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

This information is intended for U.S. healthcare professionals

Click “continue” if you are a Healthcare Professional or “cancel” to go back.
Continue Cancel
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) or Clinical Nurse Educator (CNE). Your PAL/CNE 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 1-877-633-9521 or fill out this online form.
    • 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 1-877-633-9521 or fill out this online form.
    • 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/CNE 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. They will be your partner to support and champion you while accomplishing your treatment goals.

    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, from your first infusion to your last. 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.

USE

KRYSTEXXA® (pegloticase) is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
KRYSTEXXA is not for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia).

IMPORTANT SAFETY INFORMATION

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

Serious allergic reactions may happen in some patients who receive KRYSTEXXA. These allergic reactions can be life-threatening and usually happen within 2 hours of the infusion.

KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.

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

  • wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
  • dizziness, fainting, fast or weak heartbeat or feeling nervous
  • reddening of the face, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you:

  • have a rare blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
  • have had a serious allergic reaction to KRYSTEXXA or any of its ingredients. See the end of the Medication Guide for a complete list of ingredients in KRYSTEXXA.

What should I tell my doctor before receiving treatment with KRYSTEXXA?

Before you receive KRYSTEXXA, tell your doctor about all of your medical conditions, including if you:

  • ever had any heart problems or high blood pressure.
  • are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other uric acid lowering drug, such as allopurinol, febuxostat (Uloric), or probenecid, while receiving KRYSTEXXA.

KRYSTEXXA is recommended to be given with another prescription medicine called methotrexate.  KRYSTEXXA may also be used alone. You and your doctor will decide the treatment that is right for you.

Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your risk of getting gout flares or an allergic reaction. Take these medicines as directed by your doctor or nurse. Your doctor will also test your uric acid levels prior to each treatment to monitor your response to KRYSTEXXA.

Your gout flares may increase in the first 3 months when you start receiving KRYSTEXXA. It’s important to understand that this is happening because KRYSTEXXA is breaking down uric acid in your body. Do not stop receiving KRYSTEXXA even if you have a flare, as the amount of flares will decrease after 3 months of treatment. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.

What are the possible side effects of KRYSTEXXA?

In KRYSTEXXA clinical trials:

The most common side effects of KRYSTEXXA when given together with methotrexate were gout flares, joint pain, coronavirus disease 2019 (COVID-19), nausea, and fatigue.

The most common side effects of KRYSTEXXA were gout flares, allergic reactions (including infusion reactions). See “What is the most important information I should know about KRYSTEXXA?”, nausea, bruising, sore throat, constipation, chest pain, coronavirus disease 2019 (COVID-19), and vomiting.

This is not a complete list of all possible side effects. Call your doctor for medical advice about side effects.

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.

For additional important safety information, please see the Medication Guide and discuss with your doctor.

USE

KRYSTEXXA® (pegloticase) is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
KRYSTEXXA is not for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia).

IMPORTANT SAFETY INFORMATION

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

Serious allergic reactions may happen in some patients who receive KRYSTEXXA. These allergic reactions can be life-threatening and usually happen within 2 hours of the infusion.

KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.

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

  • wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
  • dizziness, fainting, fast or weak heartbeat or feeling nervous
  • reddening of the face, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you:

  • have a rare blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
  • have had a serious allergic reaction to KRYSTEXXA or any of its ingredients. See the end of the Medication Guide for a complete list of ingredients in KRYSTEXXA.

What should I tell my doctor before receiving treatment with KRYSTEXXA?

Before you receive KRYSTEXXA, tell your doctor about all of your medical conditions, including if you:

  • ever had any heart problems or high blood pressure.
  • are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other uric acid lowering drug, such as allopurinol, febuxostat (Uloric), or probenecid, while receiving KRYSTEXXA.

KRYSTEXXA is recommended to be given with another prescription medicine called methotrexate.  KRYSTEXXA may also be used alone. You and your doctor will decide the treatment that is right for you.

Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your risk of getting gout flares or an allergic reaction. Take these medicines as directed by your doctor or nurse. Your doctor will also test your uric acid levels prior to each treatment to monitor your response to KRYSTEXXA.

Your gout flares may increase in the first 3 months when you start receiving KRYSTEXXA. It’s important to understand that this is happening because KRYSTEXXA is breaking down uric acid in your body. Do not stop receiving KRYSTEXXA even if you have a flare, as the amount of flares will decrease after 3 months of treatment. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.

What are the possible side effects of KRYSTEXXA?

In KRYSTEXXA clinical trials:

The most common side effects of KRYSTEXXA when given together with methotrexate were gout flares, joint pain, coronavirus disease 2019 (COVID-19), nausea, and fatigue.

The most common side effects of KRYSTEXXA were gout flares, allergic reactions (including infusion reactions). See “What is the most important information I should know about KRYSTEXXA?”, nausea, bruising, sore throat, constipation, chest pain, coronavirus disease 2019 (COVID-19), and vomiting.

This is not a complete list of all possible side effects. Call your doctor for medical advice about side effects.

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.

For additional important safety information, please see the Medication Guide and discuss with your doctor.