Pegvaliase-pqpz injection may cause serious or life-threatening allergic reactions. These reactions may occur soon after your injection or at any time during your treatment. You will receive your first dose in a healthcare setting. Your doctor will watch you carefully for at least 1 hour after the injection. Your doctor may give you certain medications before you receive pegvaliase-pqpz injection to help to prevent a reaction.
Your doctor will give you an epinephrine injection device to treat allergic reactions. Your doctor will teach you or a caregiver when and how to use this medication. Carry the epinephrine injection device with you at all times. If you experience any of the following symptoms at any time during your treatment, use epinephrine injection and get emergency medical care immediately: difficulty swallowing or breathing; shortness of breath; wheezing; hoarseness; swelling of the face, throat, tongue or lips; hives; flushing or sudden redness of the face, neck or upper chest; rash; itching; redness of the skin; fainting; dizziness; sudden confusion; fast heartbeat; tightness of the throat or chest; vomiting; nausea; diarrhea; or loss of bladder control.
Pegvaliase-pqpz injection is available only through a special restricted distribution program. A Palynziq ® REMS (Risk Evaluation and Mitigation Strategies) has been set up becaus of the risk of allergic reactions. You will only be able to receive pegvaliase-pqpz injection if you, your doctor, and your pharmacist are enrolled in this program.
You will be given a Palynziq ® patient safety card that describes the allergic symptoms that you may have with this medication. Carry this card with you at all times during your treatment. It is important to show your Palynziq ® patient safety card to any other healthcare provider who treats you.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to pegvaliase-pqpz injection.
You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.
Why is this medicine prescribed?
Pegvaliase-pqpz injection is used along with a specific diet to reduce blood phenylalanine levels in people who have phenylketonuria (PKU; an inherited condition in which phenylalanine may build up in the blood and cause brain damage) and who have uncontrolled blood phenylalanine levels. Pegvaliase-pqpz injection is in a class of medications called enzymes. It works by helping to reduce the amount of phenylalanine in the body.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Pegvaliase-pqpz injection comes as a solution (liquid) to inject subcutaneously (just under the skin). Initially, it is injected once a week for 4 weeks. After that, your doctor will gradually increase your dose, not more than once a week based on your body's response to the medication..
Use pegvaliase-pqpz injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You or a caregiver will be shown how to inject the medicine before your first dose. You will also be given the instructions for use. Read these carefully. Talk to your doctor or pharmacist if you have any questions on how to use the medicine.
Before you use pegvaliase-pqpz injection, look at the solution closely. The medication should be clear to pale yellow and free of floating particles. If the medication is cloudy, discolored, or contains particles, do not use it. Do not shake the prefilled syringe.
Inject pegvaliase-pqpz injection on the front of your thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. If another person is injecting your medication, the top of buttocks and the outer area of the upper arms also may be used. Do not inject the medication into skin that is tender, bruised, red, hard, or not intact, or that has scars, moles, tattoos, or bruises. Choose a different spot each time you inject the medication, at least 2 inches away from a spot that you have used before. If more than one injection is needed for a single dose, the injection sites must be at least 2 inches away from each other but can be on the same part of the body or a different part of the body.
What special precautions should I follow?
Before using pegvaliase-pqpz injection,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using pegvaliase-pqpz injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using pegvaliase-pqpz injection, call your doctor immediately.
What special dietary instructions should I follow?
Follow your diet plan carefully. Your doctor will monitor the amount of protein and phenylalanine that you eat and drink during your treatment.
What should I do if I forget to take a dose?
If a dose is missed, inject your next dose as scheduled. Do not inject a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Pegvaliase-pqpz injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- itching, bruising, or rash at the injection site
- joint pain
- headache
- stomach pain
- mouth and throat pain
- feeling tired
- anxiety
- hair loss
- cough or stuffy nose
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using pegvaliase-pqpz injection and call your doctor immediately or get emergency medical treatment:
- redness, pain, swelling, tenderness, blistering, or hardening at the injection site; fluid or pus at the injection site; or a dark scab or open wound at the injection site
- rash, itching, hives, or skin redness that lasts at least 14 days
Pegvaliase-pqpz injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in to protect from light, tightly closed, and out of reach of children. Store it in the refrigerator; do not freeze. It also may be stored at room temperature for up to 30 days. Once the medication is stored at room temperature, do not return it to the refrigerator.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.