Alglucosidase alfa Intravenous

In the U.S.

• Lumizyme
• Myozyme

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Enzyme

A nurse or other trained health professional will give you or your child alglucosidase alfa in a hospital. alglucosidase alfa is given through a needle placed in one of your veins.

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

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 swallowing
• dizziness
• dry, red, hot, or irritated skin
• ear congestion
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• headache
• hives, itching, or skin rash
• increased sweating
• irregular, fast, slow, or shallow breathing
• 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
• 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

• 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
• 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
• tender, swollen glands in the neck
• upper abdominal or stomach pain
• voice changes
• welts
• 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.

Consult your pharmacist.

How to use Alglucosidase Alfa Solution, Reconstituted (Recon Soln)

Consult your pharmacist.

Consult your pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.