Drug information for IXEMPRA KIT
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; IV (INFUSION)
15MG/VIAL
Prescription
(Reference Drug)
IXABEPILONE
ixabepilone
BRISTOL MYERS SQUIBB
22065
2011-10-20 Letter
2011-10-20 Label
2010-05-17 Letter
2010-05-17 Letter
2010-05-17 Label
2010-05-17 Label
2009-10-13 Letter
2009-10-13 Letter
2009-10-07 Label
2009-10-07 Label
2009-04-03 Label
2009-03-17 Letter
2008-03-24 Review
2007-10-22 Letter
2007-10-17 Label
INJECTABLE; IV (INFUSION)
45MG/VIAL
Prescription
(Reference Drug)
IXABEPILONE
ixabepilone
BRISTOL MYERS SQUIBB
"
Drug Adverse Effects information for IXEMPRA KIT
Role code
Indications
Reaction
# Reports
PS
BREAST CANCER
ADVERSE EVENT
1
PS
BREAST CANCER
ALOPECIA
1
PS
BREAST CANCER
BACK PAIN
1
PS
BREAST CANCER
BLOOD MAGNESIUM DECREASED
2
PS
BREAST CANCER
BONE PAIN
2
PS
BREAST CANCER
BURNING SENSATION
2
PS
BREAST CANCER
CONFUSIONAL STATE
1
PS
BREAST CANCER
DEHYDRATION
2
PS
BREAST CANCER
DYSPNOEA
1
PS
BREAST CANCER
ENTERITIS
2
PS
BREAST CANCER
EXTRAVASATION
1
PS
BREAST CANCER
GAIT DISTURBANCE
2
PS
BREAST CANCER
HYPOTENSION
1
PS
BREAST CANCER
INCORRECT DRUG ADMINISTRATION DURATION
1
PS
BREAST CANCER
INCORRECT DRUG ADMINISTRATION RATE
1
PS
BREAST CANCER
MUSCLE SPASMS
1
PS
BREAST CANCER
NAIL AVULSION
2
PS
BREAST CANCER
NAIL DISCOLOURATION
2
PS
BREAST CANCER
NAIL INFECTION
2
PS
BREAST CANCER
NEOPLASM MALIGNANT
1
PS
BREAST CANCER
NEUROPATHY PERIPHERAL
1
PS
BREAST CANCER
NEUTROPENIA
2
PS
BREAST CANCER
PAIN
2
PS
BREAST CANCER
SKIN DISCOLOURATION
2
PS
BREAST CANCER METASTATIC
ASCITES
1
PS
BREAST CANCER METASTATIC
DEATH
5
PS
BREAST CANCER METASTATIC
DRUG ADMINISTRATION ERROR
2
PS
BREAST CANCER METASTATIC
FATIGUE
1
PS
BREAST CANCER METASTATIC
INFUSION RELATED REACTION
1
PS
BREAST CANCER METASTATIC
MUCOSAL INFLAMMATION
1
PS
BREAST CANCER METASTATIC
NEUROPATHY PERIPHERAL
2
PS
BREAST CANCER METASTATIC
NEUTROPENIA
3
PS
BREAST CANCER METASTATIC
NO ADVERSE EVENT
1
PS
BREAST CANCER STAGE IV
ARTHRALGIA
1
PS
BREAST CANCER STAGE IV
BONE PAIN
1
PS
BREAST CANCER STAGE IV
FULL BLOOD COUNT DECREASED
1
PS
BREAST CANCER STAGE IV
MYALGIA
1
PS
BREAST CANCER STAGE IV
NEUTROPENIA
1
PS
BREAST CANCER STAGE IV
PLATELET COUNT DECREASED
1
PS
BREAST CANCER STAGE IV
RECALL PHENOMENON
1
PS
BREAST CANCER STAGE IV
SKIN EXFOLIATION
1
PS
ENDOMETRIAL CANCER
ALANINE AMINOTRANSFERASE INCREASED
4
PS
ENDOMETRIAL CANCER
ANAEMIA
6
PS
ENDOMETRIAL CANCER
ARTHRALGIA
3
PS
ENDOMETRIAL CANCER
ASPARTATE AMINOTRANSFERASE INCREASED
4
PS
ENDOMETRIAL CANCER
BLOOD BILIRUBIN INCREASED
4
PS
ENDOMETRIAL CANCER
DECREASED APPETITE
3
PS
ENDOMETRIAL CANCER
DYSPNOEA
3
PS
ENDOMETRIAL CANCER
FATIGUE
3
PS
ENDOMETRIAL CANCER
HYPOALBUMINAEMIA
6
PS
ENDOMETRIAL CANCER
HYPOCALCAEMIA
6
PS
ENDOMETRIAL CANCER
HYPOKALAEMIA
3
PS
ENDOMETRIAL CANCER
HYPOMAGNESAEMIA
6
PS
ENDOMETRIAL CANCER
HYPONATRAEMIA
3
PS
ENDOMETRIAL CANCER
HYPOPHOSPHATAEMIA
6
PS
ENDOMETRIAL CANCER
INTERNATIONAL NORMALISED RATIO INCREASED
3
PS
ENDOMETRIAL CANCER
NEUTROPHIL COUNT DECREASED
3
PS
ENDOMETRIAL CANCER
PAIN IN EXTREMITY
3
PS
ENDOMETRIAL CANCER
SOFT TISSUE NECROSIS
6
PS
ENDOMETRIAL CANCER
WHITE BLOOD CELL COUNT DECREASED
3
PS
NEOPLASM
HYPOPHOSPHATAEMIA
2
PS
NEOPLASM
NEUTROPHIL COUNT DECREASED
2
PS
NEOPLASM
PLATELET COUNT DECREASED
2
PS
NEOPLASM
WHITE BLOOD CELL COUNT DECREASED
2
PS
PREMEDICATION
ASCITES
3
PS
PREMEDICATION
INFUSION RELATED REACTION
3
PS
PREMEDICATION
NEUTROPENIA
3
PS
UTERINE CANCER
ABDOMINAL DISTENSION
2
PS
UTERINE CANCER
ATELECTASIS
6
PS
UTERINE CANCER
BRONCHITIS
6
PS
UTERINE CANCER
BRONCHOSPASM
6
PS
UTERINE CANCER
CARDIAC FAILURE
3
PS
UTERINE CANCER
CEREBROVASCULAR ACCIDENT
3
PS
UTERINE CANCER
CONVULSION
3
PS
UTERINE CANCER
DEPRESSED LEVEL OF CONSCIOUSNESS
3
PS
UTERINE CANCER
HYPERTENSION
6
PS
UTERINE CANCER
HYPOMAGNESAEMIA
1
PS
UTERINE CANCER
HYPOTENSION
1
PS
UTERINE CANCER
HYPOXIA
6
PS
UTERINE CANCER
LYMPHOCYTE COUNT DECREASED
1
PS
UTERINE CANCER
NEUTROPHIL COUNT DECREASED
6
PS
UTERINE CANCER
PAIN
1
PS
UTERINE CANCER
PLATELET COUNT DECREASED
6
PS
UTERINE CANCER
PLEURAL EFFUSION
6
PS
UTERINE CANCER
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
6
PS
UTERINE CANCER
PURPURA
1
PS
UTERINE CANCER
PYREXIA
1
PS
UTERINE CANCER
SINUSITIS
6
PS
UTERINE CANCER
SKIN INFECTION
1
C
BREAST CANCER METASTATIC
EJECTION FRACTION DECREASED
8
C
BREAST CANCER METASTATIC
HYPOTENSION
8
C
METASTASES TO BONE
EJECTION FRACTION DECREASED
8
C
METASTASES TO BONE
HYPOTENSION
8
C
METASTASES TO LIVER
EJECTION FRACTION DECREASED
8
C
METASTASES TO LIVER
HYPOTENSION
8
C
METASTASES TO LUNG
EJECTION FRACTION DECREASED
12
C
METASTASES TO LUNG
HYPOTENSION
12
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