MYLOTARG Side Effects

6983940-9 | Abdominal Pain, Nausea, Painful Respiration
on May 07, 2009 Male patient from UNITED STATES , weighting 200.2 lb, was diagnosed with acute myeloid leukaemia, infection prophylaxis, diabetes mellitus, prophylaxis of nausea and vomiting and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), nausea (What is nausea?), painful respiration. Mylotarg dosage: 5ml Over 2 Hours On Day 8 Of A 28 Day Cycle For A Total Of 5 Cycles. During the same period patient was treated with LEVAQUIN (Onging) (View Levaquin Review and Levaquin Label ), METFORMIN HCL (View Metformin Hcl Review and Metformin Hcl Label ), ANTIEMETICS AND ANTINAUSEANTS (24 Mg Prior To Each Chemo) (View Antiemetics And Antinauseants Review and Antiemetics And Antinauseants Label ), AZACITIDINE (150 Mg Q Day X 5 Days Every 4 Weeks) (View Azacitidine Review and Azacitidine Label ).

6983775-7 | Thrombocytopenia
Patient was taking Mylotarg (View Usage). Patient had the following side effects: thrombocytopenia on Jan 26, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 167.2 lb, was diagnosed with acute myeloid leukaemia, pneumocystis jiroveci pneumonia, febrile neutropenia, fungal infection (What is fungal infection?) and. Mylotarg dosage: One Dose Received. During the same period patient was treated with BACTRIM (^ds^ Dosage Form 2 Times Per 1 Day) (View Bactrim Review and Bactrim Label ), CEFEPIME (2g Every Eight Hours) (View Cefepime Review and Cefepime Label ), VORICONAZOLE (View Voriconazole Review and Voriconazole Label ).

6983572-2 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased
Adverse event was reported on Oct 06, 2008 by a Female patient taking Mylotarg (View Usage) (Dosage: 16.3 Mg; Frequency Not Specified) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , weighting 167.6 lb, After Mylotarg was administered, patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased. During the same period patient was treated with ACYCLOVIR SODIUM (View Acyclovir Sodium Review and Acyclovir Sodium Label ), VITAMIN B6 (View Vitamin B6 Review and Vitamin B6 Label ), CALCIUM CARBONATE (View Calcium Carbonate Review and Calcium Carbonate Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), NYSTATIN (View Nystatin Review and Nystatin Label ), MEROPENIN (View Meropenin Review and Meropenin Label ), VANCOMYCIN (View Vancomycin Review and Vancomycin Label ).

6907418-3 | Platelet Count Decreased, White Blood Cell Count Decreased
on Nov 05, 2009 Male patient from UNITED STATES , 76 years of age, weighting 211.4 lb, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: platelet count decreased, white blood cell count decreased. Mylotarg dosage: 19.4 Mg 1x Per 1 Day, Intravenous. During the same period patient was treated with ATENOLOL (View Atenolol Review and Atenolol Label ), ENALAPRIL MALEATE (View Enalapril Maleate Review and Enalapril Maleate Label ), HYDROCHLOROTHIAZIDE (View Hydrochlorothiazide Review and Hydrochlorothiazide Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), TAMSULOSIN HCL (View Tamsulosin Hcl Review and Tamsulosin Hcl Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), VITAMIN D (View Vitamin D Review and Vitamin D Label ), MULTIVITAMINS (ASCORBIC ACID/ERGOCALCIFEROL/FOLIC ACID/NICOTINAMIDE/PA (View Multivitamins (ascorbic Acid/ergocalciferol/folic Acid/nicotinamide/pa Review and Multivitamins (ascorbic Acid/ergocalciferol/folic Acid/nicotinamide/pa Label ). Patient was hospitalized.


6866310-3 | Abscess, Peritonitis, Staphylococcal Infection
on Jul 13, 2010 Male patient from JAPAN , 81 years of age, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). Patient had the following side effects: abscess (What is abscess?), peritonitis, staphylococcal infection (What is staphylococcal infection?). Mylotarg dosage: . During the same period patient was treated with ETOPOSIDE (View Etoposide Review and Etoposide Label ), CISPLATIN (View Cisplatin Review and Cisplatin Label ), NOVANTRONE (View Novantrone Review and Novantrone Label ).

6832479-X | Abscess, Peritonitis, Staphylococcal Infection
Patient was taking Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: abscess (What is abscess?), peritonitis, staphylococcal infection (What is staphylococcal infection?) on Jul 01, 2010 from JAPAN Additional patient health information: Male patient , 81 years of age, was diagnosed with acute myeloid leukaemia and. Mylotarg dosage: . During the same period patient was treated with ETOPOSIDE (View Etoposide Review and Etoposide Label ), CISPLATIN (View Cisplatin Review and Cisplatin Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6816586-3 | Bacillus Infection, Brain Abscess, Parkinsonism, Pupils Unequal, Sepsis
Adverse event was reported on Jun 25, 2010 by a Male patient taking Mylotarg (View Usage) (Dosage: Not Provided) was diagnosed with acute myeloid leukaemia recurrent and. Location: JAPAN , 56 years of age, Patient experienced the following unwanted or unexpected effects: bacillus infection, brain abscess, parkinsonism, pupils unequal, sepsis (What is sepsis?). During the same period patient was treated with CYTARABINE (Not Provided) (View Cytarabine Review and Cytarabine Label ), IDARUBICIN HCL (Not Provided) (View Idarubicin Hcl Review and Idarubicin Hcl Label ).

6750791-X | Bacillus Infection, Brain Abscess, Parkinsonism, Pupils Unequal, Sepsis
on May 27, 2010 Male patient from JAPAN , 56 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Mylotarg (View Usage). Patient had the following side effects: bacillus infection, brain abscess, parkinsonism, pupils unequal, sepsis (What is sepsis?). Mylotarg dosage: Not Provided. During the same period patient was treated with CYTARABINE (Not Provided) (View Cytarabine Review and Cytarabine Label ), IDARUBICIN HCL (Not Provided) (View Idarubicin Hcl Review and Idarubicin Hcl Label ).

6743212-4 | Bacillus Infection, Brain Abscess, Parkinsonism, Pupils Unequal, Sepsis
on May 19, 2010 Male patient from JAPAN , 56 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: bacillus infection, brain abscess, parkinsonism, pupils unequal, sepsis (What is sepsis?). Mylotarg dosage: Not Provided. During the same period patient was treated with CYTARABINE (Not Provided) (View Cytarabine Review and Cytarabine Label ), IDARUBICIN HCL (Not Provided) (View Idarubicin Hcl Review and Idarubicin Hcl Label ).

6638430-X | Ascites, Hepatorenal Syndrome, Multi-organ Failure, Stem Cell Transplant, Unresponsive To Stimuli
Patient was taking Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: ascites, hepatorenal syndrome, multi-organ failure, stem cell transplant, unresponsive to stimuli on Mar 16, 2010 from UNITED STATES Additional patient health information: Male patient , 49 years of age, weighting 178.6 lb, was diagnosed with refractory anaemia and. Mylotarg dosage: 16 Mg Daily Oral 047. Patient was hospitalized.

6633328-5 | Lung Disorder, Venoocclusive Liver Disease
Adverse event was reported on Mar 09, 2010 by a Female patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia, lung disorder and. Location: JAPAN , weighting 88.18 lb, Patient had the following side effects: lung disorder, venoocclusive liver disease. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (140 Mg/m^2) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), PENTAMIDINE ISETHIONATE (View Pentamidine Isethionate Review and Pentamidine Isethionate Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), PIPERACILLIN AND TAZOBACTAM (View Piperacillin And Tazobactam Review and Piperacillin And Tazobactam Label ), MICAFUNGIN SODIUM (View Micafungin Sodium Review and Micafungin Sodium Label ), CARPERITIDE (0.1 Mg/kg/minute) (View Carperitide Review and Carperitide Label ), DOPAMINE HYDROCHLORIDE (3 Ug/kg/min) (View Dopamine Hydrochloride Review and Dopamine Hydrochloride Label ), BUSULFEX (0.8 Mg/kg) (View Busulfex Review and Busulfex Label ).

6614540-8 | Chest Pain, Hypotension, Hypoxia, Pruritus, Tachycardia, Urticaria
on Mar 04, 2010 Male patient from UNITED STATES , weighting 147.5 lb, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: chest pain (What is chest pain?), hypotension, hypoxia, pruritus, tachycardia, urticaria. Mylotarg dosage: 9mg/m2=15mg Q2weeks Iv. During the same period patient was treated with TYLENOL 500 (View Tylenol-500 Review and Tylenol-500 Label ), BENADRYL (View Benadryl Review and Benadryl Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), VASOTEC (View Vasotec Review and Vasotec Label ), PAXIL (View Paxil Review and Paxil Label ), FLEXERIL (View Flexeril Review and Flexeril Label ), OXYCODONE HCL (View Oxycodone Hcl Review and Oxycodone Hcl Label ).

6517993-9 | Venoocclusive Liver Disease
on Dec 22, 2009 Male patient from JAPAN , 69 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: venoocclusive liver disease. Mylotarg dosage: .

6457769-4 | Venoocclusive Liver Disease
Patient was taking Mylotarg (View Usage). Patient had the following side effects: venoocclusive liver disease on Nov 18, 2009 from JAPAN Additional patient health information: Male patient , child 11 years of age, was diagnosed with acute myeloid leukaemia and. Mylotarg dosage: 6 Mg/m2.

6419573-2 | Pneumonia, Respiratory Failure
Adverse event was reported on Oct 26, 2009 by a Female patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia, prophylaxis and. Location: JAPAN , weighting 105.8 lb, After Mylotarg was administered, patient had the following side effects: pneumonia (What is pneumonia?), respiratory failure. During the same period patient was treated with LIPITOR (View Lipitor Review and Lipitor Label ), MEROPEN (View Meropen Review and Meropen Label ), ITRIZOLE (View Itrizole Review and Itrizole Label ), MEPTIN (View Meptin Review and Meptin Label ), MODACIN (View Modacin Review and Modacin Label ), AMLODIN (View Amlodin Review and Amlodin Label ), MAGNESIUM OXIDE (View Magnesium Oxide Review and Magnesium Oxide Label ).

6409284-1 | Platelet Count Decreased, Pyrexia, Venoocclusive Liver Disease
on Oct 14, 2009 Female patient from JAPAN , 56 years of age, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: platelet count decreased, pyrexia, venoocclusive liver disease. Mylotarg dosage: 10 Mg/day.

6407111-X | Cerebral Toxoplasmosis, Hepatic Encephalopathy, Hepatic Failure
on Oct 14, 2009 Female patient from JAPAN , 75 years of age, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). Patient had the following side effects: cerebral toxoplasmosis, hepatic encephalopathy, hepatic failure. Mylotarg dosage: Not Provided. During the same period patient was treated with ETOPOSIDE (Not Provided) (View Etoposide Review and Etoposide Label ), CYTARABINE (Not Provided) (View Cytarabine Review and Cytarabine Label ), MITOXANTRONE HYDROCHLORIDE (Not Provided) (View Mitoxantrone Hydrochloride Review and Mitoxantrone Hydrochloride Label ).

6398677-7 | Venoocclusive Liver Disease
Patient was taking Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: venoocclusive liver disease on Oct 07, 2009 from JAPAN Additional patient health information: Male patient , 70 years of age, was diagnosed with acute myeloid leukaemia and. Mylotarg dosage: . Patient was hospitalized.

6394567-4 | Acute Respiratory Distress Syndrome
Adverse event was reported on Oct 07, 2009 by a Female patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 51 years of age, weighting 217.8 lb, Patient experienced the following unwanted or unexpected effects: acute respiratory distress syndrome. During the same period patient was treated with CYTARABINE (100mg/m^2/day Continuous 1-7 Days (induction)) (View Cytarabine Review and Cytarabine Label ), DAUNORUBICIN HCL (45mg/m^2 Iv Push 1-3 Days (induction)) (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ). Patient was hospitalized.

6378055-7 | Acute Myeloid Leukaemia Recurrent, Ascites, Hepatic Function Abnormal, Pulmonary Haemorrhage
on Sep 24, 2009 Male patient from JAPAN , weighting 132.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with Mylotarg (View Usage). Patient had the following side effects: acute myeloid leukaemia recurrent, ascites, hepatic function abnormal, pulmonary haemorrhage. Mylotarg dosage: . During the same period patient was treated with LASIX (View Lasix Review and Lasix Label ), ITRIZOLE (View Itrizole Review and Itrizole Label ), MAXIPIME (View Maxipime Review and Maxipime Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ). Patient was hospitalized.

6356723-0 | Bone Marrow Failure, Cerebellar Haemorrhage, Hepatotoxicity, Venoocclusive Liver Disease
on Sep 11, 2009 Male patient from UNITED STATES , 20 years of age, weighting 227.1 lb, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: bone marrow failure, cerebellar haemorrhage, hepatotoxicity, venoocclusive liver disease. Mylotarg dosage: 16mg Once Iv One Time Dose.

6348755-3 | Neutrophil Count Decreased, Pulmonary Alveolar Haemorrhage
Patient was taking Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: neutrophil count decreased, pulmonary alveolar haemorrhage on Sep 09, 2009 from JAPAN Additional patient health information: Female patient , weighting 136.7 lb, was diagnosed with acute myeloid leukaemia recurrent and. Mylotarg dosage: . During the same period patient was treated with SOL MELCORT (View Sol-melcort Review and Sol-melcort Label ), SOL MELCORT (View Sol-melcort Review and Sol-melcort Label ), FUNGUARD (View Funguard Review and Funguard Label ), PAZUCROSS (View Pazucross Review and Pazucross Label ). Patient was hospitalized.

6342390-9 | Neutrophil Count Decreased, Platelet Count Decreased, Pneumonia Staphylococcal
Adverse event was reported on Sep 03, 2009 by a Male patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 56 years of age, Patient had the following side effects: neutrophil count decreased, platelet count decreased, pneumonia staphylococcal. During the same period patient was treated with DAUNORUBICIN HCL (45 Mg/m2 D1-3 (total Dose Administered This Course 465mg)) (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), ARA C (100 Mg/m2/day D1-7 (total Dose Administered This Course 1799mg)) (View Ara-c Review and Ara-c Label ).

6316089-9 | Acute Respiratory Distress Syndrome, Hypotension, Pyrexia, Tachycardia
on Aug 19, 2009 Male patient from UNITED STATES , 61 years of age, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: acute respiratory distress syndrome, hypotension, pyrexia, tachycardia. Mylotarg dosage: 6.9mg -3mg/m2- Iv.

6297831-2 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Blood Lactate Dehydrogenase Increased, Bronchopulmonary Aspergillosis, Febrile Neutropenia, Pneumocystis Jiroveci Pneumonia, Sepsis
on Jul 31, 2009 Male patient from JAPAN , weighting 134.5 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, bronchopulmonary aspergillosis, febrile neutropenia, pneumocystis jiroveci pneumonia, sepsis (What is sepsis?). Mylotarg dosage: . During the same period patient was treated with NOVANTRONE (Not Provided) (View Novantrone Review and Novantrone Label ), MAXIPIME (View Maxipime Review and Maxipime Label ), CRAVIT (View Cravit Review and Cravit Label ), ITRIZOLE (View Itrizole Review and Itrizole Label ).

6297001-8 | Blood Pressure Decreased, Cholecystitis, Pneumonia
Patient was taking Mylotarg (View Usage). Patient had the following side effects: blood pressure decreased, cholecystitis, pneumonia (What is pneumonia?) on Jul 30, 2009 from JAPAN Additional patient health information: Female patient , weighting 90.39 lb, was diagnosed with acute myeloid leukaemia recurrent and. Mylotarg dosage: .

6287301-X | Disseminated Intravascular Coagulation, Haematemesis, Liver Disorder, Melaena
Adverse event was reported on Jul 23, 2009 by a Female patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia recurrent and. Location: JAPAN , weighting 121.3 lb, After Mylotarg was administered, patient had the following side effects: disseminated intravascular coagulation, haematemesis, liver disorder, melaena. During the same period patient was treated with BLOPRESS (View Blopress Review and Blopress Label ), MEVALOTIN (View Mevalotin Review and Mevalotin Label ), ROCEPHIN (View Rocephin Review and Rocephin Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ). Patient was hospitalized.

6269900-4 | Anaemia, Ascites, Febrile Neutropenia, Hepatomegaly, Malaise, Neutrophil Count Decreased, Platelet Count Decreased, Weight Increased
on Jul 06, 2009 Female patient from JAPAN , weighting 134.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, ascites, febrile neutropenia, hepatomegaly, malaise, neutrophil count decreased, platelet count decreased, weight increased. Mylotarg dosage: . During the same period patient was treated with NU LOTAN (View Nu-lotan Review and Nu-lotan Label ), POLYMYXIN B SULFATE (View Polymyxin-b-sulfate Review and Polymyxin-b-sulfate Label ), FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), MUCOSTA (View Mucosta Review and Mucosta Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), BAKTAR (View Baktar Review and Baktar Label ).

6264545-4 | Pseudomonal Sepsis
on Jun 29, 2009 Male patient from JAPAN , weighting 88.18 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with Mylotarg (View Usage). Patient had the following side effects: pseudomonal sepsis. Mylotarg dosage: . During the same period patient was treated with STRONG NEO MINOPHAGEN C (60 Ml/day) (View Strong Neo-minophagen C Review and Strong Neo-minophagen C Label ), OZEX (3 Df/day) (View Ozex Review and Ozex Label ), ITRIZOLE (3 Df/day) (View Itrizole Review and Itrizole Label ), ACLARUBICIN (700 Mg/m2 Total Dose Administered) (View Aclarubicin Review and Aclarubicin Label ), FAMOTIDINE (20 Mg/day) (View Famotidine Review and Famotidine Label ), HYDREA (Not Provided) (View Hydrea Review and Hydrea Label ), NOVANTRONE (28 Mg/m2 Total Dose Administered) (View Novantrone Review and Novantrone Label ).

6260523-X | Pneumonia, Respiratory Failure, Shock
Patient was taking Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: pneumonia (What is pneumonia?), respiratory failure, shock on Jun 29, 2009 from JAPAN Additional patient health information: Female patient , weighting 105.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and. Mylotarg dosage: . During the same period patient was treated with LIPITOR (View Lipitor Review and Lipitor Label ), MEROPEN (View Meropen Review and Meropen Label ), ITRIZOLE (View Itrizole Review and Itrizole Label ), MEPTIN (View Meptin Review and Meptin Label ), MODACIN (View Modacin Review and Modacin Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), MAGNESIUM OXIDE (View Magnesium Oxide Review and Magnesium Oxide Label ).

6260465-X | Sepsis
Adverse event was reported on Jun 29, 2009 by a Female patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and. Location: JAPAN , weighting 141.1 lb, Patient experienced the following unwanted or unexpected effects: sepsis (What is sepsis?). During the same period patient was treated with DENOSINE (View Denosine Review and Denosine Label ), URSO 250 (6 Dose Form) (View Urso 250 Review and Urso 250 Label ).

6257579-7 | Anaemia, Blood Lactate Dehydrogenase Increased, Cardiac Failure Congestive, Depression, Disseminated Intravascular Coagulation, Herpes Zoster, Neutrophil Count Decreased, Post Herpetic Neuralgia, Retinal Haemorrhage
on Jun 29, 2009 Female patient from JAPAN , weighting 114.6 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with Mylotarg (View Usage). Patient had the following side effects: anaemia, blood lactate dehydrogenase increased, cardiac failure congestive, depression (What is depression?), disseminated intravascular coagulation, herpes zoster, neutrophil count decreased, post herpetic neuralgia, retinal haemorrhage. Mylotarg dosage: . During the same period patient was treated with NOVANTRONE (View Novantrone Review and Novantrone Label ), BAKTAR (1 Dose Form Per Day) (View Baktar Review and Baktar Label ), MINOCYCLINE HCL (View Minocycline Hcl Review and Minocycline Hcl Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ), MEROPEN (View Meropen Review and Meropen Label ), FUNGUARD (View Funguard Review and Funguard Label ), AMIKACIN SULFATE (View Amikacin Sulfate Review and Amikacin Sulfate Label ). Patient was hospitalized and became disabled.

6255982-2 | Haematocrit Decreased, Haemoglobin Decreased, Lymphocyte Count Increased, Neutrophil Count Decreased, Red Blood Cell Count Decreased, White Blood Cell Count Decreased
on Jun 24, 2009 Female patient from JAPAN , weighting 74.96 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, constipation (What is constipation?) and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: haematocrit decreased, haemoglobin decreased, lymphocyte count increased, neutrophil count decreased, red blood cell count decreased, white blood cell count decreased. Mylotarg dosage: . During the same period patient was treated with MINOCYCLINE HYDROCHLORIDE (View Minocycline Hydrochloride Review and Minocycline Hydrochloride Label ), FUNGUARD (View Funguard Review and Funguard Label ), MAXIPIME (View Maxipime Review and Maxipime Label ), MAGNESIUM OXIDE (View Magnesium Oxide Review and Magnesium Oxide Label ), URSO 250 (View Urso 250 Review and Urso 250 Label ).

6252439-X | Bacteraemia, Enterococcal Infection
Patient was taking Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: bacteraemia, enterococcal infection on Jun 27, 2009 from UNITED STATES Additional patient health information: Female patient , 51 years of age, weighting 217.8 lb, was diagnosed with acute myeloid leukaemia and. Mylotarg dosage: 12 Mg Total Dose Administered. During the same period patient was treated with ARA C (198 Mg Total Dose Administered) (View Ara-c Review and Ara-c Label ), DAUNOMYCIN (90 Mg Total Dose Administered) (View Daunomycin Review and Daunomycin Label ). Patient was hospitalized.

6244824-7 | Disseminated Intravascular Coagulation, Haematemesis, Liver Disorder, Melaena
Adverse event was reported on Jun 17, 2009 by a Female patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia recurrent and. Location: JAPAN , weighting 121.3 lb, Patient had the following side effects: disseminated intravascular coagulation, haematemesis, liver disorder, melaena. During the same period patient was treated with BLOPRESS (View Blopress Review and Blopress Label ), MEVALOTIN (View Mevalotin Review and Mevalotin Label ), ROCEPHIN (View Rocephin Review and Rocephin Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ). Patient was hospitalized.

6237411-8 | Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Disseminated Intravascular Coagulation, Gamma-glutamyltransferase Increased, Oral Herpes, Pyrexia, Sepsis, Tumour Lysis Syndrome
on Jun 15, 2009 Female patient from JAPAN , weighting 105.8 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, disseminated intravascular coagulation, gamma-glutamyltransferase increased, oral herpes, pyrexia, sepsis (What is sepsis?), tumour lysis syndrome. Mylotarg dosage: . During the same period patient was treated with BAKTAR (View Baktar Review and Baktar Label ), VFEND (View Vfend Review and Vfend Label ), MEROPEN (2 G/day) (View Meropen Review and Meropen Label ), ACLARUBICIN (View Aclarubicin Review and Aclarubicin Label ), DALACIN (1200 Mg/day) (View Dalacin Review and Dalacin Label ), GRAN (75 Ug/day) (View Gran Review and Gran Label ). Patient was hospitalized.

6235006-3 | Chills, Febrile Neutropenia, Insomnia, Pancytopenia, Pseudomembranous Colitis, Pyrexia
on Jun 02, 2009 Male patient from JAPAN , 45 years of age, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: chills, febrile neutropenia, insomnia, pancytopenia, pseudomembranous colitis, pyrexia. Mylotarg dosage: 9 Mg/m^2 1x Per 1 Day Intravenous Drip ; 9 Mg/m^2 1x Per 1 Day Intravenous Drip. During the same period patient was treated with CYTARABINE (Intravenous) (View Cytarabine Review and Cytarabine Label ), ETOPOSIDE (Intravenous) (View Etoposide Review and Etoposide Label ), NOVANTRONE (Intravenous) (View Novantrone Review and Novantrone Label ), VANCOMYCIN (View Vancomycin Review and Vancomycin Label ), HEPARIN SODIUM (View Heparin Sodium Review and Heparin Sodium Label ), SODIUM BICARBONATE (View Sodium Bicarbonate Review and Sodium Bicarbonate Label ), HUMULIN R (View Humulin R Review and Humulin R Label ). Patient was hospitalized.

6231636-3 | Plasmacytoma
Patient was taking Mylotarg (View Usage). Patient had the following side effects: plasmacytoma on Jun 05, 2009 from JAPAN Additional patient health information: Male patient , weighting 83.78 lb, was diagnosed with acute myeloid leukaemia and. Mylotarg dosage: . During the same period patient was treated with PARIET (View Pariet Review and Pariet Label ), BAKTAR (View Baktar Review and Baktar Label ), CLOSTRIDIUM BUTYRICUM (View Clostridium Butyricum Review and Clostridium Butyricum Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ), ZYLORIC (View Zyloric Review and Zyloric Label ), SAXIZON (View Saxizon Review and Saxizon Label ), NASEA (View Nasea Review and Nasea Label ).

6231280-8 | Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Blood Fibrinogen Increased, Blood Lactate Dehydrogenase Increased, Blood Potassium Decreased, Condition Aggravated, Febrile Neutropenia, Fibrin Degradation Products Increased, Fungaemia
Adverse event was reported on Jun 02, 2009 by a Female patient taking Mylotarg (View Usage) (Dosage: 9 Mg/m^2 1x Per Q Day Intravenous Drip;) was diagnosed with acute myeloid leukaemia and. Location: JAPAN , 63 years of age, After Mylotarg was administered, patient had the following side effects: aspartate aminotransferase increased, blood bilirubin increased, blood fibrinogen increased, blood lactate dehydrogenase increased, blood potassium decreased, condition aggravated, febrile neutropenia, fibrin degradation products increased, fungaemia. During the same period patient was treated with MAXIPIME (View Maxipime Review and Maxipime Label ), FUNGUARD (MICAFUNGIN SODIUM) (View Funguard (micafungin Sodium) Review and Funguard (micafungin Sodium) Label ), KYTRIL (View Kytril Review and Kytril Label ), ORGARAN (View Orgaran Review and Orgaran Label ), METHYCOBAL (MECOBALAMIN) (View Methycobal (mecobalamin) Review and Methycobal (mecobalamin) Label ), MUCOSTA (REBAMIPIDE) (View Mucosta (rebamipide) Review and Mucosta (rebamipide) Label ), ZOLPIDEM TARTRATE (View Zolpidem Tartrate Review and Zolpidem Tartrate Label ).

6226951-3 | Anaemia, Coagulopathy, Hypokalaemia, Ileus Paralytic, Liver Disorder, Neutrophil Count Decreased, Oedema, Performance Status Decreased, Platelet Count Decreased
on Jun 02, 2009 Male patient from JAPAN , 58 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, coagulopathy, hypokalaemia, ileus paralytic, liver disorder, neutrophil count decreased, oedema, performance status decreased, platelet count decreased. Mylotarg dosage: 9 Mg/m^2 1x Per 1 Day Intravenous Drip. During the same period patient was treated with URSO (URSODEOXYCHOLIC ACID) (View Urso (ursodeoxycholic Acid) Review and Urso (ursodeoxycholic Acid) Label ), VFEND (View Vfend Review and Vfend Label ), CIPRO (View Cipro Review and Cipro Label ), ENTERONON (LACTOBACILLUS ACIDOPHILUS) (View Enteronon (lactobacillus Acidophilus) Review and Enteronon (lactobacillus Acidophilus) Label ), MUCOSTA (REBAMIPIDE) (View Mucosta (rebamipide) Review and Mucosta (rebamipide) Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), SOLITA T (ELECTROLYTES NOS) (View Solita T (electrolytes Nos) Review and Solita T (electrolytes Nos) Label ). Patient was hospitalized.

6223479-1 | Acute Respiratory Distress Syndrome, Depressed Level Of Consciousness, Embolic Stroke, Ischaemic Stroke, Multi-organ Failure, Pancytopenia, Pneumonia, Urinary Bladder Haemorrhage
on Jun 05, 2009 Female patient from UNITED STATES , 57 years of age, weighting 121.9 lb, was diagnosed with acute myeloid leukaemia and was treated with Mylotarg (View Usage). Patient had the following side effects: acute respiratory distress syndrome, depressed level of consciousness, embolic stroke, ischaemic stroke, multi-organ failure, pancytopenia, pneumonia (What is pneumonia?), urinary bladder haemorrhage. Mylotarg dosage: 9.2 Mg Over 2 Hours On Day 4 (9.2 Mg Total Dose Administered This Course), Intravenous. During the same period patient was treated with CYTARABINE (154 Mg On Days 1 Through 7 (154 Mg Total Dose Administered This Course), Intravenous) (View Cytarabine Review and Cytarabine Label ), DAUNORUBICIN HCL (69 Mg Iv Push On Days 1, 2, 3 (69 Mg Total Dose Administered This Course), Intravenous) (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ). Patient was hospitalized.

6221681-6 | Acute Hepatic Failure, Agitation, Tachypnoea
Patient was taking Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: acute hepatic failure, agitation, tachypnoea on May 26, 2009 from UNITED STATES Additional patient health information: Male patient , 49 years of age, was diagnosed with acute myeloid leukaemia and. Mylotarg dosage: 6 Mg/m^2 1x Per 1 Day, Intravenous. Patient was hospitalized.

6209315-8 | Neoplasm Malignant
Adverse event was reported on May 27, 2009 by a Male patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia and. Location: JAPAN , 70 years of age, Patient experienced the following unwanted or unexpected effects: neoplasm malignant.

6203761-4 | Condition Aggravated, Platelet Count Decreased, Shock Haemorrhagic, Small Intestinal Haemorrhage
on May 20, 2009 Female patient from JAPAN , weighting 110.2 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with Mylotarg (View Usage). Patient had the following side effects: condition aggravated, platelet count decreased, shock haemorrhagic, small intestinal haemorrhage. Mylotarg dosage: . During the same period patient was treated with OMEPRAZOLE (20 Mg/day) (View Omeprazole Review and Omeprazole Label ), MAXIPIME (2 G/day) (View Maxipime Review and Maxipime Label ), CARBENIN (1g/day) (View Carbenin Review and Carbenin Label ), MICAFUNGIN SODIUM (100 Mg/day) (View Micafungin Sodium Review and Micafungin Sodium Label ).

6180026-0 | Anaemia, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Hypoalbuminaemia, Leukopenia, Neutropenia, Pneumonia, Renal Failure, Thrombocytopenia
on Apr 28, 2009 Male patient from JAPAN , weighting 119.0 lb, was diagnosed with acute myeloid leukaemia recurrent, anxiety (What is anxiety?), insomnia, prophylaxis and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: anaemia, blood alkaline phosphatase increased, blood bilirubin increased, hypoalbuminaemia, leukopenia, neutropenia, pneumonia (What is pneumonia?), renal failure, thrombocytopenia. Mylotarg dosage: . During the same period patient was treated with DEPAS (View Depas Review and Depas Label ), SILECE (View Silece Review and Silece Label ), LENOGRASTIM (View Lenograstim Review and Lenograstim Label ), CRAVIT (View Cravit Review and Cravit Label ), VFEND (View Vfend Review and Vfend Label ), CYLOCIDE (View Cylocide Review and Cylocide Label ). Patient was hospitalized.

6161824-6 | Dehydration
Patient was taking Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: dehydration on Apr 14, 2009 from UNITED STATES Additional patient health information: Female patient , 53 years of age, weighting 180.6 lb, was diagnosed with acute myeloid leukaemia and. Mylotarg dosage: Total Dose Administered This Course: 9.55mg. Patient was hospitalized.

6158461-6 | Cytomegalovirus Enterocolitis, Graft Versus Host Disease, Sepsis, Venoocclusive Liver Disease
Adverse event was reported on Apr 13, 2009 by a Male patient taking Mylotarg (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia recurrent and. Location: JAPAN , weighting 116.8 lb, Patient had the following side effects: cytomegalovirus enterocolitis, graft versus host disease, sepsis (What is sepsis?), venoocclusive liver disease.

6144785-5 | Haematocrit Decreased, Haemoglobin Decreased, Lymphocyte Count Increased, Neutrophil Count Decreased, Red Blood Cell Count Decreased, White Blood Cell Count Decreased
on Mar 31, 2009 Female patient from JAPAN , weighting 74.96 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, constipation (What is constipation?) and was treated with Mylotarg (View Usage). After Mylotarg was administered, patient had the following side effects: haematocrit decreased, haemoglobin decreased, lymphocyte count increased, neutrophil count decreased, red blood cell count decreased, white blood cell count decreased. Mylotarg dosage: . During the same period patient was treated with MINOCYCLINE HYDROCHLORIDE (View Minocycline Hydrochloride Review and Minocycline Hydrochloride Label ), FUNGUARD (View Funguard Review and Funguard Label ), MAXIPIME (View Maxipime Review and Maxipime Label ), MAGNESIUM OXIDE (View Magnesium Oxide Review and Magnesium Oxide Label ), URSO 250 (View Urso 250 Review and Urso 250 Label ).

6137719-0 | Anaemia, Blood Lactate Dehydrogenase Increased, Cardiac Failure Congestive, Depression, Disseminated Intravascular Coagulation, Herpes Zoster, Neutrophil Count Decreased, Post Herpetic Neuralgia, Retinal Haemorrhage
on Mar 26, 2009 Female patient from JAPAN , weighting 114.6 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with Mylotarg (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, blood lactate dehydrogenase increased, cardiac failure congestive, depression (What is depression?), disseminated intravascular coagulation, herpes zoster, neutrophil count decreased, post herpetic neuralgia, retinal haemorrhage. Mylotarg dosage: . During the same period patient was treated with NOVANTRONE (View Novantrone Review and Novantrone Label ), BAKTAR (1 Dose Form Per Day) (View Baktar Review and Baktar Label ), MINOCYCLINE HCL (View Minocycline Hcl Review and Minocycline Hcl Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ), MEROPEN (View Meropen Review and Meropen Label ), FUNGUARD (View Funguard Review and Funguard Label ), AMIKACIN SULFATE (View Amikacin Sulfate Review and Amikacin Sulfate Label ). Patient was hospitalized and became disabled.

6130073-X | Anaemia, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Creatinine Increased, Blood Urea Increased, Hypoalbuminaemia, Neutropenia, Pneumonia, Thrombocytopenia
Patient was taking Mylotarg (View Usage). Patient had the following side effects: anaemia, blood alkaline phosphatase increased, blood bilirubin increased, blood creatinine increased, blood urea increased, hypoalbuminaemia, neutropenia, pneumonia (What is pneumonia?), thrombocytopenia on Mar 19, 2009 from JAPAN Additional patient health information: Male patient , weighting 119.0 lb, was diagnosed with acute myeloid leukaemia recurrent, anxiety (What is anxiety?), insomnia, prophylaxis and. Mylotarg dosage: . During the same period patient was treated with DEPAS (View Depas Review and Depas Label ), SILECE (View Silece Review and Silece Label ), ACLACINON (View Aclacinon Review and Aclacinon Label ), CRAVIT (View Cravit Review and Cravit Label ). Patient was hospitalized.