alglucosidase alfa (injection)

What is the most important information I should know about alglucosidase alfa?

What is alglucosidase alfa?

Alglucosidase alfa helps replace an enzyme that is missing in people with a certain genetic disorder.

Alglucosidase alfa is used to treat a glycogen storage disorder called Pompe disease, (also called GAA deficiency) in adults and children.

Alglucosidase alfa may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before receiving alglucosidase alfa?

Tell your doctor if you have ever had:

• heart disease; or
• lung disease or breathing disorder.

Babies who develop Pompe disease in the first year of life may need specialized medical tests to improve treatment with alglucosidase alfa treatment.

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.

How is alglucosidase alfa given?

Alglucosidase alfa is given as an infusion into a vein. 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.

If you need surgery, tell the surgeon ahead of time that you are using alglucosidase alfa.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving alglucosidase alfa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of alglucosidase alfa?

• a 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.

• 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:

• hives; difficult breathing; swelling of your face, lips, tongue, or throat;
• pale skin, blue lips, feeling hot or feverish;
• skin rash, itching, flushing (warmth, redness, or tingly feeling);
• headache, dizziness, agitation, muscle twitching;
• fast heart rate, rapid breathing, chest discomfort, cough;
• increased blood pressure;
• 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.

What other drugs will affect alglucosidase alfa?

Other drugs may affect alglucosidase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about alglucosidase alfa.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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