Pegunigalsidase alfa-iwxj Injection

Pegunigalsidase alfa-iwxj has been associated with hypersensitivity (severe allergic) reactions, including anaphylaxis, and may cause infusion-related reactions during and within 24 hours after infusions. Your doctor or nurse will monitor you very closely during your infusion. If you experience any of the following symptoms, tell your doctor immediately or seek emergency medical care: headache; nausea; vomiting; diarrhea; stomach pain; swelling of your face, lips, tongue, or throat; rash; hives; itching; fever; chills; dizziness; weakness; difficulty breathing; fast or irregular heartbeat; or chest pain. Your doctor may given you medicines prior to each infusion to reduce the chance of these events occurring.

Pegunigalsidase alfa-iwxj injection is used to treat Fabry disease (an inherited condition in which a type of fatty substance builds up in the body, resulting in nerve and organ damage). Pegunigalsidase alfa-iwxj injection is in a class of medications called enzymes. It works by replacing an enzyme that is normally produced by the body that helps prevents the build of the fatty substance in the body.

Pegunigalsidase alfa-iwxj injection comes as a solution (liquid) to be injected intravenously (into a vein) by a healthcare provider. Pegunigalsidase alfa-iwxj injection is usually infused (injected slowly) intravenously over a period of 90 minutes to 6 hours once every 2 weeks.

Initially, you will receive pegunigalsidase alfa-iwxj injection in a medical facility for at least the 4 to 6 infusions. If previous infusions are tolerated, your doctor may decide that this medication may be given at home under the supervision of a healthcare provider.

Pegunigalsidase alfa-iwxj injection may cause serious reactions during or after you receive your infusion. A doctor or nurse will watch you carefully for these side effects while the medication is being infused. Your doctor may need to slow down or temporarily stop your infusion if you experience these reactions.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving pegunigalsidase alfa-iwxj injection,

• tell your doctor and pharmacist if you are allergic to pegunigalsidase alfa-iwxj, any other medications, or any of the ingredients in pegunigalsidase alfa-iwxj injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had heart or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving pegunigalsidase alfa-iwxj injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive a dose of pegunigalsidase alfa-iwxj injection, call your doctor right away.

Pegunigalsidase alfa-iwxj may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nasal congestion or runny nose
• sore throat
• arm, leg, or back pain
• fatigue
• numbness or tingling in the your hands, feet, arms, or legs
• redness or swelling at the injection site

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• decreased urination; foamy, pink, or brown colored urine; swelling in hands, face, feet or stomach

Pegunigalsidase alfa-iwxj may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to pegunigalsidase alfa-iwxj injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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