end result [1,:<1, 61) 15 years (> <1, 69) Age, n(%)> < 17 years 17 years 44 (43%) 58 (57%) 22 (29%) 53 (71%) 189 (54%) 162 (46%) Race, n(%) White Black/African American Asian Other 77 (75%) 6 (6%) 4 (4%) 15 (15%) 61 (81%) 6 (8%) 2 (3%) 6 (8%) 237 (68%) 21 (6%) 15 (4%) 78 (22%) Gender, n(%) Male Female 64 (63%) 38 (37%) 41 (55%) 34 (45%) 184 (52%) 167 (48% ) Median number of days on treatment (days) (range) 21.5 days (1,58) 19.5 days (3,83) 21.0 days a (1,93) Type of graft, n(%) Allograft Autograft 90 (88%) 12 (12%) 67 (89%) 8 (11%) 317 (90%) 34 (10%) Ventilator or Dialysis Dependent at Study Entry, n(%) 34 (33%) 8 (11%) 149 (42%) a Duration of treatment from first dose to last dose is presented because days without treatment were not captured for the expanded access study. The efficacy of Defitelio was based on survival at Day + 100 after HSCT. In Study 1, the survival rate was 38% (95% CI: 29%, 48%) at 100 days after transplantation. In Study 2 the survival rate was 44% (95% CI: 33%, 55%) at 100 days after transplantation. In Study 3, the Day + 100 survival was 45% (95% CI: 40%, 51%). Based on published reports and analyses of patient level data for individuals with hepatic VOD with renal or pulmonary dysfunction who received supportive care or interventions other than Defitelio, the expected Day +100 survival rates are 21% to 31%. How Supplied/Storage and Handling Defitelio (defibrotide sodium) injection is supplied in a single-patient-use, clear glass vial as a clear, light yellow to brown, sterile, preservative-free solution for intravenous infusion. Each vial (NDC 68727-800-01) contains 200 mg/2.5 mL (at a concentration of 80 mg/mL) of defibrotide sodium. Each carton of Defitelio (defibrotide sodium) injection (NDC 68727-800-02) contains 10 vials. Store Defitelio (defibrotide sodium) injection at 20 C-25 C (68 F-77 F); excursions permitted between 15 C to 30 C (59 F to 86 F) (see USP controlled room temperature). Patient Counseling Information Hemorrhage: Advise patients and caregivers that Defitelio may increase the risk of bleeding (hemorrhage). Instruct patients to immediately report any signs or symptoms suggestive of hemorrhage (unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision) [see Warnings and Precautions (5.1) ] . Hypersensitivity Reactions: Ask patients if they have been treated with defibrotide sodium previously. Instruct patients on the risk of allergic reactions, including anaphylaxis. Describe the symptoms of allergic reactions, including anaphylaxis, and instruct the patient to seek medical attention immediately if they experience such symptoms [see Warnings and Precautions (5.2) ] . PACKAGE/LABEL PRINCIPAL DISPLAY PANEL This product's label may have been updated. For full prescribing information, please visit labels.fda.gov. Distributed by: Jazz Pharmaceuticals, Inc. Palo Alto, CA 94304 Defitelio is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries. 2016 Jazz Pharmaceuticals Defitelio defibrotide sodium injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68727-800 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEFIBROTIDE SODIUM (DEFIBROTIDE FREE ACID ) DEFIBROTIDE SODIUM 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength TRISODIUM CITRATE DIHYDRATE WATER HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:68727-800-01 2.5 mL in 1 VIAL 2 NDC:68727-800-02 25 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208114 03/30/2016 Labeler - Jazz Pharmaceuticals, Inc. (135926363) Establishment Name Address ID/FEI Operations Gentium SrL 432729114 MANUFACTURE(68727-800) Revised: 03/2016 Jazz Pharmaceuticals, Inc. Next Interactions Print this page Add to My Med List More about Defitelio (defibrotide) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous coagulation modifiers Consumer resources Defitelio Defitelio (Advanced Reading) Professional resources Defitelio (AHFS Monograph) Related treatment guides Hepatic Veno-Occlusive Disease ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Jazz Pharmaceuticals plc Drug Class Miscellaneous coagulation modifiers Related Drugs miscellaneous coagulation modifiers pentoxifylline , Trental , tranexamic acid , Amicar , Lysteda , BeneFix Hepatic Veno-Occlusive Disease defibrotide , More... 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treatments Defitelio work at home
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