Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10009813serious1Date Last Updated09/04/2014receiptdateformat102companynumbUS-INCYTE CORPORATION-2012IN002690occurcountryUSduplicate1Date Received12/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age74Unit of Onset AgeyearsWeight76.64SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionNauseaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionInfluenza like illnessOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionChillsOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionPainOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductJAKAFIdrugbatchnumbNOT AVAILABLEdrugauthorizationnumb202192drugdosagetextNOT SPECIFIEDdrugdosageformTABLETdrugadministrationroute048drugindicationMYELOFIBROSISactiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA202192Brand NameJAKAFIGeneric NameRUXOLITINIBManufacturersIncyte Corporationproduct_ndc50881-005, 50881-010, 50881-015, 50881-020, 50881-025Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRUXOLITINIBRXCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, ... spl_id1cf98918-4377-4b1b-8b2f-1ae23681d1d2spl_set_idf1c82580-87ae-11e0-bc84-0002a5d5c51bPackage NDC 50881-005-60, 50881-010-01, 50881-010-60, 50881-015-60, 50881-020-60, 50881-025- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII82S8X8XX8H

2)

drugcharacterization1medicinalproductJAKAFIdrugauthorizationnumb202192drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, MONDAY, WEDNESDAY AND FRIDAY AFTER DIALYSISdrugdosageformTABLETdrugadministrationroute048actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA202192Brand NameJAKAFIGeneric NameRUXOLITINIBManufacturersIncyte Corporationproduct_ndc50881-005, 50881-010, 50881-015, 50881-020, 50881-025Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRUXOLITINIBRXCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, ... spl_id1cf98918-4377-4b1b-8b2f-1ae23681d1d2spl_set_idf1c82580-87ae-11e0-bc84-0002a5d5c51bPackage NDC 50881-005-60, 50881-010-01, 50881-010-60, 50881-015-60, 50881-020-60, 50881-025- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII82S8X8XX8H

3)

drugcharacterization1medicinalproductJAKAFIdrugauthorizationnumb202192drugdosagetext25 MG ON DAYS OF DIALYSISdrugdosageformTABLETdrugadministrationroute048actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA202192Brand NameJAKAFIGeneric NameRUXOLITINIBManufacturersIncyte Corporationproduct_ndc50881-005, 50881-010, 50881-015, 50881-020, 50881-025Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRUXOLITINIBRXCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, ... spl_id1cf98918-4377-4b1b-8b2f-1ae23681d1d2spl_set_idf1c82580-87ae-11e0-bc84-0002a5d5c51bPackage NDC 50881-005-60, 50881-010-01, 50881-010-60, 50881-015-60, 50881-020-60, 50881-025- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII82S8X8XX8H

4)

drugcharacterization2medicinalproductTAMSULOSIN

5)

drugcharacterization2medicinalproductFINASTERIDE

openFDA Info on Medication

Application Number ANDA203687, ANDA090121, ANDA091643, ANDA090061, ANDA207750, ANDA078341, NDA02078 ... Brand NameFINASTERIDE, PROPECIA, PROSCARGeneric NameFINASTERIDEManufacturers Aurobindo Pharma Limited, Rising Health, LLC, Accord Healthcare, Inc., Camber Ph ... product_ndc 65862-927, 65862-686, 57237-061, 16729-090, 16729-089, 31722-525, 67877-455, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINASTERIDERXCUI200172, 310346, 213178, 201961spl_id 7f209776-8fde-4aac-b266-f342525ea9ca, 019ae597-49a2-40c1-b87a-e656f9c471fc, 42b2 ... spl_set_id 7d140366-2388-488e-bd86-67e6edf44345, 01b88593-99d3-4dd6-a7b6-5438c15bd7b7, adfb ... Package NDC 65862-927-30, 65862-927-90, 65862-927-99, 65862-686-30, 65862-686-90, 65862-686- ... NUIN0000175836, N0000000126Established Pharmacologic Class5-alpha Reductase Inhibitor [EPC]Mechanism of Action5-alpha Reductase Inhibitors [MoA]UNII57GNO57U7G

6)

drugcharacterization2medicinalproductROPINIROLE

openFDA Info on Medication

Application Number ANDA201047, ANDA090869, ANDA090135, ANDA204022, ANDA202786, ANDA077852, ANDA0788 ... Brand NameROPINIROLEGeneric NameROPINIROLEManufacturers Sandoz Inc, Actavis Pharma, Inc., Glenmark Pharmaceuticals Inc., USA, Accord Hea ... product_ndc 0781-5780, 0781-5782, 0781-5784, 0781-5786, 0781-5788, 0228-3640, 0228-3658, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROPINIROLE HYDROCHLORIDERXCUI 799054, 799055, 799056, 824959, 848582, 283858, 312845, 312846, 312847, 312849, ... spl_id 62610145-8e1d-402e-92b2-14c6f16ce860, 84f40ca0-7fd0-4773-8c08-1cbcf7ba2c54, 7984 ... spl_set_id 2ed1aae8-ca68-41f7-8922-3662329117c4, 300946bf-2f83-471d-868d-9820b65c52bb, 8597 ... Package NDC 0781-5780-31, 0781-5780-92, 0781-5782-31, 0781-5782-92, 0781-5784-31, 0781-5786- ... UNIID7ZD41RZI9

7)

drugcharacterization2medicinalproductPANTOPRAZOLE

openFDA Info on Medication

Application NumberANDA205119, ANDA202882, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturers Amneal Pharmaceuticals LLC, Camber Pharmaceuticals, Inc., Dr.Reddy's Laboratorie ... product_ndc65162-636, 65162-637, 31722-712, 31722-713, 55111-332, 55111-333Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI251872, 314200spl_id 5c7a8fef-13ea-42c4-9e13-d8bc23c8f8a4, bbacc015-1a10-08f1-e053-2a95a90a301c, 02f0 ... spl_set_id f3ded82a-cf0d-4844-944a-75f9f9215ff0, 9daa1483-5a36-44db-9e0d-904d100da262, 5647 ... Package NDC 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-11, 65162-637- ... UNII6871619Q5X

8)

drugcharacterization2medicinalproductDRONABINOL

openFDA Info on Medication

Application NumberANDA078292, ANDA079217, NDA018651, ANDA207421, NDA205525, ANDA201463Brand NameDRONABINOL, SYNDROS, MARINOLGeneric NameDRONABINOLManufacturers Rhodes Pharmaceuticals L.P., Akorn, Inc., Ascend Laboratories, LLC, AvKARE, Benu ... product_ndc 42858-867, 42858-868, 42858-869, 17478-761, 17478-762, 17478-763, 67877-568, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDRONABINOLRXCUI197634, 197635, 197636, 1928948, 1928954, 205641, 205642, 205645spl_id 5467a1be-b888-4f7c-9a62-5faf6c977b05, dc76bfc1-db41-459c-8401-512058213bb0, 39f1 ... spl_set_id 3c06ccda-4819-40f8-b2db-fa294bb8a2fa, a0409d82-a61e-4b9e-8717-ced299ccedb2, 0bb0 ... Package NDC 42858-867-06, 42858-868-06, 42858-869-06, 17478-761-06, 17478-762-06, 17478-763- ... NUIN0000175782, M0003267Established Pharmacologic ClassCannabinoid [EPC]Chemical StructureCannabinoids [CS]UNII7J8897W37S

9)

drugcharacterization2medicinalproductVITAMIN D

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

10)

drugcharacterization2medicinalproductSYMMETREL

11)

drugcharacterization2medicinalproductZOLOFT

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

12)

drugcharacterization2medicinalproductPREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

13)

drugcharacterization2medicinalproductFLUTICASONE

openFDA Info on Medication

Application NumberANDA078492Brand NameFLUTICASONEGeneric NameFLUTICASONE PROPIONATEManufacturersMorton Grove Pharmaceuticals, Inc.product_ndc60432-264Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907spl_ida9e7f8b6-a38a-4128-b1c8-8a008bd15842spl_set_id7c692ed5-959e-4c48-aeec-0799d8979693Package NDC60432-264-15UNIIO2GMZ0LF5W

Report Duplicate

duplicatesourceINCYTEduplicatenumbUS-INCYTE CORPORATION-2012IN002690

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use