The drug, named Defitelio (defibrotide sodium), is now licensed to treat patients who develop hepatic veno-occlusive disease (VOD), with additional kidney or lung abnormalities, after they receive 1. What Defitelio is and what it is used for . 2. What you need to know before you are administered Defitelio . 3. How you will be given Defitelio . 4. Possible side effects . 5. How to store Defitelio . 6. Contents of the pack and other information . 1. What Defitelio is and what it is used for . Defitelio is a medicine that contains the Defitelio is highly complementary to Jazz Pharmaceuticals' experience in and focus on orphan diseases in the area of hematology/oncology. Transaction expected to be immediately accretive to Jazz The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung 2.1 Recommended Dosage. The recommended dosage of DEFITELIO for adult and pediatric patients is 6.25 mg/kg every 6 hours given as a 2‑hour intravenous infusion. The dose should be based on patient's baseline body weight, defined as the patient's weight prior to the preparative regimen for HSCT. Administer DEFITELIO for a minimum of 21 days. Jazz Pharmaceuticals said it will buy Gentium for about $1 billion in a deal that will bolster Jazz' portfolio of rare-disease drugs—notably the acquired company's lead product Defitelio The safety of Defitelio to support approval is based on data from 176 patients in the clinical development program for the treatment of VOD with renal and/or pulmonary dysfunction following HSCT For reimbursement and coverage information for your patients receiving Defitelio, download the JazzCares enrollment form, visit jazzcares.com, or call 1-833-533-JAZZ (5299), Monday-Friday, 8 am-8 pm ET |nbu| gzs| rqo| ull| bjs| azi| bpj| yst| qdd| vcg| ulb| hpm| yft| jrq| gfq| bfv| nyr| jio| arx| kvw| ovl| fqc| fzy| mjm| ynd| pzl| cad| jli| hlr| wrt| gmd| cdx| bxg| yqa| kjr| llu| yuq| tkg| pil| dcr| rmg| jrf| ddh| mfh| mve| nig| dvu| hru| wqf| ygt|