Drug information for XGEVA

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; SUBCUTANEOUS	70MG/ML	Prescription		DENOSUMAB	denosumab	AMGEN	125320 2012-05-02 Letter 2012-05-01 Label 2011-10-07 Other 2011-09-20 Label 2011-09-20 Label 2011-09-20 Letter 2011-09-20 Letter 2010-11-22 Letter 2010-11-19 Label 2010-08-18 Review 2010-08-18 Summary Review 2010-06-04 Letter 2010-06-03 Other 2010-06-02 Label 2010-06-02 Other

Drug Adverse Effects information for XGEVA

Role code	Indications	Reaction	# Reports
PS	ATRIAL FIBRILLATION	HYPOCALCAEMIA	1
PS	ATRIAL FIBRILLATION	INCORRECT ROUTE OF DRUG ADMINISTRATION	1
PS	BONE LOSS	MEDICATION ERROR	2
PS	BONE SARCOMA	BLOOD COUNT ABNORMAL	3
PS	BONE SARCOMA	NEUTROPENIA	1
PS	BREAST CANCER	OESOPHAGITIS	1
PS	BREAST CANCER	OSTEONECROSIS OF JAW	1
PS	BREAST CANCER	THROMBOCYTOPENIA	1
PS	BREAST CANCER	TUMOUR MARKER INCREASED	2
PS	BREAST CANCER METASTATIC	BONE PAIN	1
PS	BREAST CANCER METASTATIC	CHILLS	1
PS	BREAST CANCER METASTATIC	DIZZINESS	1
PS	BREAST CANCER METASTATIC	DYSPNOEA	1
PS	BREAST CANCER METASTATIC	NAUSEA	1
PS	BREAST CANCER METASTATIC	PALPITATIONS	1
PS	BREAST CANCER METASTATIC	PARALYSIS	1
PS	BREAST CANCER METASTATIC	POLLAKIURIA	1
PS	BREAST CANCER METASTATIC	PYREXIA	1
PS	DIABETES MELLITUS	THROMBOSIS	1
PS	HYPERCALCAEMIA	HYPERCALCAEMIA	1
PS	HYPERCALCAEMIA	RENAL IMPAIRMENT	1
PS	HYPERTENSION	THROMBOSIS	1
PS	HYPERURICAEMIA	EYE DISORDER	1
PS	HYPERURICAEMIA	HYPERMETROPIA	1
PS	HYPERURICAEMIA	NAUSEA	2
PS	HYPERURICAEMIA	VERTIGO	2
PS	HYPERURICAEMIA	VISION BLURRED	1
PS	HYPERURICAEMIA	VISUAL IMPAIRMENT	1
PS	HYPERURICAEMIA	VOMITING	2
PS	LUNG NEOPLASM MALIGNANT	EMOTIONAL DISTRESS	1
PS	LUNG NEOPLASM MALIGNANT	INFECTED SKIN ULCER	1
PS	LUNG NEOPLASM MALIGNANT	INJURY	1
PS	LUNG NEOPLASM MALIGNANT	PAIN OF SKIN	1
PS	LUNG NEOPLASM MALIGNANT	PURULENT DISCHARGE	1
PS	LUNG NEOPLASM MALIGNANT	SEXUAL DYSFUNCTION	1
PS	METASTASES TO BONE	ABASIA	1
PS	METASTASES TO BONE	ANAEMIA	1
PS	METASTASES TO BONE	ANGINA PECTORIS	1
PS	METASTASES TO BONE	ARRHYTHMIA	2
PS	METASTASES TO BONE	BACK PAIN	1
PS	METASTASES TO BONE	BONE PAIN	3
PS	METASTASES TO BONE	BONE SCAN ABNORMAL	1
PS	METASTASES TO BONE	CARDIAC FAILURE CONGESTIVE	1
PS	METASTASES TO BONE	CHEST X-RAY ABNORMAL	2
PS	METASTASES TO BONE	COLITIS	1
PS	METASTASES TO BONE	COLITIS ISCHAEMIC	1
PS	METASTASES TO BONE	CONFUSIONAL STATE	2
PS	METASTASES TO BONE	DEATH	1
PS	METASTASES TO BONE	DECUBITUS ULCER	1
PS	METASTASES TO BONE	DERMATOMYOSITIS	1
PS	METASTASES TO BONE	DISEASE PROGRESSION	1
PS	METASTASES TO BONE	DIVERTICULUM INTESTINAL	1
PS	METASTASES TO BONE	DYSPHAGIA	2
PS	METASTASES TO BONE	DYSPNOEA	3
PS	METASTASES TO BONE	EMOTIONAL DISTRESS	1
PS	METASTASES TO BONE	ENDODONTIC PROCEDURE	1
PS	METASTASES TO BONE	EYE DISORDER	1
PS	METASTASES TO BONE	FEELING ABNORMAL	1
PS	METASTASES TO BONE	FOOT FRACTURE	1
PS	METASTASES TO BONE	GASTROINTESTINAL HAEMORRHAGE	1
PS	METASTASES TO BONE	GENERAL PHYSICAL HEALTH DETERIORATION	1
PS	METASTASES TO BONE	GOUT	1
PS	METASTASES TO BONE	HOSPITALISATION	1
PS	METASTASES TO BONE	HYPERCALCAEMIA OF MALIGNANCY	1
PS	METASTASES TO BONE	HYPERMETROPIA	1
PS	METASTASES TO BONE	HYPOCALCAEMIA	18
PS	METASTASES TO BONE	HYPOPHOSPHATAEMIA	2
PS	METASTASES TO BONE	IMPAIRED HEALING	1
PS	METASTASES TO BONE	INCORRECT ROUTE OF DRUG ADMINISTRATION	2
PS	METASTASES TO BONE	INFECTED SKIN ULCER	1
PS	METASTASES TO BONE	INJURY	1
PS	METASTASES TO BONE	MALAISE	1
PS	METASTASES TO BONE	MEDICAL DEVICE COMPLICATION	1
PS	METASTASES TO BONE	METASTASES TO BONE	2
PS	METASTASES TO BONE	METASTASES TO CENTRAL NERVOUS SYSTEM	2
PS	METASTASES TO BONE	MUSCLE INJURY	1
PS	METASTASES TO BONE	NAUSEA	4
PS	METASTASES TO BONE	NEOPLASM MALIGNANT	2
PS	METASTASES TO BONE	NEUROPATHY PERIPHERAL	1
PS	METASTASES TO BONE	NEUTROPENIA	1
PS	METASTASES TO BONE	ORAL NEOPLASM	1
PS	METASTASES TO BONE	OSTEONECROSIS OF JAW	6
PS	METASTASES TO BONE	OXYGEN SATURATION DECREASED	1
PS	METASTASES TO BONE	PAIN IN EXTREMITY	1
PS	METASTASES TO BONE	PAIN IN JAW	4
PS	METASTASES TO BONE	PAIN OF SKIN	1
PS	METASTASES TO BONE	PANCYTOPENIA	1
PS	METASTASES TO BONE	PLEURAL EFFUSION	1
PS	METASTASES TO BONE	PNEUMONITIS	2
PS	METASTASES TO BONE	POLYNEUROPATHY	1
PS	METASTASES TO BONE	POSTOPERATIVE WOUND COMPLICATION	1
PS	METASTASES TO BONE	PULMONARY OEDEMA	1
PS	METASTASES TO BONE	PURULENT DISCHARGE	1
PS	METASTASES TO BONE	RADIATION SKIN INJURY	1
PS	METASTASES TO BONE	RENAL FAILURE ACUTE	2
PS	METASTASES TO BONE	RENAL IMPAIRMENT	2
PS	METASTASES TO BONE	RESPIRATORY DISTRESS	1
PS	METASTASES TO BONE	SEPSIS	1
PS	METASTASES TO BONE	SEXUAL DYSFUNCTION	1
PS	METASTASES TO BONE	SWELLING FACE	1
PS	METASTASES TO BONE	TREMOR	1
PS	METASTASES TO BONE	TUMOUR MARKER INCREASED	1
PS	METASTASES TO BONE	VERTIGO	2
PS	METASTASES TO BONE	VISION BLURRED	1
PS	METASTASES TO BONE	VISUAL IMPAIRMENT	1
PS	METASTASES TO BONE	VITAMIN D INCREASED	1
PS	METASTASES TO BONE	VOMITING	4
PS	METASTASES TO BONE	WALKING AID USER	1
PS	METASTASES TO BONE	WHEEZING	1
PS	OSTEOPOROSIS	HYPOCALCAEMIA	1
PS	OSTEOPOROSIS	INCORRECT ROUTE OF DRUG ADMINISTRATION	1
PS	PAIN	DYSPNOEA	1
PS	PAIN	EYE DISORDER	3
PS	PAIN	HYPERMETROPIA	3
PS	PAIN	NAUSEA	6
PS	PAIN	OXYGEN SATURATION DECREASED	1
PS	PAIN	VERTIGO	6
PS	PAIN	VISION BLURRED	3
PS	PAIN	VISUAL IMPAIRMENT	3
PS	PAIN	VOMITING	6
PS	PRODUCT USED FOR UNKNOWN INDICATION	ACCIDENTAL EXPOSURE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ANAPHYLACTIC REACTION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	BLOOD PRESSURE ABNORMAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DEATH	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	DERMATITIS ALLERGIC	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DISCOMFORT	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DYSGEUSIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ERYTHEMA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	GASTROINTESTINAL DISORDER	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	HEADACHE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HOSPITALISATION	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPERSENSITIVITY	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPOAESTHESIA ORAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPOCALCAEMIA	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPOXIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	INCORRECT ROUTE OF DRUG ADMINISTRATION	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	INTERSTITIAL LUNG DISEASE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	LUNG CANCER METASTATIC	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	LUNG INFILTRATION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	METASTASES TO SPINE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	OSTEONECROSIS OF JAW	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	PAIN IN JAW	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PANCYTOPENIA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	PARAESTHESIA ORAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	RASH ERYTHEMATOUS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	RASH PRURITIC	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	REFUSAL OF TREATMENT BY PATIENT	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	RENAL FAILURE ACUTE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	SCLERAL DISORDER	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	TENSION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	THROMBOCYTOPENIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	THROMBOSIS	2
PS	PROSTATE CANCER	ABDOMINAL PAIN	2
PS	PROSTATE CANCER	ANAEMIA	1
PS	PROSTATE CANCER	ANGIOPATHY	2
PS	PROSTATE CANCER	ASCITES	2
PS	PROSTATE CANCER	ASTHENIA	1
PS	PROSTATE CANCER	BACTERAEMIA	1
PS	PROSTATE CANCER	CHILLS	2
PS	PROSTATE CANCER	CONSTIPATION	1
PS	PROSTATE CANCER	DECREASED APPETITE	1
PS	PROSTATE CANCER	DIARRHOEA	1
PS	PROSTATE CANCER	DYSPNOEA	2
PS	PROSTATE CANCER	HEPATOMEGALY	2
PS	PROSTATE CANCER	HYPERTENSION	1
PS	PROSTATE CANCER	HYPOTENSION	1
PS	PROSTATE CANCER	HYPOTONIA	2
PS	PROSTATE CANCER	METASTASIS	2
PS	PROSTATE CANCER	OTITIS MEDIA	1
PS	PROSTATE CANCER	PROSTATE CANCER	1
PS	PROSTATE CANCER	URINARY RETENTION	1
PS	PROSTATE CANCER METASTATIC	BONE PAIN	1
PS	PROSTATE CANCER METASTATIC	CARDIAC DISORDER	1
PS	PROSTATE CANCER METASTATIC	PAIN IN JAW	1
PS	PROSTATE CANCER METASTATIC	TOOTHACHE	1
PS	RENAL CELL CARCINOMA	OSTEONECROSIS OF JAW	1
PS	RENAL CELL CARCINOMA	PAIN IN JAW	1
PS	VITAMIN D DECREASED	GOUT	1
PS	VITAMIN D DECREASED	HYPOCALCAEMIA	1
SS	ATRIAL FIBRILLATION	HYPOCALCAEMIA	1
SS	ATRIAL FIBRILLATION	INCORRECT ROUTE OF DRUG ADMINISTRATION	1
SS	HYPERURICAEMIA	EYE DISORDER	1
SS	HYPERURICAEMIA	HYPERMETROPIA	1
SS	HYPERURICAEMIA	NAUSEA	2
SS	HYPERURICAEMIA	VERTIGO	2
SS	HYPERURICAEMIA	VISION BLURRED	1
SS	HYPERURICAEMIA	VISUAL IMPAIRMENT	1
SS	HYPERURICAEMIA	VOMITING	2
SS	METASTASES TO BONE	ABASIA	2
SS	METASTASES TO BONE	CARDIAC FAILURE CONGESTIVE	1
SS	METASTASES TO BONE	DEATH	1
SS	METASTASES TO BONE	DECUBITUS ULCER	1
SS	METASTASES TO BONE	DRUG NAME CONFUSION	2
SS	METASTASES TO BONE	EYE DISORDER	1
SS	METASTASES TO BONE	HYPERMETROPIA	1
SS	METASTASES TO BONE	HYPOCALCAEMIA	3
SS	METASTASES TO BONE	HYPOPHOSPHATAEMIA	2
SS	METASTASES TO BONE	INCORRECT ROUTE OF DRUG ADMINISTRATION	1
SS	METASTASES TO BONE	MUSCLE INJURY	2
SS	METASTASES TO BONE	NAUSEA	2
SS	METASTASES TO BONE	PAIN IN EXTREMITY	2
SS	METASTASES TO BONE	POSTOPERATIVE WOUND COMPLICATION	1
SS	METASTASES TO BONE	PULMONARY OEDEMA	1
SS	METASTASES TO BONE	RADIATION SKIN INJURY	2
SS	METASTASES TO BONE	VERTIGO	2
SS	METASTASES TO BONE	VISION BLURRED	1
SS	METASTASES TO BONE	VISUAL IMPAIRMENT	1
SS	METASTASES TO BONE	VOMITING	2
SS	METASTASES TO BONE	WALKING AID USER	2
SS	METASTASES TO CENTRAL NERVOUS SYSTEM	DISEASE PROGRESSION	1
SS	METASTASES TO CENTRAL NERVOUS SYSTEM	GINGIVAL RECESSION	1
SS	METASTASES TO CENTRAL NERVOUS SYSTEM	RENAL CELL CARCINOMA	1
SS	METASTASES TO CENTRAL NERVOUS SYSTEM	STOMATITIS	1
SS	METASTASES TO CENTRAL NERVOUS SYSTEM	TOOTH LOSS	1
SS	METASTASES TO LUNG	DISEASE PROGRESSION	1
SS	METASTASES TO LUNG	GINGIVAL RECESSION	1
SS	METASTASES TO LUNG	RENAL CELL CARCINOMA	1
SS	METASTASES TO LUNG	STOMATITIS	1
SS	METASTASES TO LUNG	TOOTH LOSS	1
SS	OSTEONECROSIS	DISEASE PROGRESSION	1
SS	OSTEONECROSIS	GINGIVAL RECESSION	1
SS	OSTEONECROSIS	RENAL CELL CARCINOMA	1
SS	OSTEONECROSIS	STOMATITIS	1
SS	OSTEONECROSIS	TOOTH LOSS	1
SS	OSTEOPOROSIS	HYPOCALCAEMIA	1
SS	OSTEOPOROSIS	INCORRECT ROUTE OF DRUG ADMINISTRATION	1
SS	OSTEOPOROSIS POSTMENOPAUSAL	DRUG ADMINISTRATION ERROR	4
SS	PAIN	EYE DISORDER	3
SS	PAIN	HYPERMETROPIA	3
SS	PAIN	NAUSEA	6
SS	PAIN	VERTIGO	6
SS	PAIN	VISION BLURRED	3
SS	PAIN	VISUAL IMPAIRMENT	3
SS	PAIN	VOMITING	6
SS	PROSTATE CANCER METASTATIC	BONE PAIN	1
SS	PROSTATE CANCER METASTATIC	CARDIAC DISORDER	1
SS	PROSTATE CANCER METASTATIC	PAIN IN JAW	1
SS	PROSTATE CANCER METASTATIC	TOOTHACHE	1
SS	RENAL CELL CARCINOMA	DISEASE PROGRESSION	1
SS	RENAL CELL CARCINOMA	GINGIVAL RECESSION	1
SS	RENAL CELL CARCINOMA	RENAL CELL CARCINOMA	1
SS	RENAL CELL CARCINOMA	STOMATITIS	1
SS	RENAL CELL CARCINOMA	TOOTH LOSS	1
C	ANTIEMETIC SUPPORTIVE CARE	BONE PAIN	1
C	ANTIEMETIC SUPPORTIVE CARE	DEEP VEIN THROMBOSIS	1
C	ANTIEMETIC SUPPORTIVE CARE	HEADACHE	1
C	ANTIEMETIC SUPPORTIVE CARE	NEOPLASM MALIGNANT	1
C	ANTIEMETIC SUPPORTIVE CARE	OEDEMA PERIPHERAL	1
C	ANTIEMETIC SUPPORTIVE CARE	PAIN IN EXTREMITY	1
C	ANTIEMETIC SUPPORTIVE CARE	PANCYTOPENIA	1
C	ANTIEMETIC SUPPORTIVE CARE	RASH	1
C	ANTIEMETIC SUPPORTIVE CARE	VOMITING	1
C	BONE PAIN	BONE PAIN	2
C	BONE PAIN	DEEP VEIN THROMBOSIS	2
C	BONE PAIN	HEADACHE	2
C	BONE PAIN	NEOPLASM MALIGNANT	2
C	BONE PAIN	OEDEMA PERIPHERAL	2
C	BONE PAIN	PAIN IN EXTREMITY	2
C	BONE PAIN	PANCYTOPENIA	2
C	BONE PAIN	RASH	2
C	BONE PAIN	VOMITING	2
C	BREAST CANCER METASTATIC	BONE PAIN	1
C	BREAST CANCER METASTATIC	DEEP VEIN THROMBOSIS	1
C	BREAST CANCER METASTATIC	HEADACHE	1
C	BREAST CANCER METASTATIC	NEOPLASM MALIGNANT	1
C	BREAST CANCER METASTATIC	OEDEMA PERIPHERAL	1
C	BREAST CANCER METASTATIC	PAIN IN EXTREMITY	1
C	BREAST CANCER METASTATIC	PANCYTOPENIA	1
C	BREAST CANCER METASTATIC	RASH	1
C	BREAST CANCER METASTATIC	VOMITING	1
C	DEPRESSION	BONE PAIN	1
C	DEPRESSION	DEEP VEIN THROMBOSIS	1
C	DEPRESSION	HEADACHE	1
C	DEPRESSION	NEOPLASM MALIGNANT	1
C	DEPRESSION	OEDEMA PERIPHERAL	1
C	DEPRESSION	PAIN IN EXTREMITY	1
C	DEPRESSION	PANCYTOPENIA	1
C	DEPRESSION	RASH	1
C	DEPRESSION	VOMITING	1
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	BONE PAIN	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	DEEP VEIN THROMBOSIS	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	HEADACHE	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	NEOPLASM MALIGNANT	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	OEDEMA PERIPHERAL	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	PAIN IN EXTREMITY	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	PANCYTOPENIA	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	RASH	2
C	IDIOPATHIC THROMBOCYTOPENIC PURPURA	VOMITING	2
C	METASTASES TO BONE	BONE PAIN	1
C	METASTASES TO BONE	DEEP VEIN THROMBOSIS	1
C	METASTASES TO BONE	HEADACHE	1
C	METASTASES TO BONE	NEOPLASM MALIGNANT	1
C	METASTASES TO BONE	OEDEMA PERIPHERAL	1
C	METASTASES TO BONE	PAIN IN EXTREMITY	1
C	METASTASES TO BONE	PANCYTOPENIA	1
C	METASTASES TO BONE	RASH	1
C	METASTASES TO BONE	VOMITING	1
C	THYROID CANCER	ACNE	1
C	THYROID CANCER	BLOOD PRESSURE INCREASED	1
C	THYROID CANCER	BLOOD THYROID STIMULATING HORMONE INCREASED	1
C	THYROID CANCER	DIARRHOEA	1
C	THYROID CANCER	FAECES DISCOLOURED	1
C	THYROID CANCER	FEELING ABNORMAL	1
C	THYROID CANCER	HOT FLUSH	1
C	THYROID CANCER	RASH	1
C	THYROID CANCER	STOMATITIS	1

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