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Cytoxan (Cyclophosphamide) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



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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