Elelyso

/ Pfizer

Recommendations Prior to Treatment
Administration of this medical product should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Initiate ELELYSO in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. To reduce the risk of hypersensitivity reactions, consider pretreatment with antihistamines and/or corticosteroids.
Recommended Dosage: Treatment-naïve patients: The recommended dosage for treatment-naïve adult and pediatric patients above 2 years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion.
Patients switching from imiglucerase: If it is acceptable to switch from a stable imiglucerase dosage to Taliglucerase alfa, initiate Taliglucerase alfa intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer this medical product every other week. Dosage adjustments can be made based on achievement and maintenance of each patient’s therapeutic goals.
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Taliglucerase alfa for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults and pediatric patients above 2 years with a confirmed diagnosis of Type 1 Gaucher disease.

Hypersensitivity to the active substance or to any of the excipients.

Hypersensitivity Reactions Including Anaphylaxis
Administration 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. This medical product should be initiated 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.
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Headache, arthralgia, fatigue, vomiting.
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Pregnancy: There are no adequate and well-controlled studies of Taliglucerase alfa in pregnant women.
Lactation: It is not known whether Taliglucerase alfa is present in human milk.
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Storage: Store Taliglucerase alfa under refrigeration at 2° C to 8° C. Do not freeze. Protect vials from light.
See prescribing information for full details.