For Patients and Caregivers For Healthcare Professionals Important Safety Information Medication Guide BKEMV.com REMS

This information is intended for U.S. healthcare professionals

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Kelly: A new diagnosis can make you feel alone. Outside of just processing the change to your life, understanding everything that goes into your treatment can feel overwhelming. Amgen By Your Side is a patient support program designed specifically for someone prescribed an Amgen Rare Disease medication. Our dedicated team is your partner committed to providing non-medical personalized support so you can start and continue treatment as your doctor recommends. Once you are prescribed an Amgen Rare Disease medication, you will work with your doctor to be enrolled into Amgen By Your Side and get matched with a Patient Access Liaison or PAL, or in some cases, a clinical nurse educator, a CNE.

Lindsey: I'm available to help you as you need for anything that might come up. I'm basically your advocate, your cheerleader, your friend. I'm here to support you through the entire journey.

Khash: My primary care physician said we're going to have a Patient Access Liaison get in contact with you to discuss it further with you and tell you all the pluses, minuses, and all that stuff. Lindsey really took the time to explain it all to me, including the commitment it's going to take on my side to get this done.

Kelly: A PAL is your partner to support and champion you while accomplishing your treatment goals. Some of the ways your PAL can support you include learning about insurance coverage and the approval process, understanding potential costs or cost assistance options, sharing additional resources, connect to advocacy groups, or connect with others if interested.

Roxie: I did work with the Patient Access Liaison, more commonly known as PALs, and she kept in touch with me. I was really worried about insurance and about out-of-pocket cost. Although I was willing to do whatever it took, she checked out my insurances, and I'm so blessed because it was 100% covered.

Randi: They assigned me a Patient Access Liaison after I was approved for treatment and just helped guide me through the process as far as what to expect, the process that I was going to go through, and just to be there for general support for me.

Melanie: She really took the time to explain everything and go through it and has been there for me for every single question ever since.

Kelly: With everything you and your caregivers have going on, it can be difficult to fit treatment into your routine. Your PAL can help you understand what to expect at the start of treatment, how treatment can fit into your routine, and send reminders to help you stay on track.

Carol: I want them to understand that I will be a point person for them. First and foremost, I'm there to listen and also let them know that I'm there to support them through the process, and ultimately, to empower them.

Latoya: They remind you of things that you typically forget even when it comes to testing kits, it was able to work out a plan. The PAL also makes sure when it's time to renew insurance at the end of the year, they'll shoot you a text message or call. I think they're a great resource. They really are.

Melanie: They call me to do refills earlier than I need them so that I don't run out of the medication.

Carol: We don't want patients to feel that they're just out there alone and floating in the space of the unknown. They can reach out to us at any time. We're always available to them.

Kelly: The Amgen By Your Side team can also help you become more comfortable with your diagnosis, even visiting to teach you hands-on how to take your medication and help you find medicine in case of an emergency.

Jerry: As a clinical nurse educator, my responsibility in my job is to make sure that our patients are well taken care of and that their needs are met. We also have communication with their primary doctors to make sure that they know and they're up to date in their treatment.

Shannon: I teach them about lifestyle modifications needed to stay healthy, a lot of disease state education.

Kelly: We can also help connect you with a peer mentor who are other Amgen patients that are going through a similar experience.

Randi: I may talk to three or four newly diagnosed patients a week. They want to know what the experience was like for me.

Kelly: Amgen By Your Side has many other resources available to patients and caregivers through our website, AmgenByYourSide.com. There, you'll find information about enrollment, treatment cost assistance options, treatment planning, and many other resources to assist you during your treatment experience. In the end, Amgen By Your Side is designed to be just that, by your side.

Melanie: I was so happy because I was so scared. She was there from the very beginning. I am trying to manage this disease by myself, but I'm not really by myself because I have these people in my corner that are available to me at any time.

Roxanne: After being so dismissed and I'm feeling like I was doing this by myself, it was so helpful to have somebody who understood, who knew it. It gave me hope and it let me know that, at some point, I was going to be able to go on with my life and not be held back by this anymore.

Our mission is to connect, coordinate, and champion YOU at important steps along the way:

Connect-Icon

CONNECT: You will be connected to one person dedicated to partner with you throughout your treatment experience

Coordinate-icon

COORDINATE: You will receive support across areas from insurance and financial support information to coordinating appointments and more

Champion-Icon

CHAMPION: Your dedicated partner will strive to empower you—through education and resources—to be focused, motivated, and committed to maintaining your treatment goals.

  • CONNECT:

    You will be connected to one person dedicated to partner with you throughout your treatment experience

  • COORDINATE:

    You will receive support across areas from insurance and financial support information to coordinating appointments and more

  • CHAMPION:

    Your dedicated partner will strive to empower you—through education and resources—to be focused, motivated, and committed to maintaining your treatment goals

Amgen By Your Side is a patient support program designed specifically for patients like you, patients prescribed BKEMV. Our dedicated team is your partner, committed to providing nonmedical, personalized support so you can start and continue treatment as your doctor prescribes.

How Will Amgen By Your Side Support You?

PAL-IconPAL-Icon

Getting you started and setting expectations

Your PAL is your partner to support and champion you while accomplishing your treatment goals.
bkemv-hcp-financialbkemv-hcp-financial

Explaining insurance and financial information

Your PAL can educate and assist you with learning about insurance coverage criteria and approval process and understanding cost assistance options.
Infusion-iconInfusion-icon

Get ready for your infusions

Your PAL will discuss what to expect at the start of treatment with BKEMV, how treatment, as prescribed, can fit into your routine and provide reminders to help you stay on BKEMV, as prescribed.
KXX-Patient-Motivate-IconKXX-Patient-Motivate-Icon

Assisting you throughout your treatment

Your PAL will empower you to be focused, motivated, and committed to maintaining your treatment goals.

See how Amgen By Your Side can help educate patients on important health information

APPROVED USE

BKEMV is a prescription medicine used to treat:

  • people with paroxysmal nocturnal hemoglobinuria (PNH).
  • people with atypical hemolytic uremic syndrome (aHUS).

BKEMV is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

  • adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

It is not known if BKEMV is safe and effective in children with PNH or gMG.

IMPORTANT SAFETY INFORMATION

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

BKEMV is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

  • BKEMV increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria that may quickly become life-threatening or cause death if not recognized and treated early.
    • You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of BKEMV.
    • If you have not been vaccinated and BKEMV must be started right away, you should receive the required vaccine(s) as soon as possible.
    • If you have not been vaccinated and BKEMV must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
    • If you had a meningococcal vaccine in the past, you might need additional vaccines before starting BKEMV. Your healthcare provider will decide if you need additional meningococcal vaccines.
    • Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of BKEMV. Your risk of meningococcal infection may continue for several weeks after your last dose of BKEMV. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

BKEMV is only available through a program called the BKEMV Risk Evaluation and Mitigation Strategy (REMS). Before you can receive BKEMV, your healthcare provider must:

  • enroll in the REMS program
  • counsel you about the risk of serious meningococcal infections
  • give you information about the signs and symptoms of serious meningococcal infection
  • make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start BKEMV right away and you are not up to date on your vaccines
  • give you a Patient Safety Card about your risk of meningococcal infection.

BKEMV may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.

  • If your child is treated with BKEMV, your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
  • Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
  • Certain fungal infections (Aspergillus) may occur if you take BKEMV and have a weak immune system or a low white blood cell count.

Who should not receive BKEMV?

Do not receive BKEMV if you have a serious meningococcal infection when you are starting BKEMV.

Before you receive BKEMV, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if BKEMV will harm your unborn baby or if it passes into your breast milk.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. BKEMV and other medicines can affect each other causing side effects. Know the medications you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of BKEMV?

BKEMV can cause serious side effects, including serious infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of these symptoms during your BKEMV infusion: headache, back pain, diarrhea, upper respiratory infection, urinary tract infections, fever, pain in your abdomen, pain or swelling of your nose or throat, common cold, cough, nausea, vomiting, chest pain, high blood pressure, low red blood cell count, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, swelling of legs or feet, muscle and joint pain, and feeling faint or passing out. If you have an infusion-related reaction to BKEMV, your healthcare provider may need to infuse BKEMV more slowly, or stop BKEMV.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of BKEMV. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for BKEMV.

APPROVED USE

BKEMV is a prescription medicine used to treat:

  • people with paroxysmal nocturnal hemoglobinuria (PNH).
  • people with atypical hemolytic uremic syndrome (aHUS).

BKEMV is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

  • adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

It is not known if BKEMV is safe and effective in children with PNH or gMG.

IMPORTANT SAFETY INFORMATION

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

BKEMV is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

  • BKEMV increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria that may quickly become life-threatening or cause death if not recognized and treated early.
    • You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of BKEMV.
    • If you have not been vaccinated and BKEMV must be started right away, you should receive the required vaccine(s) as soon as possible.
    • If you have not been vaccinated and BKEMV must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
    • If you had a meningococcal vaccine in the past, you might need additional vaccines before starting BKEMV. Your healthcare provider will decide if you need additional meningococcal vaccines.
    • Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of BKEMV. Your risk of meningococcal infection may continue for several weeks after your last dose of BKEMV. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

BKEMV is only available through a program called the BKEMV Risk Evaluation and Mitigation Strategy (REMS). Before you can receive BKEMV, your healthcare provider must:

  • enroll in the REMS program
  • counsel you about the risk of serious meningococcal infections
  • give you information about the signs and symptoms of serious meningococcal infection
  • make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start BKEMV right away and you are not up to date on your vaccines
  • give you a Patient Safety Card about your risk of meningococcal infection.

BKEMV may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.

  • If your child is treated with BKEMV, your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
  • Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
  • Certain fungal infections (Aspergillus) may occur if you take BKEMV and have a weak immune system or a low white blood cell count.

Who should not receive BKEMV?

Do not receive BKEMV if you have a serious meningococcal infection when you are starting BKEMV.

Before you receive BKEMV, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if BKEMV will harm your unborn baby or if it passes into your breast milk.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. BKEMV and other medicines can affect each other causing side effects. Know the medications you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of BKEMV?

BKEMV can cause serious side effects, including serious infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of these symptoms during your BKEMV infusion: headache, back pain, diarrhea, upper respiratory infection, urinary tract infections, fever, pain in your abdomen, pain or swelling of your nose or throat, common cold, cough, nausea, vomiting, chest pain, high blood pressure, low red blood cell count, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, swelling of legs or feet, muscle and joint pain, and feeling faint or passing out. If you have an infusion-related reaction to BKEMV, your healthcare provider may need to infuse BKEMV more slowly, or stop BKEMV.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of BKEMV. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for BKEMV.