Find pku support - BioMarin Palynziq Patient EN-US

Living with PKU can be challenging, but you’ve come to the right place to find support. BioMarin is committed to offering support and resources for those treating PKU with PALYNZIQ.

We’ll worry about logistics, so you don’t have to

BioMarin RareConnections™ Case Managers provide one-on-one support from insurance coverage to ordering. They can also:

Work with your clinic on prior authorization and insurance coverage

Coordinate with specialty pharmacies to order and deliver your PALYNZIQ

Identify personalized financial support, including co-pay assistance

Did You Know: 97% of insured patients had coverage for PALYNZIQ*

You may pay as little as $0 with the PALYNZIQ Co-Pay Assistance Program^† (For eligible, commercially insured patients).

*Source: BioMarin RareConnections™ data. Jan–Dec 2022.

^†Valid only for those with commercial insurance. Offer not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicare or any other federal or state program (including any state prescription drug assistance programs) (eg, VA, DoD, TriCare), for cash-paying patients, where product is not covered by patient’s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. No claim for reimbursement of the out-of-pocket expense amount covered by the program shall be submitted to any third party payer, whether public or private. Offer is not valid where prohibited by law. Valid only in the United States and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. Co-payment assistance under the program is not transferable. BioMarin Pharmaceutical Inc. reserves the right to rescind, revoke or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. This program is subject to termination or modification at any time. The PALYNZIQ Co-Pay Assistance Program will cover up to $18,200 in assistance per calendar year for eligible patients. Some restrictions apply.

Your BioMarin Clinical Coordinator is always a text, phone call, or visit away

BioMarin Clinical Coordinators are available to provide ongoing product support and education, including:

Education about the product and support throughout your time on treatment, whether you’re new to PALYNZIQ, or restarting it

Injection training as often as you need it

Making PALYNZIQ part of your routine

Help and reminders to stay on track with your treatment plan

I provide patients with education and support throughout every step of their medication journey. Before they even take their first dose, I’ll meet them at their home—or another place convenient for them—and give them all the background information on the medication they could ever want.”
—Leah, BioMarin Clinical Coordinator

Take the first step to getting dedicated one-on-one support. Reach out to your clinic team to find out if PALYNZIQ is right for you.

myPAL app

Keep track of your PALYNZIQ treatment—and so much more with the myPAL app.

myPAL empowers you to track your treatment effortlessly and helps you focus on reaching your Phe level goals.

Schedule treatment reminders
View injection site rotations
Manage your care team contacts
Share key data and information with your care team

Available for Apple and Android

PKU events

Stay connected with the PKU community.
Stay informed about managing PKU by attending an event or watching a live event on Facebook. If you attend an in-person event, you can meet other people living with PKU, learn about PKU management, and build your circle of support.

See upcoming events

PALYNZIQ Co-Pay Assistance Program

99% of participating patients paid $0 out-of-pocket for their prescription
The PALYNZIQ Co-Pay Assistance Program will cover all co-pay costs related to both your PALYNZIQ and auto-injectable epinephrine prescriptions, up to the annual maximum, for as long as you remain on therapy

Eligible patients will receive up to 3 fills of auto-injectable epinephrine per year at no additional cost

The PALYNZIQ Risk Evaluation and Mitigation Strategy (REMS)

You can only get PALYNZIQ through the PALYNZIQ REMS program.
This ensures that you know about the risk of anaphylaxis when taking PALYNZIQ, and that you know about this risk before you start treatment.

Your clinic team can tell you more about the PALYNZIQ REMS and help you enroll.

Find a healthcare provider who will help you get enrolled in the PALYNZIQ REMS.

*Valid only for those with commercial insurance. Offer not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicare, Medicaid or any other federal or state program (including any state prescription drug assistance programs) (eg, VA, DoD, TriCare), for cash-paying patients, where product is not covered by patient’s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third-party payer, whether public or private. Offer is not valid where prohibited by law. Valid only in the United States and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. Co-payment assistance under the Program is not transferable. BioMarin Pharmaceutical Inc. reserves the right to rescind, revoke or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. This program is subject to termination or modification at any time.

Learn more about PALYNZIQ

Provide your contact information to receive important news and updates about PALYNZIQ.

Sign up now

Financial assistance may be available

BioMarin RareConnections^™ can help with understanding insurance coverage and more.

See how we can help

IMPORTANT SAFETY INFORMATION

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

PALYNZIQ can cause a severe allergic reaction (anaphylaxis) that may be life⁠–⁠threatening and may happen any time during treatment. Severe allergic reactions are a serious and common side effect of PALYNZIQ.

You will get your first injection under the supervision of a healthcare provider prepared to manage a severe allergic reaction. You will be watched for at least 1 hour after your injection for a severe allergic reaction.

If you have a severe allergic reaction during treatment with PALYNZIQ, you will need to receive an immediate administration of epinephrine and get emergency medical help right away.
Your healthcare provider will decide if you (or your caregiver) are able to give PALYNZIQ injections, to recognize the signs and symptoms of a severe allergic reaction, and how to use your epinephrine and call for medical help, if needed.
Your healthcare provider may ask an adult observer (or your caregiver) to be with you during and for at least 1 hour after each injection to watch for signs of a severe allergic reaction. If needed, they should be ready to give you epinephrine and call 911 to get medical help right away.

Stop PALYNZIQ and get emergency medical care right away if you have any of the following signs or symptoms of a severe allergic reaction during treatment with PALYNZIQ: fainting (passing out); dizziness or lightheadedness; sudden confusion; trouble breathing or wheezing; chest discomfort or chest tightness; fast heart rate; swelling of your face, lips, eyes, or tongue; throat swelling or tightness; flushed or red skin; skin rash, itching, or raised bumps on skin; nausea, vomiting, or diarrhea; losing control of urine or stools.

Your healthcare provider will give you a prescription for epinephrine and teach you (or your caregiver) and your observer, if needed, how to use it if you have a severe allergic reaction. Keep epinephrine with you at all times during treatment with PALYNZIQ. Read the Patient Information that comes with epinephrine for more details.
If you have a severe allergic reaction, stop taking PALYNZIQ until you talk with your healthcare provider. Tell them that you had a severe allergic reaction. They will decide if it is safe for you to keep using it.
Your healthcare provider may prescribe other medicines to take before your PALYNZIQ injection to help reduce the symptoms of an allergic reaction.
If your healthcare provider decides you can keep taking PALYNZIQ, you will receive your next injection under the supervision of a healthcare provider prepared to manage a severe allergic reaction, where you will be closely watched for at least 1 hour after your injection for signs of a severe allergic reaction.
Your healthcare provider will give you a PALYNZIQ Patient Wallet Card that lists the signs and symptoms of a severe allergic reaction. You (or your caregiver), or your observer, should call 911 right away if any of these signs or symptoms occur. Keep this card with you at all times while using PALYNZIQ. Show this card to any other healthcare provider who treats you.

PALYNZIQ REMS: PALYNZIQ is only available through a restricted program called the PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Before you can receive PALYNZIQ, you must:

enroll in the program.
learn about the risk of a severe allergic reaction (anaphylaxis) from a healthcare provider certified in the PALYNZIQ REMS so you can understand the risks and benefits of treatment.
fill a prescription of epinephrine and carry it with you at all times while using PALYNZIQ.
keep the PALYNZIQ Patient Wallet Card with you at all times.

What should I tell my healthcare provider BEFORE starting PALYNZIQ?

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

Tell your healthcare provider about all of your medical conditions, including if you:

cannot or do not want to use epinephrine to treat a severe allergic reaction.
are pregnant or plan to become pregnant. It is not known whether PALYNZIQ will harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant while taking PALYNZIQ.
- If your Phe levels are too high or too low during pregnancy, this may also affect your unborn baby. You and your healthcare provider can decide the best way for you to manage your blood Phe levels and if taking PALYNZIQ is right for you and your unborn baby.
- It is very important to keep your Phe at the levels your healthcare provider recommends during pregnancy.
- Pregnancy Surveillance Program. There is a pregnancy surveillance program for females who take PALYNZIQ during pregnancy, or who become pregnant while taking PALYNZIQ or within 1 month after their last dose of PALYNZIQ. This program collects information about the health of you and your baby while taking PALYNZIQ. To join, talk to your healthcare provider or call BioMarin at 1-866-906-6100.
are breastfeeding or plan to breastfeed. It is not known if PALYNZIQ passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take PALYNZIQ.

What are the possible side effects of PALYNZIQ?

PALYNZIQ may cause serious side effects, including:

Serious allergic reactions. See “What is the most important information I should know about PALYNZIQ?”
Other allergic reactions to PALYNZIQ can happen during treatment. Call your healthcare provider right away if you have any of the following symptoms of an allergic reaction including: rash, itching, or swelling of the face, lips, eyes, or tongue. Your healthcare provider may change your dose of PALYNZIQ, pause your treatment, or give you medicine for you to take before your injection to help reduce the symptoms of an allergic reaction.
Injection site infections. Serious infections at the injection site have happened in people during treatment with PALYNZIQ. Some of these injection site infections required hospitalization, surgery, treatment with antibiotics given through the vein, or stopping treatment with PALYNZIQ. Change (rotate) your injection site and check your injection site for redness, swelling, or tenderness before each injection. Tell your healthcare provider right away if you develop signs or symptoms of an infection at your injection site that are new, do not go away, or get worse, including: pain, redness, swelling, or tenderness; the area feels hard; fluid or pus; blisters; a dark scab; an open wound.

Do not inject PALYNZIQ into the affected area until the infection has cleared.

Low levels of Phe in your blood (hypophenylalaninemia, or HypoPhe). Your healthcare provider will monitor your blood Phe levels during treatment.

The most common side effects of PALYNZIQ include: injection site reactions: redness, itching, pain, bruising, rash, swelling, tenderness; joint pain; allergic reactions; headache; skin reactions that spread and last at least 14 days, such as itching, rash, redness; nausea; stomach pain; vomiting; cough; mouth and throat pain; itching; diarrhea; stuffy nose; feeling very tired; dizziness; anxiety; low levels of Phe in your blood.

The most common side effects of PALYNZIQ in people 12 years to less than 18 years of age include: injection site reactions: redness, itching, pain, bruising, rash, swelling, tenderness; joint pain; headache; fever; allergic reactions; dizziness; nausea; vomiting; feeling very tired; pain in your arms or legs.

These are not all the possible side effects of PALYNZIQ. Call your healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Important notes

Blood Phe testing and diet

Your healthcare provider will monitor your blood Phe levels during PALYNZIQ treatment.
Monitor the amount of protein and Phe you eat or drink. Your healthcare provider may change your diet based on the amount of Phe in your blood. Follow your healthcare provider’s instructions about the amount of protein and Phe you should have in your diet.

Missed dose

If a dose is missed, take the next dose at the regular time. Do not take 2 doses of PALYNZIQ to make up for the missed dose.

Please see full Prescribing Information, including Important Warning, and the Medication Guide.

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