Avalglucosidase alfa-ngpt Injection

Avalglucosidase alfa-ngpt injection may cause serious or life-threatening reactions including hypersensitivity reactions such as anaphylaxis, infusion-associated reactions or acute cardiorespiratory failure. These reactions may occur during and up to 3 hours after your injection.Tell your doctor if you have are feeling ill on the day of infusion or have respiratory infection or have ever had breathing problems or any lung conditions that affect your breathing. Also tell your doctor if you have heart disease. If you experience any of the following symptoms, tell your doctor immediately: difficulty breathing; chest pain; changes in heartbeat; fever; chills; nausea; dizziness; rash; hives,; swelling of the face, arms, legs, throat, lips or tongue; flushing; itching; difficulty swallowing; cough.

Talk to your doctor about the risks of receiving avalglucosidase alfa-ngpt injection.

Avalglucosidase alfa-ngpt injection is used to treat the symptoms of Pompe disease (an inherited condition in which the body lacks a certain enzyme to break down glycogen in the body). Avalglucosidase alfa-ngpt injection is in a class of medications called enzymes. It works by providing the enzyme to break down glycogen in the body.

Avalglucosidase alfa-ngpt injection comes comes as a powder to dilute and give intravenously (into a vein) by a healthcare professional in a hospital or healthcare facility. It is given once every 2 weeks.

Your doctor may prescribe medications for you to take prior to your scheduled dose to reduce the risk of serious reactions to avalglucosidase alfa-ngpt injection. Be sure you take these medicines exactly as prescribed and ask your doctor or pharmacist if you have any questions.

Avalglucosidase alfa-ngpt injection controls Pompe disease but does not cure it. Continue to receive avalglucosidase alfa-ngpt injection even if you feel well. Do not stop receiving avalglucosidase alfa-ngpt injection without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving avalglucosidase alfa-ngpt 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 prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving avalglucosidase alfa-ngpt injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Avalglucosidase alfa-ngpt injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• tiredness
• diarrhea, nausea, vomiting
• joint or muscle pain
• tingling, burning, numbness, or pricking sensation

Some side effects can be serious. If you experience any symptoms listed in the IMPORTANT WARNING section call your doctor immediately or get emergency medical treatment.

Avalglucosidase alfa-ngpt injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to avalglucosidase alfa-ngpt injection

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.

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