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.
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
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
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.