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Overview: Palynziq is used to treat phenylketonuria in certain people. Common side effects include joint pain; allergic reactions; and pain, redness, or itching where the needle entered your skin. Carry your medicine called epinephrine for severe allergic reactions with you at all times. If you have an allergic reaction, get emergency help even if you use epinephrine, and do not use another dose of this medicine without first talking with your health care provider.

Uses

What is Palynziq used for?

Palynziq (pegvaliase-pqpz) is commonly used to treat phenylketonuria.

Palynziq may also be used for other conditions as determined by your health care provider.

How does Palynziq work (mechanism of action)?

People with phenylketonuria are unable to break down enough of a normal substance in the body called phenylalanine. Palynziq is a human-made protein (enzyme) that changes phenylalanine to other substances that your body can remove.

How is Palynziq supplied (dosage forms)?

Brands and other names

  • Palynziq

Dosage forms and strengths

  • 2.5 mg/0.5 mL, 10 mg/0.5 mL, and 20 mg/mL prefilled syringes

How should I store Palynziq?

Palynziq should be stored in the refrigerator, between 36 F and 46 F (2 C and 8 C). Do not freeze or shake it. Keep Palynziq in its original container to protect it from light.

If needed, Palynziq can be stored in its original container at room temperature, between 68 F and 77 F (20 C and 25 C), for up to 30 days. Once it has been stored at room temperature, do not return it to the refrigerator. Throw away any unused Palynziq if it has been stored at room temperature for 30 days or after the expiration date on the container, whichever comes first.

Side Effects

What are the most common side effects of Palynziq?

The most common side effects of Palynziq are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near the injection site
  • Joint pain
  • Severe allergic reactions (see below)
  • Headache
  • Skin reactions that last at least 14 days, such as itching, rash, and redness
  • Nausea or vomiting
  • Stomach pain
  • Cough
  • Sore throat
  • Itching
  • Diarrhea
  • Nasal congestion
  • Tiredness
  • Dizziness
  • Anxiety

There may be other side effects of Palynziq that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Palynziq?

While less common, the most serious side effects of Palynziq are described below, along with what to do if they happen.

Severe Allergic Reactions. Palynziq may cause allergic reactions, which can be serious. Severe allergic reactions can happen at any time. Keep the auto-injectable epinephrine that is used for severe allergic reactions with you at all times. Stop using Palynziq and get help right away even if you have used epinephrine if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Palynziq?

Allergies to Ingredients. People who are allergic to any of the following should not use Palynziq.

  • Palynziq
  • Pegvaliase-pqpz
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Palynziq.

What should I know about Palynziq before using it?

Do not use Palynziq unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Palynziq with other people, even if they have the same condition as you. It may harm them.

Keep Palynziq out of the reach of children.

Palynziq is only available through a special program, from certain pharmacies, and to certain people. This is because of the risk of severe allergic reactions. Your health care provider will prescribe an epinephrine injection to use in case of severe allergic reaction. Carry epinephrine with you at all times. Your health care provider will give you a Palynziq Patient Wallet Card you should keep with you at all times and show to all of your health care providers. If you have any questions about this program, you can go to www.palynziqrems.com or call 855‑758‑REMS (855‑758‑7367).

This medicine is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use Palynziq. Avoid injecting in areas of your skin where you have moles, birthmarks, scars, injuries, tattoos, or any kind of skin irritation. If more than one injection is needed for a single dose, choose injection sites on your body that are at least 2 inches apart. If you have any questions, talk to your health care provider.

If you have an allergic reaction, do not use Palynzig again until you talk with your health care provider. You will need to get the next dose of this medicine in a clinic or hospital so that you can be watched for any problems. Take any medicines your health care provider may give you to help reduce the symptoms of an allergic reaction.

Ask your pharmacist for instructions on throwing away Palynziq in a sharps container.

Talk with your health care provider about protein and phenylalanine in your diet. Phenylalanine levels that are either too high or too low can be dangerous. It is important that you keep all of your appointments, including labs or other testing, while using Palynziq.

What should I tell my health care provider before using Palynziq?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Palynziq is right for you.

In particular, make sure that you discuss any of the following.

Cannot Use Epinephrine. Tell your health care provider if you are unable or unwilling to use an epinephrine injection on your own in case of a severe allergic reaction.

Other Medicines and Supplements. Palynziq may interact with other medicines and supplements. Before using Palynziq, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Palynziq may cause harm to a fetus. Phenylalanine levels that are either too high or too low during pregnancy may also affect your fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Palynziq while you are pregnant or trying to get pregnant. If you become pregnant while using Palynziq or within one month after your last dose, you can sign up for a registry program by calling the drugmaker at 866-906-6100. This registry collects information about the health of you and your fetus while using Palynziq during pregnancy.

Breastfeeding. It is not known if Palynziq passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Palynziq while breastfeeding.

How can I get more information about Palynziq?

For more information about Palynziq, you can visit the drugmaker’s website at www.palynziq.com or call them at 866-906-6100.

Interactions

Does Palynziq interact with foods or drinks?

There are no known interactions between Palynziq and foods or drinks.

It is unknown if drinking alcohol will affect Palynziq.

Does Palynziq interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using injectable forms of medroxyprogesterone (Depo Provera, Depo-SubQ Provera 104), which is a medicine used to prevent pregnancy.

This may not be a complete list of medicines that can interact with Palynziq. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Palynziq?

If you or someone else has used too much Palynziq, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Palynziq?

If you miss a dose, skip the missed dose and use your next dose at the regular time. Do not use double or extra doses.