Aldurazyme, illustration of injection vial form (not a photo of the actual pack)

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Aldurazyme

Laronidase

Prescription required

$1115.00

500U/5ml · 1 vial

BrandBranded medicine· By Sanofi (via Genzyme/BioMarin)

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FDA boxed warningHypersensitivity reactions including anaphylaxis, and acute respiratory complications associated with administration

Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment.

Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions and require additional monitoring. Appropriate respiratory support should be available during infusion.

Read this with the rest of the clinical information

About Aldurazyme

Overview

Aldurazyme (laronidase) is an enzyme replacement medicine given by intravenous infusion. It treats adults and children with the Hurler and Hurler-Scheie forms of mucopolysaccharidosis I (MPS I), and patients with the Scheie form who have moderate to severe symptoms. It supplies an enzyme that is deficient in MPS I, helping cells break down substances called glycosaminoglycans that would otherwise build up in the body. Its effects on the central nervous system symptoms of MPS I have not been evaluated.

What it treats

- Hurler and Hurler-Scheie forms of mucopolysaccharidosis I (MPS I) in adults and children. - Scheie form of MPS I in patients with moderate to severe symptoms.

Safety information

Side effects

Common side effects include infusion reactions such as fever, chills, increased blood pressure, a fast heartbeat and reduced blood oxygen levels in patients aged 6 months and older. In patients aged 6 years and older, common side effects also include rash, upper respiratory tract infection, reactions at the injection site, overactive reflexes, tingling or prickling sensations, flushing and difficulty accessing a vein. Serious reactions include severe allergic reactions, including anaphylaxis, sudden breathing complications, acute heart and breathing failure, and severe infusion reactions. Seek immediate medical attention if a serious reaction occurs. Patients with a fever or respiratory illness at the time of infusion may be at greater risk of infusion reactions. Patients prone to fluid overload may be at increased risk of serious worsening of heart or breathing problems during infusion. Tell the treating doctor about these conditions before an infusion.

FDA boxed warning

Hypersensitivity reactions including anaphylaxis, and acute respiratory complications associated with administration

Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue ALDURAZYME immediately and initiate appropriate medical treatment.

Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions and require additional monitoring. Appropriate respiratory support should be available during infusion.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical help immediately for new or worsening trouble breathing during an infusion. - Tell the infusion team immediately if you develop fever, chills or a fast heartbeat. - Tell the infusion team immediately if you develop a rash or sudden redness or warmth of the skin.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

The FDA label lists no contraindications for Aldurazyme. Extra caution is needed if you have a fever or an acute respiratory illness at the time of infusion, as these may increase the risk of infusion reactions. Your healthcare team may consider delaying the infusion. Sleep apnea is common in people with MPS I. Your healthcare team may assess whether your airway is clear before treatment begins. Appropriate breathing support should be available during infusion. People susceptible to fluid overload may be at increased risk of serious worsening of heart or breathing problems during infusion. Appropriate medical monitoring and support should be available. If a severe infusion-related reaction occurs, Aldurazyme must be stopped and appropriate medical treatment started.

Using Aldurazyme

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] (DailyMed, retrieved 19 September 2026).

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