Importance of Early Diagnosis
Type 1 Gaucher disease is a progressive, debilitating disease, but early diagnosis and treatment can help. Cerezyme has been shown to help relieve, reduce or reverse many of the signs and symptoms of Type 1 Gaucher disease, but some of the most serious symptoms, such as osteonecrosis (death of bone tissue) and advanced liver disease, may become irreversible if treatment is delayed.
In addition, some aspects of Type 1 Gaucher disease respond more slowly to treatment than others. For instance, improvements in bone mineral density (a measurement of bone strength) occur more slowly than blood or organ-related improvements.
Recognizing Early Symptoms
One reason diagnosis and treatment may be delayed is that some signs and symptoms of Type 1 Gaucher disease are similar to other, more common diseases, so patients may be misdiagnosed. For example, joint pain may be diagnosed as arthritis or growing pains. Low levels of red blood cells or platelets may at first be diagnosed as a blood disorder. Other misdiagnoses may include:
- Leukemia (a cancer of the blood or bone marrow)
- Lymphoma (a cancer in the lymphatic cells of the immune system)
- Bleeding disorders
- Osteomyelitis (infection of the bone)
Early diagnosis and treatment are critical to ensure optimal outcomes in Type 1 Gaucher disease. Please see Diagnosing Gaucher Disease for more information.
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). These patients have a higher risk of an allergic reaction (hypersensitivity). Use Cerezyme® (imiglucerase for injection) carefully if you have had an allergic reaction to the product in the past. Symptoms suggestive of allergic reaction happened in 6.6% of patients, and include 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.
Side effects related to Cerezyme administration have been reported in less than 15% of patients. Each of the following events occurred in less than 2% of the total patient population. Reported side effects 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: discomfort, itching, burning, swelling or uninfected abscess. Cerezyme is available by prescription only. For more information, consult your physician.
Please see Full Prescribing Information (PDF).