Gemtuzumab and hepatotoxicity Patient Reports February 13, 2012

Gemtuzumab Side Effects Report #4688359-1
Gemtuzumab side effect was reported by a Consumer or non-health professional from on June 01, 2005. Male patient, 72 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: ascites, bronchopulmonary aspergillosis, fluid retention, hepatic congestion, hepatic steatosis, hepatomegaly, hepatotoxicity, hyperbilirubinaemia, lung disorder. Gemtuzumab dosage: 11.6 MG. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN. 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 #4603388-1
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: ascites, cholestasis, cytolytic hepatitis, hepatomegaly, hepatotoxicity, multi-organ failure, oliguria, renal failure acute, sepsis . Gemtuzumab dosage: 4.8 MG 1X PER 1 CYC. 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 #4721952-6
Gemtuzumab side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on July 08, 2005. Female patient, 59 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, bone marrow depression, hepatotoxicity. Gemtuzumab dosage: unknown. During the same period patient was treated with CYTARABINE, FLUDARABINE, GRANULOCYTE COLONY STIMULATING FACTOR, IDARUBICIN, NOVANTRONE. Patient recovered.

Gemtuzumab Side Effects Report #4749236-0
Gemtuzumab side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 08, 2005. Female patient, 59 years of age, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: bone marrow depression, hepatotoxicity. Gemtuzumab dosage: unknown. During the same period patient was treated with CYTARABINE, FLUDARABINE, GRANULOCYTE COLONY STIMULATING FACTOR, IDARUBICIN, NOVANTRONE. Patient recovered.

Gemtuzumab Side Effects Report #6057696-0
Gemtuzumab side effect was reported by a Physician from SPAIN on Jan 27, 2009. Male patient, 35 years of age, weighting 174.2 lb, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: ascites, bacteraemia, haematotoxicity, hepatotoxicity, hyperbilirubinaemia, hypotension, hypovolaemic shock, ischaemic hepatitis, neutropenic colitis. Gemtuzumab dosage: unknown. During the same period patient was treated with CYTARABINE, IDARUBICIN. Patient was hospitalized and became disabled. Patient recovered.

Gemtuzumab Side Effects Report #5300516-X
Gemtuzumab side effect was reported by a Health Professional from UNITED STATES on Apr 13, 2007. Male patient, weighting 181.9 lb, was diagnosed with acute myeloid leukaemia and was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: hepatotoxicity. Gemtuzumab dosage: 9 MG/M2/DAY -18.27 X1 IV DRIP. 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 #5297997-7
Gemtuzumab side effect was reported by a Physician from BELGIUM on Apr 11, 2007. Male patient, 62 years of age, weighting 154.3 lb, was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: disseminated intravascular coagulation, encephalopathy, hepatotoxicity, pyrexia, rectal haemorrhage. Gemtuzumab dosage: unknown. Patient was hospitalized. Patient recovered.

Gemtuzumab Side Effects Report #5853048-4
Gemtuzumab side effect was reported by a Physician from BELGIUM on Aug 11, 2008. Male patient, 62 years of age, weighting 154.3 lb, was treated with Gemtuzumab. After drug was administered, patient experienced the following side effects: disseminated intravascular coagulation, encephalopathy, hepatotoxicity, pyrexia, rectal haemorrhage. Gemtuzumab dosage: unknown. Patient was hospitalized. Patient recovered.