Charitable Access Program
The Charitable Access Program (CAP) has been established in the United States through the Genzyme Charitable Foundation, Inc. The program is committed to providing Cerezyme® to individuals who:
- Medically need Cerezyme and
- Are uninsured or have inadequate insurance coverage for Cerezyme
Qualified individuals with Gaucher disease whose physicians have recommended treatment with Cerezyme may be eligible for the Charitable Access Program. To be considered for the program, your patient will be asked to provide the following:
Your Genzyme Case Manager will coordinate with you and your patient to help obtain the necessary documentation and will keep you updated on the status of your patient's application. Applications are reviewed on a monthly basis and are kept confidential by the Charitable Access Program Committee. If your patient is ineligible for our program, your Genzyme Case Manager will work with you and your patient to explore alternative coverage options.
Please note that the Charitable Access Program is considered a temporary program. Patients and their families are expected to continue exploring alternative resources with the assistance of a Genzyme Case Manager. These may include:
- Private insurance
- Government programs
To Learn More
If you have questions about Genzyme’s Charitable Access Program, please call 1-800-745-4447, Option 3 to speak with a Genzyme Case Manager.
For additional information regarding the Charitable Access Program or to request an application form, email Genzyme:
Disclaimer: Genzyme's Charitable Access Program may be discontinued at anytime at the discretion of the Charitable Access Program Committee
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:
- bone disease
- hepatomegaly or splenomegaly
Important Safety Information
Approximately 15% of patients have developed IgG antibodies to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.
Hypersensitivity has also been observed in patients without detectable IgG antibodies. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of all patients, and anaphylactoid reactions in less than 1%. Treatment with Cerezyme should be approached with caution in patients who have exhibited hypersensitivity symptoms such as pruritus, flushing, urticarial, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Pre-treatment with antihistamines and/or corticosteroids and a reduced rate of infusion may allow continued treatment in most patients.
In less than 1% of patients, pulmonary hypertension and pneumonia have been observed during treatment with Cerezyme. These are known complications of Gaucher disease regardless of treatment. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.
Approximately 13.8% of patients have experienced adverse events related to treatment with Cerezyme. Some of these are injection site reactions such as discomfort, pruritus, burning, swelling or sterile abscess at the site at the site of venipuncture. Additional adverse reactions that have been reported include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Transient peripheral edema has also been reported for this therapeutic class of drug.
To report suspected adverse reactions, contact Genzyme at 800-745-4447, option 2 or FDA at 800-FDA-1088 or http://www.fda.gov/Safety/MedWatch
Please see Full Prescribing Information (PDF).