For people with
late-onset Pompe disease:

CH ICE A NEW IS HERE
N W NEXVIAZYME IS APPROVED
N READ TO LEARN MORE

NEXVIAZYME is the first new enzyme replacement therapy for Pompe disease in 15 years. So now, for the first time, you have a choice. Ask your healthcare provider if NEXVIAZYME may be the right choice for you.

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IMPORTANT SAFETY
INFORMATION

WARNING: SEVERE HYPERSENSITIVITY REACTIONS, INFUSION-ASSOCIATED REACTIONS, AND RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS

Hypersensitivity Reactions Including Anaphylaxis

If you are taking NEXVIAZYME, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis and severe hypersensitivity reactions may occur during and after NEXVIAZYME treatment. You should seek immediate medical care if signs and symptoms of anaphylaxis or hypersensitivity reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after NEXVIAZYME administration.

Infusion-Associated Reactions (IARs)

If severe IARs occur during your NEXVIAZYME infusion, your doctor may decide to immediately discontinue the infusion and provide appropriate medical care. If you have an acute underlying illness at the time of NEXVIAZYME infusion you may be at greater risk for IARs. If you have advanced Pompe disease you may have compromised heart and breathing function, which may put you at a higher risk of severe complications from IARs.

Risk of Acute Cardiorespiratory Failure in Susceptible Patients

If you are likely to develop fluid volume overload, or have acute underlying breathing problems or compromised heart or breathing function that may require fluid restriction, there may be a risk of worsening of your heart or breathing status during NEXVIAZYME infusion. Your doctor may decide that close observation during NEXVIAZYME administration may be necessary.

talking about pompe talking about pompe

It’s always good to know how you’re doing on your current management plan. Our discussion guide can help you self-assess and prepare for your next conversation with your healthcare provider. This can be especially helpful if you’ve missed your regularly scheduled check-up due to Covid or concerns about Covid.

When you talk with your healthcare provider about changes you’ve noticed, goals and needs, you can ask if NEXVIAZYME can help you get where you want to be. Your healthcare provider can also help you understand what to expect with NEXVIAZYME.

GET YOUR
PERSONALIZED GUIDE
NEXVIAZYME personalized support NEXVIAZYME personalized support

Personalized support as you start NEXVIAZYME

If you’re already a member of CareConnectPSS®, you can keep the same dedicated Case Manager and Patient Education Liaison you’ve been working closely with already. They will continue to support you as you move to NEXVIAZYME and will help make the change a smooth one.

Whether you’re newly diagnosed, or starting treatment for the first time, it can be overwhelming. A member of the CareConnectPSS® team will be there to help you through each step. They offer a wide range of support services for you and your family that’s one-on-one, confidential, and personalized. Below is just some of what’s available to you.

Speaking Pompe

Pompe can be hard to understand or explain. CareConnectPSS® offers in-person or virtual disease and treatment education for you, your family, and even others in your life like those at work or school.

Care connect

How do you find a medical facility with experts in Pompe? What if you relocate? Or you need treatment when you’re out of town? CareConnectPSS® can help with the logistics.

Insurance coverage

This doesn’t have to be difficult. CareConnectPSS® are experts at navigating the healthcare system and can help you understand your benefit coverage and options.

Financial assistance

Understanding and managing treatment costs, following up on claims, and finding assistance programs is not something you have to do on your own. CareConnectPSS® is there to help.

Stay current on the latest news about Pompe disease and NEXVIAZYME by signing up to receive email updates from Sanofi Genzyme.

Call 1-800-745-4447, option 3, and talk to a CareConnectPSS® team member about signing up.

stay informed about Nexviazyme

NEXVIAZYME Co-Pay Program

This program helps eligible US individuals, who are prescribed NEXVIAZYME, pay for their eligible, out-of-pocket, drug-related expenses, including co-pays, coinsurance, and deductibles.

To be eligible, you must meet certain conditions and must not have coverage or prescriptions paid for in part or in full under any state or federally funded healthcare program.

Your CareConnectPSS® Case Manager can provide more information about the Co-Pay Assistance Program and the application process and/or you can get more details below.

GET THE PROGRAM APPLICATION

To participate in this program, you must complete an enrollment application. Once enrolled, Sanofi Genzyme will cover 100% of your eligible out-of-pocket NEXVIAZYME drug costs up to the program maximum.

Get the program application today or to learn more about the program call 1-800-747-4447, option 3.

Regardless of financial status, the program is open to individuals who:

  • Have primary commercial insurance
  • Are prescribed treatment with NEXVIAZYME

You are NOT eligible if you:

  • Have coverage or prescriptions paid for in part or full under any state or federally funded healthcare program including:
    • Medicare
    • Medicare Advantage Plans (Example: Freedom Blue offered through Blue Cross Blue Shield)
    • Medicare Part D
    • Medicaid
    • Medigap
    • Veterans Affairs, Department of Defense or TRICARE

If you have any questions, a CareConnectPSS Case Manager would be happy to help you.

Getting started

getting started step 1

Complete the program application

Helpful information to have on hand when you apply:

  • Your treating physician’s contact information
  • Your health insurance card

Get the program application

getting started step 2

Your eligibility is verified

Your application will be reviewed for eligibility. If you are eligible, you will be automatically enrolled in the program. Enrollment in the program is subject to confirmation.

getting started step 3

You’re enrolled!

Once approved, you will receive a confirmation letter and an enrollment card within 7-10 days. Contact your Case Manager if you do not receive this confirmation. Your healthcare provider or specialty pharmacy will also receive a phone call with instructions on how to submit claims for reimbursement through the program. Your enrollment in the program is effective from the date of approval through the end of the calendar year (calendar year is January 1 through December 31).

If you are currently enrolled in our Co-Pay Assistance Program you will be automatically enrolled in the program for the next calendar year (January 1 through December 31) unless you decide to opt out of the program or your insurance coverage changes and you are no longer eligible for the program. read less

*No claim for reimbursement of any out-of-pocket expense covered by the Co-Pay Program may be submitted to any third-party payer, where public or private. The Co-Pay Program is available only in the United States and cannot be combined with any other rebate/coupon, free trial, or similar offer. Co-Pay Benefits are not transferable. The Co-Pay Program assists patients with their out-of-pocket X-rays costs and infusion-related costs of their Sanofi Genzyme therapy treatment only and does not cover or provide support for the cost of MD office visits/evaluations, nursing services/observation periods, blood work, X-rays or other testing, premedications/other medications, EpiPens, transportation or other related services. Sanofi Genzyme reserves the right to make eligibility decisions, set program maximums, and rescind, revoke, or amend this program without notice.

IMPORTANT SAFETY
INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

WARNING: SEVERE HYPERSENSITIVITY REACTIONS, INFUSION-ASSOCIATED REACTIONS, AND RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS

Hypersensitivity Reactions Including Anaphylaxis

If you are taking NEXVIAZYME, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis and severe hypersensitivity reactions may occur during and after NEXVIAZYME treatment. You should seek immediate medical care if signs and symptoms of anaphylaxis or hypersensitivity reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after NEXVIAZYME administration.

Infusion-Associated Reactions (IARs)

If you are taking NEXVIAZYME, you should know that severe IARs may occur during and after NEXVIAZYME treatment. If severe IARs occur during your NEXVIAZYME infusion, your doctor may decide to immediately discontinue the infusion and provide appropriate medical care. If you have an acute underlying illness at the time of NEXVIAZYME infusion you may be at greater risk for IARs. If you have advanced Pompe disease you may have compromised heart and breathing function, which may put you at a higher risk of severe complications from IARs.

Risk of Acute Cardiorespiratory Failure in Susceptible Patients

If you are likely to develop fluid volume overload, or have acute underlying breathing problems or compromised heart or breathing function that may require fluid restriction, there may be a risk of worsening of your heart or breathing status during NEXVIAZYME infusion. Your doctor may decide that close observation during NEXVIAZYME administration may be necessary.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis: Life-threatening hypersensitivity reactions, including anaphylaxis, were observed in NEXVIAZYME-treated patients. Some of the hypersensitivity reactions were related to the immune system. Symptoms of anaphylaxis may include difficulty breathing, chest discomfort, flushing/feeling hot, cough, redness of the skin, lip swelling, itching, swollen tongue, difficulty swallowing, and rash. Symptoms of severe hypersensitivity reactions may include difficulty breathing, redness of the skin, hives, swollen tongue, and rash. Your doctor may decide to give you antihistamine, anti-fever and/or steroid medications before your infusions.

Infusion-Associated Reactions (IARs): In clinical studies, IARs were observed during and/or within a few hours after the NEXVIAZYME infusion. Symptoms of IARs that required stopping the infusion included chest discomfort, cough, dizziness, redness of the skin, flushing/feeling hot, nausea, redness of the eye, and difficulty breathing. Your doctor may decide to give you antihistamine, anti-fever and/or steroid medications before your infusions to decrease the risk of IARs; however, IARs may still occur after receiving these medications.

Risk of Acute Cardiorespiratory Failure in Susceptible Patients: If you are likely to develop fluid volume overload, or have acute underlying breathing problems or compromised heart or breathing function that may require fluid restriction, there may be a risk of worsening of your heart or breathing status during NEXVIAZYME infusion, and your doctor may decide that close observation during and after NEXVIAZYME administration may be necessary.

ADVERSE REACTIONS

The most common adverse reactions (>5%) were headache, fatigue, diarrhea, nausea, joint pain, dizziness, muscle pain, itching, vomiting, shortness of breath, rash, “pins-and-needles” sensation, and hives.

INDICATION

NEXVIAZYME (avalglucosidase alfa-ngpt) is used for the treatment of patients 1 year of age and older with late-onset Pompe disease [lysosomal acid alpha-glucosidase (GAA) deficiency].

Please see full Prescribing Information for complete details, including Boxed WARNING.