INDICATIONS UPLIZNA® (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

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UPLIZNA video resources to support you and your patients

Esther Hero 1.3

Esther

UPLIZNA patient since 2021. Individual results may vary.

HCP Testimonials 

In this video series, healthcare professionals who treat neuromyelitis optica spectrum disorder (NMOSD) explain why they made the decision to prescribe UPLIZNA.

Discover how UPLIZNA made a difference for their patients.
Individual results may vary. Please listen to the Important Safety Information at the end of each video.

  • Transcript

    When somebody first comes to me with NMO, there are different possible presentations. They may be blind in one or both eyes. They may have a spinal cord disorder, so be unable to walk. Unusual pains or all of the above. And it's a very catastrophic presentation for a lot of people. And so, there's a lot of questions.

    They really need the expertise that comes with being a neuro-immunologist and talking about the different medicines and trying to go through what's the best option for them.

    When I think about a treatment for NMOSD, disease modifying treatments is something that's immunosuppressive for a patient. I have different factors that I consider. The first is efficacy. So how good is your drug? How well will it actually work for your disease.

    And after that I think about safety. Is it something that will not make them worse either for the fact that it doesn't work or because it creates new problems. And then we also think about aspects like tolerability. How well does a patient tolerate the drug?

    So, when I think about dosing and administration, I think about how burdensome is the dosing. So, there are medicines that are twice a year and that tends to be very popular with patients. There are medicines that can be taken, you know, once a month or every two weeks or every couple months.

    I think in general, having FDA-approved drugs is helpful for patients. It means that there is actually science behind their treatments.

    It reflects a lot of effort and time and investment into the NMO community where real trials have been done, an evidence base has been created. That means that patients now have options that are based on real data that can inform their decisions.

    Before the FDA-approved therapies in the US, we had options but not the evidence behind them to really have the gravitas to know if we're giving the right medicine to the right person at the right dose at the right time. There's a lot of information that we didn't have where we were making our best judgment or our expert opinion.

    UPLIZNA targets CD19 and that is an important marker on the B cells, from some of the pre-B cells all the way to the plasmablasts. And so that includes a variety of B cells in the lineage. And that tends to have a pretty broad immunosuppression. And that's useful in terms of the production of IgG or aquaporin-4 antibody.

    It's the cause of NMO. So being able to get rid of the production of those IgGs or aquaporin-4 turns out to be a very effective and overall very safe treatment for NMO.

    There's a lot of debate in the field or even discussion about, do you wait for an attack before you switch? One of the risks of that is that if you wait for an attack, then there's already disability accrued that may be irreversible, and that may be too late to make that switch. Waiting for something to go wrong may not always be the best time to switch

    Certain patients, they switch to the UPLIZNA, and we don't really see them in the ER anymore. They don't call in with new attacks. So that's generally been a very favorable experience.

    Patients really do well in terms of the efficacy on UPLIZNA and B-cell depletion in general. The safety is generally reassuring. So, it doesn't have any black box warnings or any safety considerations that require ongoing monitoring.

    In general, this combination of dosing only twice a year, safety, high efficacy, and patients generally finding it tolerable and not burdensome has been very practically helpful.

    And I really like the fact that we can make people well and have people do well and live their normal lives again.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for six months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Dr Farrah Mateen: The Importance of Targeting CD19-Expressing B Cells

Dr Mateen shares her thoughts about B-cell depletion with UPLIZNA. Dr Mateen is a neurologist and has been compensated for her participation.

  • Transcript

    Complacency has no place in medicine. I think that you do need to make, the best recommendation for the patient based on the current state of the art knowledge of the disease, and to not do so would be providing a disservice to your patients.

    I first started working with patients with NMOSD probably close to 30 years ago. There was with a lot of trepidation that I began seeing those patients. As we know, this is a devastating neurological disease. Unfortunately, patients are oftentimes met with challenges leading to disability. And we had very few treatments available for those patients.

    We also had difficulty diagnosing those patients. We didn't have the aquaporin-4-antibody available yet. So, it was a very difficult time.

    When I first started seeing patients with NMOSD, we had no FDA-approved therapies. We were using everything off label. And frankly, flying by the seat of our pants. We were using a variety of oral Immunosuppressives and rituximab.

    And I think the decision as to which therapy we were going to use was partially based on patients’ preference, patients’ comorbidities, and also partially based on our own experiences.

    This is a very exciting time in the world of neurology and specifically in the world of NMOSD, we have multiple FDA-approved therapies available that we can offer to our patients. And this is really having a positive outcome on our patient’s long-term futures.

    In my experience, healthcare providers, we look at efficacy first and safety second. And I think patients look at safety first and efficacy second. So those two worlds have to kind of meld together. I think safety is very important. Tolerability is important. Comorbidities are important. Insurance requirements are important. All of these things have to be collated together before a decision can be made.

    With the FDA approved therapies, this gives us the confidence from the randomized clinical trials that have been done. They've gone through the rigorous process of the clinical trials, we have information about the mechanism of action, the efficacy and the safety. this adds to our, treatment choices for our patients.

    UPLIZNA depletes B-cells with the CD19 marker. CD19 B cells encompasses from pro-b cells all the way up to plasmablasts and plasma cells, and the plasmablasts and the plasma cells are the cells that are releasing the aquaporin-4-IgG antibody, which is the source of all of the trouble with NMOSD.

    They were able to manipulate the molecule to remove the fucose from the monoclonal antibody UPLIZNA. And as a result, it may be more effective in reducing or in depleting the B cells. It's believed that up to 40% of the population has a genetic polymorphism, which for those people that do have that polymorphism, taking a B cell therapy, that's not glycoengineered may render that medication less effective.

    I have more confidence using UPLIZNA because it has a broader, mechanism of action or broader range on the CD19 cells because of the, the efficacy, and the safety data is good. It makes me feel comfortable prescribing it for my patients.

    We're seeing improved patient outcomes with our patients. We're seeing less in the way of disability. And I think that's the most exciting thing for me.

    I want to do the best for my patients. I want to know and feel confident that I'm doing the right thing for them. And being on an FDA approved therapy, knowing that this therapy has been studied and been through the rigors of a clinical trial gives me that confidence that this is an appropriate therapy for them.

    It’s wonderful to be able to offer patients options about the, the various therapies for NMOSD. Prior to FDA-approved therapies, it’s very important that we, empathize with our patients and that we offer the best possible treatment for them, as if they were our own relatives sitting there.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for six months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Patricia Melville, RN, MSN, NP-C, MSCN: Making the Right NMOSD Treatment Decision 

Patricia Melville discusses why she prescribes UPLIZNA for her patients with NMOSD. Patricia Melville is a nurse practitioner and has been compensated for her participation.

  • Transcript

    NMOSD is very unique. This is a very different disease than multiple sclerosis that I routinely treated in the past. The first few patients that I was seeing in my practice, they were either on a stretcher or a wheelchair or they were blind.

    With the 1 or 2 attacks their life actually completely gets upside down so they cannot walk, they cannot have a meaningful life. Because of the amount of disability they have, they lose their social circle. Some of them, they end up in the nursing home or other facility.

    When I pick a treatment for a patient, there are several considerations. And the most important consideration is of course the efficacy of the drug. We know that each attack can be completely irreversible and cause permanent neurological damage. So, efficacy is very important. But that of course, it's so important to have a safe drug, especially considering this treatment needs to be continued for the rest of the patient's life. So, we always also consider the safety of the drug. 

    I also consider tolerability because if the patient has serious side effects from the medication, they're not going to continue. So, tolerability and route of administration is also important to make it practical.

    Before the FDA approved a drug, we were using rituximab as the most common off label medication. The problem with the rituximab was there were a lot of variation about what dose and what interval of the medication we need to use. At the same time, we also didn't have any long-term data about the safety and efficacy which created a lot of confusion and concern.

    In my practice, I noticed very early on that there were certain group of my patients that the B-cell was not fully depleted. After a few months, right after the infusion, they were repopulating.

    They have a genetic polymorphism so that unfortunately they cannot fully respond to the rituximab. And that made me very nervous. I definitely don't want to risk my patient’s life or, health, to an off-label medication.

    When FDA-approved drugs came to the market, I was very happy. We were part of almost all the clinical trials for all the NMOSD products. And I was familiar with the product, I was familiar with the data. Having them in the market allowed me to switch my other patient that they were previously on off-label medications to FDA approved drugs. Now we have much more data about the efficacy of the drug, which tells us that regardless of the type of the polymorphism they have, they have a similar response.

    One of the reasons I choose UPLIZNA, is the tolerability of the drug. The majority of my patients, they were on rituximab, they often had some infusion-related reactions. Not only we had to slow down the infusion rate, and the patient has to spend a long day in the infusion center. But also, they still had to deal with a lot of side effects from the infusion. When I switched them on UPLIZNA, I see minimum infusion-related reactions. In dosing regimen, which is only twice a year, it is more compatible with their lifestyle and their schedule.

    In the management of NMOSD, I think that B cells are the driver of the disease and targeting the B cell in my opinion is addressing the root of the problem. And I think that with UPLIZNA eliminating a large portion of the B cells, we can safely say that we are controlling the disease for the most part. I'm not actually doing frequent B-cell checks as I was doing before.

    I try to come up with the treatment decision with my patient. Hopefully we as a team come up with the best treatment approach for them that works for the long term because this is a lifelong condition. We want to have a good long-term plan for them. Now, I'm more confident about this treatment for my NMOSD patients. 

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Dr Aram Zabeti: NMOSD Treatment Backed by Evidence 

Dr Zabeti discusses the benefits of prescribing an FDA-approved treatment like UPLIZNA. Dr Zabeti is a neuroimmunologist and has been compensated for his participation. 

  • Transcript

    I’ve been treating patients with NMOSD for the last 20 years. This is very challenging. One of the things that I’ve learned over the years is to truly take a humble approach to the care of patients with rare disorders. One of the ways to manifest that is by constantly challenging yourself—have we made the right diagnosis? The same is true with therapeutic interventions. Is that truly the right approach?

    When discussing treatment options with my patients, number one, the therapies have to have evidence of efficacy that comes from rigorous scientific studies that truly were designed to understand whether this intervention is better than other interventions or placebo in the case of NMOSD patients. I like to see that the medications have been designed to truly target the underpinning mechanism of the disease process that we know plays a critical role in the pathogenesis of the disease. But also, efficacy has to come with safety. There are different factors from a patient standpoint that may increase or decrease that risk, whether it’s the presence of comorbid conditions, age, whether there are certain risks that perhaps come with exposure to environmental factors. So, it is not a linear, it's not a simple answer. Truly, we need to pay attention to all of these different factors. And lastly, how are these interventions going to perhaps be incorporated into someone’s life?

    So, when I look at the history of NMOSD, I see two very clear milestones. One is the discovery of the aquaporin-4 antibody. And that truly allows us to have a biomarker for the diagnosis of the disease. The second milestone was approval of medications—disease modifying therapies. Now we can have options. We can have tools to offer to our patients that we don’t have to necessarily struggle with insurance companies that are not approving the medication because it’s off label. Now we have a true label that is actually supporting the use of these medications. So, I think having these therapies truly changed the landscape of options in NMOSD. It also allows us to have an opportunity to talk to patients about options. We went from having no options to having multiple options. And I think that’s important to keep in mind.

    So, I remember when UPLIZNA got approved, it truly created an emotional response because it was the first and only of the approved medication that truly targets the cells expressing CD19 that are critical in the pathogenesis of the disease. It was this combination of having a therapy that makes sense, the therapy that is actually going after the mechanisms of the disease that we know play a critical role in NMOSD. And also the presence of the glycoengineered molecule on the FC receptor allows for more efficient binding to the FC gamma receptor 3a and that allows for more effective binding to the natural killer cells.

    So, all of those nuanced subtleties that are present in the understanding of the mechanism of action are critical. Now that we have an FDA-approved medication that allows us to have a therapy that comes with patient resources with access to healthcare, with all sorts of benefits of having approval behind a medication. I’ve seen lately that many of my colleagues are choosing to switch patients from rituximab to UPLIZNA. I think it's just the level of comfort and understanding on long-term side effects, understanding the difference in terms of mechanism of action, getting also more familiar with this concept of certain genetic polymorphisms that may affect the effective binding of the antibodies to the effective cells that could result eventually in differences in terms of efficacy.

    So, the advice I will give to my colleagues is to take an opportunity to challenge your decisions and truly look into the care of your patients in a more holistic way. And also, be mindful of treatment inertia. I think that there is some comfort level that we experience by not changing things around when patients are not having evidence of this disease activity. And I think that creates some sense of safety. We have to be mindful that sometimes that may not be the right choice for our patients. In a disease like NMOSD we have to be proactive, and we truly have to take an opportunity to think: is this the best, the right approach that we have for our patients? And not wait until patients relapse, not wait until patients have MRI activity to truly think about changes in therapies.

    UPLIZNA has resulted in a significant impact in the way I treat patients with NMOSD. A fulfillment of the practice of neurology comes from the realization that our patients are extremely resilient. These individuals are going through life with a very challenging diagnosis that could result in disability. So, being able to be part of that comes with a commitment of doing everything you can to provide the best service.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for six months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Dr Augusto Miravalle: Fighting Treatment Inertia in NMOSD

Dr Miravalle discusses the impact of FDA approval on his NMOSD treatment decisions. Dr Miravalle is a neurologist and has been compensated for his participation.

NMOSD Patient Stories

In this video series, real patients with neuromyelitis optica spectrum disorder (NMOSD) tell the story of their diagnosis, treatment journey, and the struggles they endured along the way.

Learn how UPLIZNA has helped patients with this debilitating disease.
Individual results may vary. Please listen to the Important Safety Information at the end of each video.

Esther: UPLIZNA Fits My Lifestyle

Esther highlights the urgency to recognize and act on NMOSD disease activity in a timely manner.

  • Transcript

    Oh, gosh. Yes. That’s me. I’m sorry. I don’t even want to look at these pictures sometimes because it tells you exactly how I was feeling. Pain and unknown, fear. Damn you, NMOSD.

    I’d just given birth to my daughter Amaya, and I started noticing some symptoms after giving birth. One of those was back pain, severe back pain. At this time now, I’ve already started visiting my PCP explaining my symptoms to her. Her explanation was maybe it’s just a normal postpartum pain and stress.

    I started noticing changes in my motor skills. I have numbness and tingling in my hands and feet. I could barely control my bladder at this point. I went to the emergency room because I could barely walk without holding onto something. Went home, nothing was done, again, was dismissed.

    And they finally did an AQP4 test, and it came back positive. We have a diagnosis.

    The most important question was, “How will this impact my life? Will I have my normal life again?” “No, this will change your life forever.” So that breaks my heart, like, “Okay, where do we go from here? What is it going to be like not just for us, but for our kids?”

    The reason why I picked UPLIZNA is the timing. It was once every six months after the first two initial dose[s]. So, that’s just a relief. It’s just convenient.
    Since my initial infusion treatment had been going really well for me, I always say, my infusion day is a time for me to celebrate my NMOSD diagnosis and my treatment.

    I’m able to be a mom, I’m able to go for a walk, I’ve been able to return to my exercise classes.
    It’s a miracle that I’m standing here and be like, “I’ve not had a relapse.” I’m able to be present, be there for whatever, just be present, be there for my kids.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for six months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Michelle: UPLIZNA Helped Me Get Back to Some of the Things That Matter Most

Michelle highlights the importance of starting patients on appropriate treatment right away.

  • Transcript

    This was my last attack and I would not wish this upon anyone. It’s just weird to see these again, because it’s been so long. This is where I was at with this disease at one point. Feeling like there was no hope.

    I am an instructor at a university teaching business and business communication. I also live on a farm with my husband and two daughters.

    I woke up one morning. It was early October and my left eye, there was just a little bit of a fuzzy in it. I had never had that before so I decided I probably should go to the eye doctor and see what’s going on. They did a visual field test, and the eye doctor said, “Hey, this looks like optic neuritis. We’re going to send you to a neuro-ophthalmologist who specializes more in these issues.”

    Then he did a blood test. A week or two later, I get the results, and that was probably the roughest day of my life. This test, the Aquaporin-4 a test says you are positive for NMOSD. And that my life would be pretty different from now on.

    I start panicking because most things on the internet are still fairly outdated with NMOSD. It’ll say things like “five-year lifespan.” My vision might totally go away.

    Horrifying disabilities. And so, I’m starting to read this thinking, “Do I only have five years left with my kids?”

    About a week or two later that neuro-ophthalmologist did have me in his office and he said, we’re going to start with this and it was just a pill and so I took that treatment for about six months and had my next attack. And that attack was uncontrollable hiccups. They gave me some steroids to help calm down my system, and then two or three months later, back in the hospital with another relapse, and that time it was vertigo, actually. Constant spinning. It felt like my hands were somewhat paralyzed. I couldn’t move my thumbs to type and things like that. They do the MRIs and say you’re in the middle of a pretty bad attack. So, I stayed in the hospital a good week on that one.

    Any time I’d have any symptom during that year, I swore I was having an attack, right? My eye would hurt a little and I’d be like oh, oh, my visions going to go. So that’s what’s really difficult with NMOSD. It’s always looming.

    After having two relapses in just a year, my neuro-ophthalmologist said, “Okay, it’s not working.” And so, he actually sent me to another doctor, and that’s where I found out about UPLIZNA.

    The twice-a-year treatment with UPLIZNA sold me on it. Because there are other treatments that are more frequent. As a busy mom, as a busy wife, as a busy worker, that completely sold me. My doctor walked me through all of the potential benefits and side effects, but for my experience, since I started UPLIZNA I have not had any infusion reactions or side effects.

    What I’ve left behind after starting UPLIZNA are relapses. I have been relapse free since I started in October of 2021. UPLIZNA gave me back my life where I could work, teach, cook, be a wife, and spend time with my friends and family.

    So, my advice to someone who’s recently been diagnosed with NMOSD is first, it’s ok to be sad. It’s ok to cry. But then you need to talk to your doctor and see all of the options that are out there available for you. Because there is life with NMOSD.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Betsy: UPLIZNA Has Made a Difference in My Life

Betsy highlights why she felt the dosing schedule with UPLIZNA was right for her.

  • Transcript

    Toughest day of my life. It was shortly after I got home, not wanting to get up off the sofa, still not able to see right. A tough day. But I think I’m here to help people. Maybe that’s why I got sick.

    In 2018 I had this sinus infection that just did not want to go anywhere. I ended up with this rash on my thighs that nobody could distinguish what it was.

    Then, in December, I had woke up and I was dizzy.

    And as the day progressed, I was getting dizzier and dizzier. Then, at one point, I was sitting down, and I just slowly slumped off to the side, and this huge white flash of light went off in my head.

    We went to the emergency department. I was brought by ambulance, and that prompted them to do some testing. I had an MRI of the brain and I have lesions in the brain and lesions in the spine.

    I was admitted to the ICU. They did lots and lots of testing all week long. It’s really scary when you don’t know what’s happening to you.

    Having to leave the hospital, I was not able to utilize my left leg. I also left the hospital with a patch on my right eye because I was still seeing double. I had to allow others to help me. When you are that person who does all that for yourself and then that is just gone. That’s frustrating.

    We opted to do the UPLIZNA, and that was one of the best decisions of my life.

    Because UPLIZNA is humanized, my doctor and I felt that this would be a better fit.

    We were told about the potential side effects, but every 6 months to have an infusion to help prevent any relapse fits right into what you need for your life, for my life, for my husband’s life.

    Things have changed since UPLIZNA has entered my life. What I left behind is all those days I could not get out of bed. All those days filled with tears.

    With UPLIZNA I don’t have that. I can actually cook dinner. I can do things around the house. I can work a full-time job.

    My husband told my provider, If I was to describe myself nobody really would know the truth about what’s going on. Nobody would ever know that I was sick.

    NMOSD will not define me. I will define it.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Jasmine: Feeling a Little Bit More Like Myself After Each Infusion

Jasmine discusses the importance of testing for AQP4-IgG.

  • Transcript

    I’m from Denver, Colorado and I work in healthcare. I started working in healthcare because I like just helping people and l ended up in neurology, working with, like, rare diseases or just autoimmune conditions.

    In January 2021 I was in school, for nurse for getting all my prereqs for nursing and I woke up and I had haziness in the left eye, some pain. Then by day two, it was more hazy vision, more pain. Then by the third day, I was driving into work, and got in the parking lot, and then my vision just went out.

    I was definitely scared. You play it in your mind, like, I just need to rest more.

    But the doctors that I worked with, when they noticed I was experiencing optic neuritis, I was admitted to the hospital for three days for steroids and then from being admitted it was just, all the tests were ran. The MRIs they sent me for. Lab work. Spinal tap.

    That Monday, we had all the testing back that was reflective of an MS diagnosis. And then later on the aquaporin-4 lab result came back and then I got the diagnosis of NMOSD.
    I’ve heard of NMOSD a few times. We’ve had maybe a handful of patients that have NMOSD. In my mind, I was just thinking, “When will this happen to me?” and comparing myself to other patients that I’ve seen. Feeling like, “Will I ever go back to work the same? Will I ever go back to school? How does my life look now?” I have so much other stuff I have to do. That was probably the hardest part.

    I worked with a doctor who knew a lot of information about NMOSD. The doctor was like, “This is probably the best time for you to be getting diagnosed because there are treatments there and now we need to figure out which treatment is going to be best for you.”
    I feel like every time I get an infusion, I’m feeling a little bit more like myself.
    I’m almost three years diagnosed. I feel really good. I feel really confident in what I’m able to do.
    What I left behind with UPLIZNA is the hospital stays.
    Before I felt like, will I ever be able to go back to school, will I ever be able to go on trips with my friends and family. And now I’m like… I can do those things.

    After getting diagnosed, it taught me how to push more for patients who are nervous to speak up for themselves, but then also like put the energy back into myself and know that I can do these things, whatever I want to do.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Carla: Never Doubt Your Own Strength

Carla stresses the importance of referring patients to NMOSD specialists for proper treatment.

  • Transcript

    There has been a time when I didn’t have a smile on my face when I was going through treatments. It’s very important that I remember moments like that, what I have gone through until where I am now, because it just motivates me to just keep living, keep experiencing life the way I should be experiencing it despite being diagnosed with NMOSD.

    I started being very tired a lot, not being able to do some of the things around the house, and the children noticed that I was getting distant. I stayed in the bed a lot. They knew that some things were changing. I started noticing that I had this pinched nerve in my neck that was excruciating pain.
    I didn’t quite understand if the symptoms were just lingering around for a little while or were there going to be permanent. At one point, I was in a wheelchair, and I’m suffering from paralysis on the left side and I can’t use my left hand. “Will I ever be able to get out of the wheelchair?” This is serious. This is scary.

    I went through a series of doctors and different doctors was telling me different things. It was the second neurologist that I had to go visit. He ran the aquaporin-4 test, and I showed up positive. He told me that I had NMOSD.

    Years had passed before I knew it was NMOSD. What scared me is that I really didn’t know if I was going to be able to continue to be working and providing for the family.

    I was young, so I was just feeling like, “What is going to happen to my body?” I was just waiting to hear from the doctors or what to expect because I don’t have an idea. Would this last for months, would this last for years, or would this last for a lifetime? You don’t know what to think or imagine. You’re just waiting for answers.

    I went through rehab, and as I went from a wheelchair to a pushing walker to a walking cane until I was actually able to actually just walk on my own. So, I started believing in myself that even though I’m going through this condition, these symptoms are going to get better.

    After the diagnosis, that’s when I go, and after that, I have two more different relapses, where I’m actually hospitalized. I was on a treatment, but it wasn’t helping with the NMOSD at the time. Every three to four months, I’ll find myself hospitalized.

    The neurologist at the time that was treating me, he realized that I probably need to go see someone else that actually just specialized in NMOSD. That’s when I went to my current neurologist, and he told me about UPLIZNA.

    What I left behind after starting UPLIZNA is the fear of hospitalizations.
    Looking at my overall health from the first time I started UPLIZNA, I haven’t had any attacks. I haven’t had any hospitalizations. What it does for me is that it gives me that reassurance that I could do some of the things that I used to enjoy before I was diagnosed. You still can go out with your friends. You still can work. You still can have a family.
    I see myself as someone that is strong, won’t settle for anything. I see myself as someone that believes that no matter what you’re going through, things can get better. It gives me an assurance that I can move on and live my life.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Panga: Getting Back to Some of the Things I Love

Panga emphasizes the need for urgency to recognize and act on NMOSD disease activity.

  • Transcript

    Even with being diagnosed and having what I have, I really don’t give up on myself. I’m not a type of person, I always say I love Panga, and so I’m not going to give up on me. Anything that I can do, for me, that’s what I do.

    In 2015, I started noticing a tingling feeling in the bottom of my feet. I ignored it because I thought always it contributed to my shoes.

    2016, I was working doing karaoke, and for some reason or another that tingling and all the sensation in their neck got a little bit worse. That night, it was excruciating.

    I had a bad experience that night that they took me to the hospital. In the waiting room where I was, the man came in that had on a lab coat. He came in and as soon as he hit the door, came into the door and he looked at me and what he said to me was, “Well, I can tell you right now, all I see is fat.” And so, I just cried.

    They just gave me three pain medications; they sent me home. And the next morning I’m thinking I’m good because I didn’t feel anything. I got ready to get out of the bed, and I went straight to the floor because I had no feelings from my stomach down to my feet. I called someone, they sent the ambulance over and took me to the hospital.

    After seven days of being in the hospital, the doctor had them run tests and he said, I had transverse myelitis.

    They sent therapists in to start trying to see if I could get up and walk. After doing that with them, they decided I probably needed to go to the rehab hospital just for the therapy. That was a 28-day process of just teaching me how to walk again.

    That day was very scary for me because I’d never heard of that. I went to YouTube and when I saw the people that were diagnosed with that, I just broke down because I thought, “Oh my God, I’m never going to be the same again and this paralysis could happen to me anytime.” That was what was going through my mind. I went through that for three years.

    Since starting UPLIZNA, I haven’t had any relapses. I’ve gained a lot of belief and strength in myself. It’s a blessing.

    I would say that Panga is almost back to her normal self. I’m not afraid to do things that I used to do, because I do have mobility. I like to do karaoke. And I sing professionally. Those are the things that give me joy.

    The only thing that’s changed is that I have NMOSD. So, it hasn’t stopped me from doing things that I love to do. And I’m going to stay hopeful for that.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

Why UPLIZNA?

Explore the mechanism of action and glycoengineered design of UPLIZNA.

UPLIZNA Mechanism of Action

  • Transcript

    UPLIZNA is an immunoglobulin G1, or IgG1, monoclonal antibody that is humanized, afucosylated, and binds specifically to CD19 for efficient B-cell depletion.

    While the precise mechanism by which inebilizumab-cdon exerts its therapeutic effects is unknown, preclinical and clinical evidence of B-cell depletion suggest potential activity in aquaporin-4–positive neuromyelitis optica spectrum disorder, or NMOSD.

    CD19 is present on pre-B cells, mature B cells, plasmablasts, and some plasma cells that contribute to NMOSD’s multimechanistic pathology through autoantibody production, cytokine/chemokine secretion, antigen presentation, and T-cell interactions.

    UPLIZNA bound to CD19 surface antigen enables antibody-dependent cellular cytolysis, ADCC, that lowered peripheral B-cell counts after 8 days, and allowed 100% of patients to experience B-cell reductions below the lower limit of normal by 4 weeks.

    The engineering of UPLIZNA contributes to its differentiated mechanistic and clinical profile, efficient depletion of CD19-positive B cells through enhanced ADCC, low rates of drug-drug interactions, low rates of anti-drug antibody generation, low rates of infusion reactions, 6-month maintenance dosing, and depletion of the spectrum of CD19-positive B cells that activate autoimmune and inflammatory disease mechanisms.

    UPLIZNA is FDA approved for use in adults with AQP4-antibody–positive NMOSD.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

The Glycoengineered Design of UPLIZNA

  • Transcript

    Studies have shown that about 40% of the population has a genetic variation (or polymorphism) that results in a mutation of the Fc gamma receptor 3A (FCGR3A) found on their natural killer (NK) cells.

    This genetic mutation reduces the receptor’s ability to bind to monoclonal antibodies, which act as a tether to bring pathogenic B cells to NK cells for destruction via antibody-dependent cellular cytotoxicity (ADCC).

    As a result, this genetic variant impacts the ability of this population to achieve efficacy from certain monoclonal antibodies.

    In neuromyelitis optica spectrum disorder (NMOSD), patients with this polymorphism who are receiving rituximab may experience insufficient B-cell depletion, require earlier retreatment, and may be at an increased risk of experiencing an attack.

    UPLIZNA (inebilizumab) was specifically designed to overcome this genetic barrier. During its development, the Fc region of UPLIZNA was modified in a way to specifically remove a fucose sugar molecule in a process called glycoengineering.

    This glycoengineered design of UPLIZNA results in an approximately 10-fold increased affinity, or ability to bind to the FCGR3A receptor on NK cells, regardless of genotype, and thus may enhance ADCC.

    For patients with NMOSD, UPLIZNA has demonstrated effective B-cell depletion without the need for dose adjustments, as well as consistent reductions in attack rate, regardless of genotype.

    In other words, UPLIZNA is designed for optimized efficacy in the treatment of NMOSD.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

    Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    Please see Full Prescribing Information for more information.

ICD-10, International Classification of Diseases, Tenth Revision.

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IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis. 

WARNINGS AND PRECAUTIONS

  • Infusion Reactions: Can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period (RCP), infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the RCP. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. 

    Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. 
  • Infections: An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the NMOSD RCP and open-label clinical trial periods were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP and open-label period, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved. 

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.

    Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. 

    Tuberculosis
    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.

    Vaccinations
    Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. 
    Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
    In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in these exposed infants may increase the risks from live or live-attenuated vaccines.  Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
  • Reductions in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. 
  • Fetal Risk: Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose. 

ADVERSE REACTIONS

  • The most common adverse reactions in NMOSD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.
  • The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and lymphopenia. 

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

UPLIZNA® is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

Please see UPLIZNA Full Prescribing Information.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis. 

WARNINGS AND PRECAUTIONS 

  • Infusion Reactions: Can cause infusion reactions, including anaphylaxis. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. During the randomized clinical trial period (RCP), infusion reactions were observed with the first course of UPLIZNA in 9.3% of NMOSD patients. Infusion reactions of UPLIZNA were observed in 7.4% of IgG4-RD patients during the RCP. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. 
    Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

  • Infections: An increased risk of infections has been observed with other B-cell depleting therapies. The most common infections reported by UPLIZNA-treated patients in the NMOSD RCP and open-label clinical trial periods were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP and open-label period, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: UPLIZNA has not been studied in combination with other immunosuppressants. If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects. 

    Hepatitis B Virus (HBV) Reactivation: Risk of HBV reactivation has been observed with other B-cell depleting antibodies. There have been no cases of HBV reactivation in patients treated with UPLIZNA, but patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment. 

    Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. 

    Tuberculosis
    Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. 

    Vaccinations
    Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. 
    Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
    In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in these exposed infants may increase the risks from live or live-attenuated vaccines.  Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
  • Reductions in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
  • Fetal Risk: BBased on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose..

ADVERSE REACTIONS

  • The most common adverse reactions in NMOSD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia. 
  • The most common adverse reactions in IgG4-RD (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infections and lymphopenia.

INDICATIONS

UPLIZNA® (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

UPLIZNA® is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

Please see UPLIZNA Full Prescribing Information.