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PATIENT RESOURCES

Resources to Support You and Your Patients Every Step of the Way

The resources below are here to help you support your patients and their families living with a rare disease treated by UPLIZNA. If your patient has a rare disease treated by UPLIZNA, these resources can assist in managing your patient’s day-to-day challenges. If you are a patient, you can learn more from these important tools, or by visiting the Amgen By Your Side UPLIZNA®
(inebilizumab-cdon) page for patients.

PAL-IconPAL-Icon

Patient Access Liaison (PAL)

The Patient Access Liaison (PAL) is a dedicated support partner who helps investigate, explain, and educate on each step of the treatment experience. They are your patient’s point of contact and champion while your patient is accomplishing their treatment goals.

Hear what an Amgen PAL has to say about how she helps patients

Watch Video
PAL-Video
Read Transcript

Carol: When I'm going to be meeting with a patient and their family, explaining what my role is. I want them to understand that I will be a point person for them first, and foremost, I'm there to listen to what their story is, and then also let them know that I will be there to support them and ultimately to empower them.

I look at my role as being able to take as much off their plate as I can as they navigate that process, but also helping them understand in layman's terms where they are in the process and what they need to do on their end. We don't want patients to feel that they're just out there alone and floating in the space of the unknown.

We want patients to know they can reach out to us at any time or family member or caregiver. We're always available to them. This company is definitely a company that puts patients first.

Read Transcript

ANNOUNCER: Get to know your Thyroid Eye Disease treatment.

Thyroid Eye Disease, or T-E-D, can be difficult to manage. But you haven’t let it stop you.

ANNOUNCER: You took control.

Got answers.

And found the help you needed.

You and your doctor chose TEPEZZA…

…a prescription medicine used to treat T-E-D. TEPEZZA is the only medicine that treats TED at its source.

Way to go! You’re on your way!

ANNOUNCER: Chapter 1: How TEPEZZA Works to Treat Thyroid Eye Disease.

To understand what causes T-E-D, you have to go behind the eye.

In the tissue behind the eye are cells that have receptors on their surface that act like switches.

But when you have T-E-D, your body’s immune system attacks this tissue, which causes molecules—known as autoantibodies—to turn these switches on.

This leads to swelling of the muscle and fat. This swelling can cause a number of symptoms like eye pain, redness in and around your eyes, and swollen eyelids.

The muscles and the fat tissue swell pushing the eyeball outward, which your doctor may call proptosis.

Similarly, it can cause double vision, which your doctor may call diplopia.

TEPEZZA is the first and only FDA-approved treatment for Thyroid Eye Disease. Unlike other medicines, TEPEZZA treats the cause of T-E-D not just the symptoms.

TEPEZZA is designed to bind to the switch and block it from turning on.

Since TEPEZZA blocks the switches so they can’t turn on, swelling of the muscle and fat tissue goes down.

This leads to reduced bulging and less redness, pain, and swelling of the eyes.

TEPEZZA can also improve double vision and, in some cases, make it completely go away.

ANNOUNCER: Chapter 2: The Insurance Approval Process

Now that you and your doctor have decided on TEPEZZA, the next step is to gain approval from your insurance provider.

TEPEZZA is a specialty medicine, which means it may require extra insurance approvals.

These approvals require steps like Benefits Investigation and Prior Authorization that usually take between 30 and 90 days, but in some cases may take longer.

If you’re not familiar with these insurance terms, don’t worry. In the next chapter of this video, you’ll learn about support services available to help you through the TEPEZZA insurance approval process.

Horizon Therapeutics, the developer of TEPEZZA, believes cost should never stop someone from getting the medicine they need.

They’re committed to helping you explore cost assistance options. That information will be in the next chapter as well.

ANNOUNCER: Chapter 3: Personalized Support with Horizon By Your Side

Horizon By Your Side, a patient support program, is here to help.

Once you and your doctor have decided TEPEZZA is right for you, you can sign up to be paired with a Patient Access Liaison, or PAL for short.

PALs from the Horizon By Your Side team are available for personal, non-medical and logistical assistance throughout your treatment, including:

Discussing what your doctor may have explained about starting treatment

Helping to understand the insurance process

Explaining financial assistance options

Helping you plan your first infusion

And more!

If you’re interested, ask your doctor if you can sign the Patient Enrollment Form before it is submitted to Horizon By Your Side. Once enrolled, you’ll receive a call from your PAL.

ANNOUNCER: Chapter 4: Getting Your TEPEZZA Infusion

TEPEZZA is an I-V, or intravenous, medicine. This means it’s delivered through a needle placed in your arm.

The process of delivering an IV medicine into the body is called an infusion. A full course of TEPEZZA treatment is 8 infusions. Each infusion is given 1 time every 3 weeks. That means that treatment with TEPEZZA will be ongoing for about 5 months.

TEPEZZA may be given at an infusion center, a type of clinic that specializes in giving infusions. It may also be given at a doctor’s office, hospital, or at home.

Check with both your insurance provider and your doctor to see if home infusion may be an option for you.

For your first infusion, having someone take you to and from the appointment is recommended.

When it’s time to start your TEPEZZA treatment, you’ll be taken to an infusion chair, which is a lot like a recliner.

Once the IV is in, all you have to do is relax and receive the infusion.

Each infusion appointment usually lasts one and a half to two and a half hours but will vary, depending on where you get your infusion.

During this time, books, music, and movies can all provide a welcome distraction.

KAREN (on camera):

I was very scared at the beginning.

To avoid everything else that was on the road for me, such as the steroids and the surgery, the infusion didn't sound so bad.

For me, it wasn't such a bad experience and then of course three weeks later, I went back for the second and it was the same thing.

They would make me very comfortable. I didn't even think of it as, "Oh my gosh, I'm sitting here getting an infusion. This is terrible." I thought, "Hey, you know, this isn't bad."

ANNOUNCER: Chapter 5: The possible side effects of TEPEZZA

It’s important to note that almost all of the side effects patients experienced in clinical trials were mild

—uncomfortable, but didn’t stop normal activity, or moderate

—uncomfortable and might impact normal activity.

Some patients experienced severe side effects

—uncomfortable, and impact normal activity, but everyone experiences side effect differently.

Here’s a list of the most common side effects of TEPEZZA and the percentage of people that experienced them in clinical studies:

Muscle cramps or spasms—25 percent of patients.

Nausea—17 percent.

Hair loss—13 percent.

Diarrhea—12 percent.

Tiredness—12 percent.

High blood sugar—10 percent.

Hearing problems—10 percent.

Changes in taste—8 percent.

Headache—8 percent.

Dry skin—8 percent.

Weight loss—6 percent.

Nail Problems—5 percent.

Changes in Menstruation—23 percent.

TEPEZZA may increase your blood sugar levels, so ask your doctor about developing a plan to have your blood sugar tested and tracked during treatment.

Always reach out to your doctor to discuss how to manage side effects.

ANNOUNCER: Chapter 6: How TEPEZZA Can Help Thyroid Eye Disease

In clinical studies, TEPEZZA has been proven to reduce eye bulging, improve double vision, provide relief from eye pain, redness, and swelling, and improve visual ability and physical appearance.

Some people had less eye bulging, redness, pain, and swelling as soon as 6 weeks after treatment with TEPEZZA, and improvement continued over the full treatment course of 8 infusions.

Once you start seeing results with TEPEZZA, you may want to stop receiving infusions, but to get the full benefit, it is recommended you receive all 8 of them.

JEANNE (on camera):

It was a slow process, but with each infusion, I did feel more and more relief. It was amazing.

It just…each time, my eyes…the bulging became less.

The redness was gone.

The double vision was gone.

To not have the itchiness, the bulgy red eyes, to not look weird. It’s really nice.

ANNOUNCER: Follow TEPEZZA on Facebook or Instagram to join the community, get important updates, and stay connected.

Congratulations on taking the first step with TEPEZZA.

Please listen to the Important Safety Information at the end of this video.

ANNOUNCER:

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:

  • High blood pressure
  • Fast heartbeat
  • Redness of the face or Feeling hot
  • Difficulty breathing
  • Headache
  • Muscle pain

If you have inflammatory bowel disease I-B-D, such as Crohn's disease or ulcerative colitis, TEPEZZA may make your I-B-D symptoms worse. Symptoms of worsening I-B-D may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening I-B-D symptoms.

TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

Before receiving TEPEZZA, tell your doctor if you:

  • Have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
  • Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
    • Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
  • Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of TEPEZZA?

The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.

This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.

Please visit TEPEZZA.com for more information.

UPLIZNA Patient Advocacy Organizations for Those Living With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Below you’ll find a list of organizations that provide education, support, and resources for those living with NMOSD.
These resources are not owned or controlled by Amgen, and Amgen is not responsible for their content. However, you may find them helpful.

  • Sumaira Foundation

    The Sumaira Foundation for NMO is an organization dedicated to generating global awareness of neuromyelitis optica spectrum disorder (NMOSD), fundraising to help find a cure, and creating a community of support for patients and their caregivers.

    sumairafoundation.org

  • Guthy-Jackson

    The Guthy-Jackson Charitable Foundation raises public awareness and creates industry-sponsored clinical trials to help find a cure for NMOSD.

    guthyjacksonfoundation.org

  • Siegel Rare Neuroimmune Association (SRNA)

    The Siegel Rare Neuroimmune Association (SRNA) is a not-for-profit international organization dedicated to the support of children, adolescents, and adults with a spectrum of rare neuroimmune disorders.

    wearesrna.org

PATIENT RESOURCES

Resources to Support You and Your Patients Every Step of the Way

The resources below are here to help you support your patients and their families living with a rare disease treated by UPLIZNA. If your patient has a rare disease treated by UPLIZNA, these resources can assist in managing your patient’s day-to-day challenges. If you are a patient, you can learn more from these important tools, or by visiting the Amgen By Your Side UPLIZNA®
(inebilizumab-cdon) page for patients.

PAL-IconPAL-Icon

Patient Access Liaison (PAL)

The Patient Access Liaison (PAL) is a dedicated support partner who helps investigate, explain, and educate on each step of the treatment experience. They are your patient’s point of contact and champion while your patient is accomplishing their treatment goals.

Hear what an Amgen PAL has to say about how she helps patients

Watch Video
PAL-Video
Read Transcript

Carol: When I'm going to be meeting with a patient and their family, explaining what my role is. I want them to understand that I will be a point person for them first, and foremost, I'm there to listen to what their story is, and then also let them know that I will be there to support them and ultimately to empower them.

I look at my role as being able to take as much off their plate as I can as they navigate that process, but also helping them understand in layman's terms where they are in the process and what they need to do on their end. We don't want patients to feel that they're just out there alone and floating in the space of the unknown.

We want patients to know they can reach out to us at any time or family member or caregiver. We're always available to them. This company is definitely a company that puts patients first.

Read Transcript

ANNOUNCER: Get to know your Thyroid Eye Disease treatment.

Thyroid Eye Disease, or T-E-D, can be difficult to manage. But you haven’t let it stop you.

ANNOUNCER: You took control.

Got answers.

And found the help you needed.

You and your doctor chose TEPEZZA…

…a prescription medicine used to treat T-E-D. TEPEZZA is the only medicine that treats TED at its source.

Way to go! You’re on your way!

ANNOUNCER: Chapter 1: How TEPEZZA Works to Treat Thyroid Eye Disease.

To understand what causes T-E-D, you have to go behind the eye.

In the tissue behind the eye are cells that have receptors on their surface that act like switches.

But when you have T-E-D, your body’s immune system attacks this tissue, which causes molecules—known as autoantibodies—to turn these switches on.

This leads to swelling of the muscle and fat. This swelling can cause a number of symptoms like eye pain, redness in and around your eyes, and swollen eyelids.

The muscles and the fat tissue swell pushing the eyeball outward, which your doctor may call proptosis.

Similarly, it can cause double vision, which your doctor may call diplopia.

TEPEZZA is the first and only FDA-approved treatment for Thyroid Eye Disease. Unlike other medicines, TEPEZZA treats the cause of T-E-D not just the symptoms.

TEPEZZA is designed to bind to the switch and block it from turning on.

Since TEPEZZA blocks the switches so they can’t turn on, swelling of the muscle and fat tissue goes down.

This leads to reduced bulging and less redness, pain, and swelling of the eyes.

TEPEZZA can also improve double vision and, in some cases, make it completely go away.

ANNOUNCER: Chapter 2: The Insurance Approval Process

Now that you and your doctor have decided on TEPEZZA, the next step is to gain approval from your insurance provider.

TEPEZZA is a specialty medicine, which means it may require extra insurance approvals.

These approvals require steps like Benefits Investigation and Prior Authorization that usually take between 30 and 90 days, but in some cases may take longer.

If you’re not familiar with these insurance terms, don’t worry. In the next chapter of this video, you’ll learn about support services available to help you through the TEPEZZA insurance approval process.

Horizon Therapeutics, the developer of TEPEZZA, believes cost should never stop someone from getting the medicine they need.

They’re committed to helping you explore cost assistance options. That information will be in the next chapter as well.

ANNOUNCER: Chapter 3: Personalized Support with Horizon By Your Side

Horizon By Your Side, a patient support program, is here to help.

Once you and your doctor have decided TEPEZZA is right for you, you can sign up to be paired with a Patient Access Liaison, or PAL for short.

PALs from the Horizon By Your Side team are available for personal, non-medical and logistical assistance throughout your treatment, including:

Discussing what your doctor may have explained about starting treatment

Helping to understand the insurance process

Explaining financial assistance options

Helping you plan your first infusion

And more!

If you’re interested, ask your doctor if you can sign the Patient Enrollment Form before it is submitted to Horizon By Your Side. Once enrolled, you’ll receive a call from your PAL.

ANNOUNCER: Chapter 4: Getting Your TEPEZZA Infusion

TEPEZZA is an I-V, or intravenous, medicine. This means it’s delivered through a needle placed in your arm.

The process of delivering an IV medicine into the body is called an infusion. A full course of TEPEZZA treatment is 8 infusions. Each infusion is given 1 time every 3 weeks. That means that treatment with TEPEZZA will be ongoing for about 5 months.

TEPEZZA may be given at an infusion center, a type of clinic that specializes in giving infusions. It may also be given at a doctor’s office, hospital, or at home.

Check with both your insurance provider and your doctor to see if home infusion may be an option for you.

For your first infusion, having someone take you to and from the appointment is recommended.

When it’s time to start your TEPEZZA treatment, you’ll be taken to an infusion chair, which is a lot like a recliner.

Once the IV is in, all you have to do is relax and receive the infusion.

Each infusion appointment usually lasts one and a half to two and a half hours but will vary, depending on where you get your infusion.

During this time, books, music, and movies can all provide a welcome distraction.

KAREN (on camera):

I was very scared at the beginning.

To avoid everything else that was on the road for me, such as the steroids and the surgery, the infusion didn't sound so bad.

For me, it wasn't such a bad experience and then of course three weeks later, I went back for the second and it was the same thing.

They would make me very comfortable. I didn't even think of it as, "Oh my gosh, I'm sitting here getting an infusion. This is terrible." I thought, "Hey, you know, this isn't bad."

ANNOUNCER: Chapter 5: The possible side effects of TEPEZZA

It’s important to note that almost all of the side effects patients experienced in clinical trials were mild

—uncomfortable, but didn’t stop normal activity, or moderate

—uncomfortable and might impact normal activity.

Some patients experienced severe side effects

—uncomfortable, and impact normal activity, but everyone experiences side effect differently.

Here’s a list of the most common side effects of TEPEZZA and the percentage of people that experienced them in clinical studies:

Muscle cramps or spasms—25 percent of patients.

Nausea—17 percent.

Hair loss—13 percent.

Diarrhea—12 percent.

Tiredness—12 percent.

High blood sugar—10 percent.

Hearing problems—10 percent.

Changes in taste—8 percent.

Headache—8 percent.

Dry skin—8 percent.

Weight loss—6 percent.

Nail Problems—5 percent.

Changes in Menstruation—23 percent.

TEPEZZA may increase your blood sugar levels, so ask your doctor about developing a plan to have your blood sugar tested and tracked during treatment.

Always reach out to your doctor to discuss how to manage side effects.

ANNOUNCER: Chapter 6: How TEPEZZA Can Help Thyroid Eye Disease

In clinical studies, TEPEZZA has been proven to reduce eye bulging, improve double vision, provide relief from eye pain, redness, and swelling, and improve visual ability and physical appearance.

Some people had less eye bulging, redness, pain, and swelling as soon as 6 weeks after treatment with TEPEZZA, and improvement continued over the full treatment course of 8 infusions.

Once you start seeing results with TEPEZZA, you may want to stop receiving infusions, but to get the full benefit, it is recommended you receive all 8 of them.

JEANNE (on camera):

It was a slow process, but with each infusion, I did feel more and more relief. It was amazing.

It just…each time, my eyes…the bulging became less.

The redness was gone.

The double vision was gone.

To not have the itchiness, the bulgy red eyes, to not look weird. It’s really nice.

ANNOUNCER: Follow TEPEZZA on Facebook or Instagram to join the community, get important updates, and stay connected.

Congratulations on taking the first step with TEPEZZA.

Please listen to the Important Safety Information at the end of this video.

ANNOUNCER:

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:

  • High blood pressure
  • Fast heartbeat
  • Redness of the face or Feeling hot
  • Difficulty breathing
  • Headache
  • Muscle pain

If you have inflammatory bowel disease I-B-D, such as Crohn's disease or ulcerative colitis, TEPEZZA may make your I-B-D symptoms worse. Symptoms of worsening I-B-D may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening I-B-D symptoms.

TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

Before receiving TEPEZZA, tell your doctor if you:

  • Have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
  • Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
    • Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
  • Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of TEPEZZA?

The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.

This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.

Please visit TEPEZZA.com for more information.

Patient Advocacy Organizations

Below you’ll find a list of organizations that provide education, support, and resources for those living with IgG4-RD.
These resources are not owned or controlled by Amgen, and Amgen is not responsible for their content. However, you may find them helpful.

  • IgG4ward!

    IgG4ward! is the first and only organization solely dedicated to IgG4-RD advocacy, research, and support.

    igg4ward.org

  • Global Genes

    Global Genes is dedicated to providing resources, information, and connections to all those affected by rare diseases.

    globalgenes.org
  • National Organization for Rare Diseases (NORD)

    NORD is a patient advocacy organization dedicated to people with rare diseases and the groups that help them. NORD provides patients and families with advocacy information, assistance programs, and connections to patient organizations.

    rarediseases.org

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

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.

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.

Please see UPLIZNA full Prescribing Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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.

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.

Please see UPLIZNA full Prescribing Information.