avalglucosidase alfa-ngpt 100 mg intravenous solution

Generic name:
Avalglucosidase alfa - injection

Pronunciation
(AY-val-gloo-KOE-si-dase)

Brand name(s)
Nexviazyme

Avalglucosidase alfa may cause certain serious side effects, including allergic and infusion reactions. Your doctor may prescribe other medications (such as antihistamines, corticosteroids) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of a serious allergic reaction or infusion reactions such as flushing/rash, itching/swelling (especially of the face, tongue, throat), severe dizziness, trouble breathing, trouble swallowing, cough, or chest discomfort/tightness. Your doctor may slow down or stop your treatment for some time.

Before starting treatment with this medication, tell your doctor if you have a history of heart problems (such as heart failure), breathing problems (such as fluid in the lungs), or swelling. These problems may get worse during the infusion. Your doctor may check your blood pressure, pulse (heart rate), and breathing more often during your infusion.

This medication is used by people with a certain inherited condition (Pompe disease) to reduce high levels of a certain substance (glycogen) that builds up in the body. High levels of glycogen in the body may cause muscle weakness, heart problems, and breathing problems. Avalglucosidase alfa works by breaking down glycogen.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 2 weeks. The dosage is based on your weight, medical condition, and response to treatment. Your doctor may prescribe other medications for you to take before treatment to help lessen the risk of infusion reactions. Carefully follow your doctor's directions. See also Warning section.

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

See also Warning section.

Dizziness, muscle/joint pain, headache, diarrhea, nausea, vomiting, or tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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.

Avalglucosidase alfa 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/medwatch.

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

See also Warning section.

Before using avalglucosidase alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

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.

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.

Do not share this medication with others.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.