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

This information is intended for U.S. healthcare professionals

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FREQUENTLY ASKED QUESTIONS

Amgen By Your Side FAQs

  • What is Amgen By Your Side?

    Amgen By Your Side is a patient support program designed specifically for you, someone prescribed an Amgen medication. Once your enrollment is complete, you will be paired with your own dedicated support partner called a Patient Access Liaison (PAL). Your PAL will serve as your partner providing resources outside of your doctor to help you navigate your unique experience, including information on insurance, cost assistance options, upcoming appointments, and other patient support services.

  • Is Amgen By Your Side free of charge?

    There is no cost to enroll, and there are two ways to join:

    • Option 1: Connect with a Patient Access Liaison (PAL) to help you explore enrollment options. Call 1-833-842-8477.
    • Option 2: Sign up through your doctor’s office. They can start the enrollment on AmgenByYourSide.com and submit it on your behalf. Patient consent is required.
  • Will my treatment be covered by my insurance?

    Paying for treatment shouldn’t get in the way of your health. Whether you have commercial insurance, government insurance, or no insurance, the Amgen By Your Side team is committed to partnering with you to help understand your insurance coverage criteria and all available cost assistance options.

  • Will I be eligible for cost savings?

    You may be eligible to pay $0 through our Amgen Commercial Co-Pay Program.* Patients with commercial insurance only.*

  • How do I enroll?

    Once you and your doctor (and/or healthcare team) decide that an Amgen treatment is right for you, enrolling in Amgen By Your Side is easy. There is no cost to enroll, and there are two ways to join:

    • Option 1: Connect with a Patient Access Liaison (PAL) to help you explore enrollment options. Call 1-833-842-8477.
    • Option 2: Sign up through your doctor’s office. They can start the enrollment on AmgenByYourSide.com and submit it on your behalf. Patient consent is required.

    Once enrollment is complete, your PAL will be your dedicated partner to help you get started and continue on your treatment, as prescribed by your doctor.

  • What is a Patient Access Liaison (PAL)?

    The Amgen By Your Side team is led by a Patient Access Liaison (PAL). The PAL is a dedicated support partner who helps investigate, explain, and educate on each step of your treatment experience.

    The PAL can educate and assist you with:

    • Learning about insurance coverage criteria and approval process
    • Understanding cost assistance options
    • Understanding infusion appointment-related information
    • Discussing what to expect at the start of treatment
    • Determining how treatment can fit into your routine
    • Receiving reminders to help you stay on your Amgen medicine
    • Discovering ways to connect with others, if interested
  • Where will I receive my treatment?

    You can count on the Amgen By Your Side team to help you plan, coordinate, and manage your ongoing infusion schedule. Your individual needs will be prioritized when working with your Patient Access Liaison (PAL). We’ll partner with you to coordinate appointments, find infusion center locations, and prepare for any upcoming appointments. We’ll be by your side, empowering you to be focused, motivated, and committed to maintaining your treatment goals.

For more information, or if you have specific questions, call 1-844-469-4297

*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.

IMPORTANT SAFETY INFORMATION

What is UPLIZNA?

UPLIZNA is a prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

It is not known if UPLIZNA is safe or effective in children.

Who should not receive UPLIZNA?

You should not receive UPLIZNA if you have:

  • –had a life-threatening infusion reaction to UPLIZNA.
  • –an active hepatitis B virus infection.
  • –active or untreated inactive (latent) tuberculosis.

Before receiving UPLIZNA, tell your healthcare provider about all of your medical conditions, including if you:

  • –have or think you have an infection.
  • –have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD. These medicines may increase your risk of getting an infection.
  • –have or have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • –have or have ever had tuberculosis.
  • –have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 4 weeks before you start treatment with UPLIZNA.
  • –are pregnant or plan to become pregnant. It is not known if UPLIZNA will harm your unborn baby. Females should use birth control (contraception) during treatment with UPLIZNA and for 6 months after your last infusion of UPLIZNA.
  • –are breastfeeding or plan to breastfeed. It is not known if UPLIZNA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive UPLIZNA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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

UPLIZNA may cause serious side effects, including:

Infusion reactions. UPLIZNA can cause infusion reactions that can be serious or may cause you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of UPLIZNA for signs and symptoms of an infusion reaction. Tell your healthcare provider right away if you get any of these symptoms:

  • headache
  • nausea
  • sleepiness
  • shortness of breath
  • fever
  • muscle aches
  • rash

If you develop an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion and treat your symptoms.

Infections. Infections can happen during treatment with UPLIZNA. Tell your healthcare provider right away if you have an infection or get any of these symptoms:

  • painful and frequent urination
  • nasal congestion, runny nose, sore throat, fever, chills, cough, body aches
  • UPLIZNA taken before or after other medicines that weaken the immune system may increase your risk of getting infections.
  • Hepatitis B virus (HBV) reactivation. Before starting treatment with UPLIZNA, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with UPLIZNA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving UPLIZNA.
  • Progressive Multifocal Leukoencephalopathy (PML). PML may happen with UPLIZNA. PML is a rare brain infection that leads to death or severe disability. Symptoms of PML may get worse over days to weeks. Call your healthcare provider right away if you get any of these symptoms:
  • –weakness on one side of the body
  • –loss of coordination in your arms and legs
  • –changes in your vision
  • –changes in thinking or memory
  • –confusion
  • –changes in your personality
  • Tuberculosis (TB). TB is caused by an infection in the lungs. Before starting treatment with UPLIZNA, your healthcare provider will check to see if you are at risk for getting TB or have ever had TB.
  • Vaccinations. Certain vaccines, called “live” or “live attenuated” vaccines, are not recommended in people receiving UPLIZNA. Talk to your healthcare provider before receiving any vaccinations. If you have a baby and you were receiving UPLIZNA during pregnancy, it is important to tell your baby’s healthcare provider about your UPLIZNA use so they can decide when your baby should receive any vaccine.

See “What are the possible side effects of UPLIZNA?” for more information about side effects.

How will I receive UPLIZNA?

  • UPLIZNA is given through a needle placed in a vein (IV or intravenous infusion) in your arm.
  • Before treatment with UPLIZNA, your healthcare provider will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help infusion reactions become less frequent and less severe. See “What is the most important information I should know about UPLIZNA?”
  • Your first dose of UPLIZNA will be given as 2 separate infusions, 2 weeks apart.
  • Your next doses of UPLIZNA will be given as one infusion every 6 months.
  • Each infusion will last about 1 hour and 30 minutes. After each infusion, you will be monitored by a healthcare provider for at least 1 hour.

What are the possible side effects of UPLIZNA?

UPLIZNA may cause serious side effects, including:

  • See “What is the most important information I should know about UPLIZNA?”
  • low blood cell counts. UPLIZNA may cause a decrease in some types of blood cells. Your healthcare provider will do blood tests to check your blood cell counts.

The most common side effects include urinary tract infection and joint pain.
These are not all the possible side effects of UPLIZNA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION

What is UPLIZNA?

UPLIZNA is a prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

It is not known if UPLIZNA is safe or effective in children.

Who should not receive UPLIZNA?

You should not receive UPLIZNA if you have:

  • –had a life-threatening infusion reaction to UPLIZNA.
  • –an active hepatitis B virus infection.
  • –active or untreated inactive (latent) tuberculosis.

Before receiving UPLIZNA, tell your healthcare provider about all of your medical conditions, including if you:

  • –have or think you have an infection.
  • –have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD. These medicines may increase your risk of getting an infection.
  • –have or have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • –have or have ever had tuberculosis.
  • –have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 4 weeks before you start treatment with UPLIZNA.
  • –are pregnant or plan to become pregnant. It is not known if UPLIZNA will harm your unborn baby. Females should use birth control (contraception) during treatment with UPLIZNA and for 6 months after your last infusion of UPLIZNA.
  • –are breastfeeding or plan to breastfeed. It is not known if UPLIZNA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive UPLIZNA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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

UPLIZNA may cause serious side effects, including:

Infusion reactions. UPLIZNA can cause infusion reactions that can be serious or may cause you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of UPLIZNA for signs and symptoms of an infusion reaction. Tell your healthcare provider right away if you get any of these symptoms:

  • headache
  • nausea
  • sleepiness
  • shortness of breath
  • fever
  • muscle aches
  • rash

If you develop an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion and treat your symptoms.

Infections. Infections can happen during treatment with UPLIZNA. Tell your healthcare provider right away if you have an infection or get any of these symptoms:

  • painful and frequent urination
  • nasal congestion, runny nose, sore throat, fever, chills, cough, body aches
  • UPLIZNA taken before or after other medicines that weaken the immune system may increase your risk of getting infections.
  • Hepatitis B virus (HBV) reactivation. Before starting treatment with UPLIZNA, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with UPLIZNA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving UPLIZNA.
  • Progressive Multifocal Leukoencephalopathy (PML). PML may happen with UPLIZNA. PML is a rare brain infection that leads to death or severe disability. Symptoms of PML may get worse over days to weeks. Call your healthcare provider right away if you get any of these symptoms:
  • –weakness on one side of the body
  • –loss of coordination in your arms and legs
  • –changes in your vision
  • –changes in thinking or memory
  • –confusion
  • –changes in your personality
  • Tuberculosis (TB). TB is caused by an infection in the lungs. Before starting treatment with UPLIZNA, your healthcare provider will check to see if you are at risk for getting TB or have ever had TB.
  • Vaccinations. Certain vaccines, called “live” or “live attenuated” vaccines, are not recommended in people receiving UPLIZNA. Talk to your healthcare provider before receiving any vaccinations. If you have a baby and you were receiving UPLIZNA during pregnancy, it is important to tell your baby’s healthcare provider about your UPLIZNA use so they can decide when your baby should receive any vaccine.

See “What are the possible side effects of UPLIZNA?” for more information about side effects.

How will I receive UPLIZNA?

  • UPLIZNA is given through a needle placed in a vein (IV or intravenous infusion) in your arm.
  • Before treatment with UPLIZNA, your healthcare provider will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help infusion reactions become less frequent and less severe. See “What is the most important information I should know about UPLIZNA?”
  • Your first dose of UPLIZNA will be given as 2 separate infusions, 2 weeks apart.
  • Your next doses of UPLIZNA will be given as one infusion every 6 months.
  • Each infusion will last about 1 hour and 30 minutes. After each infusion, you will be monitored by a healthcare provider for at least 1 hour.

What are the possible side effects of UPLIZNA?

UPLIZNA may cause serious side effects, including:

  • See “What is the most important information I should know about UPLIZNA?”
  • low blood cell counts. UPLIZNA may cause a decrease in some types of blood cells. Your healthcare provider will do blood tests to check your blood cell counts.

The most common side effects include urinary tract infection and joint pain.
These are not all the possible side effects of UPLIZNA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.