, you might experience weakness or fatigue. Nancy had managed a laboratory where medical tests like blood counts were performed. She had a very good understanding of what was normal. This was not. Well, did I lose it in surgery?

SPEAKER_05 10:53

No, you hardly lost any blood. He's just, something else is going on with you, Nancy. And I thought, I just blew through other surgeries. How come this one's so hard?

SPEAKER_04 11:05

After getting discharged from the hospital, Nancy still didn't feel any better.

SPEAKER_05 11:10

I was so fatigued, and that fatigue just wouldn't go away. So for a number of months, I had this question about what was going on with me. And it wasn't a good feeling because my whole life had changed. My knee felt better, but the rest of me felt really bad.

SPEAKER_04 11:31

For each of these women, it took months to finally get diagnosed with cold aggluten and disease. And with that diagnosis came more fear and confusion for Duffy, for Nancy, and for Gloria. How were you feeling emotionally when you heard that diagnosis? What did you think?

SPEAKER_06 11:49

I think, first of all, I was like, oh my gosh, so I'm gonna die. You know, I mean, you use the word rare disease, and I was thinking, oh my gosh, I'm gonna die.

SPEAKER_04 12:02

Their doctors told them there were no treatments specifically approved for CAD at the time.

SPEAKER_00 12:08

The first hematologist basically said, there's nothing we can do for you. Your hemoglobin is very low, and you just need to move to a warmer climate.

SPEAKER_05 12:18

And my only choice was to make good choices. And that's what I had to do. I avoided cold, I avoided having to do too many things at once when I could, and I tried to stay warm.

SPEAKER_04 12:34

They were just told to stay warm because the thinking was that avoiding cold temperatures would stop cat symptoms from being triggered. Now, a cat diagnosis is not terminal.

SPEAKER_00 12:48

I read online somebody said that their doctor said you will die with it, not from it. And that gave me a little bit of consolation, but not much.

SPEAKER_04 12:59

And even still, the disease took a lot away from each of their lives. Nancy, for one, was used to looking after her husband and son and helping her friends.

SPEAKER_05 13:08

I took them places, I took them to doctors' appointments, I fixed meals for them. Uh you know, I was just outgoing, and suddenly I couldn't do that. But she was often too tired to do that anymore. I couldn't even do my grocery shopping all at once. I'd have to sit down in the middle of grocery shopping. I'd find a place to just lean against something, um, a display case, or perhaps the deli section. Maybe I'd go into the restroom and just wait it out. I'd rest for five or ten minutes and then it'd go back out. How would you feel in those moments when you were resting? Down. I was disappointed in myself. I really kind of felt hopeless and almost a failure because I was no longer able to help people. Uh, friends, and um I couldn't do that anymore, and that was a part of me.

SPEAKER_04 14:12

Gloria also found she struggled with daily chores.

SPEAKER_06 14:15

It had gotten to the point that I'd vacuum one room, and listen, this is not a big apartment at all, but I'd vacuum one room and I'd sit down and go, huh. And I'd have to rest and catch my breath, and then I'd go, okay, you can do this, and I'd get up and do another room. Then I have to sit back down. I had to sort of psych myself up to like, you can do this, come on, get up, do it. But it it was a struggle.

SPEAKER_04 14:41

Yeah. I mean, you'd have to give yourself all these mini pep talks. You had to be your own cheerleader. And I'm just curious, what did the fatigue feel like to you?

SPEAKER_06 14:53

Absolutely no energy. Getting out of bed, you felt like you'd done a day's work. And that was hard because I'd always been a very energetic, high-energy person.

SPEAKER_04 15:06

As for Duffy, despite how CA was wearing her down, she was determined to not let it get in the way of her and her family's plans. For one thing, her youngest daughter was about to get married.

SPEAKER_00 15:18

So while I was feeling terrible, still exhausted, run down, still breathless, heart palpitations, I'm in the midst of planning a wedding for my daughter in Italy. I said to myself, we're gonna get through this. I am not gonna miss this moment in time. We had looked so forward to it.

SPEAKER_04 15:40

Duffy's first doctor gave her no treatment options. So she found a new doctor. They suggested a treatment that wasn't designed for CAD, but could be used to treat CAD symptoms. She started the treatment immediately.

SPEAKER_00 15:54

And my fingers were crossed. My kids were all nervous. I was scared, but I was hopeful that I would have a positive result. My hematologist said, in three months you'll know pretty much whether or not the monoclonal antibody has helped you. And it didn't happen. My hemoglobin remained in the crazy eights, as I like to call it.

SPEAKER_04 16:21

Duffy calls it the crazy eights because a healthy hemoglobin level for a woman of her age is around 12. Even after treatment, Duffy was still in the eights, which really affected her energy.

SPEAKER_00 16:34

So I went to Italy. I was still tired. I uh had a challenge walking up a flight of stairs and all these castles we were in, and um, I was still scared because nothing had happened, and still worried about when I am going to be like myself again.

SPEAKER_04 16:56

Meanwhile, Gloria's doctor had given her similar recommendations.

SPEAKER_06 17:00

He said, if your hemoglobin gets down to seven, you'll have to have a blood transfusion. And I don't want to have to do that if we don't have to. I was like, okay. When my hemoglobin got down to nine, that was when he decided to try a monoclonal antibody. But it didn't work, nothing worked.

SPEAKER_04 17:21

Nancy's doctor treated her with a drug that would help her body make more red blood cells.

SPEAKER_05 17:27

And that worked very well until I needed more of it, and I need it more frequently. And eventually, after a number of years, it failed to work at all. So it was a very depressing time in my life. I felt rather helpless, and my active life that I had had all my life was suddenly taken from me.

SPEAKER_04 17:54

Duffy, Nancy, and Gloria had all been active, take charge people. Cold aggluten and disease took that from them.

SPEAKER_05 18:02

I had always felt like I could solve problems, and now I wasn't capable of changing it. No one was there to help me. Uh, there were no drugs, or there was no doctor coming up with a magic potion, and I couldn't overcome it. At that point, I was without hope.

SPEAKER_04 18:23

Neither Nancy, Gloria, nor Duffy had a treatment that was working. It wasn't until 2022 that things finally changed. A new drug emerged, the first made specifically to treat CAD, and the Food and Drug Administration had just approved it for use. The drug was called NGMO or Sutimlamab Jome. This is what we heard Duffy being infused with at the beginning, and it's the only drug on the market developed specifically to treat patients with CAD. NJMO is a prescription medicine used to treat the breakdown of red blood cells in adults with cold aggluten and disease. Please stay tuned for important safety information about NJMO later in the episode. For Nancy, it was a huge lift just to hear about this option.

SPEAKER_05 19:09

Oh gosh, my daughter-in-law had gone with me to the appointment. And as soon as he started talking about this drug and the notable results that were occurring with it or had occurred with it, I looked at my daughter-in-law and she looked at me and we just smiled. And it was like a weight had been lifted off of me because the hope was real. It was just like the clouds had cleared. It was wonderful. I went up there with basically no options. I left there with an option. And my attitude was about 180 degrees difference.

SPEAKER_04 19:52

Gloria's hematologist told her about the drug, and she was also hopeful.

SPEAKER_06 19:57

He showed me the results of some studies that had been done. I was like, oh, that sounds so wonderful. It would be so nice to have some energy for a change, you know.

SPEAKER_04 20:11

But she wanted to look more closely at the studies.

SPEAKER_06 20:14

And I remember saying to him, well, those results look great, but it was a very small study, only about 40 participants. And of course, when I was in my master's program, they were talking about how you had to have so many people to do these studies and all. And I was like, So that's not a real impressive study, only 40 people. And he goes, Remember what I said? It's a rare blood disease. We can't get the numbers for a study that other diseases can get. And I said, Oh yeah, that makes sense. But like I said, the results of the study were very impressive to me.

SPEAKER_04 20:53

So kind of going back to basics, imagine I'm a patient who has just been diagnosed. Can you paint me a picture of how NJMO is working in my body?

SPEAKER_01 21:03

I guess before doing that, it might be helpful to just kind of review what is CAD.

SPEAKER_04 21:09

To understand more about NJMO and how the clinical trial study Gloria mentioned worked, I talked to Dr. Trevor Feinstein. He's a hematologist oncologist at the Piedmont Cancer Institute in Atlanta, Georgia, who has treated several patients with CAD using NGMO.

SPEAKER_01 21:25

So medically we define CAD as a rare autoimmune hemolytic anemia.

SPEAKER_04 21:30

In a normal immune response, the body produces antibodies which bind to disease-causing organisms like bacteria or viruses, targeting them for destruction. In the bodies of patients with CAD, the body produces an auto antibody.

SPEAKER_01 21:46

That preferentially binds to red blood cells. And this autoantibody is called an IgM antibody.

SPEAKER_04 21:52

So this IgM antibody binds to healthy red blood cells, marking them for destruction.

SPEAKER_01 21:58

And it has a weak binding. To red blood cells, and so it preferentially binds at cooler temperatures.

SPEAKER_04 22:04

Which explains why some CAD symptoms are triggered when the body gets cold. So this IgM antibody binding to the red blood cell sets off a chain reaction called the classical complement pathway. And that in turn makes the immune system target and destroy those red blood cells. That causes the anemia, fatigue, and other symptoms patients have described.

SPEAKER_01 22:27

And the nice thing about NJMO is you're stopping it right at the start. You're preventing the red blood cell destruction. There's other parts of the immune system, what's called a lectin, an alternative pathway, that you're leaving in checked, you're suppressing the immune system a bit, but you're still allowing part of that complement cascade to still work to helpfully fight viral or bacterial infections. You're preventing the complement pathway from being activated.

SPEAKER_04 22:52

Okay, so in JMO works by stopping activation of the classical complement pathway.

SPEAKER_01 22:59

Correct.

SPEAKER_04 22:59

Preventing red blood cells from being destroyed.

SPEAKER_01 23:02

It's a very effective way of targeting the pathway there. But you know, one of the things that sometimes people don't always realize is because of what you're affecting is complement, you're not affecting that agglutination. So you can still have kind of what we call this acrocinosis or this still bluing of the skin at cooler temperatures.

SPEAKER_04 23:22

I see. So getting into the NGMO clinical trial, how was this study of NGMO conducted?

SPEAKER_01 23:30

It was what we call a randomized double-blind study. Half your patients got NGMO and the other half got a placebo, which is key because we need to have a control to kind of just see what would happen naturally to people. It was double-blinded, meaning that the patients didn't know what they were getting and the doctors didn't know what the patient was getting either.

unknown 23:51

Dr.

SPEAKER_04 23:52

Feinstein says 22 patients were given NGMO and 20 patients were given the placebo. Patients in both groups had been diagnosed with CAD and had no history of receiving blood transfusions. The participants were infused on day zero, then infused again one week later, and then every two weeks after that. And they waited to see how they would respond. They were looking for three main outcomes.

SPEAKER_01 24:17

Meaning that the goal was to increase that hemoglobin one and a half grams, to not have any transfusions, and not use any other treatment for CAD. And here you had, I believe it was about 73% of the patients met all three endpoints.

SPEAKER_04 24:34

And he said only 15% of those on the placebo met all three of those same endpoints. To break that down further, Dr. Feinstein says that for those on NGMO, about seven out of ten had a hemoglobin increase of at least one and a half grams. And from week five through 26 of the study, about eight out of 10 were transfusion-free. And almost nine out of 10 patients used no other treatments for CAD.

SPEAKER_01 25:00

And you actually saw a rapid improvement of hemoglobin within three weeks was over two grams. So you had significant improvement of that hemoglobin. And what was nice is the patients held that hemoglobin up in the placebo arm, there was not really any improvement of that hemoglobin.

SPEAKER_04 25:15

At the end of the study at week 26, patients taking in GMO had an average hemoglobin increase of 2.66 grams per deciliter, compared to about 0.09 grams per deciliter for those on the placebo. The study also saw a significant improvement in fatigue for patients taking in GMO. During the study, they were given a survey of 13 questions asking about the impact of fatigue, each on a scale of zero, not at all, to four, very much so. They were asked questions like, how fatigued do they feel? Are they able to do their usual activities? Do they need a nap to get through the day?

SPEAKER_01 25:55

When patients enrolled on this study, their facet fatigue score was in the low 30s, which is pretty significant fatigue. You know, what you saw is that there was a significant improvement of that facet fatigue score, meaning they got into the low 40s, which improved about 11 points, which is kind of where an average person should be at.

SPEAKER_04 26:16

Patients taking the placebo, meanwhile, had a two-point improvement. Wow. Yeah, you're seeing the outcomes that you would hope for. That's great.

SPEAKER_01 26:24

Yeah.

SPEAKER_04 26:25

Yeah. So I know one of the biggest questions for those considering NGMO is about side effects. What did the study say about those?

SPEAKER_01 26:34

So the nice thing is in JMO is a usually fairly well-towered treatment. There can be a few side effects. Sometimes you see kind of a runny nose. You can see some hypertension or high blood pressure, so you have to watch for that. We can see some people get some headaches with it. And then the other sort of thing that finds is the circulatory symptoms, so like the acrocyanosis or Ray Nodes phenomenon, those don't get any better with getting in JMO.

SPEAKER_04 27:01

Dr. Feinstein says that for those in the study, two out of 22, or about 9% of patients, experienced serious side effects, an infection with a fever, and Ray Nodes phenomenon, which Dr. Feinstein mentioned. That refers to the change in color or sensation in the fingers and toes that some patients with CAD experience. As Dr. Feinstein shared earlier, NGMO is not intended to improve symptoms related to agglutination or Ray Nodes phenomenon. And what did reading that study make you think when you first encountered it?

SPEAKER_01 27:36

Everything sort of matched up with that science. I think on a personal level, I mean, it made me happy for patients that struggle with this, that, you know, it's an kind of was an unmet need, but it was also nice to get a treatment that reduced that fatigue, corrected the anemia, and got patients back to what they wanted to be doing.

SPEAKER_04 27:54

What are some of the hesitations patients have about NGMO that you've seen?

SPEAKER_01 27:59

I think the some of the hesitations I often see is sometimes people are a little bit hesitant about what is my risk of developing infections. So what one of the fears we have about when we affect complement is we can have people have an increased risk of encapsulated infections. So what we usually worry about are things like meningitis. So we want to vaccinate usually before treatment against those.

SPEAKER_04 28:23

Because NJMO is turning off a part of the immune response, it does make patients more susceptible to certain kinds of infections, some of which can be serious or even life-threatening. So patients should talk to their doctor and get the recommended vaccinations before starting in JMO. We'll include more important safety information about this later in the episode. But it makes sense that patients might take a moment to consider the risks before deciding on treatment. This was the case with Duffy, Gloria, and Nancy. Did you have any hesitations going in? I did.

SPEAKER_05 29:00

Because they also informed me that there were side effects. It opens you up to uh having a less rigorous immune system in some areas, like bacterial or viral infections. There's been some swelling in the legs, some perhaps associated rheumatoid or arthritis complications. So, yes, I had some concerns, but I took all of the vaccinations that were recommended to thwart those complications, and I felt very eager to try the drug despite any possible side effects.

SPEAKER_04 29:41

Nancy decided to go for it. For Duffy, the decision took a lot longer. When you heard about NGMO, did you have any worries?

SPEAKER_00 29:51

Oh, yeah. Everything that I read was you had to get vaccinations. All the side effects that are listed may cause dizziness, it may cause this, it may cause that. You might have, you know, blood in your urine, you might have this or that. And those were some of the things that probably kept me away.

SPEAKER_04 30:15

Duffy hesitated. Her husband is a doctor, and he had read all the studies about Njamo himself.

SPEAKER_00 30:21

What did your husband think about you trying Njamo? Oh, he was 100% on board. In fact, Ailen, he said to me, after all the research, and he has all of the medical journals, he did research like unbelievable. He understood the mechanics of what Njemo was doing inside my body and was convinced that those details are what was necessary for me to feel better and have a rise in my hemoglobin.

SPEAKER_04 30:58

But still, she was on the fence, even as the fatigue was getting to her.

SPEAKER_00 31:10

But I had just run out of steam. And my daughter was with me, and she said, Mom, why don't you just give it a try? You have been talking about this. Dad and I have read through the side effects, and why don't you just give it a try? And I think it was both her convincing and me being just wiped out from setting up a new little house. That was sort of a very interesting moment in between boxes and papers and everything that was surrounding us. I just said, okay.

SPEAKER_04 31:46

She decided to give Njemo a try, as did Gloria. Did you have any hesitations or fears going in?

SPEAKER_06 31:54

I was a little fearful of what kind of side effects I might have. Because in the infusion center, they have like a crash cart there. And I was like, oh my gosh. You know, and I'm sort of looking at everybody there to see if I think they might need the crash cart or if I'll need it, you know. But I really, I was feeling so miserable with the fatigue and all that. I was very ready to give it a try.

SPEAKER_04 32:23

And so Duffy, Gloria, and Nancy all decided to give Njemo a try. Their doctors agreed and they got vaccinated. And finally, they prepared for their first infusions. Nervous, excited, and hopeful. In part two, we'll hear how their first infusions went, and if Njemo lived up to their hopes. That episode is available for you to listen to right now. Find it in your podcast player of choice or find links in the show notes to this episode right on your device. But first, please listen to some important safety information about Njemo.

SPEAKER_02 33:06

NJMO Consumer Indication and Important Safety Inform. Indication. NJMO is a prescription medication used to treat the breakdown of red blood cells, hemolysis, in adults with cold agglutinin disease, CAD. It is not known if NJMO is safe and effective in children. Important safety information. Do not receive NJMO if you are allergic to Citimlumab Jome or any of the ingredients in NJMO. NJMO can cause serious side effects, including serious infections. NJMO is a prescription medication that affects your immune system. NGMO may lower the ability of your immune system to fight infections. NJMO increases your chance of getting serious infections, including those caused by encapsulated bacteria, including Neisseria meningitis, streptococcus pneumonia, and hemophilus influenza type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early. You must be complete or be up to date with your vaccines against Streptococcus pneumonia and Neisseria meningitis at least two weeks before your first dose of NGMO. If your healthcare provider decides that urgent treatment with NJMO is needed, you should receive vaccinations as soon as possible. If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting NGMO. Your healthcare provider will decide if you need additional vaccines. Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection, fever with or without shivers or chills, fever with chest pain and cough, fever with high heart rate, headache and fever, confusion, clammy skin, fever and a rash, fever with breathlessness or fast breathing, headache with nausea or vomiting, headache with stiff neck or stiff back, body aches with flu-like symptoms, eyes sensitive to light, infusion-related reactions. Treatment with NJMO may cause infusion-related reactions, including allergic reactions that may be serious or life-threatening. Your healthcare provider may slow down or stop your NO infusion if you have an infusion-related reaction and will treat your symptoms if needed. Tell your healthcare provider right away if you develop symptoms during your NGMO infusion that may mean you are having an infusion-related reaction, including shortness of breath, decrease in blood pressure, chest discomfort, rapid heart rate, nausea, injection-sight reaction, flushing, headache, dizziness, rash, itchy skin, risk of autoimmune disease. In JMO may increase your risk for developing an autoimmune disease, such as systemic lupus arythematosis, SLE. Tell your healthcare provider and get medical help if you develop any symptoms of SLE, including joint pain or swelling, rash on the cheeks and nose, unexplained fever. If you have CAD and you stop receiving NJMO, your healthcare provider should monitor you closely for the return of your symptoms after you stop NJMO. Stopping NJMO may cause the breakdown of your red blood cells due to CAD return. Symptoms or problems that can happen due to red blood cell breakdown include tiredness, shortness of breath, rapid heart rate, blood in your urine, or dark urine. The most common side effects of NJMO include increase in blood pressure, urinary tract infection, respiratory tract infection, bacterial infection, swelling in lower legs or hands, joint pain, headache, nausea, runny nose, bluish color to the lips and skin, dizziness, feeling tired or weak, cough, changes in color or sensation in the fingers and toes, rainodes phenomenon. These are not all the possible side effects of NO. Call your doctor for medical advice about side effects. Before receiving NGMO, tell your healthcare provider about all of your medical conditions, including if you have a fever or infection, including a history of human immunodeficiency virus, HIV, hepatitis B, or hepatitis C. Have an autoimmune disease such as systemic lupus arrhythematosis, SLE, also known as lupus, are pregnant or plan to become pregnant. It is not known if NGMO will harm your newborn baby. Are breastfeeding or plan to breastfeed? It is not known if NGMO passes into your breast milk. Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medications you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Please see accompanying full prescribing information, including medication guide. I'm Ailen, and this is Comebacks from the Cold, a podcast from Sanafi.