Nexviazyme
Generic name: avalglucosidase alfa [ AY-val-gloo-KOE-si-dase-AL-fa ]
Drug class: Lysosomal enzymes
What is Nexviazyme?
Nexviazyme helps replace an enzyme that is missing in people with a genetic disorder called late-onset Pompe disease, (also called GAA deficiency) in children at least 1 year old.
Nexviazyme may also be used for purposes not listed in this medication guide.
Nexviazyme side effects
Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.
Some reactions may occur during the injection, or within a few hours afterward. Tell your medical caregiver or get emergency medical help right away if you have:
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pale skin, blue lips or fingernails;
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swelling in your tongue;
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trouble swallowing;
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dizzines, nausea;
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rash; or
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flushing (sudden warmth, redness, or tingly feeling).
Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as itching, rash, redness or tingling, chest discomfort, wheezing, trouble breathing or swallowing, swelling in your face, pale skin, and blue lips or fingernails.
Common side effects of Nexviazyme may include:
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headache, dizziness, feeling tired;
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itching, rash, redness;
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muscle or joint pain;
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trouble breathing; or
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numbness, tingling, burning pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Related/similar drugs
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Warnings
Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as itching, rash, redness or tingling, chest discomfort, wheezing, trouble breathing or swallowing, swelling in your face, pale skin, and blue lips or fingernails.
Before taking this medicine
Tell your doctor if you have ever had:
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heart disease; or
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lung disease or breathing problems.
Tell your doctor if you are pregnant or plan to become pregnant. Having untreated Pompe disease during pregnancy may increase your risk of worsened breathing problems and joint or muscle problems. The benefit of treating Pompe disease may outweigh any risks.
Ask a doctor if it is safe to breastfeed while using Nexviazyme.
Your name may be listed on the Pompe Registry. This is to track the progress of your disease and the outcome of your treatment with Nexviazyme.
How is Nexviazyme given?
Avalglucosidase is injected into a vein by a healthcare provider, usually once every 2 weeks.
This medicine must be given slowly over 4 to 5 hours.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Nexviazyme.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Nexviazyme?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Nexviazyme?
Other drugs may affect avalglucosidase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Nexviazyme Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Nexviazyme.
Nexviazyme (avalglucosidase alfa-ngpt) - Genzyme Corporation
Formulation type | Strength |
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Single-Dose Vial | 100 mg |
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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