Pegvaliase Injection

What is this medication?

PEGVALIASE (peg VAL i ase) treats high phenylalanine levels in people with phenylketonuria (PKU). It works by helping your body break down phenylalanine. This prevents it from building up in the blood.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Palynziq

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• An unusual or allergic reaction to pegvaliase, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take the next dose as scheduled. Do not take double or extra doses.

What may interact with this medication?

• Medroxyprogesterone acetate injection

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

This medication can cause serious allergic reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Follow the directions from your care team.

Your care team will prescribe an epinephrine auto-injector for you. They will teach you and your caregiver how and when to use it. Keep the epinephrine with you at all times.

Carry the Patient Wallet Card with you at all times. Show it to all members of your care team. It describes the signs and symptoms of severe side effects you may have while taking this medication.

You may need to be on a special diet while you are taking this medication. Ask your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Headache
• Joint pain
• Pain, redness, or irritation at injection site
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Refrigerator (preferred): Store in the refrigerator. Do not freeze. Keep this medication in the original packaging until you are ready to take it. Protect from light. Get rid of any unused medication after the expiration date.

Room temperature: This medication may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 30 days. Keep it in the original packaging until you are ready to take it. Protect from light. Do not return it to the refrigerator. Get rid of any unused medication after 30 days.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of it safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.