Gemtuzumab and venoocclusive liver disease Patient Reports February 13, 2012

Gemtuzumab Side Effects Report #5819510-5
Gemtuzumab side effect was reported by a Physician from FRANCE on July 18, 2008. Female patient, 65 years of age, was diagnosed with leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: aplasia, colitis, hepatic fibrosis, hepatic steatosis, sepsis , venoocclusive liver disease. Gemtuzumab dosage: unknown. During the same period patient was treated with ARACYTINE, DAUNORUBICIN. Patient recovered.

Gemtuzumab Side Effects Report #5086084-9
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Aug 08, 2006. Male patient, 66 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cholestasis, coagulopathy, cytolytic hepatitis, loss of consciousness, multi-organ failure, thrombocytopenia, venoocclusive liver disease. Gemtuzumab dosage: 9 MG/M^2 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, AZACTAM, AMIKIN, OMEPRAZOLE, FLUCONAZOLE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #5087261-3
Gemtuzumab side effect was reported by a Health Professional from FRANCE on Aug 08, 2006. Male patient, 65 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: abdominal pain upper, ascites, cholestasis, cytolytic hepatitis, loss of consciousness, multi-organ failure, thrombocytopenia, venoocclusive liver disease, weight increased. Gemtuzumab dosage: 9 MG/M^2 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, AZACTAM, AMIKIN, OMEPRAZOLE, FLUCONAZOLE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #4673034-X
Gemtuzumab side effect was reported by a Consumer or non-health professional from on Nov 24, 2004. Female patient, 27 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: blood bicarbonate decreased, blood creatine increased, blood urea increased, venoocclusive liver disease. Gemtuzumab dosage: 14,9 MG, INTRAVENOUS. During the same period patient was treated with OMEPRAZOLE, FLUCONAZOLE, ACYCLOVIR, TARIVID, MAGNESIUM, FOLIC ACID, LYNESTRENOL, FRAXIPARINE. Patient died.


Gemtuzumab Side Effects Report #5227273-X
Gemtuzumab side effect was reported by a Physician from FRANCE on Jan 29, 2007. Female patient was diagnosed with acute myeloid leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: refractoriness to platelet transfusion, venoocclusive liver disease. Gemtuzumab dosage: 10 MG. During the same period patient was treated with NOVANTRONE, ZOFRAN, ACYCLOVIR, TIENAM, TRIFLUCAN, INIPOMP, CHIBRO, ARACYTINE. Patient recovered.

Gemtuzumab Side Effects Report #5434258-7
Gemtuzumab side effect was reported by a Physician from BELGIUM on Aug 28, 2007. Male patient, 72 years of age, weighting 163.1 lb, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: bronchopulmonary aspergillosis, fluid retention, hyperbilirubinaemia, pancytopenia, shock haemorrhagic, venoocclusive liver disease. Gemtuzumab dosage: 11.6 MG. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. Patient was hospitalized. Patient died on 03/21/2005.

Gemtuzumab Side Effects Report #4639480-5
Gemtuzumab side effect was reported by a Consumer or non-health professional from on Apr 12, 2005. Male patient, 64 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: encephalopathy, portal vein thrombosis, venoocclusive liver disease. Gemtuzumab dosage: 16 MG 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with FUROSEMIDE, RAMIPRIL, LORAZEPAM, XALATAN. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #4949815-1
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Mar 08, 2006. Male patient, 64 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: loss of consciousness, venoocclusive liver disease. Gemtuzumab dosage: 9 MG/M^2 1X PER 1 DAY; INTRAVENOUS. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, AZACTAM, AMIKIN, OMEPRAZOLE, FLUCONAZOLE. Patient was hospitalized. Patient died.

Gemtuzumab Side Effects Report #5196120-7
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Dec 20, 2006. Male patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cholestasis, cytolytic hepatitis, hepatotoxicity, multi-organ failure, renal failure acute, venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1X PER 1 CYC INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKIN, CEFTAZIDIME PENTAHYDRATE, VANCOMYCIN. Patient died.


Gemtuzumab Side Effects Report #4566328-X
Gemtuzumab side effect was reported by a Consumer or non-health professional from on Jan 24, 2005. Male patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: oliguria, renal failure acute, venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1 X PER 1 DAY, INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKLIN, FORTUM, VANCOMYCIN. Patient recovered.

Gemtuzumab Side Effects Report #4579955-0
Gemtuzumab side effect was reported by a Consumer or non-health professional from on Feb 02, 2005. Male patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: multi-organ failure, renal failure acute, venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1X PER 1 DAY INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKLIN, FORTUM, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #4607267-5
Gemtuzumab side effect was reported by a Consumer or non-health professional from on Feb 28, 2005. Male patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cholestasis, cytolytic hepatitis, hepatotoxicity, multi-organ failure, oliguria, renal failure acute, sepsis , venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1X PER 1 CYC, INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKLIN, FORTUM, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #4869580-6
Gemtuzumab side effect was reported by a Consumer or non-health professional from FRANCE on Dec 22, 2005. Male patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: cholestasis, cytolytic hepatitis, hepatotoxicity, multi-organ failure, refractoriness to platelet transfusion, renal failure acute, sepsis , venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG 1 PER 1 CYC INTRAVENOUS. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, AMIKIN, FORTUM, VANCOMYCIN. Patient died.

Gemtuzumab Side Effects Report #4653007-3
Gemtuzumab side effect was reported by a Pharmacist from on May 02, 2005. Male patient, 58 years of age, was diagnosed with acute myeloid leukaemia, neoplasm malignant and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: hepatic failure, hypotension, renal failure, venoocclusive liver disease. Gemtuzumab dosage: 17MG IV (9MG/M2). Patient died on 02/15/2005.


Gemtuzumab Side Effects Report #4867022-8
Gemtuzumab side effect was reported by a Consumer or non-health professional from NETHERLANDS on Mar 10, 2002. Female patient, 55 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: leukopenia, pyrexia, venoocclusive liver disease. Gemtuzumab dosage: 9 MG/M(2) INTRAVENOUS. During the same period patient was treated with DIFLUCAN, CIPROXIN, ZELITREX. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5293573-0
Gemtuzumab side effect was reported by a Physician from FRANCE on Apr 06, 2007. Male patient, 49 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: disease progression, multi-organ failure, venoocclusive liver disease. Gemtuzumab dosage: unknown. During the same period patient was treated with ACYCLOVIR, VANCOMYCIN, FLUDARABINE PHOSPHATE, IDARUBICIN, INIPOMP, CONTRAMAL, CIPROFLOXACIN, ZOPHREN. Patient died on 03/03/2007.

Gemtuzumab Side Effects Report #5488607-4
Gemtuzumab side effect was reported by a Physician from UNITED KINGDOM on Oct 16, 2007. Male patient, weighting 191.6 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, blood bilirubin increased, c-reactive protein increased, gamma-glutamyltransferase increased, venoocclusive liver disease. Gemtuzumab dosage: 5 MG EVERY 1 TOT. During the same period patient was treated with ETOPOSIDE, CYTARABINE, ATORVASTATIN CALCIUM, CIPROFLOXACIN, METRONIDAZOLE, GENTAMICIN. Patient recovered.

Gemtuzumab Side Effects Report #5608972-4
Gemtuzumab side effect was reported by a Physician from FRANCE on Jan 25, 2008. Male patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: hepatotoxicity, multi-organ failure, oliguria, renal failure acute, venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG EVERY 1 CYC. During the same period patient was treated with ETOPOSIDE, VANCOMYCIN, AMIKLIN, FORTUM, ARACYTINE, IDARUBICIN. Patient died on 01/25/2005.

Gemtuzumab Side Effects Report #5608973-6
Gemtuzumab side effect was reported by a Physician from FRANCE on Jan 25, 2008. Male patient, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: hepatotoxicity, multi-organ failure, oliguria, renal failure acute, venoocclusive liver disease. Gemtuzumab dosage: 4.8 MG EVERY 1 CYC. During the same period patient was treated with ETOPOSIDE, VANCOMYCIN, AMIKLIN, FORTUM, ARACYTINE, IDARUBICIN. Patient died on 01/25/2005.


Gemtuzumab Side Effects Report #5913971-9
Gemtuzumab side effect was reported by a Health Professional from JAPAN on Oct 02, 2008. Female patient was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: venoocclusive liver disease. Gemtuzumab dosage: unknown. Patient recovered.

Gemtuzumab Side Effects Report #4631147-2
Gemtuzumab side effect was reported by a Pharmacist from on Apr 07, 2005. Male patient, child 10 years of age, weighting 143.3 lb, was diagnosed with acute lymphocytic leukaemia, leukaemia recurrent and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: ascites, fluid overload, hyperbilirubinaemia, hypotension, sepsis , transaminases increased, venoocclusive liver disease. Gemtuzumab dosage: 7.8 MG X 1 DOSE INTRAVENOU. During the same period patient was treated with ALEMTUZUMAB, MEROPENEM, VANCOMYCIN, METHYLPREDNISOLONE, PENTAMIDINE, AMBISOME, PROZAC. Patient recovered.

Gemtuzumab Side Effects Report #4891991-3
Gemtuzumab side effect was reported by a Pharmacist from UNITED STATES on Jan 24, 2006. Male patient, child 10 years of age, weighting 14.33 lb, was diagnosed with acute leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: blood bilirubin increased, fluid overload, hepatic function abnormal, sepsis , transaminases increased, venoocclusive liver disease, weight increased. Gemtuzumab dosage: 6 MG /M2 IV (1 DOSE). During the same period patient was treated with ALEMTUZUMAB. Patient was hospitalized. Patient recovered.