Warnings:

Avalglucosidase alfa may cause certain serious side effects, including allergic and infusion reactions. To decrease your risk of infusion reactions, you may be given other medications before each dose (such as antihistamines, corticosteroids). A health care professional will also carefully monitor you during your infusion. Get medical help right away if you notice any signs of a serious allergic or infusion reaction, such as flushing/rash, itching/swelling (especially of the face, tongue, throat), severe dizziness, trouble breathing, trouble swallowing, cough, or chest discomfort/tightness. Your infusion may be slowed down or stopped depending on your symptoms.

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.

How to use Nexviazyme 100 Mg Intravenous Solution Metabolic Disease Enzyme Replacement, Pompe

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 the days on the calendar when you need to receive the medication.

Side Effects

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.

Precautions

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 breast-feeding.

Consult your pharmacist or physician.

Interactions

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.

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Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

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.

Storage

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

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.