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What you can expect with PALYNZIQ

Dosing, timing, and possible side effects

Building a treatment plan that’s right for you

Getting started with PALYNZIQ® (pegvaliase-pqpz) Injection

PALYNZIQ is a treatment you give yourself just under the skin (subcutaneously) in a few steps, while at home. PALYNZIQ is available in 3 dosage strengths and comes in prefilled syringes.

Hesitant about self-injection? Learn about the educational and support options available to you

 

Finding a dose to meet your treatment goals

During your PALYNZIQ treatment, your healthcare provider will adjust your injection schedule to find a dose that’s right for you. You will start injecting PALYNZIQ once a week, and your healthcare provider will then increase the number of injections per week based on how the therapy works for you.

This treatment plan is only an example. Always follow your healthcare provider’s instructions.

Additional time may be required between dose escalations based on patient tolerability.

Individualize treatment to the lowest effective and tolerated dosage. Consider increasing to a maximum of 40 mg subcutaneously once daily in patients who have not achieved a response after at least 24 weeks of continuous treatment with 20 mg subcutaneously once daily.

Discontinue PALYNZIQ if either a ≥20% reduction from baseline or a blood Phe concentration ≤600 micromol/L (10 mg/dL) is not achieved after at least 16 weeks of continuous treatment with 40 mg subcutaneously once daily.

I was a little nervous about injecting myself at first, but now it's just part of my routine.
Chase, taking PALYNZIQ

If you have concerns about self-injection, you are not alone

It’s not uncommon to feel hesitant at first. While approximately 1 out of 4 people have a fear of needles, many of the adults with PKU who are taking PALYNZIQ have been able to overcome their concerns with support and practice.

Your clinic team and BioMarin Clinical Coordinator are dedicated to offering you the education you need to become comfortable by:

  • Training you on the injection process
  • Being present as you give yourself your first injection
  • Helping you make PALYNZIQ part of your routine

 

A needle smaller than a flu shot

A needle smaller than a flu shot

These representations are not to scale.

Before you even get started, you should know a few key differences between the PALYNZIQ needle and other needles you may be familiar with. PALYNZIQ uses a short, thin needle that:

  • Is smaller than most vaccines you may have received (like the flu shot)
  • Requires only the space of a pinch of skin to be inserted
  • Retracts automatically after completing the injection
  • Is injected into soft, fatty body areas, just under the skin

 

View the PALYNZIQ injection video

This video demonstrates injection instructions that can be used as a guide to help you with PALYNZIQ. This information should not take the place of your healthcare provider’s instructions or directions related to your medical condition or your treatment.

 

Before injecting PALYNZIQ, talk to your healthcare provider right away if you cannot or will not use auto-injectable epinephrine to treat a severe allergic reaction. If you are pregnant or plan to become pregnant while taking PALYNZIQ, talk to your healthcare provider to discuss the risks and benefits of taking PALYNZIQ during pregnancy to you and your unborn baby. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider to discuss the risks and benefits of taking PALYNZIQ while breastfeeding for you and your baby.

Watch this video:

Overcoming self-injection concerns

  

Most patients experienced side effects, the majority were considered mild to moderate

Most side effects occurred less often over time

Percentage of patients who experienced common side effects in clinical trials when starting (induction) and increasing (titration) their PALYNZIQ dose (N=285)

  • During maintenance (ongoing), common side effects were injection site reactions, such as redness, itching, pain, bruising, rash, swelling, or tenderness; joint pain; hypersensitivity reactions; headache; skin reactions that spread on your skin and last at least 14 days, such as itching, rash, or redness; itching; nausea; stomach pain; nose and throat pain; feeling very tired; vomiting; cough; and diarrhea

While nearly all patients taking PALYNZIQ experienced a side effect, many side effects can be managed.

11% of patients in clinical studies discontinued PALYNZIQ due to side effects.

See what the rest of the PALYNZIQ journey looks like

 

My care team answered all my questions and addressed all my concerns about anaphylaxis before my first injection.
Mia, taking PALYNZIQ

About anaphylaxis

Anaphylaxis is different from common allergic reactions

Anaphylaxis is a serious and often sudden allergic reaction with a range of symptoms. Your clinic team will educate you on how to identify and respond to the symptoms of anaphylaxis, which include:

  • 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 tightness
  • Flushed skin
  • Skin rash, itching, or raised bumps on skin
  • Nausea, vomiting, or diarrhea
  • Losing control of urine or stools

In PALYNZIQ clinical studies, 26 out of 285 (9%) adults with PKU experienced anaphylaxis.

While serious, anaphylaxis may often be managed with prompt care

In the PALYNZIQ clinical studies, all anaphylaxis episodes were successfully managed:

  • Anaphylaxis was primarily managed with epinephrine and steroid and/or allergy medications
  • Nearly all (34 out of 42) anaphylaxis episodes occurred within 1 hour after injection
  • No further health issues occured due to anaphylaxis

 

Prior to your first injection, your clinic team will:

  • Prescribe and reinforce the importance of always carrying your auto-injectable epinephrine
  • Review what to do in case anaphylaxis occurs, including:
    • Performing an epinephrine injection
    • Contacting emergency care

 

If you experience anaphylaxis, your clinic team will consider if you should restart PALYNZIQ

Your clinic team will consider if you should continue on PALYNZIQ and may adjust your dose to help you do so.

  • Of the 26 adults with PKU who experienced anaphylaxis in the clinical trials, 18 of them restarted PALYNZIQ. The majority (72%) of them did not experience a second episode of anaphylaxis

 

 

Report any side effects to your healthcare provider.

 

Watch this video:

Common questions about anaphylaxis

 

The PALYNZIQ Risk Evaluation and Mitigation Strategy (REMS)

You can get PALYNZIQ only through the PALYNZIQ REMS program. The purpose of the program is to ensure that you have been fully informed of the risk of anaphylaxis associated with taking PALYNZIQ, and that you understand this risk before you start treatment. Your healthcare provider can tell you more about PALYNZIQ REMS and help you enroll.

 

Your journey with PALYNZIQ
 

 

 

A specialty pharmacy will confirm that you have auto-injectable epinephrine on-hand before mailing your PALYNZIQ prescription.

Learn more about PALYNZIQ

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Important Safety Information
WARNING: RISK OF ANAPHYLAXIS

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 can happen any time during treatment with PALYNZIQ.

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) Injection is a prescription medication used to lower blood levels of Phe (phenylalanine) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.

Severe allergic reactions are a serious but common side effect of PALYNZIQ

  • You will receive your first injection of PALYNZIQ in a healthcare setting where you will be closely watched for at least 1 hour after your injection for a severe allergic reaction
  • Your healthcare provider will prescribe auto-injectable epinephrine for you, and will teach you (or your caregiver) and your observer, if needed, when and how to use it if you have a severe allergic reaction
  • If you have a severe allergic reaction during treatment with PALYNZIQ, you will need to receive an injection of epinephrine immediately and get emergency medical help right away
  • Your healthcare provider will decide if you (or your caregiver) are able to give the PALYNZIQ injections, recognize the signs and symptoms of a severe allergic reaction, give an injection of epinephrine, and call for emergency help, if needed
  • Your healthcare provider may recommend that an adult observer (or your caregiver) be with you when you give your PALYNZIQ injection and for at least 1 hour after your injection to watch you for signs and symptoms of a severe allergic reaction and, if needed, give you an injection of epinephrine and call for emergency medical help

Stop injecting PALYNZIQ and get emergency medical care right away if you have any of the following symptoms:

  • 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 tightness
  • Flushed skin
  • Skin rash, itching, or raised bumps on skin
  • Nausea, vomiting, or diarrhea
  • Losing control of urine or stools
 

Keep the auto-injectable epinephrine with you at all times during treatment with PALYNZIQ. Read the Patient Information that comes with the auto-injectable epinephrine that your healthcare provider prescribes for you for more information.

If you have a severe allergic reaction, do not continue to take PALYNZIQ until you talk with your healthcare provider. Your healthcare provider will tell you if you can continue treatment with PALYNZIQ.

People taking PALYNZIQ have also experienced allergic reactions other than anaphylaxis. Talk to your healthcare provider if you experience any allergic reactions when taking PALYNZIQ.

PALYNZIQ REMS: PALYNZIQ is available only through a restricted program called the PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Talk to your healthcare provider about the PALYNZIQ REMS and how to enroll.

What should I tell my healthcare provider BEFORE starting PALYNZIQ?

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

Before injecting PALYNZIQ, talk to your healthcare provider right away if you cannot or will not use auto-injectable epinephrine to treat a severe allergic reaction. If you are pregnant or plan to become pregnant while taking PALYNZIQ, talk to your healthcare provider to discuss the risks and benefits of taking PALYNZIQ during pregnancy to you and your unborn baby. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about the best way to feed your baby if you take PALYNZIQ.

Before injecting PALYNZIQ, read the Medication Guide and Instructions for Use that come with your PALYNZIQ injection.

What should I watch for AFTER starting PALYNZIQ?

PALYNZIQ may cause serious side effects, including:

  • Severe allergic reactions (anaphylaxis)
  • Other allergic reactions to PALYNZIQ can happen during treatment with PALYNZIQ. Contact 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, stop your treatment with PALYNZIQ for a period of time, or prescribe medicine for you to take before your PALYNZIQ injection to help reduce the symptoms of an allergic reaction

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

These are not all of the possible side effects of PALYNZIQ. Speak with your healthcare provider right away about any side effects.

Important notes

Blood Phe testing and diet

  • Your healthcare provider will monitor your blood Phe concentrations during PALYNZIQ treatment
  • Monitor the amount of protein and Phe that you eat or drink. Your healthcare provider may change the amount of protein and Phe you should have in your diet during treatment with PALYNZIQ, depending on the levels 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 your next dose as scheduled and do not take two doses of PALYNZIQ to make up for the missed dose

You may report side effects to BioMarin at 1-877-695-8826 and the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

US/PAL/0593 0520

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) Injection is a prescription medication used to lower blood levels of Phe (phenylalanine) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.

Important Safety Information
WARNING: RISK OF ANAPHYLAXIS

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 can happen any time during treatment with PALYNZIQ.

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) Injection is a prescription medication used to lower blood levels of Phe (phenylalanine) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.

Severe allergic reactions are a serious but common side effect of PALYNZIQ

  • You will receive your first injection of PALYNZIQ in a healthcare setting where you will be closely watched for at least 1 hour after your injection for a severe allergic reaction
  • Your healthcare provider will prescribe auto-injectable epinephrine for you, and will teach you (or your caregiver) and your observer, if needed, when and how to use it if you have a severe allergic reaction
  • If you have a severe allergic reaction during treatment with PALYNZIQ, you will need to receive an injection of epinephrine immediately and get emergency medical help right away
  • Your healthcare provider will decide if you (or your caregiver) are able to give the PALYNZIQ injections, recognize the signs and symptoms of a severe allergic reaction, give an injection of epinephrine, and call for emergency help, if needed
  • Your healthcare provider may recommend that an adult observer (or your caregiver) be with you when you give your PALYNZIQ injection and for at least 1 hour after your injection to watch you for signs and symptoms of a severe allergic reaction and, if needed, give you an injection of epinephrine and call for emergency medical help

Stop injecting PALYNZIQ and get emergency medical care right away if you have any of the following symptoms:

  • 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 tightness
  • Flushed skin
  • Skin rash, itching, or raised bumps on skin
  • Nausea, vomiting, or diarrhea
  • Losing control of urine or stools
 

Keep the auto-injectable epinephrine with you at all times during treatment with PALYNZIQ. Read the Patient Information that comes with the auto-injectable epinephrine that your healthcare provider prescribes for you for more information.

If you have a severe allergic reaction, do not continue to take PALYNZIQ until you talk with your healthcare provider. Your healthcare provider will tell you if you can continue treatment with PALYNZIQ.

People taking PALYNZIQ have also experienced allergic reactions other than anaphylaxis. Talk to your healthcare provider if you experience any allergic reactions when taking PALYNZIQ.

PALYNZIQ REMS: PALYNZIQ is available only through a restricted program called the PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Talk to your healthcare provider about the PALYNZIQ REMS and how to enroll.

What should I tell my healthcare provider BEFORE starting PALYNZIQ?

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

Before injecting PALYNZIQ, talk to your healthcare provider right away if you cannot or will not use auto-injectable epinephrine to treat a severe allergic reaction. If you are pregnant or plan to become pregnant while taking PALYNZIQ, talk to your healthcare provider to discuss the risks and benefits of taking PALYNZIQ during pregnancy to you and your unborn baby. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about the best way to feed your baby if you take PALYNZIQ.

Before injecting PALYNZIQ, read the Medication Guide and Instructions for Use that come with your PALYNZIQ injection.

What should I watch for AFTER starting PALYNZIQ?

PALYNZIQ may cause serious side effects, including:

  • Severe allergic reactions (anaphylaxis)
  • Other allergic reactions to PALYNZIQ can happen during treatment with PALYNZIQ. Contact 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, stop your treatment with PALYNZIQ for a period of time, or prescribe medicine for you to take before your PALYNZIQ injection to help reduce the symptoms of an allergic reaction

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

These are not all of the possible side effects of PALYNZIQ. Speak with your healthcare provider right away about any side effects.

Important notes

Blood Phe testing and diet

  • Your healthcare provider will monitor your blood Phe concentrations during PALYNZIQ treatment
  • Monitor the amount of protein and Phe that you eat or drink. Your healthcare provider may change the amount of protein and Phe you should have in your diet during treatment with PALYNZIQ, depending on the levels 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 your next dose as scheduled and do not take two doses of PALYNZIQ to make up for the missed dose

You may report side effects to BioMarin at 1-877-695-8826 and the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

US/PAL/0593 0520

What is PALYNZIQ?

PALYNZIQ® (Pal-lin-zeek) (pegvaliase-pqpz) Injection is a prescription medication used to lower blood levels of Phe (phenylalanine) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment. You should discuss the potential benefits and risks of PALYNZIQ with your healthcare provider.