Alglucosidase alfa (Injection)

Brand Name(s)

Lumizyme, Myozyme

When This Medicine Should Not Be Used

Introduction

Alglucosidase Alfa (al-gloo-KOE-si-dase AL-fa)

Treats Pompe disease (deficiency in the enzyme acid alpha-glucosidase).

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• 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.
• Your doctor may have your name placed on a patient registry list. Ask your doctor if you have any questions.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have recently been sick.
• A small number of people who have used this medicine developed serious allergic reactions. Most of the cases include heart, lung, or skin problems. Serious heart problems have also occurred in patients while receiving general anesthesia for catheter placement prior to receiving this medicine.
• 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 have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.
• This medicine may cause chest pain; fever; chills; itching; hives; flushing of the face; rash; dizziness, fainting, or lightheadedness; troubled breathing; or swelling of the face, tongue, and throat within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips, fingernails, or skin.
• Chest pain or troubled breathing.
• Ear pain or discharge, trouble hearing.
• Fast or slow heartbeat.
• Fever, chills, runny nose, cough, sore throat, and body aches.
• Lightheadedness or fainting.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Swelling on the face or around your eyes.
• Swelling in your hands, ankles, or feet.
• Swollen, painful, or tender lymph glands in neck, armpit, or groin.
• Tremors.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Agitation, irritability, or restlessness.
• Feeling of constant movement of self or surroundings.
• Headache.
• Increased sweating or tearing.
• Muscle or joint pain.
• Nausea, vomiting, diarrhea, constipation, upset stomach, or stomach pain.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
• Pale skin, or skin rash or itchiness.
• Sores or white patches on your lips, mouth, tongue, or throat.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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