What is Palynziq (pegvaliase-pqpz), and how does it work?
Palynziq (pegvaliase-pqpz) is a prescription medicine used to lower blood
levels of phenylalanine in adults with PKU (phenylketonuria) who have
uncontrolled blood phenylalanine levels above 600 micromol/L (10 mg/dL) on
their current treatment.
It is not known if Palynziq is safe and effective in
children.
Palynziq is only available through a restricted
program called the Palynziq Risk Evaluation and Mitigation Strategy (REMS)
Program. Before you can receive Palynziq, you must:
- enroll in this program.
- receive education about the risk of a severe allergic
reaction (anaphylaxis) by a healthcare provider certified in the Palynziq REMS
to be sure that you understand the risks and benefits of treatment with
Palynziq. - fill the prescription your healthcare provider gives you
for the auto-injectable epinephrine and carry it with you at all times during
treatment with Palynziq. - carry the Palynziq Patient Wallet Card with you at all
times.
Talk to your healthcare provider for more information
about the Palynziq REMS and how to enroll.
What are the side effects of Palynziq?
WARNING
Palynziq can cause a severe allergic reaction
(anaphylaxis) that may be life-threatening and can happen any timeduring
treatment with Palynziq. 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. - If you have a severe allergic reaction during treatment
with Palynziq, you will need to receive an auto-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 medical 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 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 tightness
- flushed skin
- skin rash, itching, or raised bumps on skin
- nausea, vomiting, or diarrhea
- losing control of urine or stools
- Your healthcare provider will prescribe an
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.
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. Tell your
healthcare provider that you had a severe allergic reaction. Your healthcare
provider will tell you if you can continue treatment with Palynziq.- Your healthcare provider may prescribe other medicines to
take before your Palynziq injection that may help reduce the symptoms of an
allergic reaction. - If your healthcare provider decides that you can continue
treatment with Palynziq after a severe allergic reaction, you will receive your
next 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 may prescribe other medicines to
- Your healthcare provider will give you a Palynziq
Patient Wallet Card that describes symptoms that you (or your caregiver),
or your observer, should know that require you to get emergency medical care
right away. Carry this card with you at all times during treatment with
Palynziq. It is important to show your Palynziq Patient Wallet Card to any
other healthcare provider who treats you.
Palynziq may cause serious side effects, including:
- 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 or 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, tenderness - joint pain
- headache
- skin reactions that spread on your skin and last at least
14 days, such as itching, rash, redness - itching
- nausea
- stomach pain
- mouth and throat pain
- vomiting
- cough
- diarrhea
- feel very tired
- low levels of phenylalanine in your blood
These are not all the possible side effects of Palynziq.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
What is the dosage for Palynziq?
- Your healthcare provider will give you the Palynziq injection until they
decide that you (or your caregiver) can give it. - Your healthcare provider may prescribe medicine for you
to take before your Palynziq injection to help reduce the symptoms of an
allergic reaction. - If your healthcare provider decides that you (or your
caregiver) can give your Palynziq injections, you (or your caregiver) will be
shown how to prepare and give your Palynziq injections. See the “Instructions
for Use” for detailed instructions on how to prepare and give an injection of
Palynziq. - Use Palynziq exactly as your healthcare provider tells
you to. Your healthcare provider will tell you how much Palynziq to inject and
when to inject it. - Palynziq comes in prefilled syringes with 3 different
strengths (2.5 mg, 10 mg, or 20 mg). You may need more than 1 Palynziq
prefilled syringe for your prescribed dose. - Monitor the amount of protein and phenylalanine that you
eat or drink. Your healthcare provider may change the amount of protein and
phenylalanine you should have in your diet during treatment with Palynziq,
depending on the levels of phenylalanine in your blood. Follow your healthcare
provider’s instructions about the amount of protein and phenylalanine you
should have in your diet. - If you miss a dose, take your next dose at the regular
time. Do not take two doses of Palynziq to make up for a missed dose.
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What drugs interact with Palynziq?
Effect Of Palynziq On Other PEGylated Products
In a single dose study of Palynziq in adult patients with
PKU, two patients receiving concomitant injections of medroxyprogesterone
acetate suspension (a formulation containing PEG 3350) experienced
hypersensitivity reactions. One of the two patients experienced a
hypersensitivity reaction on day 15 after a single Palynziq dosage of 0.67 mg
within 15 minutes following medroxyprogesterone acetate injectable suspension,
and subsequently experienced anaphylaxis on day 89 within 30 minutes after the
next dose of medroxyprogesterone acetate injectable suspension. The other
patient experienced a hypersensitivity reaction on day 40 after a single
Palynziq dosage of 0.08 mg within 10 minutes following medroxyprogesterone
acetate injectable suspension. Both patients had high anti-PEG IgG antibody
titers at or around the time of the hypersensitivity reactions.
In Palynziq clinical trials, the majority of patients
developed anti-PEG IgM and IgG antibodies after treatment with Palynziq. The clinical effects of concomitant treatment with different
PEGylated products is unknown. Monitor patients treated with Palynziq and
concomitantly with other PEGylated products for hypersensitivity reactions
including anaphylaxis.
Is Palynziq safe to use while pregnant or breastfeeding?
Before injecting Palynziq, tell your healthcare
provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. Palynziq may
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 phenylalanine 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
phenylalanine levels and discuss the risks and benefits of taking Palynziq
during pregnancy to you and your unborn baby. It is very important to keep your
phenylalanine levels 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 receiving Palynziq or within 1 month after their
last dose of Palynziq. The purpose of this program is to collect information
about the health of you and your baby while taking Palynziq. Talk to your
healthcare provider about how you can take part in this program or call
BioMarin at 1-866-906-6100.
- If your phenylalanine levels are too high or too low
- 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.