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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