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 product, severe allergic reactions are possible. Anaphylaxis has been observed in patients treated with ELELYSO. If anaphylaxis occurs, ELELYSO should be discontinued immediately, and appropriate medical treatment should be initiated.
In patients who have experienced anaphylaxis during infusion with ELELYSO or with other enzyme replacement therapies (ERTs), caution should be exercised upon retreatment; appropriate medical support should be readily available.
Infusion reactions (including allergic reactions), defined as a reaction occurring within 24 hours of the infusion, were the most commonly observed reactions in patients (44%-46%) treated with ELELYSO in clinical studies. The most commonly observed symptoms of infusion reactions were headache (16%), chest pain or discomfort (6%), asthenia (7%), fatigue (5%), urticaria (7%), erythema (5%), increased blood pressure (5%), back pain and arthralgia (7%), and flushing (6%). Less common infusion or allergic reactions (<2%) included angioedema, wheezing, dyspnea, coughing, cyanosis, and hypotension. Most of these reactions were mild and did not require treatment intervention.
Base the management of allergic or infusion reactions on the type and severity of the reaction, e.g., temporarily stopping the infusion and/or decreasing the infusion rate, and/or treating with medications such as antihistamines and/or antipyretics.
Pretreatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required. Patients were not routinely premedicated prior to infusion of ELELYSO during clinical studies.
Other commonly observed adverse reactions in ≥10% of patients were URTI/nasopharyngitis, pharyngitis/throat infection, headache, arthralgia, influenza/flu, UTI/pyelonephritis, back pain, and extremity pain. One patient experienced a type III immune-mediated skin reaction (fixed drug eruption).
As with all therapeutic proteins, patients have developed IgG antidrug antibodies (ADA) to ELELYSO. In a clinical study, 17 of 32 treatment naive patients (53%) who were administered ELELYSO developed ADA posttreatment. In a second clinical study, 4 of 28 patients (14%) switched from imiglucerase treatment to ELELYSO treatment developed ADA after the switch. The relevance of ADA to therapeutic response and adverse events is currently unclear.
It is unknown if the presence of ADA to ELELYSO is associated with a higher risk of infusion reactions. Patients who develop infusion or immune reactions with ELELYSO should be monitored for ADA. Additionally, patients with an immune reaction to other ERTs who are switching to ELELYSO should be monitored for ADA to ELELYSO.
Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to ELELYSO with the incidence of antibodies to other products may be misleading.
Please see full Prescribing Information.
*ELELYSO™ (taliglucerase alfa) for injection $0 Co-Pay Program Terms and Conditions apply.
Click here to view full Terms and Conditions.
- This program is not health insurance
- The co-pay program is available only through the Gaucher Personal Support program
- For any questions, please call Gaucher Personal Support at 1-855-ELELYSO (1-855-353-5976). Gaucher Personal Support, 17877 Chesterfield Airport Road, Chesterfield, MO 63005
- No membership fees required. Average co-pay savings per patient per year is $2,000. The maximum limit is $10,000 per year or the amount of the co-pay you paid, whichever is less
†For eligible patients, ELELYSO can be mixed and ready by calling ahead to the infusion site. (Not available at all
infusion sites.)
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 product, severe allergic reactions are possible. Anaphylaxis has been observed in patients treated with ELELYSO. If anaphylaxis occurs, ELELYSO should be discontinued immediately, and appropriate medical treatment should be initiated.
In patients who have experienced anaphylaxis during infusion with ELELYSO or with other enzyme replacement therapies (ERTs), caution should be exercised upon retreatment; appropriate medical support should be readily available.
Infusion reactions (including allergic reactions), defined as a reaction occurring within 24 hours of the infusion, were the most commonly observed reactions in patients (44%-46%) treated with ELELYSO in clinical studies. The most commonly observed symptoms of infusion reactions were headache (16%), chest pain or discomfort (6%), asthenia (7%), fatigue (5%), urticaria (7%), erythema (5%), increased blood pressure (5%), back pain and arthralgia (7%), and flushing (6%). Less common infusion or allergic reactions (<2%) included angioedema, wheezing, dyspnea, coughing, cyanosis, and hypotension. Most of these reactions were mild and did not require treatment intervention.
Base the management of allergic or infusion reactions on the type and severity of the reaction, e.g., temporarily stopping the infusion and/or decreasing the infusion rate, and/or treating with medications such as antihistamines and/or antipyretics.
Pretreatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required. Patients were not routinely premedicated prior to infusion of ELELYSO during clinical studies.
Other commonly observed adverse reactions in ≥10% of patients were URTI/nasopharyngitis, pharyngitis/throat infection, headache, arthralgia, influenza/flu, UTI/pyelonephritis, back pain, and extremity pain. One patient experienced a type III immune-mediated skin reaction (fixed drug eruption).
As with all therapeutic proteins, patients have developed IgG antidrug antibodies (ADA) to ELELYSO. In a clinical study, 17 of 32 treatment naive patients (53%) who were administered ELELYSO developed ADA posttreatment. In a second clinical study, 4 of 28 patients (14%) switched from imiglucerase treatment to ELELYSO treatment developed ADA after the switch. The relevance of ADA to therapeutic response and adverse events is currently unclear.
It is unknown if the presence of ADA to ELELYSO is associated with a higher risk of infusion reactions. Patients who develop infusion or immune reactions with ELELYSO should be monitored for ADA. Additionally, patients with an immune reaction to other ERTs who are switching to ELELYSO should be monitored for ADA to ELELYSO.
Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to ELELYSO with the incidence of antibodies to other products may be misleading.
Please see full Prescribing Information.
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:- 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"]).
- 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.
- 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.
- 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.
- This co-pay program is not valid where otherwise prohibited by law.
- Cannot be combined with any other rebate/coupon, free trial or similar offer for the specified prescription.
- This program is not health insurance.
- 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.
- Offer good only in the US and Puerto Rico.
- Pfizer reserves the right to rescind, revoke or amend the program without notice.
- This co-pay program expires 12/31/2014.
