Drug information for ISTODAX

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
POWDER; IV (INFUSION)	10MG/VIAL	Prescription	(Reference Drug)	ROMIDEPSIN	romidepsin	CELGENE	22393 2011-10-03 Letter 2011-09-30 Label 2011-06-27 Letter 2011-06-16 Label 2011-04-15 Letter 2011-04-15 Label 2010-01-04 Review 2010-01-04 Summary Review 2009-11-13 Letter 2009-11-06 Label

Drug Adverse Effects information for ISTODAX

Role code	Indications	Reaction	# Reports
PS	FLANK PAIN	DISEASE PROGRESSION	2
PS	FLANK PAIN	INFUSION SITE EXTRAVASATION	2
PS	FLANK PAIN	PYREXIA	2
PS	FLANK PAIN	RASH	2
PS	INFECTION PROPHYLAXIS	PERIPHERAL SENSORY NEUROPATHY	2
PS	MYCOSIS FUNGOIDES	PYREXIA	1
PS	MYCOSIS FUNGOIDES	TUMOUR LYSIS SYNDROME	1
PS	PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED	PERIPHERAL SENSORY NEUROPATHY	10
PS	PRODUCT USED FOR UNKNOWN INDICATION	DEATH	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DECREASED APPETITE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	EXTRAVASATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INFUSION SITE EXTRAVASATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	NAUSEA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PYREXIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	WEIGHT DECREASED	1
PS	PROPHYLAXIS	PERIPHERAL SENSORY NEUROPATHY	2
PS	T-CELL LYMPHOMA	DISEASE PROGRESSION	1
PS	T-CELL LYMPHOMA	ELECTROCARDIOGRAM QT PROLONGED	1
PS	T-CELL LYMPHOMA	RADIATION INJURY	1
PS	T-CELL LYMPHOMA	RASH	1
PS	T-CELL LYMPHOMA	T-CELL LYMPHOMA	1

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