Drug information for MYLOTARG

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	5MG/VIAL	Discontinued		GEMTUZUMAB OZOGAMICIN	gemtuzumab	WYETH PHARMS INC	21174 2006-01-30 Letter 2006-01-25 Label 2005-10-20 Letter 2005-06-15 Letter 2004-07-28 Letter 2004-06-24 Letter 2004-04-20 Letter 2003-04-23 Label 2001-06-04 Review 2000-05-17 Letter 2000-05-17 Label

Drug Adverse Effects information for MYLOTARG

Role code	Indications	Reaction	# Reports
PS	ACUTE MYELOID LEUKAEMIA	ATRIAL FIBRILLATION	8
PS	ACUTE MYELOID LEUKAEMIA	BRAIN ABSCESS	3
PS	ACUTE MYELOID LEUKAEMIA	CARDIAC FAILURE	3
PS	ACUTE MYELOID LEUKAEMIA	CEREBRAL HAEMORRHAGE	4
PS	ACUTE MYELOID LEUKAEMIA	DEHYDRATION	3
PS	ACUTE MYELOID LEUKAEMIA	DIARRHOEA	3
PS	ACUTE MYELOID LEUKAEMIA	DYSPNOEA	2
PS	ACUTE MYELOID LEUKAEMIA	FEBRILE NEUTROPENIA	11
PS	ACUTE MYELOID LEUKAEMIA	GENERAL PHYSICAL HEALTH DETERIORATION	1
PS	ACUTE MYELOID LEUKAEMIA	HAEMOGLOBIN DECREASED	3
PS	ACUTE MYELOID LEUKAEMIA	INJECTION SITE REACTION	3
PS	ACUTE MYELOID LEUKAEMIA	LEUKOPENIA	3
PS	ACUTE MYELOID LEUKAEMIA	MULTI-ORGAN FAILURE	5
PS	ACUTE MYELOID LEUKAEMIA	NAUSEA	2
PS	ACUTE MYELOID LEUKAEMIA	NEUTROPENIA	3
PS	ACUTE MYELOID LEUKAEMIA	PANCYTOPENIA	3
PS	ACUTE MYELOID LEUKAEMIA	PLEURAL EFFUSION	3
PS	ACUTE MYELOID LEUKAEMIA	PNEUMONITIS	6
PS	ACUTE MYELOID LEUKAEMIA	PNEUMOTHORAX	3
PS	ACUTE MYELOID LEUKAEMIA	PYREXIA	3
PS	ACUTE MYELOID LEUKAEMIA	SEPSIS	12
PS	ACUTE MYELOID LEUKAEMIA	SUPRAVENTRICULAR TACHYCARDIA	3
PS	ACUTE MYELOID LEUKAEMIA	TACHYCARDIA	2
PS	ACUTE MYELOID LEUKAEMIA	TACHYPNOEA	2
PS	ACUTE MYELOID LEUKAEMIA	THROMBOCYTOPENIA	3
PS	ACUTE MYELOID LEUKAEMIA	VENOOCCLUSIVE LIVER DISEASE	1
PS	ACUTE MYELOID LEUKAEMIA	VOMITING	2
PS	ACUTE MYELOID LEUKAEMIA	WHITE BLOOD CELL COUNT DECREASED	3
PS	EMBOLISM VENOUS	CEREBRAL HAEMORRHAGE	1
SS	ACUTE LEUKAEMIA	ACIDOSIS	3
SS	ACUTE LEUKAEMIA	BLOOD BILIRUBIN INCREASED	3
SS	ACUTE LEUKAEMIA	BLOOD CREATININE INCREASED	3
SS	ACUTE LEUKAEMIA	BLOOD DISORDER	3
SS	ACUTE LEUKAEMIA	CARDIAC ARREST	3
SS	ACUTE LEUKAEMIA	FUNGAL INFECTION	9
SS	ACUTE LEUKAEMIA	GAMMA-GLUTAMYLTRANSFERASE INCREASED	6
SS	ACUTE LEUKAEMIA	HAEMORRHAGE	3
SS	ACUTE LEUKAEMIA	HEPATORENAL FAILURE	3
SS	ACUTE LEUKAEMIA	HYPERNATRAEMIA	3
SS	ACUTE LEUKAEMIA	HYPOKALAEMIA	3
SS	ACUTE LEUKAEMIA	NEUTROPENIA	3
SS	ACUTE LEUKAEMIA	PANCYTOPENIA	9
SS	ACUTE LEUKAEMIA	POLYURIA	3
SS	ACUTE LEUKAEMIA	PULMONARY NECROSIS	6
SS	ACUTE LEUKAEMIA	PYREXIA	5
SS	ACUTE LEUKAEMIA	RASH GENERALISED	3
SS	ACUTE LEUKAEMIA	STATUS EPILEPTICUS	2
SS	ACUTE MYELOID LEUKAEMIA	ALANINE AMINOTRANSFERASE INCREASED	7
SS	ACUTE MYELOID LEUKAEMIA	ASCITES	1
SS	ACUTE MYELOID LEUKAEMIA	ASPARTATE AMINOTRANSFERASE INCREASED	1
SS	ACUTE MYELOID LEUKAEMIA	BLOOD CREATININE INCREASED	1
SS	ACUTE MYELOID LEUKAEMIA	BRAIN ABSCESS	6
SS	ACUTE MYELOID LEUKAEMIA	CLOSTRIDIUM DIFFICILE COLITIS	3
SS	ACUTE MYELOID LEUKAEMIA	DEHYDRATION	3
SS	ACUTE MYELOID LEUKAEMIA	DIALYSIS	1
SS	ACUTE MYELOID LEUKAEMIA	DIARRHOEA	3
SS	ACUTE MYELOID LEUKAEMIA	FEBRILE NEUTROPENIA	3
SS	ACUTE MYELOID LEUKAEMIA	GAMMA-GLUTAMYLTRANSFERASE INCREASED	3
SS	ACUTE MYELOID LEUKAEMIA	GENERAL PHYSICAL HEALTH DETERIORATION	1
SS	ACUTE MYELOID LEUKAEMIA	HAEMOGLOBIN DECREASED	6
SS	ACUTE MYELOID LEUKAEMIA	HYPOKALAEMIA	3
SS	ACUTE MYELOID LEUKAEMIA	HYPOMAGNESAEMIA	3
SS	ACUTE MYELOID LEUKAEMIA	HYPOTENSION	3
SS	ACUTE MYELOID LEUKAEMIA	INFECTION	3
SS	ACUTE MYELOID LEUKAEMIA	LEUKOPENIA	6
SS	ACUTE MYELOID LEUKAEMIA	MULTI-ORGAN FAILURE	1
SS	ACUTE MYELOID LEUKAEMIA	NEUTROPENIA	6
SS	ACUTE MYELOID LEUKAEMIA	NEUTROPENIC SEPSIS	3
SS	ACUTE MYELOID LEUKAEMIA	PANCYTOPENIA	6
SS	ACUTE MYELOID LEUKAEMIA	PLATELET COUNT INCREASED	4
SS	ACUTE MYELOID LEUKAEMIA	PLEURAL EFFUSION	1
SS	ACUTE MYELOID LEUKAEMIA	PULMONARY EMBOLISM	3
SS	ACUTE MYELOID LEUKAEMIA	PURPURA	1
SS	ACUTE MYELOID LEUKAEMIA	PYREXIA	1
SS	ACUTE MYELOID LEUKAEMIA	RENAL IMPAIRMENT	3
SS	ACUTE MYELOID LEUKAEMIA	RENAL TUBULAR DISORDER	3
SS	ACUTE MYELOID LEUKAEMIA	SEPSIS	7
SS	ACUTE MYELOID LEUKAEMIA	STATUS EPILEPTICUS	1
SS	ACUTE MYELOID LEUKAEMIA	THROMBOCYTOPENIA	6
SS	ACUTE MYELOID LEUKAEMIA	URINE OUTPUT DECREASED	1
SS	ACUTE MYELOID LEUKAEMIA	VENOOCCLUSIVE DISEASE	1
SS	ACUTE MYELOID LEUKAEMIA	WEIGHT INCREASED	1
SS	ANTIFUNGAL TREATMENT	ASCITES	1
SS	ANTIFUNGAL TREATMENT	ASPARTATE AMINOTRANSFERASE INCREASED	1
SS	ANTIFUNGAL TREATMENT	BLOOD CREATININE INCREASED	1
SS	ANTIFUNGAL TREATMENT	DIALYSIS	1
SS	ANTIFUNGAL TREATMENT	GENERAL PHYSICAL HEALTH DETERIORATION	1
SS	ANTIFUNGAL TREATMENT	MULTI-ORGAN FAILURE	1
SS	ANTIFUNGAL TREATMENT	PLEURAL EFFUSION	1
SS	ANTIFUNGAL TREATMENT	PURPURA	1
SS	ANTIFUNGAL TREATMENT	SEPSIS	1
SS	ANTIFUNGAL TREATMENT	URINE OUTPUT DECREASED	1
SS	ANTIFUNGAL TREATMENT	VENOOCCLUSIVE DISEASE	1
SS	ANTIFUNGAL TREATMENT	WEIGHT INCREASED	1
SS	BLOOD BILIRUBIN INCREASED	BLOOD BILIRUBIN INCREASED	1
SS	MYELODYSPLASTIC SYNDROME	ASCITES	1
SS	MYELODYSPLASTIC SYNDROME	ASPARTATE AMINOTRANSFERASE INCREASED	1
SS	MYELODYSPLASTIC SYNDROME	BLOOD CREATININE INCREASED	1
SS	MYELODYSPLASTIC SYNDROME	DIALYSIS	1
SS	MYELODYSPLASTIC SYNDROME	GENERAL PHYSICAL HEALTH DETERIORATION	1
SS	MYELODYSPLASTIC SYNDROME	MULTI-ORGAN FAILURE	1
SS	MYELODYSPLASTIC SYNDROME	PLEURAL EFFUSION	1
SS	MYELODYSPLASTIC SYNDROME	PURPURA	1
SS	MYELODYSPLASTIC SYNDROME	SEPSIS	1
SS	MYELODYSPLASTIC SYNDROME	URINE OUTPUT DECREASED	1
SS	MYELODYSPLASTIC SYNDROME	VENOOCCLUSIVE DISEASE	1
SS	MYELODYSPLASTIC SYNDROME	WEIGHT INCREASED	1
SS	MYELOID LEUKAEMIA	BODY TEMPERATURE INCREASED	3
SS	MYELOID LEUKAEMIA	LOCAL SWELLING	3
SS	MYELOID LEUKAEMIA	NECK PAIN	3
SS	MYELOID LEUKAEMIA	SUBCLAVIAN VEIN THROMBOSIS	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	ALANINE AMINOTRANSFERASE INCREASED	17
SS	PRODUCT USED FOR UNKNOWN INDICATION	PLATELET COUNT INCREASED	17
SS	PRODUCT USED FOR UNKNOWN INDICATION	PYREXIA	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	STATUS EPILEPTICUS	1
SS	PYREXIA	ASCITES	4
SS	PYREXIA	ASPARTATE AMINOTRANSFERASE INCREASED	4
SS	PYREXIA	BLOOD CREATININE INCREASED	4
SS	PYREXIA	DIALYSIS	4
SS	PYREXIA	GENERAL PHYSICAL HEALTH DETERIORATION	4
SS	PYREXIA	MULTI-ORGAN FAILURE	4
SS	PYREXIA	PLEURAL EFFUSION	4
SS	PYREXIA	PURPURA	4
SS	PYREXIA	SEPSIS	4
SS	PYREXIA	URINE OUTPUT DECREASED	4
SS	PYREXIA	VENOOCCLUSIVE DISEASE	4
SS	PYREXIA	WEIGHT INCREASED	4
C	ACUTE MYELOID LEUKAEMIA	ACUTE MYELOID LEUKAEMIA	5
C	ACUTE MYELOID LEUKAEMIA	ALOPECIA	5
C	ACUTE MYELOID LEUKAEMIA	BLOOD CHOLESTEROL INCREASED	5

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