Laronidase Injection

Laronidase injection may cause serious or life-threatening allergic reactions. These reactions may occur during and up to 3 hours after your injection.Tell your doctor if you have a respiratory infection or have ever had breathing problems or any lung conditions that affect your breathing. Also tell your doctor if you use supplemental oxygen or a continuous positive airway pressure (CPAP) machine during sleep. If you experience any of the following symptoms, tell your doctor immediately: difficulty breathing, changes in heartbeat, fever, chills, dizziness, rash, hives, or swelling of the throat or tongue.

Talk to your doctor about the risks of receiving laronidase injection.

Laronidase injection is used to treat people with Hurler and Hurler-Scheie syndrome (mucopolysaccharidosis type I [MPS I)]; an inherited condition in which the body doesn't break down certain sugar substances in the body called glycosaminoglycans [GAG]). Laronidase injection is in a class of medications called enzymes. It works by helping to reduce the levels of glycosaminoglycans in the body.

Laronidase comes as a solution (liquid) to dilute and give intravenously (into a vein) by a healthcare professional. It is given once weekly at a hospital or healthcare facility.

Your doctor may prescribe medications for you to take prior to your scheduled dose to reduce the risk of serious reactions to laronidase injection. Be sure you take these medicines exactly as prescribed and ask your doctor or pharmacist if you have any questions.

Laronidase controls Hurler and Hurler-Scheie syndromes but does not cure them. Continue to receive laronidase injection even if you feel well. Do not stop receiving laronidase injection without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving laronidase,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.

Unless your doctor tells you otherwise, continue your normal diet.

Laronidase may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, redness, or swelling at the site of injection
• tingling, burning, numbness, or pricking sensation
• increased reflex response

Some side effects can be serious. If you experience symptoms listed below or in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment.

• flushing, headache, rash, swelling of face or lips or throat or tongue, feeling warm, sweating, nausea or vomiting, itching, difficulty breathing

Laronidase may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to laronidase.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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