Lumizyme injection

Lumizyme injection

Lumizyme injection

What is Lumizyme?

Lumizyme is used to treat a glycogen storage disorder called Pompe disease (also called GAA deficiency) in adults and children.

Lumizyme may also be used for purposes not listed in this medication guide.

Warnings

Some people who received Lumizyme have experienced severe allergic reactions during or shortly after infusion of this medicine.Tell your caregivers or get medical help immediately if you notice any signs of a serious allergic reaction.such as itching, rash, redness or tingling, severe headache, dizziness, fast or slow heartbeat, wheezing, difficulty breathing, pale skin and blue lips or fingernails.

Before you receive Lumizyme, tell your doctor if you have heart disease, lung disease, a breathing disorder, or if you are allergic to mice, hamsters, or medicines made from “murine” proteins.

Before each injection, tell your doctor if you have recently had a cold, flu, or other illness. Some people who received a Lumizyme injection have experienced a reaction to the infusion. This type of reaction can occur when the medicine is injected into the vein or up to 3 hours after the injection.

Before you take this medicine

To make sure Lumizyme is safe for you, tell your doctor if you have ever had:

• heart disease; or

• Lung disease or breathing disorder.

Babies who develop Pompe disease in the first year of life may need special medical tests to improve treatment with Lumizyme.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or planning to become pregnant.

You should not breastfeed within 24 hours of using Lumizyme.If you use a breast pump during this time, throw away any collected milk. Do not feed it to your baby.

Your name may be listed in the Pompe Register. This is to track the progress of your disease and the outcome of your treatment with Lumizyme.

How is Lumizyme administered?

Lumizyme is given as an infusion into a vein. A doctor will give you this injection.

Lumizyme must be administered slowly and the intravenous infusion may take up to 4 hours.

This medicine is usually given every 2 weeks.

Before each injection, tell your doctor if you have recently had a cold, flu, or other illness.

If you need surgery, tell the surgeon in advance that you are using Lumizyme.

Lumizyme can have long-lasting effects on your body. Your blood will need to be tested every 3 months for 2 years and once a year thereafter.

Dosage information

Usual Adult Dose for Pompe Disease:

20 mg/kg as an intravenous infusion every 2 weeks

Comments:
-The total infusion volume depends on the patient's body weight and should be infused over a period of approximately 4 hours.

Usual Pediatric Dose for Pompe Disease:

20 mg/kg as an intravenous infusion every 2 weeks

Comments:
-The total infusion volume depends on body weight and should be infused over a period of approximately 4 hours.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Lumizyme injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid while taking Lumizyme?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

Side effects of Lumizyme

If necessary, get emergency medical helpSigns of an allergic reaction to Lumizyme: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Some allergic reactions may occur during the injection or up to 3 hours afterward. Tell your caregivers or get emergency medical help immediately if you have:

• a feeling as if one might faint, even while lying down;

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• bronchospasm (wheezing, tightness in the chest or throat, difficulty breathing);

• pale skin, cold or clammy skin, blue lips or fingernails, cold hands or feet;

• warmth, redness, numbness, or tingling under the skin;

• rash, itching, sweating, fever;

• severe headache, nausea, restlessness or nervousness;

• seizure (convulsions); or

• fast heartbeat, throbbing in the neck or ears, fear, confusion.

Also call your doctor immediately if you have:

• skin changes (wounds, lesions, ulcers, discoloration); or

• swollen eyes, swelling of the ankles or feet, weight gain, foamy urine.

Common side effects of Lumizyme may include:

• hives; difficult breathing; swelling of your face, lips, tongue, or throat;

• pale skin, blue lips, feeling hot or feverish;

• rash, itching, redness (warmth, redness, or tingling);

• Headache, dizziness, restlessness, muscle twitching;

• fast heartbeat, rapid breathing, chest discomfort, cough;

• increased blood pressure;

• nausea, vomiting;

• trembling, shaking, increased sweating; or

• Muscle pain, fatigue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs affect Lumizyme?

Other medications may interact with alglucosidase alfa, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and only use Lumizyme for the prescribed indication.