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|Alglucosidase Alfa

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 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.

This may not be a complete list of all interactions that may occur. 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 administered as an injection at your doctor"s office, hospital, or clinic.
• If Alglucosidase Alfa contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper 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 immediately.

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 to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Alglucosidase Alfa in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Alglucosidase Alfa , discuss with your doctor the benefits and risks of using Alglucosidase Alfa during pregnancy. It is unknown if Alglucosidase Alfa is excreted in breast milk. If you are or will be breast-feeding while you are using Alglucosidase Alfa , check with your doctor or pharmacist to discuss the 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:

Constipation; cough; diarrhea; heartburn; stuffy nose.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation, irritability, or restlessness; blue skin or nails; chest pain or tightness; chills; cold hands or feet; ear pain; excessive or cold sweat; fast, slow, or irregular heartbeat; feeling hot; fever; flushing; headache; increased tear production; nausea; pain, swelling, or redness at the injection site; pale skin; purplish skin discoloration; rapid or difficult breathing; severe headache or dizziness; stomach pain; swelling of the hands, legs, or feet; throat tightness; tremor; unexplained cough; unusual tiredness or weakness; vomiting; wheezing; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), 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.