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US Brand Names

Description

Alglucosidase alfa injection is an enzyme that treats Pompe disease, which is also called glycogen storage disease type II. Alglucosidase alfa contains a human enzyme called acid alpha-glucosidase. This enzyme helps with the digestion and absorption of glycogen. People with Pompe disease are not able to make enough of this enzyme.

The Lumizyme™ form of this medicine is only available under a special restricted distribution program called Lumizyme™ ACE (Alglucosidase alfa Control and Education) program.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alglucosidase alfa injection in children.

Geriatric

No information is available on the relationship of age to the effects of alglucosidase alfa injection in the geriatric population.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or
• Cardiac hypertrophy (heart is larger than normal) or
• Heart rhythm problems (e.g., arrhythmia) or
• Lung disease—Use with caution. May make these conditions worse.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine must be given slowly, so the needle will remain in place for a few hours. You may also receive medicines to help prevent possible allergic reactions to the injection.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause chest pain; fever; chills; itching; hives or a rash; a fast heartbeat; flushing of the face; dizziness, fainting, or lightheadedness; trouble with breathing; or swelling of the face, tongue, and throat within a few hours after it is given. Check with your doctor or nurse right away if you or your child have any of these symptoms.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Blue lips, fingernails, or skin
• Body aches or pain
• Chest discomfort or pain
• Chills
• Cough
• Difficult or labored breathing
• Difficulty with breathing
• Difficulty with swallowing
• Dizziness
• Dry, red, hot, or irritated skin
• Ear congestion
• Fast, pounding, or irregular heartbeat or pulse
• Feeling of warmth
• Fever
• Headache
• Hives
• Increased sweating
• Irregular, fast, slow, or shallow breathing
• Itching
• Lightheadedness, dizziness, or fainting
• Loss of voice
• Nasal congestion
• Pain
• Pale skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid shallow breathing
• Redness of the face, neck, arms, and occasionally, upper chest
• Redness or pain at the catheter site
• Runny nose
• Shakiness in the legs, arms, hands, or feet
• Shortness of breath
• Skin rash
• Slow or irregular heartbeat
• Sneezing
• Sore throat
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Tightness in the chest
• Trembling or shaking of the hands or feet
• Troubled breathing
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Wheezing

• Blood in the urine
• Convulsions
• Decreased urine
• Dry mouth
• Increased thirst
• Loss of appetite
• Mood changes
• Muscle pain or cramps
• Nausea or vomiting
• Numbness or tingling in the hands, feet, or lips
• Pain in the groin or genitals
• Sharp back pain just below the ribs

• Blue-green to black skin discoloration
• Blurred vision
• Confusion
• Dilated neck veins
• Extreme fatigue
• Heart stops
• Inability to speak
• No breathing
• No pulse or blood pressure
• Pain, redness, swelling, or sloughing of the skin at the place of injection
• Seizures
• Severe or sudden headache
• Severe pain in the chest
• Slurred speech
• Sudden and severe weakness in the arm or leg on one side of the body
• Sudden onset of severe breathing difficulty
• Swelling of the face, fingers, feet, or lower legs
• Temporary blindness
• Unconscious
• Weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• Acid or sour stomach
• Belching
• Body aches or pain
• Change in hearing
• Congestion
• Constipation
• Dryness or soreness of the throat
• Ear discomfort or pain
• Ear drainage
• Earache
• Feeling of constant movement of self or surroundings
• General feeling of discomfort or illness
• Heartburn
• Hives or welts
• Hoarseness
• Indigestion
• Muscle or bone pain, stiffness, or tightness
• Muscle twitching
• Redness of the skin
• Redness or swelling in the ear
• Sensation of spinning
• Sore mouth or tongue
• Stomach discomfort, upset, or pain
• Stuffy nose
• Tender, swollen glands in the neck
• Trouble with swallowing
• Upper abdominal or stomach pain
• Voice changes
• White patches in the mouth or on the tongue

• Bloody nose
• Sleepiness or unusual drowsiness

• Burning, dry, or itching eyes
• Discharge, excessive tearing
• Muscle spasm
• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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