pegvaliase

What is the most important information I should know about pegvaliase?

Pegvaliase can cause a serious allergic reaction. Your first dose will be given in a medical setting.

What is pegvaliase?

Pegvaliase is used to lower phenylalanine blood levels in adults with phenylketonuria (PKU) not controlled with other treatment.

Pegvaliase is available only from a certified pharmacy under a special program.

Pegvaliase may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using pegvaliase?

Tell your doctor if you think you might be unable to give yourself an emergency epinephrine injection.

Follow your doctor's instructions about using this medicine if you are pregnant. Controlling your phenylalanine levels is very important during pregnancy. Your name may be listed on a pregnancy registry to track the effects of pegvaliase on the baby.

How should I use pegvaliase?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Pegvaliase is injected under the skin. You may be given other medications to help prevent serious side effects or an allergic reaction.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not shake the prefilled syringe or you may ruin the medicine.

Your healthcare provider will show you where to inject pegvaliase. Do not inject into the same place two times in a row.

You may need to have someone with you for at least 1 hour after you inject this medicine at home, to watch you for signs of an allergic reaction and give the epinephrine injection if needed.

Read the Warning Card about allergic reactions and learn what symptoms to watch for. Keep the card with you at all times.

You will need frequent medical tests.

You will need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Throw away a prefilled syringe after one use, even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while using pegvaliase?

Avoid injecting into skin that is red, bruised, hard, tender, injured, or irritated. Do not inject this medicine into skin areas with moles, scars, birthmarks, or tattoos.

What are the possible side effects of pegvaliase?

• hives, rash, itching;
• confusion, dizziness, feeling like you might pass out;
• nausea, vomiting, diarrhea;
• loss of bladder or bowel control;
• fast heartbeats;
• wheezing, chest tightness, difficult breathing;
• flushing (warmth, redness, or tingly feeling); or
• swelling of your face, lips, tongue, or throat.

Common side effects may include:

• cough, stuffy nose;
• mouth and throat pain;
• dizziness;
• anxiety;
• low phenylalanine blood levels;
• a spreading skin reaction (itching, redness, rash) that could last at least 14 days;
• headache, joint pain;
• nausea, vomiting, stomach pain, diarrhea;
• tiredness; or
• pain, tenderness, bruising, redness, itching, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pegvaliase?

Other drugs may affect pegvaliase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your pharmacist can provide more information about pegvaliase.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 4.01. Revision date: 6/11/2021.