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: Available data, including data from a product registry and pharmacovigilance reports, have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes in pregnant women. Additionally, there are risks associated with untreated symptomatic Type I Gaucher disease in pregnant women.
Lactation: There are no data on the presence of taliglucerase alfa in human milk, or the effects of taliglucerase alfa on milk production. Lactation data from a product registry have not identified adverse reactions in infants exposed to taliglucerase alfa during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed child from this medical product or from the underlying maternal condition.

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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.