Palynziq

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.

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.

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.

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.

Tell your doctor right away if you have any serious side effects, including: fluid or pus at the injection site.

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/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

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

Store in the refrigerator. Do not freeze. Keep the medication in the original package to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 30 days. 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.

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 using 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.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using pegvaliase and each time you get a refill. Ask your health care professional how to prepare and use this medication. 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.

Inject this medication under the skin as directed by your doctor, usually starting with once weekly for 4 weeks, then gradually increasing over 5 weeks to once daily. The injection is given in the thigh, abdomen, top of the buttocks, or upper arm. 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.

Take the medication out of the refrigerator at least 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Do not shake the medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is injured, tender, hard, red, bruised, or tattooed, or into moles, scars, birthmarks or rashes. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.