Alglucosidase Alfa Injection (ALGLUCOSIDASE ALFA - INJECTION)

Instructions

This medicine is given as an IV injection into a vein.

This medicine should be given over 4 hours.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The medicine needs to be mixed before being injected.

Follow package direction for diluting medicine with IV fluids or as instructed by your doctor or nurse.

Do not dilute the medicine until ready to use.

Always inspect the medicine before using.

The liquid should be clear and colorless.

Do not use the medicine if it contains any opaque particles or if it has changed color.

Check the medicine before each use. If the liquid medicine has any particles in it, appears discolored, or if the vial appears damaged, do not use it.

It is normal for the medicine to contain some thin clear or white fibers.

Gently tilt and roll the vial to mix the medicine. Do not shake, swirl, or invert the vial.

Keep medicine in refrigerator. Do not freeze. Protect from light.

Keep the medicine in its original container.

Take the medicine out of the refrigerator about 30 minutes before use to warm to room temperature.

Inject the medicine immediately after mixing.

Never use any medicine that has expired.

Discard any remaining medicine after your dose is given.

Discard any unused, mixed medicine after 24 hours in refrigerator.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Brand Name(s): Lumizyme

Generic Name: Alglucosidase Alfa

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• headaches
• nausea and vomiting
• sweating

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• wheezing or difficulty breathing
• chest pain
• dizziness
• swelling of the face, mouth, tongue or throat
• feeling of heat or flushing
• fast, irregular, or slow heartbeat
• itching
• signs of kidney damage (such as change in urine color or bubbly urine)
• shakiness
• shortness of breath
• red, peeling or blistering skin
• blood in urine

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.