Report

reporttype2Version of Safety Report ID54receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10098017serious1Date Last Updated21/11/2018receiptdateformat102companynumbCA-ROCHE-1298604occurcountryCAseriousnessother1duplicate1Date Received23/04/2014seriousnesshospitalization1transmissiondate04/02/2019primarysourcecountryCA

Primary Source

reportercountryCAqualification3

Patient

Onset Age74Unit of Onset AgeyearsWeight70SexMale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
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- 10)
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- 29)
Drug
summary

Reaction

1)

reactionmeddraversionpt21.1ReactionLung neoplasm malignantOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt21.1ReactionLimb asymmetryOutcomeUnknown

3)

reactionmeddraversionpt21.1ReactionOral herpesOutcomeRecovering/resolving

4)

reactionmeddraversionpt21.1ReactionInfusion related reactionOutcomeUnknown

5)

reactionmeddraversionpt21.1ReactionWeight increasedOutcomeUnknown

6)

reactionmeddraversionpt21.1ReactionNasopharyngitisOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt21.1ReactionHyperkeratosisOutcomeUnknown

8)

reactionmeddraversionpt21.1ReactionLimb injuryOutcomeRecovered/resolved

9)

reactionmeddraversionpt21.1ReactionEating disorderOutcomeUnknown

10)

reactionmeddraversionpt21.1ReactionRheumatoid arthritisOutcomeUnknown

11)

reactionmeddraversionpt21.1ReactionSoft tissue sarcomaOutcomeRecovered/resolved

12)

reactionmeddraversionpt21.1ReactionBalance disorderOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt21.1ReactionWeight decreasedOutcomeRecovered/resolved

14)

reactionmeddraversionpt21.1ReactionImpaired healingOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt21.1ReactionHyperkeratosisOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt21.1ReactionAnxietyOutcomeUnknown

17)

reactionmeddraversionpt21.1ReactionSpinal fractureOutcomeUnknown

18)

reactionmeddraversionpt21.1ReactionWoundOutcomeRecovering/resolving

19)

reactionmeddraversionpt21.1ReactionDecreased appetiteOutcomeUnknown

20)

reactionmeddraversionpt21.1ReactionScratchOutcomeUnknown

21)

reactionmeddraversionpt21.1ReactionSkin cancerOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt21.1ReactionOsteoporosisOutcomeNot recovered/not resolved

23)

reactionmeddraversionpt21.1ReactionImpaired healingOutcomeRecovered/resolved

24)

reactionmeddraversionpt21.1ReactionArthritisOutcomeUnknown

25)

reactionmeddraversionpt21.1ReactionPostoperative wound infectionOutcomeUnknown

26)

reactionmeddraversionpt21.1ReactionPulmonary oedemaOutcomeUnknown

27)

reactionmeddraversionpt21.1ReactionSkin injuryOutcomeUnknown

28)

reactionmeddraversionpt21.1ReactionBack painOutcomeUnknown

29)

reactionmeddraversionpt21.1ReactionArthralgiaOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb528drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate03/11/2011actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

Application NumberBLA125276, BLA125472Brand NameACTEMRAGeneric NameTOCILIZUMABManufacturersGenentech, Inc.product_ndc50242-135, 50242-136, 50242-137, 50242-138, 50242-143Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsTOCILIZUMABRXCUI 1441527, 1441530, 1657974, 1657976, 1657979, 1657980, 1657981, 1657982, 2106073, ... spl_idf02f041c-92cf-483e-8f67-a085be49bd33spl_set_id2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13Package NDC 50242-135-01, 50242-136-01, 50242-137-01, 50242-138-01, 50242-138-86, 50242-143- ... NUIN0000190478, N0000190480Mechanism of ActionInterleukin 6 Receptor Antagonists [MoA]Established Pharmacologic ClassInterleukin-6 Receptor Antagonist [EPC]UNIII031V2H011

2)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb512drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate03/01/2012actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

3)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate26/06/2015actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

4)

drugcharacterization2medicinalproductDICLOFENAC

activesubstance

activesubstancenameDICLOFENAC

openFDA Info on Medication

Application NumberANDA204306, ANDA206116, ANDA208077, NDA204592, ANDA203383, ANDA077845Brand NameDICLOFENAC SODIUM, DICLOFENAC, ZORVOLEXGeneric NameDICLOFENAC, DICLOFENAC SODIUMManufacturers Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, TriVue Pharmaceuticals, ... product_ndc 0378-8750, 65162-911, 65162-833, 73480-242, 59390-149, 42291-256, 17478-892, 693 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, OPHTHALMICActive IngredientsDICLOFENAC SODIUM, DICLOFENACRXCUI855633, 857700, 1442128, 854801, 1442116, 1442122, 1442130spl_id 7f7def3c-80d9-498d-8be4-d6525e81ee48, 0c5957bf-66c8-49dc-b633-dfada57bff9b, 8bfd ... spl_set_id 585549fe-dca3-47cb-a454-7a3b42fa8443, 78873f83-cea9-44d4-8ad4-8cb9257e5c7f, f64b ... Package NDC 0378-8750-06, 65162-911-74, 65162-833-66, 73480-242-90, 59390-149-02, 59390-149- ... UNIIQTG126297Q, 144O8QL0L1NUIN0000000160, N0000008836, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

5)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb536drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate05/07/2011actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

6)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb496drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate17/08/2017actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

7)

drugcharacterization2medicinalproductQUETIAPINE.

activesubstance

activesubstancenameQUETIAPINE

openFDA Info on Medication

Application Number ANDA207655, NDA022047, ANDA201109, ANDA077745, NDA020639, ANDA202152, ANDA211405 ... Brand Name QUETIAPINE FUMARATE, SEROQUEL XR, QUETIAPINE, SEROQUEL, QUETIAPINE EXTENDED RELE ... Generic NameQUETIAPINE, QUETIAPINE EXTENDED-RELEASEManufacturers Aurobindo Pharma Limited, AstraZeneca Pharmaceuticals LP, BluePoint Laboratories ... product_ndc 65862-873, 65862-874, 65862-875, 65862-876, 65862-877, 0310-0280, 0310-0282, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721794, 721796, 853201, 895670, 721793, 721795, 721797, 853202, 895671, ... spl_id a9b33f56-b991-4396-989f-63f631a55b8c, 1a826d85-aac4-42e4-a3e2-a18df915dc33, b829 ... spl_set_id 6562eb60-0d70-4909-bd07-88d5c9241516, 473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 874e ... Package NDC 65862-873-60, 65862-873-01, 65862-873-05, 65862-874-60, 65862-874-01, 65862-874- ... UNII2S3PL1B6UJ

8)

drugcharacterization2medicinalproductMETHOTREXATE.

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA040632, ANDA201529, ANDA201530, NDA008085 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Hikma Pharmac ... product_ndc 61703-350, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 0143-9830, 674 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL, SUBCUTANEOUSActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625, ... spl_id 60bbb387-0ce5-4c7e-a917-5bc4b4685616, 78d0abc0-9ade-4302-ada0-72fd6d67eff9, 46c4 ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-350-09, 61703-350-10, 51285-366-01, 51285-367- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

9)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb528drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate23/05/2014actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

10)

drugcharacterization2medicinalproductATORVASTATIN

activesubstance

activesubstancenameATORVASTATIN

openFDA Info on Medication

11)

drugcharacterization2medicinalproductSERTRALINE

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

12)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb528drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate22/02/2011actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

13)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb544drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate05/05/2016actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

14)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb544drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate06/10/2011actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

15)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb560drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate08/10/2013actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

16)

drugcharacterization2medicinalproductFOLIC ACID.

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

17)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb520drugstructuredosageunit003drugdosagetextLAST DOSE RECEIVED ON 26/OCT/2010?ON HOLDdrugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugindicationRHEUMATOID ARTHRITISdrugstartdateformat102drugstartdate23/11/2010drugenddateformat102drugenddate20/12/2017actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

18)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb520drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate29/11/2011actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

19)

drugcharacterization1medicinalproductACTEMRAdrugbatchnumbB20343,B20162,B2059,B2039,B2048,B20drugauthorizationnumb125276drugstructuredosagenumb488drugstructuredosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate31/01/2012actiondrug5drugrecurreadministration3drugadditional3

activesubstance

activesubstancenameTOCILIZUMAB

openFDA Info on Medication

summary

narrativeincludeclinicalCASE EVENT DATE: 20131227

Report Duplicate

duplicatesourceROCHEduplicatenumbCA-ROCHE-1298604

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

12)

13)

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29)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

openFDA Info on Medication

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

openFDA Info on Medication

9)

activesubstance

openFDA Info on Medication

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

12)

activesubstance

openFDA Info on Medication

13)

activesubstance

openFDA Info on Medication

14)

activesubstance

openFDA Info on Medication

15)

activesubstance

openFDA Info on Medication