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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... View more

Safety

Cerezyme is the ONLY ERT (enzyme replacement therapy) that hasshown long-term efficacy and safety in multiple studies over 10 yearsand has been prescribed for over 20 years.

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Possible side effects

As with any medicine, there may be possible side effects with Cerezyme.
Side effects related to Cerezyme administration have been reported in approximately 13.8% of patients

  • Other side effects, which occurred in less than 2% of the total patient population, include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and rapid heart rate
  • Because Cerezyme therapy is administered by intravenous infusion, reactions at the site of injection may occur, including discomfort, itching, burning, swelling or uninfected abscess

Most commonly reported side effects

In children (age 2 to 12 years)
Difficulty breathing
Fever
Nausea
Flushing
Vomiting
Coughing
In adolescents (>12 to 16 years)
and in adults (>16 years)
Headache
Itchy skin
Rash

Allergic reaction

Use Cerezyme carefully if you have had an allergic reaction to the treatment in the past

  • Symptoms suggestive of allergic reaction happened in 6.6% of patients, and included anaphylactoid reaction (a serious allergic reaction), itching, flushing, hives, an accumulation of fluid under the skin, chest discomfort, shortness of breath, coughing, cyanosis (a bluish discoloration of the skin due to diminished oxygen), and low blood pressure

Immune responses

Approximately 15% of patients have developed immune responses due to a higher risk of an allergic reaction or a hypersensitivity

  • Most of immune responses occurred within the first 6 months, and rarely after 12 months of therapy
  • Your doctor should monitor you for immune response during the first year of treatment

Immune responses did not interfere with the effectiveness of Cerezyme


High blood pressure in lung arteries and pneumonia

In less than 1% of the patient population, high blood pressure in the arteries in the lungs and pneumonia (lung infection) have also been seen during treatment with Cerezyme.

  • These two conditions are known complications of Gaucher disease and have been observed both in patients receiving and not receiving Cerezyme

Notify your doctor immediately if you experience any side effects while undergoing treatment with Cerezyme

What is Cerezyme?

Choose Cerezyme

The ERT of choice for children and adults with Gaucher disease type 1

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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:

  • anemia (low red blood cell count)
  • thrombocytopenia (low blood platelet count)
  • bone disease
  • 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).