Alglucosidase Alfa

What Is Alglucosidase Alfa?

Alglucosidase alfa contains an enzyme that naturally occurs in the body in healthy people. Some people lack this enzyme because of a genetic disorder. Alglucosidase alfa helps replace this missing enzyme in such people.
Alglucosidase alfa is used to treat a glycogen storage disorder called Pompe disease, (also called GAA deficiency) in adults and children who are at least 8 years old.
Alglucosidase alfa may also be used for purposes not listed in this medication guide.
Some people receiving alglucosidase alfa have had serious allergic reactions during or shortly after infusion of this medicine. Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as itching, rash. redness or tingling, severe headache, feeling like you might pass out, fast or slow heart rate, wheezing, trouble breathing, pale skin, and blue lips or fingernails.
If you have heart disease or a breathing disorder, using alglucosidase alfa could make these conditions worse. Tell your doctor about all your medical conditions.
You should not receive alglucosidase alfa if you are allergic to it.
To make sure alglucosidase alfa is safe for you, tell your doctor if you have:

• heart disease;
• lung disease or breathing disorder;
• if you are allergic to mice, hamsters, or drug products made with "murine" proteins.

FDA pregnancy category C. It is not known whether alglucosidase alfa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
Alglucosidase alfa can pass into breast milk and may harm a nursing baby. Do not breast-feed within 24 hours after receiving alglucosidase alfa. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.
Your name may be listed on the Pompe Registry. This is to track the progress of your disease and the outcome of your treatment with alglucosidase alfa.

Alglucosidase Alfa Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people receiving alglucosidase alfa have had serious allergic reactions when the medicine was injected into the vein, or as long as 3 hours afterward. Tell your caregivers or get emergency medical help right away if you have any of these signs of a severe allergic reaction:

• feeling like you might pass out, even while lying down;
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• bronchospasm (wheezing, tight feeling in your chest or throat, trouble breathing);
• pale skin, cold or clammy skin, blue lips or fingernails, cold hands or feet;
• warmth, redness, numbness, or tingly feeling under your skin;
• rash, itching, sweating, fever;
• severe headache, nausea, feeling restless or nervous;
• seizure (convulsions); or
• fast heart rate, pounding in your neck or ears, anxiety, confusion.

Also call your doctor at once if you have:

• skin changes (sores, lesions, ulcers, discoloring); or
• puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy.

Common side effects may include:

• pale skin, blue lips, feeling hot or feverish;
• skin rash, flushing (warmth, redness, or tingly feeling);
• headache, dizziness, agitation, muscle twitching;
• fast heart rate, rapid breathing, chest discomfort, cough;
• nausea, vomiting;
• tremor, shaking, increased sweating; or
• muscle pain, tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Alglucosidase Alfa Interactions

Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Other drugs may interact with alglucosidase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Alglucosidase Alfa Dosage

Alglucosidase alfa is injected into a vein through an IV. A healthcare provider will give you this injection. Alglucosidase alfa must be given slowly, and the IV infusion can take up to 4 hours to complete.
This medicine is usually given once every 2 weeks.
Before each injection, tell your doctor if you have recently been sick with a cold, flu, or other illness.
If you need surgery, tell the surgeon ahead of time that you are using alglucosidase alfa.
Alglucosidase alfa can have long lasting effects on your body. Your blood will need to be tested every 3 months for 2 years and then once every year after that.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Call your doctor for instructions if you miss an appointment for your alglucosidase alfa injection.