Rx Item-Elelyso 200U (200 Units) Powder Vial 1X1 Ea

These highlights do not include all the information needed to use ELELYSO safely and effectively. See full prescribing information for ELELYSO. ELELYSO � (taliglucerase alfa) for injection, for intravenous use Initial U.S. Approval: 2012 INDICATIONS AND USAGE ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease (1). DOSAGE AND ADMINISTRATION Recommended Dosage in Patients 4 Years and Older (2.1) Treatment-na�ve: 60 units/kg administered every other week as a 60 to 120 minute intravenous infusion Patients switching from imiglucerase: Begin ELELYSO at the same unit/kg dose as the patient's previous imiglucerase dose. Administer ELELYSO every other week as a 60 to 120 minute intravenous infusion. Dosage adjustments can be based on achievement and maintenance of each patient's therapeutic goals. Preparation and Administration (2.2, 2.3) Reconstitute, dilute and administer under the supervision of a healthcare professional. See Full Prescribing Information for complete instructions. DOSAGE FORMS AND STRENGTHS For injection: 200 units, lyophilized powder in single-use vials for reconstitution (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Anaphylaxis: Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment. Reduction in the infusion rate and/or pre-medication may prevent subsequent reactions (5.1, 6.3). ADVERSE REACTIONS The most common adverse reactions are: Treatment-Na�ve Adults (?5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria (6.1). Patients Switched from Imiglucerase, after 9 Months on Treatment (?10%): arthralgia, headache, pain in extremity (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 12/2016 CLOSE

RX ITEM-Elelyso 200U (200 Units) Powder
Generic Name: TALIGLUCERASE ALFA Description: ELELYSO, 200U, (200 UNITS), POWDER VIAL, 1X1 EA Alt Item #: 5276704 NDC: 00069-0106-01 UPC: 300690-106014 Contract: Contract Alias: Strength:

Elelyso 200U (200 Units) Powder Vial 1X1
BRAND: Elelyso NDC: RX00069-0106-01 ,RX00069010601 UPC: 300690-106014,300690106014 Generic Name: TALIGLUCERASE ALFA Description: ELELYSO, 200U, (200 UNITS), POWDER VIAL, 1X1 EA Alt Item #: 52767

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