Alglucosidase Alfa

Warning

Alglucosidase alfa may cause serious (sometimes fatal) allergic reactions that may happen during and up to 3 hours after the infusion. Your doctor may prescribe other medications (such as antihistamines, fever reducers, corticosteroids) before each treatment to help prevent these side effects. Get medical help right away if you notice any signs of a serious allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or chest pain. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Rarely, people using this medication have developed severe skin/kidney problems. Tell your doctor right away if you develop changes in skin color, change in the amount of urine, or pink/bloody urine.

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 or nurse may monitor you for longer periods after your infusion.

Precautions

See also Warning section.

Before using alglucosidase 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.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

See also Warning and How To Use sections.

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.

Alglucosidase 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.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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