Alglucosidase Alfa

Alglucosidase Alfa is used for:

Treating Pompe disease (alfa-glucosidase deficiency).

Alglucosidase Alfa is a glycoprotein. It works by replacing the enzyme alfa-glucosidase in the body.

Do NOT use Alglucosidase Alfa if:

• you are allergic to any ingredient in Alglucosidase Alfa

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alglucosidase Alfa :

Some medical conditions may interact with Alglucosidase Alfa . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have ever had a reaction (eg, swelling, trouble breathing) to any intravenous (IV) medicine
• if you are or have recently been ill
• if you have heart problems (eg, enlarged heart) or lung problems

Some MEDICINES MAY INTERACT with Alglucosidase Alfa . However, no specific interactions with Alglucosidase Alfa are known at this time.

Ask your health care provider if Alglucosidase Alfa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alglucosidase Alfa :

Use Alglucosidase Alfa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alglucosidase Alfa will be given as an injection at your doctor's office, hospital, or clinic.
• Do not use Alglucosidase Alfa if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• Continue to use Alglucosidase Alfa even if you feel well. Do not miss any doses.
• If you miss a dose of Alglucosidase Alfa , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Alglucosidase Alfa .

Important safety information:

• Lab tests, including liver function, may be performed while you use Alglucosidase Alfa . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Alglucosidase Alfa in CHILDREN; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alglucosidase Alfa while you are pregnant. It is not known if Alglucosidase Alfa is found in breast milk. If you are or will be breast-feeding while you use Alglucosidase Alfa , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Alglucosidase Alfa :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Alglucosidase Alfa is usually handled and stored by a health care provider. If you are using Alglucosidase Alfa at home, store Alglucosidase Alfa as directed by your pharmacist or health care provider. Keep Alglucosidase Alfa out of the reach of children and away from pets.

General information:

• If you have any questions about Alglucosidase Alfa , please talk with your doctor, pharmacist, or other health care provider.
• Alglucosidase Alfa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Alglucosidase Alfa . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.