Drug information for JEVTANA KIT

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SOLUTION; IV (INFUSION)	60MG/1.5ML (40MG/ML)	Prescription	(Reference Drug)	CABAZITAXEL	cabazitaxel	SANOFI AVENTIS US	201023 2010-07-30 Review 2010-07-30 Summary Review 2010-06-21 Letter 2010-06-17 Label

Drug Adverse Effects information for JEVTANA KIT

Role code	Indications	Reaction	# Reports
PS	PAIN	ABDOMINAL PAIN	1
PS	PAIN	ABSCESS	2
PS	PAIN	BACTERIAL SEPSIS	2
PS	PAIN	BLOOD LACTATE DEHYDROGENASE INCREASED	2
PS	PAIN	CHOLESTASIS	2
PS	PAIN	COOMBS POSITIVE HAEMOLYTIC ANAEMIA	2
PS	PAIN	DECUBITUS ULCER	2
PS	PAIN	DIARRHOEA	2
PS	PAIN	DIZZINESS	1
PS	PAIN	ERYTHEMA MULTIFORME	1
PS	PAIN	GASTROINTESTINAL HAEMORRHAGE	1
PS	PAIN	HYPERKALAEMIA	1
PS	PAIN	HYPOPROTEINAEMIA	2
PS	PAIN	MELAENA	1
PS	PAIN	MULTI-ORGAN FAILURE	1
PS	PAIN	MUSCLE ATROPHY	2
PS	PAIN	NAUSEA	1
PS	PAIN	PULMONARY HAEMORRHAGE	2
PS	PAIN	RENAL FAILURE	3
PS	PAIN	SKIN LESION	1
PS	PAIN	STEVENS-JOHNSON SYNDROME	1
PS	PAIN	THROMBOCYTOPENIA	2
PS	PALLIATIVE CARE	DEATH	1
PS	PREMEDICATION	ABDOMINAL PAIN	1
PS	PREMEDICATION	CONFUSIONAL STATE	4
PS	PREMEDICATION	DELIRIUM	4
PS	PREMEDICATION	DISORIENTATION	4
PS	PREMEDICATION	DIZZINESS	1
PS	PREMEDICATION	GASTROINTESTINAL HAEMORRHAGE	1
PS	PREMEDICATION	HALLUCINATION	4
PS	PREMEDICATION	MELAENA	1
PS	PREMEDICATION	NAUSEA	1
PS	PREMEDICATION	NEUROTOXICITY	4
PS	PROSTATE CANCER	ABSCESS	2
PS	PROSTATE CANCER	BACTERIAL SEPSIS	2
PS	PROSTATE CANCER	BLOOD LACTATE DEHYDROGENASE INCREASED	2
PS	PROSTATE CANCER	CHOLESTASIS	2
PS	PROSTATE CANCER	COOMBS POSITIVE HAEMOLYTIC ANAEMIA	1
PS	PROSTATE CANCER	DEATH	21
PS	PROSTATE CANCER	DECUBITUS ULCER	1
PS	PROSTATE CANCER	DELIRIUM	1
PS	PROSTATE CANCER	DIARRHOEA	3
PS	PROSTATE CANCER	DISEASE PROGRESSION	2
PS	PROSTATE CANCER	ERYTHEMA MULTIFORME	1
PS	PROSTATE CANCER	HAEMOLYTIC ANAEMIA	1
PS	PROSTATE CANCER	HYPOPROTEINAEMIA	1
PS	PROSTATE CANCER	ILEUS	2
PS	PROSTATE CANCER	MULTI-ORGAN FAILURE	1
PS	PROSTATE CANCER	MUSCLE ATROPHY	1
PS	PROSTATE CANCER	NEUTROPENIA	4
PS	PROSTATE CANCER	PNEUMONIA	3
PS	PROSTATE CANCER	PROSTATIC SPECIFIC ANTIGEN INCREASED	2
PS	PROSTATE CANCER	PULMONARY EMBOLISM	3
PS	PROSTATE CANCER	PULMONARY HAEMORRHAGE	2
PS	PROSTATE CANCER	RENAL FAILURE	1
PS	PROSTATE CANCER	ROAD TRAFFIC ACCIDENT	1
PS	PROSTATE CANCER	SKIN LESION	1
PS	PROSTATE CANCER	SKIN NECROSIS	1
PS	PROSTATE CANCER	STEVENS-JOHNSON SYNDROME	1
PS	PROSTATE CANCER	THROMBOCYTOPENIA	1
PS	PROSTATE CANCER	TOXICITY TO VARIOUS AGENTS	2
PS	PROSTATE CANCER	WEIGHT DECREASED	2
PS	PROSTATE CANCER METASTATIC	CONFUSIONAL STATE	1
PS	PROSTATE CANCER METASTATIC	DELIRIUM	1
PS	PROSTATE CANCER METASTATIC	DISORIENTATION	1
PS	PROSTATE CANCER METASTATIC	GASTROINTESTINAL HAEMORRHAGE	2
PS	PROSTATE CANCER METASTATIC	HALLUCINATION	1
PS	PROSTATE CANCER METASTATIC	MUSCULAR WEAKNESS	2
PS	PROSTATE CANCER METASTATIC	NEUROTOXICITY	1
PS	PROSTATE CANCER METASTATIC	PANCYTOPENIA	1
PS	PROSTATE CANCER METASTATIC	SEPTIC SHOCK	1
PS	PROSTATE CANCER METASTATIC	SPINAL CORD COMPRESSION	2
SS	PAIN	ABDOMINAL PAIN	1
SS	PAIN	ABSCESS	2
SS	PAIN	BACTERIAL SEPSIS	2
SS	PAIN	BLOOD LACTATE DEHYDROGENASE INCREASED	2
SS	PAIN	CHOLESTASIS	2
SS	PAIN	COOMBS POSITIVE HAEMOLYTIC ANAEMIA	2
SS	PAIN	DECUBITUS ULCER	2
SS	PAIN	DIARRHOEA	2
SS	PAIN	DIZZINESS	1
SS	PAIN	GASTROINTESTINAL HAEMORRHAGE	1
SS	PAIN	HYPOPROTEINAEMIA	2
SS	PAIN	MELAENA	1
SS	PAIN	MUSCLE ATROPHY	2
SS	PAIN	NAUSEA	1
SS	PAIN	PULMONARY HAEMORRHAGE	2
SS	PAIN	RENAL FAILURE	2
SS	PAIN	THROMBOCYTOPENIA	2
SS	PALLIATIVE CARE	DEATH	3
SS	PREMEDICATION	ABDOMINAL PAIN	1
SS	PREMEDICATION	CONFUSIONAL STATE	4
SS	PREMEDICATION	DELIRIUM	4
SS	PREMEDICATION	DISORIENTATION	4
SS	PREMEDICATION	DIZZINESS	1
SS	PREMEDICATION	GASTROINTESTINAL HAEMORRHAGE	1
SS	PREMEDICATION	HALLUCINATION	4
SS	PREMEDICATION	MELAENA	1
SS	PREMEDICATION	NAUSEA	1
SS	PREMEDICATION	NEUROTOXICITY	4
SS	PROSTATE CANCER	ABSCESS	2
SS	PROSTATE CANCER	BACTERIAL SEPSIS	2
SS	PROSTATE CANCER	BLOOD LACTATE DEHYDROGENASE INCREASED	2
SS	PROSTATE CANCER	CHOLESTASIS	2
SS	PROSTATE CANCER	COOMBS POSITIVE HAEMOLYTIC ANAEMIA	1
SS	PROSTATE CANCER	DEATH	45
SS	PROSTATE CANCER	DECUBITUS ULCER	1
SS	PROSTATE CANCER	DIARRHOEA	7
SS	PROSTATE CANCER	DISEASE PROGRESSION	10
SS	PROSTATE CANCER	HAEMOLYTIC ANAEMIA	1
SS	PROSTATE CANCER	HYPOPROTEINAEMIA	1
SS	PROSTATE CANCER	MUSCLE ATROPHY	1
SS	PROSTATE CANCER	NEUTROPENIA	2
SS	PROSTATE CANCER	PNEUMONIA	8
SS	PROSTATE CANCER	PROSTATIC SPECIFIC ANTIGEN INCREASED	6
SS	PROSTATE CANCER	PULMONARY EMBOLISM	8
SS	PROSTATE CANCER	PULMONARY HAEMORRHAGE	2
SS	PROSTATE CANCER	RENAL FAILURE	1
SS	PROSTATE CANCER	ROAD TRAFFIC ACCIDENT	2
SS	PROSTATE CANCER	SKIN NECROSIS	1
SS	PROSTATE CANCER	THROMBOCYTOPENIA	1
SS	PROSTATE CANCER	WEIGHT DECREASED	6
SS	PROSTATE CANCER METASTATIC	CONFUSIONAL STATE	1
SS	PROSTATE CANCER METASTATIC	DELIRIUM	1
SS	PROSTATE CANCER METASTATIC	DISORIENTATION	1
SS	PROSTATE CANCER METASTATIC	HALLUCINATION	1
SS	PROSTATE CANCER METASTATIC	MUSCULAR WEAKNESS	2
SS	PROSTATE CANCER METASTATIC	NEUROTOXICITY	1
SS	PROSTATE CANCER METASTATIC	PANCYTOPENIA	2
SS	PROSTATE CANCER METASTATIC	SEPTIC SHOCK	2
SS	PROSTATE CANCER METASTATIC	SPINAL CORD COMPRESSION	2

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