For Healthcare Professionals For Patients and Caregivers Important Safety Information Medication Guide UPLIZNAhcp.com
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Amgen By Your Side

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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.

Roxie: 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 your patient at the most important steps along the way:

Connect-Icon

CONNECT: Your patient will be connected to one person dedicated to partnering with them throughout their treatment experience

Coordinate-icon

COORDINATE: Your patient will receive educational support on insurance, financial assistance options, important appointment-related information, and more

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CHAMPION: Your patient's dedicated partner will strive to empower them to be confident self-advocates committed to maintaining their treatment goals

  • CONNECT:

    Your patient will be connected to one person dedicated to partnering with them throughout their treatment experience

  • COORDINATE:

    Your patient will receive educational support on insurance, financial assistance options, important appointment-related information, and more

  • CHAMPION:

    Your patient's dedicated partner will strive to empower them to be confident self-advocates committed to maintaining their treatment goals

Amgen By Your Side is a support program for patients prescribed UPLIZNA® (inebilizumab-cdon). Our dedicated team is your patient’s partner, committed to providing nonmedical support to help patients as they start and continue on treatment as you prescribe.

How Will Amgen By Your Side Support Your Patients?

Patient-IconPatient-Icon

Patient Support

  • Making sure patients have everything they need to begin treatment
  • Checking in with your patients prior to each infusion and sending appointment reminders
  • Connecting them with a real UPLIZNA patient as part of our Peer Mentor Program
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Insurance Benefits Explanation

  • Helping to conduct benefits investigations
  • Providing education for prior authorization, medical exception, or appeal processes
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Financial Assistance

  • Helping patients understand their coverage and addressing financial barriers
  • Patients with commercial insurance may be eligible for a $0 co-pay for the cost of the medication and the infusion administration through our Amgen Commercial Co-Pay Program*
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Treatment Planning

  • Determining how treatment can fit into your patient’s routine
  • Prioritizing your patient’s individual needs and partnering with them to coordinate appointments, find infusion center locations, and prepare for upcoming visits
  • Working to ensure your patient remains focused, motivated, and committed to their treatment goals

Initiate patient enrollment in Amgen By Your Side

*The Amgen Commercial Co-Pay Program may be available to patients who meet the following minimum criteria:

  • Patient’s prescription cannot be paid in part or in full by any government-funded program including but not limited to: Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, Department of Defense (DOD), TRICARE, or any state, patient foundation, or other pharmaceutical program
  • Patient is prescribed a covered Amgen rare disease medication for an indication approved by the Food and Drug Administration; the indication for each product is shown in its prescribing information
  • Patient is a resident of the United States
  • Patient must be commercially insured and have financial responsibility for a portion of the drug and/or infusion cost if applicable

The assistance offered under this co-pay program is subject to additional terms and conditions, including but not limited to the following:

Terms and Conditions: Offer cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription. Not valid for prescriptions reimbursed in whole or in part by any government-funded program including but not limited to Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, DOD, TRICARE, or any state, patient foundation, or other pharmaceutical program. Offer good only in the United States at participating specialty pharmacies or sites of care. Offer not valid where otherwise prohibited by law, for example by applicable state law prohibiting co-pay cards. Amgen reserves the right to rescind, revoke, or amend offer without notice. The selling, purchasing, trading, or counterfeiting of any co-pay card or benefits is prohibited by law. This co-pay program is not insurance and is not intended to substitute for insurance. Age for eligibility is dependent on product indication.

Participating Pharmacies or Healthcare Providers: By using this co-pay program, you acknowledge and confirm that the prescription will not be reimbursed in whole or in part by any government-funded program (such as, without limitation, Medicare, Medicaid, VA, DOD, TRICARE) and the patient and prescription meet the eligibility criteria set forth in the terms and conditions. You are responsible for reporting the receipt of the co-pay program benefits as required by an insurer, payor, or applicable law or regulation.

Patients: By enrolling in this co-pay program, you acknowledge and confirm that you and the prescription meet the eligibility requirements set forth in the terms and conditions, including that the prescription will not be reimbursed in whole or in part by any government-funded program (such as, without limitation, Medicare, Medicaid, VA, DOD, TRICARE). You may not seek any claims to government payors or other payors or insurers for this prescription. You may not seek reimbursement from any health savings, flexible savings, or other healthcare reimbursement account for any amounts received from the co-pay program. You are responsible for reporting the receipt of the co-pay program benefits as required by an insurer, payor, or applicable law or regulation.

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.