Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10419351primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype2serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received29/08/2014receiptdateformat102Date Last Updated11/09/2015fulfillexpeditecriteria1companynumbUS-ASTELLAS-2014US011279duplicate1

Report Duplicate

duplicatesourceASTELLASduplicatenumbUS-ASTELLAS-2014US011279

Primary Source

reportercountryGBqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionPleuritic painOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionPainOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionDyspnoeaOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionOff label useOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionBlood glucose increasedOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionFatigueOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionPleural effusionOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionPleurodesisOutcomeUnknown

9)

reactionmeddraversionpt18.1ReactionMalignant neoplasm progressionOutcomeUnknown

10)

reactionmeddraversionpt18.1ReactionMetastases to liverOutcomeUnknown

11)

reactionmeddraversionpt18.1ReactionMetastases to lungOutcomeUnknown

12)

reactionmeddraversionpt18.1ReactionCardiac hypertrophyOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductERLOTINIBdrugauthorizationnumb021743drugdosageformTABLETdrugindicationBREAST CANCER METASTATIC

activesubstance

activesubstancenameERLOTINIB

openFDA Info on Medication

Application NumberANDA211960, ANDA213065, ANDA208488, ANDA210300, ANDA091059Brand NameERLOTINIBGeneric NameERLOTINIB HYDROCHLORIDE, ERLOTINIBManufacturers Armas Pharmaceuticals Inc., Cadila Healthcare Limited, Breckenridge Pharmaceutic ... product_ndc 72485-217, 70771-1521, 70771-1522, 70771-1523, 51991-890, 51991-891, 51991-892, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDE, ERLOTINIBRXCUI603208, 603203, 603206spl_id 35e3a161-752e-4479-b27c-3dc8efd3ca9e, 5624fa69-eae5-43bf-aa7e-379266edd77f, b219 ... spl_set_id 53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8c, daaa1329-3a3f-439c-b13d-b301daa234d4, 3527 ... Package NDC 72485-217-30, 70771-1521-3, 70771-1521-9, 70771-1521-2, 70771-1521-7, 70771-1522 ... UNIIDA87705X9K, J4T82NDH7ENUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]

2)

drugcharacterization1medicinalproductXELODAdrugdosagetextUNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationBREAST CANCER METASTATICactiondrug5

activesubstance

activesubstancenameCAPECITABINE

openFDA Info on Medication

Application NumberNDA020896Brand NameXELODAGeneric NameCAPECITABINEManufacturersGenentech, Inc.product_ndc0004-1100, 0004-1101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCAPECITABINERXCUI200327, 200328, 213292, 213293spl_ida4ecab24-8f42-4ffb-8f47-706219d879cespl_set_ida1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8Package NDC0004-1100-20, 0004-1101-50NUIN0000000233, N0000175595Mechanism of ActionNucleic Acid Synthesis Inhibitors [MoA]Established Pharmacologic ClassNucleoside Metabolic Inhibitor [EPC]UNII6804DJ8Z9U

3)

drugcharacterization1medicinalproductERLOTINIBdrugauthorizationnumb021743drugstructuredosagenumb150drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationBREAST CANCER FEMALEactiondrug1

activesubstance

activesubstancenameERLOTINIB

openFDA Info on Medication

Application NumberANDA211960, ANDA213065, ANDA208488, ANDA210300, ANDA091059Brand NameERLOTINIBGeneric NameERLOTINIB HYDROCHLORIDE, ERLOTINIBManufacturers Armas Pharmaceuticals Inc., Cadila Healthcare Limited, Breckenridge Pharmaceutic ... product_ndc 72485-217, 70771-1521, 70771-1522, 70771-1523, 51991-890, 51991-891, 51991-892, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDE, ERLOTINIBRXCUI603208, 603203, 603206spl_id 35e3a161-752e-4479-b27c-3dc8efd3ca9e, 5624fa69-eae5-43bf-aa7e-379266edd77f, b219 ... spl_set_id 53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8c, daaa1329-3a3f-439c-b13d-b301daa234d4, 3527 ... Package NDC 72485-217-30, 70771-1521-3, 70771-1521-9, 70771-1521-2, 70771-1521-7, 70771-1522 ... UNIIDA87705X9K, J4T82NDH7ENUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]

4)

drugcharacterization2medicinalproductADRIAMYCINdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameDOXORUBICIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA062921, ANDA062975, ANDA064097Brand NameADRIAMYCINGeneric NameDOXORUBICIN HYDROCHLORIDEManufacturersHikma Pharmaceuticals USA Inc.product_ndc 0143-9275, 0143-9277, 0143-9369, 0143-9370, 0143-9371, 0143-9372, 0143-9547, 014 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsDOXORUBICIN HYDROCHLORIDERXCUI 1790095, 1790103, 2001100, 2001102, 1191138, 1790097, 1790099, 1790100, 1799305, ... spl_id a88e80b5-b556-4dd0-8532-bed33bcd25b8, 7ee0404d-d766-461d-87cd-6a2bf5414589, 782e ... spl_set_id 090bc1b1-3dc2-408d-94e6-48d2a3d4426c, b05d7515-2179-4f4b-b37e-dccc77127f8f, 0f15 ... Package NDC 0143-9275-01, 0143-9277-01, 0143-9369-01, 0143-9370-01, 0143-9371-01, 0143-9372- ... UNII82F2G7BL4E

5)

drugcharacterization2medicinalproductCYCLOPHOSPHAMIDE.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCYCLOPHOSPHAMIDE

openFDA Info on Medication

Application Number ANDA211608, NDA212501, ANDA040745, ANDA210046, ANDA209872, ANDA204555, NDA012141 ... Brand NameCYCLOPHOSPHAMIDEGeneric NameCYCLOPHOSPHAMIDEManufacturers Cipla USA Inc., Athenex Pharmaceutical Division, LLC., Baxter Healthcare Corpora ... product_ndc 69097-516, 69097-517, 70860-218, 10019-943, 10019-944, 10019-945, 70121-1238, 70 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCYCLOPHOSPHAMIDE ANHYDROUS, CYCLOPHOSPHAMIDERXCUI 1437968, 1437969, 2386859, 1734917, 1734919, 1734921, 197549, 197550, 2568661, 2 ... spl_id f57dbebf-f145-4e3c-bfef-b7907f6e01eb, 7eaabaf5-ac12-406b-8432-8e01db8e519d, 0eb9 ... spl_set_id 0e1cb955-99c8-4fe5-89d1-399c8e52174e, a0e99679-f939-4fb3-9d38-dfdb824f89bc, cef0 ... Package NDC 69097-516-07, 69097-517-07, 70860-218-03, 70860-218-05, 70860-218-10, 10019-943- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNII6UXW23996M, 8N3DW7272P

6)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

7)

drugcharacterization1medicinalproductAVASTINdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformFORMULATION UNKNOWNdrugadministrationroute042drugindicationBREAST CANCER METASTATICdrugstartdateformat102drugstartdate15/09/2005actiondrug4

activesubstance

activesubstancenameBEVACIZUMAB

openFDA Info on Medication

Application NumberBLA125085Brand NameAVASTINGeneric NameBEVACIZUMABManufacturersGenentech, Inc.product_ndc50242-060, 50242-061Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsBEVACIZUMABRXCUI1657066, 1657068, 1657073, 1657074spl_idfae4c2c2-fa31-44c5-807d-0c4f50bfdbffspl_set_id939b5d1f-9fb2-4499-80ef-0607aa6b114ePackage NDC50242-060-01, 50242-060-10, 50242-061-01, 50242-061-10NUIN0000193543, N0000178291, N0000193542Established Pharmacologic ClassVascular Endothelial Growth Factor Inhibitor [EPC]Mechanism of Action Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA], Vascula ... UNII2S9ZZM9Q9V

8)

drugcharacterization2medicinalproductTAXANESdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

9)

drugcharacterization2medicinalproductDURAGESICdrugstructuredosagenumb200drugstructuredosageunit004drugdosagetext200 ?G, EVERY 72 HOURS, EVERY 3 DAYSdrugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFENTANYL

openFDA Info on Medication

Application NumberNDA019813Brand NameDURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-101, 50458-102, 50458-104, 50458-105, 50458-106Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsFENTANYLRXCUI197696, 245134, 245135, 245136, 261184, 261185, 261186, 262071, 577057, 583490spl_id05923670-9dd6-4a7c-91b6-1483b3db3c29spl_set_id4c3a6171-19e4-40c2-83f3-fb54d4736e4bPackage NDC50458-101-05, 50458-102-05, 50458-104-05, 50458-105-05, 50458-106-05NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNIIUF599785JZ

10)

drugcharacterization2medicinalproductROXANOLdrugdosagetext20 MG/ML, AS NEEDEDdrugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMORPHINE SULFATE

11)

drugcharacterization2medicinalproductCOUMADINdrugstructuredosagenumb2drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameWARFARIN SODIUM

openFDA Info on Medication

12)

drugcharacterization2medicinalproductARIMIDEXdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameANASTROZOLE

openFDA Info on Medication

Application NumberNDA020541Brand NameARIMIDEXGeneric NameANASTROZOLEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-670Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsANASTROZOLERXCUI151124, 199224spl_id5ffddc9f-23b6-4aff-b27a-4e8ed029a283spl_set_idacbfaaa9-503c-4691-9828-76a7146ed6dePackage NDC62559-670-30NUIN0000175563, N0000175080Established Pharmacologic ClassAromatase Inhibitor [EPC]Mechanism of ActionAromatase Inhibitors [MoA]UNII2Z07MYW1AZ

13)

drugcharacterization2medicinalproductSYNTHROIDdrugstructuredosagenumb175drugstructuredosageunit004drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

14)

drugcharacterization2medicinalproductGEMZARdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameGEMCITABINE HYDROCHLORIDE