Cerezyme® (generic name: imiglucerase) is an ‌enzyme replacement therapy (ERT)‌ developed by Sanofi Genzyme for Gaucher disease. It is a recombinant DNA-derived analog of human β-glucocerebrosidase, which catalyzes the hydrolysis of accumulated glucocerebroside into glucose and ceramide to reduce toxic lipid storage in macrophages.

Indications

Cerezyme® is indicated for ‌long-term ERT treatment‌ in adult and pediatric patients (2 years of age and older) with confirmed Type 1 or chronic neuropathic (Type 3) Gaucher disease with clinically significant non-neurological manifestations, including:

Anemia and thrombocytopenia
Bone disease (osteoporosis, bone pain, osteonecrosis)
Hepatosplenomegaly (enlarged liver or spleen)

Latest Progress
In China, Cerezyme® is the ‌only domestically approved treatment for Gaucher disease‌. As of 2023, it has been included in the serious illness insurance coverage in 23 Chinese provinces, significantly reducing patients’ financial burden.
In January 2026, the FDA expanded its approval to formally cover Type 3 Gaucher disease with significant non-neurological symptoms, marking the first approved therapy specifically for this subtype, benefiting more patients worldwide.
Long-term clinical data over 25 years has confirmed its sustained efficacy and safety, with maintained improvement in hematological indicators and organ volume in most patients.

Common Side Effects

Reported common side effects in clinical use include:

Systemic reactions: Back pain, chills, dizziness, fatigue, headache, pyrexia (fever)
Gastrointestinal reactions: Nausea, vomiting, abdominal pain, diarrhea
Infusion-related and hypersensitivity reactions: Itching, flushing, hypotension, dyspnea, cyanosis, rare severe anaphylaxis. Risk can be reduced by pre-treatment with antihistamines or corticosteroids for sensitive patients
In children (2–12 years old), the most common adverse reactions are dyspnea, fever, nausea, and vomiting, while headache and rash are more frequent in adults

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