|
Index of reports
> Cases with Febrile Neutropenia (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Mylotarg (Gemtuzumab Ozogamicin) where reactions include febrile neutropenia. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Mylotarg side effects in female
Reported by a physician from United States on 2012-06-04
Patient: female, weighing 64.9 kg (142.8 pounds)
Reactions: White Blood Cell Count Decreased, Pneumonia, Febrile Neutropenia, Disease Progression, Cardiac Failure, Injection Site Reaction, Sepsis, Pleural Effusion, Neutrophil Count Decreased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-11-04
End date: 2011-11-12
Vidaza
Dosage: 125 milligram/sq. meter
Start date: 2011-11-04
End date: 2011-11-10
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-10
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-10-04
End date: 2011-10-12
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-11
Mylotarg
Dosage: 5.1 milligram
Start date: 2011-11-07
End date: 2011-11-11
Other drugs received by patient: Levothyroxine Sodium; Diphenhydramine HCL; Lipitor; Hydrocodone
Possible Mylotarg side effects in 66 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-16
Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)
Reactions: White Blood Cell Count Decreased, Pneumonia, Cardiac Failure, Injection Site Reaction, Pleural Effusion, Febrile Neutropenia, Neutrophil Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-11
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-11-04
End date: 2011-11-12
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-10
Mylotarg
End date: 2011-11-11
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-10-04
End date: 2011-10-12
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-11-04
Other drugs received by patient: Hydrocodone; Lipitor; Diphenhydramine HCL; Levothyroxine Sodium
Possible Mylotarg side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-11-22
End date: 2011-11-22
Azacitidine
Dosage: 160 milligram
Start date: 2011-11-15
End date: 2011-11-21
Possible Mylotarg side effects in 66 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28
Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)
Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-11
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-10
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-10-04
End date: 2011-10-12
Other drugs received by patient: Levothyroxine Sodium; Lipitor; Diphenhydramine HCL; Hydrocodone
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2012-02-10
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Azacitidine
Dosage: 75 mg/m2 on days 1-7, 160 mg per day
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Possible Mylotarg side effects in 60 year old female
Reported by a physician from United States on 2012-02-07
Patient: 60 year old female, weighing 75.0 kg (165.0 pounds)
Reactions: Acute Myeloid Leukaemia, Sepsis, Febrile Neutropenia, Pyrexia, Disease Progression
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Vidaza
Dosage: 75 mg/m2, sc or iv on days 1-7
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-03
Mylotarg
Dosage: 3 mg/m2, on days 4 and 8
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-07
End date: 2011-09-07
Zolinza
Dosage: 400 mg, on days 1-9
Administration route: Oral
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-03
Other drugs received by patient: Acyclovir; Insulin; Oxycodone; Omeprazole; Meperidine HCL; Allopurinol; Aluminium Hydroxide / Diphenhydramine / Magnesium Hydroxide / Lidocaine; Acetaminophen; Chlorhexidine Gluconate; Albuterol; Loratadine; Ondansetron; Diphenhydramine; Lorazepam; Metoclopramide; Prochlorperazine
Possible Mylotarg side effects in 65 year old male
Reported by a physician from United States on 2012-01-26
Patient: 65 year old male, weighing 70.0 kg (153.9 pounds)
Reactions: Respiratory Failure, Sepsis, Febrile Neutropenia, Pneumonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-08-23
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-10-25
End date: 2011-10-31
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-10-25
End date: 2011-11-02
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-08-23
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-08-23
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-10-25
End date: 2011-10-30
Possible Mylotarg side effects in 66 year old female
Reported by a physician from United States on 2012-01-26
Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)
Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: 400 mg, on days 1-9
Administration route: Oral
Indication: Acute Myeloid Leukaemia
Start date: 2011-10-04
End date: 2011-10-12
Mylotarg
Dosage: 3 mg/m2, on days 4 and 8
Indication: Acute Myeloid Leukaemia
Start date: 2011-10-04
End date: 2011-10-11
Vidaza
Dosage: 75 mg/m2, on days 1-7
Indication: Acute Myeloid Leukaemia
Start date: 2011-10-04
End date: 2011-10-10
Other drugs received by patient: Hydrocodone; Lipitor; Benadryl; Levothyroxine Sodium
Possible Mylotarg side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-13
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75 milligram/sq. meter
Start date: 2011-11-15
End date: 2011-11-21
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-11-22
End date: 2011-11-22
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2011-12-28
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Multi-Organ Failure, Sepsis, Atrial Fibrillation, Febrile Neutropenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8, total dose administered this course 6.45mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Azacitidine
Dosage: 75mg/m2 on days 1-7, 160mg per day, total dose administered this course 1121mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2011-12-27
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Vomiting, Dyspnoea, Nausea, Tachycardia, Febrile Neutropenia, Atrial Fibrillation, Multi-Organ Failure, Sepsis, Tachypnoea
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75mg/m2 on days 1-7, 160mg per day, total dose administered this course 1121mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8, total dose administered this course 6.45mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2011-12-21
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75mg/m2 on days 1-7, 160mg per day, total dose administered this course 1121mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8, total dose administered this course 6.45mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Possible Mylotarg side effects in 74 year old male
Reported by a physician from United States on 2011-12-12
Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Sepsis, Febrile Neutropenia, Atrial Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75mg/m2 on days 1-7, 160mg per day, total dose administered this course 1121mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-15
End date: 2011-11-21
Mylotarg
Dosage: 3 mg/m2 over 2 hours on day 8, total dose administered this course 6.45mg
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-22
End date: 2011-11-22
Possible Mylotarg side effects in 66 year old female
Reported by a physician from United States on 2011-11-23
Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)
Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75 mg/m2/day, sc or iv on days 1-7 (total dose this course: 896mg)
Indication: Acute Myeloid Leukaemia
Start date: 2011-10-04
End date: 2011-10-10
Zolinza
Dosage: 400 mg, 1x/day on days 1-9 (total dose this course: 3600mg)
Administration route: Oral
Indication: Acute Myeloid Leukaemia
Start date: 2011-10-04
End date: 2011-10-12
Mylotarg
Dosage: 3 mg/m2, over 2 hrs on days 4 and 8 (total dose this course: 10.2mg)
Indication: Acute Myeloid Leukaemia
Start date: 2011-10-04
End date: 2011-10-11
Other drugs received by patient: Levothyroxine Sodium; Benadryl; Hydrocodone; Lipitor
Possible Mylotarg side effects in 67 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-14
Patient: 67 year old male
Reactions: Renal Tubular Disorder, Renal Impairment, Hypomagnesaemia, Hypotension, Pulmonary Embolism, Febrile Neutropenia, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Evoltra (Clofarabine) Solution FOR Infusion, UNK
Dosage: 45 mg, qdx5, intravenous ; 45 mg, qdx5, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-10-08
End date: 2009-10-12
Evoltra (Clofarabine) Solution FOR Infusion, UNK
Dosage: 45 mg, qdx5, intravenous ; 45 mg, qdx5, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-11-17
End date: 2009-11-21
Daunorubicin HCL
Dosage: 1 df, qod, intravenous ; 1 df, qod, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-11-17
End date: 2009-11-21
Daunorubicin HCL
Dosage: 1 df, qod, intravenous ; 1 df, qod, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-10-08
End date: 2009-10-12
Mylotarg
Dosage: 1 df, once, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-10-08
End date: 2009-10-08
|
