laronidase 2.9 mg/5 mL intravenous solution

Generic name:
Laronidase - injection

Pronunciation
(lar-ON-i-dase)

Brand name(s)
Aldurazyme

Laronidase can rarely cause a very serious (sometimes fatal) allergic reaction. This reaction may occur during or up to 3 hours after the infusion. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness, fainting, or rash/hives. Your health care professional will monitor you closely for any signs of allergic reactions during your infusion and for some time after.

Before you start your infusion, tell your doctor if you have a fever or an infection (such as cold or flu) or if you have a history of heart problems (such as heart failure), breathing problems, interrupted breathing during sleep (such as sleep apnea), or swelling.

Laronidase is used to treat a certain rare genetic problem (mucopolysaccharidosis-MPS I). It works by replacing a certain natural substance (lysosomal enzyme) that is missing in people with this genetic problem. This medication improves lung function and how far you can walk. Laronidase is not a cure and treatment must be continued for life.

Read the Patient Information Leaflet if available from your pharmacist before you start using laronidase and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually every week. The injection is given by a health care professional, usually over 3 to 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. Your doctor may prescribe other medications 60 minutes before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as flushing, fever, headache, or abdominal pain. Your doctor may slow down or stop your treatment for some time. See also Warning section.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition gets worse.

See also How to Use section and Warning section.

Cold symptoms (such as stuffy/runny nose, cough) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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.

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.

See Warning section.

Before using laronidase, 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.

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.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

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.

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.

Lab and/or medical tests (such as lung function, urine tests, immunoglobulin levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

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.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.