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Lumizyme
Alglucosidase Alfa
$986.00
50mg · 50 vial
BrandBranded medicine· By Sanofi
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FDA boxed warningHypersensitivity reactions including anaphylaxis, immune-mediated reactions, and risk of acute cardiorespiratory failure
Hypersensitivity Reactions Including Anaphylaxis
Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate LUMIZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LUMIZYME and immediately initiate appropriate medical treatment, including use of epinephrine.
Immune-Mediated Reactions
Risk of Acute Cardiorespiratory Failure
Infantile-onset Pompe disease (IOPD) patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload and require additional monitoring.
About Lumizyme
Overview
Lumizyme contains alglucosidase alfa, an enzyme replacement medicine given by intravenous infusion. It is used to treat Pompe disease, an inherited condition caused by a lack or marked deficiency of the enzyme acid alpha-glucosidase (GAA). It works by supplying GAA to help break down glycogen inside cells.
What it treats
Pompe disease (acid alpha-glucosidase [GAA] deficiency).
Safety information
Side effects
Commonly reported side effects include rash, hives, fever, flushing or feeling hot, headache, increased sweating, nausea, vomiting, cough, dizziness, tiredness, muscle pain or twitching, chills, shaking and agitation. Serious reactions include severe allergic reactions, including anaphylaxis, and reactions associated with the infusion. Contact a doctor immediately for chest discomfort, rapid breathing, a fast heartbeat, reduced oxygen levels, bluish skin, or signs of an allergic reaction such as rash or hives. Increased blood pressure and pale or red skin have also been reported. Abnormal heart rhythms and sudden cardiac death are risks during general anesthesia for placement of a central venous catheter intended for Lumizyme infusion. Antibodies against alglucosidase alfa may also develop.
FDA boxed warning
Hypersensitivity reactions including anaphylaxis, immune-mediated reactions, and risk of acute cardiorespiratory failure
Hypersensitivity Reactions Including Anaphylaxis
Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate LUMIZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LUMIZYME and immediately initiate appropriate medical treatment, including use of epinephrine.
Immune-Mediated Reactions
Risk of Acute Cardiorespiratory Failure
Infantile-onset Pompe disease (IOPD) patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload and require additional monitoring.
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
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no contraindications to Lumizyme. Caution is needed because infusion-associated reactions can occur. If a reaction develops, the healthcare team may slow or temporarily stop the infusion and/or give antihistamines or fever-reducing medicines. General anesthesia for placement of a central venous catheter for Lumizyme infusion requires caution because of the risk of abnormal heart rhythms and sudden cardiac death. Patients with infantile-onset Pompe disease are at risk of developing antibodies against alglucosidase alfa. They should have an early cross-reactive immunologic material (CRIM) assessment and be managed by a specialist familiar with immune tolerance induction in Pompe disease.
Using Lumizyme
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 LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] (DailyMed, retrieved 19 September 2026).
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