Nexviazyme

Nexviazyme

What is Nexviazyme?

Nexviazyme may also be used for purposes not listed in this medication guide.

Side effects of Nexviazyme

If necessary, get emergency medical helpSigns 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 after it. Tell your doctor or get emergency medical help immediately if you have:

• wheezing, coughing, chest discomfort, difficulty breathing;

• pale skin, blue lips or fingernails;

• swelling in your tongue;

• difficulty swallowing;

• dizziness, nausea;

• rash; or

• Flushing (sudden warmth, redness, or tingling).

Tell your healthcare provider or get medical help immediately if you notice any signs of a serious allergic reaction, such as: B. Itching, rash, redness or tingling, chest discomfort, wheezing, difficulty breathing or swallowing, facial swelling, pale skin, etc. Blue lips or fingernails.

Common side effects of Nexviazyme may include:

• headache, dizziness, fatigue;

• nausea, vomiting, diarrhea;

• itching, rash, redness;

• muscle or joint pain;

• difficulty breathing; or

• 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

Tell your caregivers or get medical help immediately if you notice any signs of a serious allergic reaction.such as itching, rash, redness or tingling, chest discomfort, wheezing, difficulty breathing or swallowing, facial swelling, pale skin, and blue lips or fingernails.

Before you take this medicine

Tell your doctor if you have ever had:

• heart disease; or

• Lung disease or breathing problems.

Tell your doctor if you are pregnant or planning to become pregnant. If Pompe disease is not treated during pregnancy, the risk of worsening breathing problems and joint or muscle problems may increase. The benefits of treating Pompe disease may outweigh the risks.

Ask a doctor if it is safe to breastfeed while using Nexviazyme.

Your name may be listed on the Pompe Register. This is to track the progress of your disease and the outcome of your treatment with Nexviazyme.

How is Nexviazyme administered?

Avalglucosidase is injected into a vein by a doctor, usually every two weeks.

This medicine must be given slowly over 4 to 5 hours.

You may be given other medications to prevent serious side effects or allergic reactions. Take these medicines for as long as your doctor tells you.

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 hotline at 1-800-222-1222.

What should I avoid while taking Nexviazyme?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs affect Nexviazyme?

Other medications can affect avalglucosidase, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.