Lumizyme

Generic name: Alglucosidase Alfa (injection)
Brand names: Lumizyme
Drug class: Lysosomal enzymes

Usage of Lumizyme

Lumizyme 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.

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

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

Lumizyme side effects

Get emergency medical help if you have signs of an allergic reaction to Lumizyme: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some allergic reactions may occur during the injection, or as long as 3 hours afterward. Tell your caregivers or get emergency medical help right away if you have:

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.

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 Lumizyme 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.

Before taking Lumizyme

To make sure Lumizyme is safe for you, 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 Lumizyme treatment.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed within 24 hours after receiving Lumizyme. 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 Lumizyme.

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How to use Lumizyme

Usual Adult Dose for Pompe disease:

20 mg/kg via IV infusion every 2 weeks Comments: -Total volume of infusion is determined by patient's body weight and should be infused over about 4 hours.

Usual Pediatric Dose for Pompe disease:

20 mg/kg via IV infusion every 2 weeks Comments: -Total volume of infusion is determined by body weight and should be infused over about 4 hours.

Warnings

Some people receiving Lumizyme 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 light-headed, fast or slow heart rate, wheezing, trouble breathing, pale skin, and blue lips or fingernails.

Before receiving Lumizyme, tell your doctor if you have heart disease, lung disease or a breathing disorder, or if you are allergic to mice, hamsters, or drug products made with "murine" proteins.

Before each injection, tell your doctor if you have recently been sick with a cold, flu, or other illness. Some people receiving an injection of Lumizyme have had a reaction to the infusion. This type of reaction can occur when the medicine is injected into the vein, or as long as 3 hours after the injection.

What other drugs will affect Lumizyme

Other drugs may interact with 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.

Disclaimer

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