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.
uses
What is Palynziq (Pegvaliase) used for?
- Phenylketonuria
warnings
What is the most important information I should know about Palynziq (Pegvaliase)?
Pegvaliase can cause a serious allergic reaction. Your doctor may prescribe an epinephrine injection kit to use in case you have a severe allergic reaction. Keep this injection kit with you at all times.
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.
Ask a doctor if it is safe to breastfeed while using this medicine.
Not approved for use by anyone younger than 18 years old.
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Side Effects
What are the side effects of Palynziq (Pegvaliase)?
Stop the pegvaliase injection and get emergency medical help if you have signs of an allergic reaction:
- 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.
Pregnancy & Breastfeeding
Can I take Palynziq (Pegvaliase) if I’m pregnant or breastfeeding?
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.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Palynziq (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.
Dosage Guidelines & Tips
How to take Palynziq (Pegvaliase)?
Use Palynziq (Pegvaliase) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
You will receive your first dose in a medical setting to make sure you do not have 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.
Store this medicine in the refrigerator, do not freeze.
You may store the medicine for up to 30 days at room temperature in its original container, protected from light. Do not put the medicine back into the refrigerator. Throw away any unused medicine after 30 days or after the expiration date on the label has passed.
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.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Palynziq (Pegvaliase)?
(800) 222-1222
911