Agalsidase Beta (Intravenous Route)

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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 immediately if any of the following side effects occur:

• Blurred vision
• Chest pain or discomfort
• Confusion
• Cough producing mucus
• Difficulty breathing
• Difficulty in moving
• Dizziness;
• Fatigue
• Faintness or lightheadedness when getting up from a lying or sitting position suddenly
• Feeling unusually cold shivering
• Headache
• Hives or welts
• Irregular heartbeat
• Itching
• Joint pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Nervousness
• Pain
• Pounding in the ears
• Redness of skin
• Shortness of breath
• Skin rash
• Stomach pain
• Sweating
• Swelling of ankles, feet, and lower legs
• Swollen joints
• Tightness in chest
• Unusual tiredness or weakness
• Wheezing

• Cloudy or bloody urine
• Decreased cardiac output
• Difficulty in speaking
• Double vision
• Feeling of constant movement of self or surroundings
• High blood pressure
• Inability to move arms, legs, or facial muscles
• Inability to speak
• No blood pressure or pulse
• Partial loss of hearing
• Pounding or rapid pulse
• Problems with muscle control or coordination
• Sensation of spinning
• Shakiness and unsteady walk
• Slow speech
• Stopping of heart
• Swelling of face
• Swelling of the lip or ear
• Throat tightness
• Trembling
• Unconsciousness

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:

• Acid or sour stomach
• Belching
• Body aches or pain
• Body produces substance that can bind to drug making it less effective or cause side effects
• Burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• Congestion
• Discouragement
• Dryness or soreness of throat
• Fear
• Feeling sad or empty
• Fever, not related to infusion
• Heartburn
• Hoarseness
• Indigestion
• Irritability
• Lack of appetite
• Loss of interest or pleasure
• Nausea
• Pain or tenderness around eyes and cheekbones
• Paleness of skin
• Runny nose
• Sensation of change in temperature
• Skeletal pain
• Sneezing
• Stuffy nose; swelling of testes
• Tender, swollen glands in neck
• Trouble concentrating
• Trouble sleeping
• Trouble in swallowing
• Voice changes

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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