Cerezyme

Cerezyme

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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. 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.

What Is Gaucher Disease Type 1?

Gaucher (pronounced go-shay) disease is a rare, progressive, inherited condition that causes a fatty substance, called glucosylceramide (gloo-ko-sil-sara-mide, also called GL-1) to build up in certain organs or bones. As GL-1 builds up, people with Gaucher disease may experience excessive bruising and bleeding, and protruding abdomens caused by swelling of the liver and/or spleen.

It is the buildup of GL-1 that causes the signs and symptoms of Gaucher disease, but some patients may not have any symptoms at all despite disease progression.

There are 3 types of Gaucher disease (Types 1, 2, and 3), more than 90% of patients have type 1 making it the most common. Gaucher disease type 1 can be effectively managed once a diagnosis is made. The goal of treatment is to reduce or prevent the buildup of GL-1. Treatment for Gaucher disease type 1 not only helps alleviate certain symptoms, but can also help reduce the chance of more severe or permanent changes. The 2 treatment approaches available are substrate reduction therapy (an oral medicine) and enzyme replacement therapy (ERT).

Treatment for Gaucher disease type 1 not only helps alleviate certain symptoms, but can also help reduce the chance of more severe or permanent changes. The goal of treatment is to reduce the accumulation of GL-1. The 2 treatment approaches available are substrate reduction therapy (an oral medicine) and enzyme replacement therapy (ERT).

Treatment with Cerezyme (imiglucerase for injection)

Cerezyme is an enzyme replacement therapy (ERT), indicated for the long-term treatment of pediatric and adult patients with Gaucher disease type 1 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). Cerezyme helps your body break down the excess GL-1. If you stop or miss treatment GL-1 may re-accumulate and symptoms can return.

Dosing and Administration

Your doctor will determine your Cerezyme dose and frequency. Dose should be individualized to each patient and is based on weight and disease severity. Cerezyme is given by intravenous (IV) infusion, meaning that the medication is delivered directly into your bloodstream. An infusion of Cerezyme typically takes 1-2 hours. It is generally administered every two weeks. If you miss an infusion, talk to your doctor about whether you need to make up the dose.

Side Effects

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. Patients should notify their physician immediately if they experience any side effects while undergoing treatment with Cerezyme. For more information, consult your physician.

Before Taking Cerezyme

Therapy with Cerezyme does not mean you should stop using other medication. You should tell your doctor or pharmacist if you are using, have used recently, or might use any other medicine, including over-the-counter medicines and herbal supplements, while taking Cerezyme. You should not change your medication unless directed to do so by your doctor. Your doctor will work with you to determine the appropriate course of treatment.

Talk to your doctor about any of the following situations that apply to you, as they may affect how your doctor will choose to treat you.

  • Pregnancy or breast-feeding: It is not known whether Cerezyme can cause fetal harm when administered to a pregnant woman or can affect the ability to get pregnant. Cerezyme should not be administered during pregnancy except when the indication and need are clear and the potential benefit is judged by your doctor to substantially justify the risk. If you think you are pregnant or if you plan to become pregnant, your doctor needs to know as soon as possible. Also, tell your doctor if you are breastfeeding. It is not known whether Cerezyme is present in the mother’s milk. Because many drugs are present in the mother’s milk, caution should be exercised when Cerezyme is administered to a nursing woman.
  • Medical problems or allergies: Be sure your doctor is aware of any medical problems or allergies you have now or have had in the past even if they are not related to Type 1 Gaucher disease. Other medications: Talk to your doctor about any medications you are taking, including over-the-counter medicines and dietary supplements (vitamins).

There are no known contraindications (a specific situation where a drug, procedure, or surgery should not be used, because it may be harmful to the patient) to the use of Cerezyme. Your doctor should carefully re-evaluate treatment if you experience a significant allergic reaction while taking Cerezyme. The safety and effectiveness of Cerezyme in patients younger than 2 years have not been established.

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)