Uses

This medication is used by people with a certain inherited condition (Pompe disease) to reduce high levels of a certain substance (glycogen) that builds up in the body. High levels of glycogen in the body may cause muscle weakness, heart problems, and breathing problems. Alglucosidase alfa works by breaking down glycogen.

How to use Lumizyme 50 Mg Intravenous Solution Metabolic Disease Enzyme Replacement, Pompe

Read the Patient Information Leaflet if available from your pharmacist before you start using alglucosidase alfa and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 2 weeks. It is injected slowly into a vein over 4 hours. The dosage is based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug and for a short time afterward. Tell your doctor right away if you have any symptoms of infusion reactions such as shortness of breath, fever, chills, muscle/joint pain, flushing, fast heartbeat, headache or nausea. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.

Side Effects

See also Warning and How To Use sections.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Alglucosidase alfa can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Warnings

Alglucosidase alfa may cause serious (sometimes fatal) allergic reactions that may happen during and up to 3 hours after the infusion. Your doctor may prescribe other medications (such as antihistamines, fever reducers, corticosteroids) before each treatment to help prevent these side effects. Get medical help right away if you notice any signs of a serious allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or chest pain. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Rarely, people using this medication have developed severe skin/kidney problems. Tell your doctor right away if you develop changes in skin color, change in the amount of urine, or pink/bloody urine.

Before starting treatment with this medication, tell your doctor if you have a history of heart problems (such as heart failure), breathing problems (such as fluid in the lungs), or swelling. These problems may get worse during the infusion. Your doctor or nurse may monitor you for longer periods after your infusion.

Precautions

See also Warning section.

Before using alglucosidase alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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Overdose

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Notes Notes

Lab and/or medical tests (such as urine tests, immunoglobulin levels) should be done while you are using this medication. Keep all medical and lab appointments.

Missed Dose Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage Storage

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.