Index of reports
> Cases with Off Label Use (7)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Cytoxan (Cyclophosphamide) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Cytoxan side effects in
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-24
Patient:
Reactions: Off Label Use, Hyperglycaemia, Ketoacidosis
Drug(s) suspected as cause:
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: days 22,29, 32, previous protocol, re-induction
Methotrexate
Dosage: weekly; previous protocol; continuation phase
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 every 8 weeks during 1 year, previous protocol, continuation phase
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 on days 1, 8, previous protocol, consolidation phase
Methotrexate
Dosage: age dependent dose on days 1, 22, previous protocol, re-induction phase
Prednisone
Dosage: days 1-29, previous protocol, remission induction
Vincristine
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 on days 2,4,6,8,10,12 previous protocol, reinduction
Cytarabine
Dosage: on days 22, 29, 32, previous protocol, remission induction
Cytarabine
Dosage: hd; in h patients; days 43, 44; previous protocol; re-induction phase
Mercaptopurine
Dosage: daily, previous protocol, continuation phase
Dexamethasone
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, remission induction
Vincristine
Mercaptopurine
Dosage: days 1-14, previous protocol, consolidation phase
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: age dependent dose on days 1, 22 (extra 8, 15), previous protocol, remission induction
Cytarabine
Dosage: every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: on days 22, 29, 32, previous protocol, remission induction
Elspar
Dosage: 10,000 u/m2 or 25, 000u/m2 on days 2,4,6,8,10,12 previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Prednisone
Dosage: days 1-29, previous protocol, re-induction induction
Indication: Acute Lymphocytic Leukaemia
Vincristine
Indication: Acute Lymphocytic Leukaemia
Elspar
Dosage: 25,000u/m2 weeklyduring first 19 weeks; previous protocol; continuation
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 thrice weekly(reinduction i, ii), weekly (reinduction i) previous protocol
Methotrexate
Dosage: previous protocol, continuation phase
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: age dependent dose on days 1,8,previous protocol, consolidation
Etoposide
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: on days 22, 29, 32, previous protocol, re-induction
Cytoxan
Dosage: stable/high, every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Other drugs received by patient: Leucovorin Calcium; Cotrim
Possible Cytoxan side effects in
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-24
Patient:
Reactions: Off Label Use, Leukaemia
Drug(s) suspected as cause:
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, remission induction
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 on days 2,4,6,8,10,12 previous protocol, reinduction
Etoposide
Dosage: on days 22, 29, 32, previous protocol, remission induction
Cytoxan
Dosage: stable/high, every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: age dependent dose on days 1,8,previous protocol, consolidation
Dexamethasone
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: age dependent dose on days 1, 22 (extra 8, 15), previous protocol, remission induction
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 on days 1, 8, previous protocol, consolidation phase
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Elspar
Dosage: 25,000u/m2 weeklyduring first 19 weeks; previous protocol; continuation
Cytarabine
Dosage: every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: weekly; previous protocol; continuation phase
Prednisone
Dosage: days 1-29, previous protocol, re-induction induction
Indication: Acute Lymphocytic Leukaemia
Prednisone
Dosage: days 1-29, previous protocol, remission induction
Elspar
Dosage: 10,000 u/m2 or 25, 000u/m2 on days 2,4,6,8,10,12 previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: hd; in h patients; days 43, 44; previous protocol; re-induction phase
Methotrexate
Dosage: previous protocol, continuation phase
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: age dependent dose on days 1, 22, previous protocol, re-induction phase
Mercaptopurine
Dosage: days 1-14, previous protocol, consolidation phase
Indication: Acute Lymphocytic Leukaemia
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, remission induction
Vincristine
Dosage: every 4 weeks, previous protocol, continuation
Cytarabine
Dosage: days 22,29, 32, previous protocol, re-induction
Cytarabine
Dosage: on days 22, 29, 32, previous protocol, remission induction
Mercaptopurine
Dosage: daily, previous protocol, continuation phase
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 every 8 weeks during 1 year, previous protocol, continuation phase
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, re-induction induction
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: on days 22, 29, 32, previous protocol, re-induction
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 thrice weekly(reinduction i, ii), weekly (reinduction i) previous protocol
Other drugs received by patient: Cotrim; Leucovorin Calcium
Possible Cytoxan side effects in
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-24
Patient:
Reactions: Off Label Use, Diabetes Mellitus
Drug(s) suspected as cause:
Methotrexate
Dosage: weekly; current protocol; continuation phase
Cytoxan
Dosage: on days 22, 29, 32, previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Mercaptopurine
Dosage: days 22-35, current protocol, remission-induction
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: low risk 8 mg/m2, 5 days, stable/high risk 12 mg/m2, every 4 weeks, current protocol, continuation
Methotrexate
Dosage: weekly; previous protocol; continuation phase
Radiotherapy
Indication: Acute Lymphocytic Leukaemia
Elspar
Dosage: 10,000 u/m2 or 25, 000u/m2 on days 2,4,6,8,10,12 previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: on days 22, 29, 32, previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 on days 1, 8, previous protocol, consolidation phase
Mercaptopurine
Dosage: 50-70 mg/m2, daily, current protocol, continuation phase
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on days 22, 29, 32, previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: age dependent dose on days 1, 22 (extra 8, 15), previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Prednisone
Dosage: days 1-29, previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: days 1-8, 15-22, current protocol, remission-induction
Indication: Acute Lymphocytic Leukaemia
Other drugs received by patient: Cotrim; Leucovorin Calcium
Possible Cytoxan side effects in
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-24
Patient:
Reactions: Off Label Use, Treatment Failure
Drug(s) suspected as cause:
Mercaptopurine
Dosage: daily, previous protocol, continuation phase
Dexamethasone
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Prednisone
Dosage: days 1-29, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 on days 1, 8, previous protocol, consolidation phase
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Cytoxan
Dosage: stable/high, every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Elspar
Etoposide
Dosage: on days 22, 29, 32, previous protocol, re-induction
Elspar
Methotrexate
Dosage: age dependent dose on days 1,8,previous protocol, consolidation
Methotrexate
Dosage: weekly; previous protocol; continuation phase
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, remission induction
Elspar
Dosage: 10,000 u/m2 or 25, 000u/m2 on days 2,4,6,8,10,12 previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Elspar
Cytarabine
Dosage: days 22,29, 32, previous protocol, re-induction
Etoposide
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 every 8 weeks during 1 year, previous protocol, continuation phase
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, re-induction induction
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, remission induction
Vincristine
Dosage: every 4 weeks, previous protocol, continuation
Cytarabine
Dosage: on days 22, 29, 32, previous protocol, remission induction
Methotrexate
Dosage: age dependent dose on days 1, 22, previous protocol, re-induction phase
Prednisone
Dosage: days 1-29, previous protocol, remission induction
Cytarabine
Dosage: hd; in h patients; days 43, 44; previous protocol; re-induction phase
Etoposide
Dosage: on days 22, 29, 32, previous protocol, remission induction
Mercaptopurine
Dosage: days 1-14, previous protocol, consolidation phase
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: previous protocol, continuation phase
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: age dependent dose on days 1, 22 (extra 8, 15), previous protocol, remission induction
Other drugs received by patient: Cotrim; Leucovorin Calcium
Possible Cytoxan side effects in
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-24
Patient:
Reactions: Off Label Use, Neuropathy Peripheral, Cerebrovascular Accident
Drug(s) suspected as cause:
Cytarabine
Dosage: hd; in h patients; days 43, 44; previous protocol; re-induction phase
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 on days 1, 8, previous protocol, consolidation phase
Mercaptopurine
Dosage: days 1-14, previous protocol, consolidation phase
Prednisone
Dosage: days 1-29, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: every 4 weeks, previous protocol, continuation
Elspar
Dosage: 10,000 u/m2 or 25, 000u/m2 on days 2,4,6,8,10,12 previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Cytoxan
Dosage: stable/high, every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Doxorubicin HCL
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, remission induction
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 every 8 weeks during 1 year, previous protocol, continuation phase
Prednisone
Dosage: days 1-29, previous protocol, remission induction
Etoposide
Dosage: on days 22, 29, 32, previous protocol, re-induction
Methotrexate
Dosage: age dependent dose on days 1,8,previous protocol, consolidation
Methotrexate
Dosage: weekly; previous protocol; continuation phase
Cytarabine
Dosage: every 8 weeks, previous protocol, continuation
Cytarabine
Dosage: days 22,29, 32, previous protocol, re-induction
Dexamethasone
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, re-induction induction
Indication: Acute Lymphocytic Leukaemia
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 on days 2,4,6,8,10,12 previous protocol, reinduction
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 thrice weekly(reinduction i, ii), weekly (reinduction i) previous protocol
Elspar
Dosage: 25,000u/m2 weeklyduring first 19 weeks; previous protocol; continuation
Cytarabine
Dosage: on days 22, 29, 32, previous protocol, remission induction
Etoposide
Dosage: on days 22, 29, 32, previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: every 4 weeks, previous protocol, continuation
Methotrexate
Dosage: age dependent dose on days 1, 22 (extra 8, 15), previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: previous protocol, continuation phase
Methotrexate
Dosage: age dependent dose on days 1, 22, previous protocol, re-induction phase
Mercaptopurine
Dosage: daily, previous protocol, continuation phase
Indication: Acute Lymphocytic Leukaemia
Other drugs received by patient: Cotrim; Leucovorin Calcium
Possible Cytoxan side effects in
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-24
Patient:
Reactions: Off Label Use, Treatment Related Secondary Malignancy
Drug(s) suspected as cause:
Vincristine
Dosage: every 4 weeks, previous protocol, continuation
Elspar
Dosage: 25,000u/m2 weeklyduring first 19 weeks; previous protocol; continuation
Methotrexate
Dosage: previous protocol, continuation phase
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, remission induction
Cytoxan
Dosage: stable/high, every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: days 22,29, 32, previous protocol, re-induction
Etoposide
Dosage: on days 22, 29, 32, previous protocol, remission induction
Mercaptopurine
Dosage: days 1-14, previous protocol, consolidation phase
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 every 8 weeks during 1 year, previous protocol, continuation phase
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Etoposide
Dosage: on days 22, 29, 32, previous protocol, re-induction
Methotrexate
Dosage: age dependent dose on days 1,8,previous protocol, consolidation
Methotrexate
Dosage: age dependent dose on days 1, 22 (extra 8, 15), previous protocol, remission induction
Doxorubicin HCL
Dosage: on days 1, 8 and extra on day 15, previous protocol, remission induction
Prednisone
Dosage: days 1-29, previous protocol, re-induction
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: on days 1, 8, 15, 22, previous protocol, re-induction induction
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: every 8 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on days 22, 29, 32, previous protocol, remission induction
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 thrice weekly(reinduction i, ii), weekly (reinduction i) previous protocol
Cytarabine
Dosage: hd; in h patients; days 43, 44; previous protocol; re-induction phase
Dexamethasone
Dosage: every 4 weeks, previous protocol, continuation
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: l:1.5 g/m2, s: 2g/m2, h: 5 g/m2 on days 1, 8, previous protocol, consolidation phase
Elspar
Dosage: 10,000 u/m2 or 25, 000u/m2 on days 2,4,6,8,10,12 previous protocol, remission induction
Indication: Acute Lymphocytic Leukaemia
Elspar
Dosage: 10,000 u/m2 or 25,000u/m2 on days 2,4,6,8,10,12 previous protocol, reinduction
Mercaptopurine
Dosage: daily, previous protocol, continuation phase
Methotrexate
Dosage: age dependent dose on days 1, 22, previous protocol, re-induction phase
Methotrexate
Dosage: weekly; previous protocol; continuation phase
Prednisone
Dosage: days 1-29, previous protocol, remission induction
Other drugs received by patient: Cotrim; Leucovorin Calcium
Possible Cytoxan side effects in male
Reported by a consumer/non-health professional from China on 2012-05-24
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Off Label Use, Rash Erythematous, Gastric Cancer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fluorouracil
Indication: Gastric Cancer Stage III
Doxorubicin HCL
Indication: Gastric Cancer Stage III
Doxorubicin HCL
Start date: 2011-10-30
End date: 2011-11-02
Doxorubicin HCL
Epirubicin
Indication: Gastric Cancer Stage III
Cytoxan
Indication: Gastric Cancer Stage III
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