pegvaliase-pqpz 2.5 mg/0.5 mL subcutaneous syringe


The photos shown are samples only

Medication name

Generic name:
Pegvaliase - subcutaneous injection


Brand name(s)


This medication has caused serious allergic reactions which can be life-threatening. This reaction can happen at any time during treatment. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: flushing/rash, itching/swelling (especially of the face, tongue, throat), severe dizziness, trouble breathing, fast heartbeat, fainting, chest discomfort/tightness, nausea, vomiting, or diarrhea. To be sure that you do not have a serious reaction, you will need to stay in a health care setting (such as a doctor's office) for at least 1 hour after taking this drug for the first time so your doctor can carefully monitor you and provide medical help if needed.

After the first injection, you and your doctor may decide you can use this medication at home. Your health care provider will instruct you and/or your caregiver how to inject this medication the right way.

Your doctor will also prescribe another medication (epinephrine) in case you have a serious allergic reaction outside the health care setting. Read the Patient Information Leaflet for this medication provided by your pharmacist. Learn ahead of time when and how to use your brand of epinephrine. If you have to use it, get medical help as soon as you have used it.

To receive pegvaliase in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.


This medication is used by people with a certain inherited condition (phenylketonuria) to reduce high levels of a certain substance (phenylalanine) that builds up in the blood. Having high levels of phenylalanine in the blood may cause brain damage, heart problems, an abnormally small head size, and behavioral problems. Pegvaliase works by breaking down phenylalanine in the blood.

Along with using this medication, you should follow a special diet to control your blood phenylalanine levels. Ask your doctor for details.

How to use

Read the Medication Guide provided by your pharmacist before you start using pegvaliase and each time you get a refill. Carefully read and learn the Instructions for Use. If you have any questions, ask your doctor or pharmacist. Carry the Patient Wallet Card with you at all times. Show the card to all of your health care providers to let them know that you are being treated with pegvaliase.

Before use, take pegvaliase out of the refrigerator. Let it warm up to room temperature for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin of the thigh, abdomen, top of the buttocks, or upper arm as directed by your doctor, usually starting with once weekly for 4 weeks, then gradually increasing over 5 weeks to once daily. The dosage is based on your medical condition and response to treatment. Your doctor may prescribe other medications (such as antihistamines, acetaminophen) before each dose to help prevent side effects. Carefully follow your doctor's directions.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into moles, scars, birthmarks, bruises, rashes, or areas of skin that are injured, tender, hard, red, or tattooed.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.

Learn how to store and discard medical supplies safely.

Side effects

See also Warning section.

Redness, itching, pain, or bruising at the injection site may occur. Muscle/joint/back/neck pain, headache, mouth/throat/abdominal pain, dizziness, cough, or tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return if treatment is ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Pegvaliase can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.


Before using pegvaliase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.


If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.


Do not share this medication with others.

Lab and/or medical tests (such as phenylalanine levels) must be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

Missed dose

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.


Store in the original package in the refrigerator away from moisture. Do not freeze. After removing from the refrigerator, this medication can be stored at room temperature for up to 30 days. Do not put the medication back in the refrigerator after it has reached room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised May 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.