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HomeClinical DataDosingSupport & ResourcesSupport & ResourcesMaterialsELELYSO Request FormAccess and Support for ELELYSO PatientsPatient Support Offerings
Prescribing InformationIndication
Dosage and Administration Guide: 

Information on dosage, preparation, administration, billing, and storage and handling

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Clinical Data: 

Overview of ELELYSO clinical trial results

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Pfizer Gaucher Personal Support (GPS): 

Assistance for patients taking ELELYSO and their caregivers

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PP-ELE-USA-0666
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 Hypersensitivity reactions, including serious hypersensitivity reactions such as anaphylaxis, occurred in some ELELYSO-treated patients. Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment.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.
Due to the potential for anaphylaxis, appropriate medical support should be readily available during the ELELYSO infusion. Observe patients closely for 3 hours after the start of the infusion. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur.
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 severe hypersensitivity reactions including anaphylaxis occur, immediately stop the ELELYSO infusion and initiate appropriate treatment.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.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 see Full Prescribing Information.