Pegvaliase-pqpz Injection
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. The first dose should be given by a doctor or nurse in a healthcare setting where these reactions can be treated and where you can be closely observed 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 a prefilled automatic epinephrine injection device (Adrenaclick, Auvi-Q, EpiPen, others) to treat a life-threatening allergic reaction. Your doctor will teach you and your caregiver how to use this medication and how to recognize the signs of an allergic reaction. Carry the epinephrine injection with you at all times. If you experience any of the following symptoms at any time during your treatment, use the 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; chest pain or discomfort; tightness of the throat or chest; vomiting; nausea; diarrhea; or loss of bladder control.
Because of the risks with this medication, pegvaliase-pqpz injection is available only through a special restricted distribution program called Palynziq ® Risk Evaluation and Mitigation Strategies (REMS) Program. You, your doctor, and your pharmacist must be enrolled in this program before you can receive pegvaliase-pqpz injection. Ask your doctor if you have any questions about how you will receive your medication.
Your healthcare provider will give you 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.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with pegvaliase-pqpz injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
🔔 Why is this medication prescribed?
Pegvaliase-pqpz injection is used along with a specific diet to reduce blood phenylalanine levels in people who have phenylketonuria (PKU; an inborn condition in which phenylalanine may build up in the blood and causes decreased intelligence and a decreased ability to focus, remember, and organize information) 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.
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🔔 How should this medicine be used?
Pegvaliase-pqpz injection comes as a solution (liquid) to inject subcutaneously (just under the skin). It is usually injected once weekly for 4 weeks, and then increased gradually over the next 5 weeks to once daily. Your doctor will change your dose based on your body’s response to the medication. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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.
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.
You may 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.
🔔 Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.