Palynziq

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.

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 www.fda.gov/medwatch.

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 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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.

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.