Pegvaliase Prefilled Syringe (PEGVALIASE - SUBCUTANEOUS INJECTION)

Instructions

This medicine is injected into the skin. Ask your doctor, nurse, or pharmacist where on your body this medicine can be injected and how to inject it.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

Always inspect the medicine before using.

The liquid should be clear or light yellow.

Do not use the medicine if it contains any particles or if it has changed color.

Do not shake the medicine before using.

Keep medicine in refrigerator. Do not freeze. Protect from light.

Keep the medicine in its original container.

You may store this medicine at room temperature for up to 30 days. Do not put back in refrigerator.

Do not store in the bathroom.

If your medicine is stored in the refrigerator, take it out of the refrigerator about 30 minutes before use to warm to room temperature.

Injecting cold drug may be uncomfortable.

Discard unused medicine after 30 days at room temperature.

Never use any medicine that has expired.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

The first dose will be given by health care provider who will monitor for a severe allergic reaction. Later doses may be given by a health care provider or at home.

If using this medicine at home, ask your doctor, nurse, or pharmacist to show you or a family member how to use this medicine correctly.

Do not inject into moles, scars, stretch marks, or into skin that is tender, bruised, red, scaly, thickened, or hard.

Avoid injecting the medicine within 2 inches around the navel.

If your dose is 2 syringes or injections, inject each in 2 different locations.

Change location of injection each time.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep all appointments for medical exams and tests while on this medicine.

Brand Name(s): Palynziq

Generic Name: Pegvaliase-pqpz

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Please check with your doctor before drinking alcohol while on this medicine.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• coughing
• dizziness
• lack of energy and tiredness
• hair loss
• headaches
• pain, redness, swelling near injection
• joint or muscle pain
• red, burning, or itchy skin

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• chest pain
• diarrhea
• fainting
• fast or irregular heart beats
• nausea and vomiting
• throat tightness

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.