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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: 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 cost assistance options 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?

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

Indication

BKEMV™ (eculizumab-aeeb) is indicated for:

  • The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use: BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.

Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS.

Contraindications: BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Other Infections

Use caution when administering BKEMV to patients with any other systemic infection. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after BKEMV Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing BKEMV for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing BKEMV, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis.

In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during BKEMV treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during BKEMV treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during BKEMV treatment.

If TMA complications occur after BKEMV discontinuation, consider reinstitution of BKEMV treatment, plasma therapy, or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt BKEMV infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

Indication

BKEMV™ (eculizumab-aeeb) is indicated for:

  • The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use: BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.

Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS.

Contraindications: BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Other Infections

Use caution when administering BKEMV to patients with any other systemic infection. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after BKEMV Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing BKEMV for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing BKEMV, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis.

In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during BKEMV treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during BKEMV treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during BKEMV treatment.

If TMA complications occur after BKEMV discontinuation, consider reinstitution of BKEMV treatment, plasma therapy, or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt BKEMV infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.