Why Cerezyme?

Cerezyme is the longest studied ERT in Gaucher Disease Type 1¹.

Cerezyme:

  • Has been demonstrated to help improve many of the blood and organ-related symptoms of Type 1 Gaucher disease such as anemia (low red blood cell count), thrombocytopenia (low blood platelet count), certain symptoms of bone disease, and hepatomegaly or splenomegaly (enlarged liver or spleen)
  • Is supported by over 20 years of clinical data and experience
  • Is backed by Sanofi Genzyme’s comprehensive educational programs, insurance reimbursement support

Cerezyme has shown the positive impact that treatment can have on many manifestations of the disease.

  • In clinical trials, Cerezyme improved anemia, thrombocytopenia, reduced spleen and liver size and decreased cachexia.
  • In a study of previously untreated patients with one or more skeletal manifestations found that Cerezyme therapy improved bone pain as early as 3 months, decreased incidence of bone crisis within 12 months, and improved bone mineral density after 24 months
  • Within 4 years of initiating Cerezyme therapy, 93% of patients (n=195) in the ICGG Gaucher Registry met at least 4 of 6 therapeutic goals, including hemoglobin, platelet count, liver volume, spleen volume, bone pain, and bone crises
  • Approximately 13.8% of patients experienced adverse events which were judged to be related to Cerezyme administration and which occurred an increase in frequency. Some of the adverse events were related to the site of administration. These include discomfort, pruritus, burning, swelling, or sterile abscess at the site of venipuncture.

Additional adverse reactions that have been reported in approximately 6.5% of patients treated with Cerezyme include: nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia  

Sanofi Genzyme developed Cerezyme in 1994 in cooperation with the National Institutes of Health. Today, Sanofi Genzyme is a global leader in research and product development for Gaucher disease and other lysosomal storage disorders.

Reference. 1. Data on file. Genzyme Corporation; Cambridge, MA.

Indication & Usage

Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

  1. anemia (low red blood cell count)
  2. thrombocytopenia (low blood platelet count)
  3. bone disease
  4. hepatomegaly or splenomegaly (enlarged liver or spleen)

Important Safety Information

Approximately 15% of patients have developed immune responses (antibodies) to Cerezyme during the first year of therapy. These patients have a higher risk of an allergic reaction (hypersensitivity). Your doctor may periodically test for the presence of antibodies. Serious allergic reactions (anaphylaxis) have been reported in less than 1% of patients. Symptoms suggestive of allergic reaction happened in approximately 7% of patients, and include itching, flushing, hives, swelling, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), and low blood pressure. If you have had an allergic reaction to Cerezyme, you and your doctor should use caution if you continue to receive treatment with Cerezyme.

High blood pressure in the arteries of the lungs (pulmonary hypertension) and pneumonia have been observed in less than 1% of patients during treatment with Cerezyme. These are also known complications of Gaucher disease regardless of treatment. If you experience symptoms such as shortness of breath or chest pain, with or without fever, contact your doctor.

Approximately 14% of patients have experienced side effects related to treatment with Cerezyme. Some of these reactions occur at the site of injection such as discomfort, itching, burning, swelling or uninfected abscess. Other side effects, each of which was reported by less than 2% of patients, include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and rapid heart rate. Temporary swelling in the legs has also been observed with drugs like Cerezyme.

Please see Full Prescribing Information (PDF).

You may report side effects to the FDA at 1-800-FDA-1088.

Reference 1. Data on file. Genzyme Corporation; Cambridge, MA.