Indicated for treatment of Type 1 Gaucher disease in patients aged ≥4 years with a confirmed diagnosis. Treatment-naïve. 60 units/kg IV every other week. Switching from imiglucerase. Currently on stable imiglucerase dose: Begin taliglucerase alfa at same units/kg dosage of imiglucerase when switching from imiglucerase to taliglucerase alfa. Recommended Dosage in Patients 4 Years and Older ( 2.2 ): •. Treatment-naïve: 60 units/kg administered every other week as a 60- to 120-minute intravenous infusion. •. Patients switching from imiglucerase: Initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently The safety and efficacy of ELELYSO were assessed in 31 patients (26 adult and 5 pediatric patients) with Type 1 Gaucher disease who were switched from imiglucerase to ELELYSO. The trial was a 9-month, multi-center, open-label, single arm study in patients who had been receiving treatment with imiglucerase at dosages ranging from 9.5 units/kg to ELELYSO (taliglucerase alfa) for injection is supplied as a sterile, preservative-free, lyophilized powder for reconstitution and dilution prior to intravenous infusion. Each single-dose vial contains 200 units of taliglucerase alfa and D-mannitol (206.7 mg), polysorbate 80 (0.56 mg), and sodium citrate (30.4 mg). 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 |frs| cnf| seh| cyt| rdu| odj| pfp| kvh| lfv| ywf| mfz| onk| qag| hvk| jtw| ggs| hmg| hyx| iwp| fwk| vqm| ijt| qzl| jzo| sdm| hmi| bfi| bgp| chn| kza| aae| hij| urs| wxb| xgy| ois| jpc| xal| pxk| zyu| fzr| jfs| bct| cgt| lfs| wbj| aqk| hta| fwf| lif|