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Pegunigalsidase Alfa-Iwxj is available as a 20 mg/10 mL or 5 mg/2.5 mL (2 mg/mL) solution in a singledose vial.

Pegunigalsidase Alfa-Iwxj is an enzyme replacement therapy used to treat Fabry disease in adults.

Pegunigalsidase Alfa-Iwxj provides the body with an enzyme (protein) called alpha-galatosidase A. In Fabry disease, your body isn’t able to make the alpha-galatosidase A enzyme. Without this enzyme, fat builds up in the body and causes damage to many parts of the body, including the skin, kidneys, heart, and nervous system. By replacing the missing alpha-galatosidase A enzyme, Pegunigalsidase Alfa-Iwxj helps lower fat buildup in the body for people with Fabry disease.

Your healthcare provider will calculate the right dose of Pegunigalsidase Alfa-Iwxj for you based on your body weight. The typical dose is 1 mg/kg of body weight injected into the veins (intravenous or IV) every 2 weeks.

Pegunigalsidase Alfa-Iwxj is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Pegunigalsidase Alfa-Iwxj:

• Infusion-related reactions
• Common cold symptoms
• Headache
• Diarrhea
• Fatigue
• Nausea
• Back pain
• Pain in arms or legs
• Stomach pain

Serious side effects are rare with Pegunigalsidase Alfa-Iwxj. Contact your healthcare provider immediately if you experience any of the following:

• Serious allergic reaction (e.g., anaphylaxis): difficulty breathing, tightness in the throat, hives, itching, fast heartbeat, nausea, dizziness, lightheadedness, swelling in the face or tongue

There are no major drug interactions listed for this medication. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking.

Various FDA-approved generic manufacturers

It is not known whether this medication is safe for you and your unborn baby during pregnancy. Talk to your doctor if you are already pregnant or if you have plans on becoming pregnant. They will recommend what is best for you.

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