ELELYSO™ (taliglucerase alfa) for injection is supplied as 200 Units per vial and is available by prescription only.
INDICATION
ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease.
IMPORTANT SAFETY INFORMATION
As with any intravenous protein medicine, like enzyme replacement therapy (ERT), severe allergic reactions (including anaphylaxis) have been observed in patients treated with ELELYSO. If this occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated. Patients who have experienced anaphylaxis to ELELYSO or another ERT should proceed with caution upon retreatment.
In addition, infusion reactions (including allergic reactions)—defined as a reaction occurring within 24 hours of the infusion—were the most commonly observed reactions to ELELYSO. The most commonly observed infusion reactions were headache, chest pain or discomfort, weakness, fatigue, hives, abnormal redness of the skin, increased blood pressure, back or joint pain, and flushing. Other infusion or allergic reactions included swelling of the face, mouth, and/or throat; wheezing; shortness of breath; skin color turning blue; coughing; and low blood pressure. Most of these reactions were mild and did not require treatment.
Management of infusion reactions is based on the type and severity of the reaction. Your doctor may manage infusion reactions by temporarily stopping the infusion, slowing the infusion rate, or treating with medications such as an antihistamine and/or a fever reducer. Treatment with antihistamines and/or corticosteroids prior to infusion with ELELYSO may prevent these reactions.
Other common adverse reactions observed were upper respiratory tract infections, throat infection, flu, urinary tract infection, and pain in extremities.
As with all therapeutic proteins, including ERTs, there is a possibility of developing antibodies to ELELYSO. However, it is currently unclear whether this has an impact on the clinical response or adverse reactions. Patients with an immune response to other ERTs who are switching to ELELYSO should continue to be monitored for antibodies. Comparison of the frequency of antibodies across ERTs may be misleading. Patients who have developed infusion or immune reactions with ELELYSO or with another ERT should be monitored for antidrug antibodies when being treated with ELELYSO.
If you are pregnant, or plan to become pregnant, you should talk to your doctor about potential benefits and risks.
Please click here for full Prescribing Information.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care provider, considering the unique characteristics of the patient.
This product information is intended only for residents of the United States.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Terms and Conditions
By using the co-pay program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
| 1. | This co-pay program is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma de Salud"]). |
| 2. | This co-pay program is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs. |
| 3. | 100% of prescription co-pays will be covered for the majority of patients. Average co-pay savings is $2,000 per year. The maximum limit is $10,000 per year or the amount of the co-pay you paid, whichever is less. |
| 4. | You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf. |
| 5. | This co-pay program is not valid where otherwise prohibited by law. |
| 6. | Cannot be combined with any other rebate/coupon, free trial or similar offer for the specified prescription. |
| 7. | This program is not health insurance. |
| 8. | The co-pay program is available only through the Gaucher Personal Support program. For any questions, please contact Gaucher Personal Support at 1-855-ELELYSO (1-855-353-5976). Gaucher Personal Support, 17877 Chesterfield Airport Road, Chesterfield, MO 63005. |
| 9. | Offer good only in the US and Puerto Rico. |
| 10. | Pfizer reserves the right to rescind, revoke or amend the program without notice. |
| 11. | This co-pay program expires 12/31/2014. |
Need help paying for ELELYSO™ (taliglucerase alfa) for injection? Call GPS toll free 1-855-ELELYSO (1-855-353-5976).
