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HomeClinical DataDosingSupport & ResourcesSupport & ResourcesMaterialsELELYSO Request FormAccess and Support for ELELYSO PatientsPatient Support Offerings

Prescribing Information, including BOXED WARNING

Indication

Access and Support for ELELYSO PatientsPfizer Gaucher Personal Support (GPS)

The Pfizer Gaucher Personal Support (GPS) program can help address some of the financial and insurance benefit concerns of patients taking ELELYSO, and can provide them infusion support*

 

*Pfizer GPS does not provide infusion administration support.

The GPS program offers patients, as well as their parents and caregivers, several support options.

Pfizer GPS Case Manager
  • A GPS Case Manager is the primary contact to help coordinate ELELYSO support offerings for patients, parents, and caregivers
  • The GPS team is available by phone to assist your patients
TitleCall Pfizer Gaucher Personal Support (GPS) at 1-855-ELELYSO (1-855-353-5976)     Financial Assistance & Access Support for Your Patients

  • Help eligible, commercially insured patients gain access to co-pay savings

  • Help with insurance benefits verification and understanding prior authorization requirements
  • Provide information regarding insurance coverage appeals process
  • Provide support to patients experiencing an insurance change
Elelyso Co-pay Program

  • Eligible commercially insured patients may pay as low as $0 per prescription*

  • To enroll patients in the Elelyso Co-pay Program, please call Gaucher Personal Support at 1-855-ELELYSO (1-855-353-5976)

Pfizer Patient Assistance Program†
  • ELELYSO may be available at no cost to qualified uninsured or government insured patients‡
Eligibility required. Annual savings up to $15,000. State and federal beneficiaries not eligible. Terms and conditions apply; see below.The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.Eligible patients must meet financial qualifications and also be diagnosed with the FDA-approved indication. They must be US residents who are treated by US physicians and must complete the Patient Assistance Program Application and Patient Authorization Form.

TERMS AND CONDITIONS

By using this co-pay card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
  • Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Patient must have private insurance. Offer is not valid for cash paying patients. The value of this Co-pay Card is limited to a maximum of $15,000 per calendar year.
  • This co-pay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
  • You must deduct the value of this co-pay card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the co-pay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the co-pay card, as may be required. You should not use the co-pay card if your insurer or health plan prohibits use of manufacturer co-pay cards.
  • This co-pay card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third party insurance.
  • This co-pay card is not valid where prohibited by law.
  • Co-pay card cannot be combined with any other savings, free trial or similar offer for the specified prescription.
  • Co-pay card will be accepted only at participating pharmacies.
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • This co-pay card 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).
  • Offer good only in the U.S. and Puerto Rico.
  • Co-pay card is limited to 1 per person during this offering period and is not transferable.
  • No other purchase is necessary.
  • No membership fee.  
  • Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other co-pay card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke or amend this offer without notice.
  • Offer expires 12/31/2023. 
For more information, visit our website www.elelyso.com, call 1-855-353-5976, or contact us at 2730 S. Edmonds Lane, Suite 300, Lewisville, TX 75067.

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2025 Pfizer Inc. All rights reserved.

PP-ELE-USA-0686
IndicationELELYSO® (taliglucerase alfa) for injection is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease.
Important Safety Information

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred in some ELELYSO-treated patients. Administration of ELELYSO should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions, including anaphylaxis.  Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate ELELYSO in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. Observe patients closely for 3 hours after the start of each infusion. If a severe hypersensitivity reaction occurs, discontinue ELELYSO and immediately initiate appropriate medical treatment, including use of epinephrine.  

 

In clinical trials, (patients were not routinely pretreated with antihistamines and/or corticosteroids prior to ELELYSO infusions during the clinical trials):

2 of 72 (3.0%) ELELYSO-treated patients experienced signs and symptoms of anaphylaxis, including urticaria, hypotension, flushing, wheezing, chest tightness, nausea, vomiting, and dizziness. These reactions have occurred during ELELYSO infusion.

 

21 of 72 (29%) ELELYSO-treated patients experienced hypersensitivity reactions, including the 2 ELELYSO-treated patients who experienced signs and symptoms consistent with anaphylaxis. This included pruritus, angioedema, flushing, erythema, rash, nausea, vomiting, cough, chest tightness, and throat irritation. These reactions occurred during ELELYSO infusion and up to 3 hours after the start of infusion.

ELELYSO-treated patients who developed anti-taliglucerase alfa antibodies (referred to as anti-drug antibodies (ADA)) generally had a greater frequency of hypersensitivity reactions compared to those who did not develop ADA. Closely monitor for hypersensitivity reactions in patients who develop ADA.

 

Management of hypersensitivity reactions should be based on the severity of the reaction and includes slowing or temporary interruption of the infusion and/or administration of antihistamines, antipyretics, and/or corticosteroids for mild reactions. To reduce the risk of hypersensitivity reactions, consider pretreatment with antihistamines and/or corticosteroids. If a severe hypersensitivity reaction (e.g. anaphylaxis occurs), discontinue ELELYSO and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

 

Consider the risks and benefits of re-administering ELELYSO in patients who have experienced a severe hypersensitivity reaction associated with ELELYSO. Caution should be exercised upon rechallenge.

 

The most common adverse reactions (≥5%) in treatment-naïve adults treated with ELELYSO were headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, and urticaria.

 

The most common adverse reaction (≥10%) for treatment-naïve pediatric patients treated with ELELYSO was vomiting.

The most common adverse reactions (≥10%) in patients who switched from imiglucerase to ELELYSO were arthralgia, headache, and pain in extremity.

 

Clinical trials (Trials 1, 2 and 3) evaluated ELELYSO enzyme replacement therapy (ERT)-naïve and ERT- experienced adult and pediatric patients with Gaucher disease. In patients with Type 1 Gaucher disease, hypersensitivity reactions occurred in 36% (9/25) of ELELYSO treated patients who developed ADA during the treatment period and in 15% (6/41) of ELELYSO-treated patients who did not develop ADA during the treatment period. Of the 9 ELELYSO-treated patients who tested positive for ADA and who developed hypersensitivity reactions, 2 patients had anaphylaxis and 1 additional patient discontinued ELELYSO due to hypersensitivity reactions.

 

The recommended dosage for treatment-naïve adult and pediatric patients 4 years of age and older is 60 units per kg of body weight administered once every 2 weeks as a 60- to 120-minute intravenous infusion.

 

If it is acceptable to switch from a stable imiglucerase dosage to ELELYSO, initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer ELELYSO every other week. Dose adjustments can be made based on achievement and maintenance of each patient’s therapeutic goals.

 

ELELYSO is supplied as 200 units per vial and is available by prescription only.

 

Please click here for Full Prescribing Information, including BOXED WARNING. 

 

Indication ELELYSO® (taliglucerase alfa) for injection is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease.

Please click here for Full Prescribing Information, including BOXED WARNING.