Clofarabine Safety Reports submitted to FDA

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Total Clofarabine reports: 208.
Clofarabine FDA safety alerts: No.
Reported deaths: 98 Reported hospitalizations: 146.
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FDA Reported Clofarabine Side Effects: febrile neutropenia, hypotension, diarrhoea, blood culture positive, bone marrow failure, neutropenia, alanine aminotransferase increased, sepsis, bacterial infection, disease progression, renal failure.
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Clofarabine Side Effects Report #5087936-6
Pharmacist from UNITED STATES reported CLOFARABINE problem on Aug 07, 2006. Male patient, 18 years of age, weighting 108.9 lb, was diagnosed with precursor b-lymphoblastic lymphoma and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, cardiac arrest, depressed level of consciousness, gastrointestinal haemorrhage, hypotension, mental impairment, mental status changes, respiratory arrest, respiratory distress. CLOFARABINE dosage: 52 MG/M2 QD X 5 IV. During the same period patient was treated with HYDROMORPHONE, PLE ANTIBIOTICS, PLE ANTIFUNGALS, ETHOSUXIMIDE, SENNA, CEFEPIME, ACYCLOVIR, ABELCET. Patient died on 08/07/2006.

Clofarabine Side Effects Report #5088626-6
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Aug 10, 2006. Male patient, 69 years of age, weighting 240.0 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: clostridial infection, enterocolitis infectious, febrile neutropenia, klebsiella infection, myalgia, pancytopenia, pneumonia, pyrexia. CLOFARABINE dosage: 30 MG/M2 DAILY IV. During the same period patient was treated with CYTOSINE ARABINOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5088628-X
Health Professional from UNITED STATES reported CLOFARABINE problem on Aug 10, 2006. Male patient, 73 years of age, was diagnosed with acute myeloid leukaemia, myelodysplastic syndrome and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bacterial infection, breath sounds abnormal, confusional state, rales, renal failure acute, respiratory distress. CLOFARABINE dosage: 71 MG DAILY IV. Patient died on 08/04/2006.

Clofarabine Side Effects Report #5090937-5
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 10, 2006. Male patient, 66 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, hypertonia, hypotension, infection, loss of consciousness, metabolic acidosis, nephropathy toxic, neutropenia. CLOFARABINE dosage: 30 MG/M2 QD X 5 IV. During the same period patient was treated with BROAD SPECTRUM ANTIBIOTICS. Patient was hospitalized. Patient died on 06/30/2004.

Clofarabine Side Effects Report #5090938-7
Physician from UNITED STATES reported CLOFARABINE problem on Aug 16, 2006. Female patient, 72 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, haemolytic uraemic syndrome, infection, malnutrition, multi-organ failure, nephritis interstitial, nephropathy toxic, rectal haemorrhage, renal failure acute. CLOFARABINE dosage: 40 MG/M2 QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, BACTRIM, VALTREX, ZOSYN, LEVOTHYROXINE, MAGNESIUM, PIPERACILLIN. Patient was hospitalized. Patient died on 05/12/2006.

Clofarabine Side Effects Report #5090939-9
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 14, 2006. Female patient, 77 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: aplasia, candidiasis, capillary leak syndrome, fungaemia, hypotension, opportunistic infection, pleural effusion, pulmonary oedema, respiratory failure. CLOFARABINE dosage: 30 MG/M2 QD X 5 IV. During the same period patient was treated with CYTARABINE. Patient was hospitalized. Patient died on 09/30/2004.

Clofarabine Side Effects Report #5091346-5
Physician from UNITED STATES reported CLOFARABINE problem on Aug 09, 2006. Female patient, child 6 years of age, weighting 46.96 lb, was diagnosed with acute lymphocytic leukaemia recurrent and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: angiopathy, ascites, bladder disorder, blood amylase increased, blood urine present, colitis, computerised tomogram abnormal, cystitis, ejection fraction decreased. CLOFARABINE dosage: 17 MG QD X 5; IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, MORPHINE, DIPHENHYDRAMINE, ACETAMINOPHEN, REGULAR INSULIN, FAMOTIDINE, NEUPOGEN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5091349-0
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on July 12, 2006. Male patient, 71 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: arrhythmia supraventricular, atrial fibrillation, chest discomfort, dyspnoea, febrile neutropenia. CLOFARABINE dosage: 49.3 MG QD X 5; IV. During the same period patient was treated with CYTARABINE, IDARUBICIN, VANCOMYCIN, ZOSYN, ACYCLOVIR, MORPHINE, NPH INSULIN, ZOFRAN. Patient died on 08/11/2006.

Clofarabine Side Effects Report #5092258-3
Consumer or non-health professional from UNITED STATES reported CLOFARABINE problem on Aug 15, 2006. Male patient, 59 years of age, was diagnosed with myelodysplastic syndrome and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bacterial infection, blood culture positive, dialysis, hypotension, lung infiltration, pneumonia, renal failure acute, supraventricular tachycardia. CLOFARABINE dosage: 40 MG PO. During the same period patient was treated with AMBISOME, VANCOMYCIN. Patient was hospitalized. Patient died on 08/12/2006.

Clofarabine Side Effects Report #5097830-2
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 22, 2006. Female patient, child 6 years of age, weighting 46.96 lb, was diagnosed with acute lymphocytic leukaemia, leukaemia recurrent and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, alpha haemolytic streptococcal infection, ascites, bk virus infection, blood amylase increased, bone marrow failure, colitis, cystitis haemorrhagic. CLOFARABINE dosage: 17 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, MORPHINE, DIPHENHYDRAMINE, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5097831-4
Physician from UNITED STATES reported CLOFARABINE problem on Aug 22, 2006. Male patient, 62 years of age, was diagnosed with chronic myelomonocytic leukaemia, myelodysplastic syndrome and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: ascites, dialysis, renal failure. CLOFARABINE dosage: 78 MG QD X 5 IV. During the same period patient was treated with ALLOPURINOL, CEFEPIME, LEVAQUIN, VANCOMYCIN, AZTREONAM, VORICONAZOLE. Patient recovered.

Clofarabine Side Effects Report #5098007-7
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 22, 2006. Male patient, 59 years of age, was diagnosed with myelodysplastic syndrome and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: hypotension, infection, pneumonia, renal failure acute, supraventricular tachycardia. CLOFARABINE dosage: 40 MG PO. During the same period patient was treated with AMBISOME, VANCOMYCIN, VORICONAZOLE. Patient was hospitalized. Patient died on 08/12/2006.

Clofarabine Side Effects Report #5098008-9
Physician from UNITED STATES reported CLOFARABINE problem on Aug 22, 2006. Male patient, 72 years of age, weighting 185.0 lb, was diagnosed with chronic myelomonocytic leukaemia, myelodysplastic syndrome and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acidosis, blood phosphorus increased, blood potassium increased, dyspnoea, hypotension, renal impairment. CLOFARABINE dosage: 30 MG DAILY IV. During the same period patient was treated with HYDROXYUREA, VANTIN, ALLOPURINOL, NEXIUM, LASIX, XOPENEX. Patient died on 07/23/2006.

Clofarabine Side Effects Report #5098011-9
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Aug 22, 2006. Male patient, 68 years of age, weighting 194.0 lb, was diagnosed with myelodysplastic syndrome and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: aspergillosis, blood creatinine increased, blood culture positive, blood urea increased, dehydration, dialysis, hypotension, muscular weakness. CLOFARABINE dosage: 62.7 MG QD X 5 IV. During the same period patient was treated with BACTRIM, ITRACONAZOLE, PROCRIT. Patient was hospitalized. Patient died on 07/17/2006.

Clofarabine Side Effects Report #5098014-4
Physician from UNITED STATES reported CLOFARABINE problem on Aug 22, 2006. Female patient, 72 years of age, weighting 112.9 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acute lymphocytic leukaemia recurrent, bile duct stone, diarrhoea, haemolytic uraemic syndrome, ill-defined disorder, infection, malnutrition, multi-organ failure, nephritis interstitial. CLOFARABINE dosage: 40 MG/M2 QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, BACTRIM, VALTREX, ZOSYN, MESNA, PIPERACILLIN, FOLTX. Patient was hospitalized. Patient died on 05/12/2006.

Clofarabine Side Effects Report #5098022-3
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 22, 2006. Male patient, 73 years of age, weighting 246.0 lb, was diagnosed with acute myeloid leukaemia, myelodysplastic syndrome and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, breath sounds abnormal, confusional state, eye haemorrhage, infection, rales, renal failure acute. CLOFARABINE dosage: unknown. During the same period patient was treated with LEVAQUIN, VALTREX, FLUCONAZOLE, GLYBURIDE, LASIX. Patient died on 08/04/2006.

Clofarabine Side Effects Report #5099600-8
Physician from UNITED STATES reported CLOFARABINE problem on Aug 23, 2006. Female patient, 33 years of age, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, abdominal pain upper, alpha haemolytic streptococcal infection, blood culture positive, bone marrow transplant, constipation, faecaloma, fatigue. CLOFARABINE dosage: 20 MG/M2 QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, VANCOMYCIN, VORICONAZOLE, ACETAMINOPHEN, ALLOPURINOL, HYDROCORTISONE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5101926-6
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 25, 2006. Male patient, 60 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: hypotension, klebsiella infection, neutropenia, sepsis. CLOFARABINE dosage: 58 MG QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, BACTRIM, DIFLUCAN, MYCOSTATIN, VALCYTE, NEXIUM, MEGACE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5105823-1
Health Professional from UNITED STATES reported CLOFARABINE problem on Aug 29, 2006. Male patient, 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bacterial infection, blood culture positive, febrile neutropenia, hypoxia, pancytopenia, pneumonia, renal failure, respiratory distress, respiratory failure. CLOFARABINE dosage: 87.2 MG DAILY IV. During the same period patient was treated with CYTARABINE, FLAGYL, NPH INSULIN, ATENOLOL, ALLOPURINOL, FAMVIR, ALTACE, LASIX. Patient died on 07/24/2006.

Clofarabine Side Effects Report #5105824-3
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Sept 06, 2006. Female patient, 59 years of age, weighting 143.3 lb, was diagnosed with acute leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: enterococcal bacteraemia, haemodialysis, hypotension, renal disorder, renal failure, sepsis. CLOFARABINE dosage: 17 MG DAILY. During the same period patient was treated with CYCLOPHOSPHAMIDE, ACETAMINOPHEN, ALLOPURINOL, HYDROCORTISONE. Patient was hospitalized. Patient died on 09/02/2006.

Clofarabine Side Effects Report #5114826-2
Health Professional from UNITED STATES reported CLOFARABINE problem on Sept 22, 2006. Male patient was diagnosed with non-hodgkin's lymphoma and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: pancytopenia. CLOFARABINE dosage: 6 MG. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5115004-3
CLOFARABINE problem was reported by a Physician from UNITED STATES on Sept 08, 2006. Male patient, 15 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, condition aggravated, hypotension, neutropenia, sepsis. CLOFARABINE dosage: 52 MG/M2 QD X 5 IV. Patient died on 09/06/2006.

Clofarabine Side Effects Report #5115023-7
Health Professional from UNITED STATES reported CLOFARABINE problem on Sept 08, 2006. Male patient, 48 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, cholecystitis, febrile neutropenia, pathogen resistance, pneumonia, streptococcal bacteraemia, syncope. CLOFARABINE dosage: 46.8 MG QD X 5 IV. During the same period patient was treated with IDARUBICIN, MAGNESIUM SULPHATE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATES, PHOSPHATES, INSULIN, BACLOFEN, LINEZOLID. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5115025-0
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Sept 11, 2006. Female patient, 59 years of age, weighting 143.3 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, chromosomal deletion, confusional state, dysplasia, enterococcal bacteraemia, haematuria, haemodialysis, hypotension, pyrexia. CLOFARABINE dosage: 17 MG DAILY. During the same period patient was treated with CYCLOPHOSPHAMIDE, ACUTE MYELOGENOUS LEUKEMIA, ACETAMINOPHEN, ALLOPURINOL, HYDROCORTISONE. Patient was hospitalized. Patient died on 09/01/2006.

Clofarabine Side Effects Report #5115594-0
Health Professional from UNITED STATES reported CLOFARABINE problem on Sept 12, 2006. Female patient, 56 years of age, weighting 153.7 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, febrile neutropenia, haemolysis, hepatic steatosis, hepatitis, lip dry, pneumonia fungal, transfusion reaction. CLOFARABINE dosage: unknown. During the same period patient was treated with CYTOXAN, BLOOD TRANSFUSION, TOPROL, PROTONIX, AMBIEN, ATIVAN, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5119010-4
CLOFARABINE problem was reported by a Physician from UNITED STATES on Sept 11, 2006. Female patient, 59 years of age, weighting 143.3 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, bacteraemia, cardio-respiratory arrest, chromosomal deletion, confusional state, haematuria, haemodialysis, myelodysplastic syndrome, pathogen resistance. CLOFARABINE dosage: 17 MG DAILY. During the same period patient was treated with CYCLOPHOSPHAMIDE, ACETAMINOPHEN, ALLOPURINOL, HYDROCORTISONE. Patient was hospitalized. Patient died on 09/01/2006.

Clofarabine Side Effects Report #5119084-0
Physician from UNITED STATES reported CLOFARABINE problem on Sept 22, 2006. Male patient, 58 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anxiety, asthenia, atelectasis, blood creatinine increased, blood phosphorus decreased, dehydration, dermatitis contact, diarrhoea, dyspnoea. CLOFARABINE dosage: 10 MG/M2 DAILY IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, ACETAMINOPHEN, ALLOPURINOL, HYDROCORTISONE, BACTRIM. Patient was hospitalized. Patient died on 08/30/2006.

Clofarabine Side Effects Report #5122353-1
CLOFARABINE problem was reported by a Pharmacist from UNITED STATES on Sept 20, 2006. Male patient, 56 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: blast cell count decreased, blood creatinine decreased, capillary leak syndrome, dyspnoea, fluid overload, hypoxia. CLOFARABINE dosage: 40 MG/M2, UNK. Patient recovered.

Clofarabine Side Effects Report #5126364-1
Consumer or non-health professional from UNITED STATES reported CLOFARABINE problem on Sept 26, 2006. Male patient, child 5 years of age, weighting 42.33 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: ear pain, neutropenia, occult blood positive, pyrexia, rectal fissure, vomiting, white blood cell count decreased. CLOFARABINE dosage: 15 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, NEUPOGEN, BENADRYL, CYCLOPHOSPHAMIDE, TYLENOL. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5132148-0
CLOFARABINE problem was reported by a Physician from UNITED STATES on Oct 02, 2006. Female patient, 56 years of age, weighting 153.7 lb, was diagnosed with myeloid leukaemia, infection and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: chest pain, febrile neutropenia, haemolysis, hepatitis, lip dry, lung infiltration, nausea, pleuritic pain, pneumonia fungal. CLOFARABINE dosage: 400 MG/M2 IV. During the same period patient was treated with CLOPARABINE, CYTOXAN, BLOOD TRANSFUSION, TOPROL, PROTONIX, AMBIEN, ATIVAN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5134716-9
Physician from UNITED STATES reported CLOFARABINE problem on Oct 05, 2006. Male patient, 49 years of age, weighting 208.8 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: alopecia, body temperature increased, convulsion, diabetes mellitus, facial bones fracture, fall, hypovolaemia, nausea, nervousness. CLOFARABINE dosage: 86 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, VANCOMYCIN, LEVAQUIN, ZYRTEC, FLUCONAZOLE, NORVASC. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5135849-3
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 26, 2006. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bronchiectasis, catheter site discharge, catheter site erythema, fungal infection, fungus serology test positive, hypokalaemia, inflammation, lower respiratory tract infection, obstructive airways disorder. CLOFARABINE dosage: 20 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE. Patient recovered.

Clofarabine Side Effects Report #5138367-1
Physician from UNITED STATES reported CLOFARABINE problem on Oct 10, 2006. Male patient, 23 years of age, weighting 141.0 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bacterial sepsis, catheter related infection, erythema, inflammation, oedema peripheral, osteomyelitis, pain in extremity, pancytopenia. CLOFARABINE dosage: 40 MG QD X 5 IV. During the same period patient was treated with CYTARABINE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5143241-0
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 17, 2006. Male patient, 80 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: renal failure acute. CLOFARABINE dosage: unknown. Patient was hospitalized. Patient died on 10/09/2006.

Clofarabine Side Effects Report #5147886-3
Consumer or non-health professional from UNITED STATES reported CLOFARABINE problem on Oct 23, 2006. Male patient, child 5 years of age, weighting 42.33 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: cellulitis, disease recurrence, ear pain, erythema, facial palsy, neutropenia, occult blood, pyrexia. CLOFARABINE dosage: 15 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, NEUPOGEN, BENADRYL, TYLENOL. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5147964-9
CLOFARABINE problem was reported by a Physician from UNITED STATES on Oct 25, 2006. Male patient, 23 years of age, weighting 141.0 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bacteraemia, bacterial infection, bone disorder, catheter related infection, chills, erythema, fatigue, heart rate increased, inflammation. CLOFARABINE dosage: 40 MG QD X 5 IV. During the same period patient was treated with CYTARABINE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5147965-0
Physician from UNITED STATES reported CLOFARABINE problem on Oct 25, 2006. Female patient, 56 years of age, weighting 153.7 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, condition aggravated, febrile neutropenia, haemolysis, hepatitis, lip dry, lung infiltration, nausea, pleuritic pain. CLOFARABINE dosage: 400 MG/M2 IV. During the same period patient was treated with CYTOXAN, BLOOD TRANSFUSION, TOPROL, PROTONIX, AMBIEN, ATIVAN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5148128-5
CLOFARABINE problem was reported by a Physician from IRELAND on Sept 15, 2006. Female patient, 16 years of age, weighting 164.9 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. CLOFARABINE dosage: 52 MG QD IV. Patient died.

Clofarabine Side Effects Report #5148756-7
Physician from UNITED STATES reported CLOFARABINE problem on Oct 24, 2006. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia recurrent and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, bronchiectasis, catheter site discharge, catheter site erythema, corynebacterium infection, enterococcal infection, fungus serology test positive, hypokalaemia. CLOFARABINE dosage: 20 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE. Patient recovered.

Clofarabine Side Effects Report #5153634-3
CLOFARABINE problem was reported by a Physician from FRANCE on Oct 30, 2006. Female patient, 61 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, cognitive disorder, compartment syndrome, confusional state, crying, delirium, encephalopathy, hallucination. CLOFARABINE dosage: 40 MG QD IV. During the same period patient was treated with ARACYTINE, ZOFRAN, EFFEXOR, BROMAZEPAM, OMEPRAZOLE, MORPHINE, NEFOPAM. Patient recovered.

Clofarabine Side Effects Report #5155554-7
Physician from UNITED STATES reported CLOFARABINE problem on Nov 08, 2006. Male patient, 64 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: aortic valve sclerosis, aspergillosis, cardio-respiratory arrest, confusional state, fungus sputum test positive, myocardial infarction, tricuspid valve incompetence. CLOFARABINE dosage: 82 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, BENADRYL. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5155556-0
CLOFARABINE problem was reported by a Physician from UNITED STATES on Nov 06, 2006. Female patient, 50 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: venoocclusive disease. CLOFARABINE dosage: unknown. Patient recovered.

Clofarabine Side Effects Report #5160216-6
Physician from UNITED STATES reported CLOFARABINE problem on Nov 15, 2006. Male patient, 64 years of age, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, aortic valve sclerosis, aspergillosis, blood ph decreased, blood potassium decreased, bone marrow failure, bone marrow transplant, brain herniation, cardio-respiratory arrest. CLOFARABINE dosage: 82 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, BENADRYL, HYDROXYUREA, PROTONIX, ALLOPURINOL. Patient was hospitalized. Patient died on 11/10/2006.

Clofarabine Side Effects Report #5162174-7
CLOFARABINE problem was reported by a Physician from UNITED KINGDOM on Nov 13, 2006. Female patient, 15 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: hypotension, ill-defined disorder, neutropenic sepsis, renal failure, tachycardia. CLOFARABINE dosage: unknown. Patient died on 11/12/2006.

Clofarabine Side Effects Report #5162254-6
Physician from UNITED STATES reported CLOFARABINE problem on Nov 17, 2006. Male patient, 70 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: fall, febrile neutropenia, hypotension, sepsis, skin laceration, staphylococcal infection, syncope. CLOFARABINE dosage: 80 MG QD X 5 IV. During the same period patient was treated with VANCOMYCIN, FORTAZ, LEVAQUIN, CANCIDAS, ZOSYN, ACYCLOVIR, AMIODARONE, VERSED. Patient was hospitalized. Patient died on 11/07/2006.

Clofarabine Side Effects Report #5166003-7
CLOFARABINE problem was reported by a Physician from UNITED STATES on Nov 14, 2006. Female patient, child 11 years of age, weighting 74.96 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, blood amylase increased, blood bilirubin increased, diarrhoea, febrile neutropenia, lipase increased, nausea, septic shock. CLOFARABINE dosage: 35 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, BACTRIM, VORICONAZOLE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5166020-7
Physician from UNITED STATES reported CLOFARABINE problem on Nov 22, 2006. Female patient, 26 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, cellulitis gangrenous, hypotension, neutropenia, skin nodule, vaginal cellulitis. CLOFARABINE dosage: 60 MG QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, AMBISOME, AUGMENTIN, BACTRIM DS, COMPAZINE, CYTARABINE, DEXAMETHASONE, KEPPRA. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5166376-5
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Nov 17, 2006. Female patient, 60 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure. CLOFARABINE dosage: 35 MG QD X 5 IV. During the same period patient was treated with IDARUBICIN, AUGMENTIN, VORICONAZOLE, VALTREX, MEGACE, NEXIUM, POTASSIUM ACETATE, MAGNESIUM. Patient recovered.

Clofarabine Side Effects Report #5167220-2
Physician from UNITED KINGDOM reported CLOFARABINE problem on Nov 15, 2006. Female patient, 15 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, back pain, depressed level of consciousness, haematemesis, hypotension, neutropenic sepsis, peripheral circulatory failure, renal failure. CLOFARABINE dosage: unknown. During the same period patient was treated with LIQUID PARAFFIN, ZOPLICONE, FENTANYL, HYOSCINE HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE, MAGNESIUM, GABAPENTIN, LEVOMEPROMAZINE. Patient died on 11/12/2006.

Clofarabine Side Effects Report #5209374-5
CLOFARABINE problem was reported by a Pharmacist from UNITED STATES on July 28, 2006. Female patient, 72 years of age, weighting 112.4 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, blood culture positive. CLOFARABINE dosage: 60 MG DAILY IV. During the same period patient was treated with LOSARTAN POSTASSIUM, HYDROCHLOROTHIAZIDE. Patient recovered.

Clofarabine Side Effects Report #5170281-8
Consumer or non-health professional from UNITED KINGDOM reported CLOFARABINE problem on Nov 22, 2006. Female patient, 70 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, blood bilirubin increased, blood culture positive, blood potassium increased, blood pressure decreased, bone marrow failure, cardiac failure, confusional state, diarrhoea. CLOFARABINE dosage: unknown. Patient was hospitalized. Patient died on 11/21/2006.

Clofarabine Side Effects Report #5170282-X
CLOFARABINE problem was reported by a Consumer or non-health professional from FRANCE on Nov 10, 2006. Female patient, 13 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, haemoglobin decreased, soft tissue necrosis, vaginal lesion. CLOFARABINE dosage: 52 MG/M2 QD X 5 IV. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5173528-7
Health Professional from UNITED STATES reported CLOFARABINE problem on Dec 04, 2006. Female patient, 26 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, ascites, cellulitis gangrenous, erythema, hyperbilirubinaemia, hypotension, neutropenia, pyrexia, skin nodule. CLOFARABINE dosage: 60 MG QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, AMBISOME, AUGMENTIN, BACTRIM DS, COMPAZINE, CYTARABINE, DEXAMETHASONE, KEPPRA. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5179509-1
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Nov 27, 2006. Female patient, 70 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, blood pressure decreased, bone marrow failure, cardiac failure, confusional state, diarrhoea, dyspnoea, epistaxis, escherichia infection. CLOFARABINE dosage: unknown. Patient was hospitalized. Patient died on 11/21/2006.

Clofarabine Side Effects Report #5179515-7
Consumer or non-health professional from UNITED KINGDOM reported CLOFARABINE problem on Nov 23, 2006. Male patient, 66 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: flushing, loss of consciousness, vomiting. CLOFARABINE dosage: 20 MG/M2 QD IV. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5188736-9
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Dec 04, 2006. Female patient, child 9 years of age, weighting 64.37 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, pancreatitis, splenomegaly. CLOFARABINE dosage: 32 MG QD IV. During the same period patient was treated with ETOPOSIDE, ACETAMINOPHEN, ALLOPURINOL, ALUMINUM HYDROXIDE, AMIKACIN, CEFEPIME, DEXAMETHASONE, DIPHENHYDRAMINE. Patient recovered.

Clofarabine Side Effects Report #5188784-9
Physician from UNITED STATES reported CLOFARABINE problem on Dec 11, 2006. Female patient, 68 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: alopecia, chills, confusional state, decreased appetite, dehydration, diarrhoea, febrile neutropenia, haemangioma. CLOFARABINE dosage: unknown. During the same period patient was treated with HIDAC, ACYCLOVIR, AMILORIDE HYDROCHLORIDE, ABELCET, TYLENOL, BENADRYL, HYDROCORTISONE. Patient was hospitalized. Patient died on 11/18/2006.

Clofarabine Side Effects Report #5192272-3
CLOFARABINE problem was reported by a Physician from UNITED STATES on Dec 11, 2006. Male patient, 23 years of age, weighting 141.0 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, central line infection, electrocardiogram t wave abnormal, fatigue, febrile neutropenia, headache, heart rate increased, lethargy, nausea. CLOFARABINE dosage: 40 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, COUMADIN, AVELOX. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5192273-5
Health Professional from UNITED STATES reported CLOFARABINE problem on Dec 18, 2006. Male patient, 70 years of age, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, blood culture positive, face injury, fall, febrile neutropenia, hypotension, laceration, sepsis, staphylococcal infection. CLOFARABINE dosage: 80 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, LEVAQUIN, ACYCLOVIR, VERSED. Patient was hospitalized. Patient died on 11/07/2006.

Clofarabine Side Effects Report #5192565-X
CLOFARABINE problem was reported by a Physician from UNITED STATES on Dec 14, 2006. Female patient, 26 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, cellulitis gangrenous, dialysis, erythema, febrile neutropenia, hyperbilirubinaemia, hypotension, oxygen saturation decreased, pseudomonas infection. CLOFARABINE dosage: 60 MG QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, BACTRIM DS, COMPAZINE, CYTARABINE, KEPPRA, MORPHINE SULPHATE, NEXIUM. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5194809-7
Health Professional from UNITED STATES reported CLOFARABINE problem on Dec 19, 2006. Male patient, 64 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, agitation, aortic valve sclerosis, arthralgia, aspergillosis, asthenia, blood bicarbonate decreased, blood lactate dehydrogenase increased, blood ph decreased. CLOFARABINE dosage: 82 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, BENADRYL, HYDROXYUREA, PROTONIX, ALLOPURINOL. Patient was hospitalized. Patient died on 11/10/2006.

Clofarabine Side Effects Report #5194810-3
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Dec 19, 2006. Male patient, 23 years of age, weighting 141.0 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, aspergillosis, bacteraemia, bacterial infection, catheter related infection, condition aggravated, electrocardiogram t wave abnormal, erythema, febrile neutropenia. CLOFARABINE dosage: 40 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, COUMADIN, AVELOX. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5195619-7
Health Professional from UNITED STATES reported CLOFARABINE problem on Dec 26, 2006. Male patient, weighting 155.2 lb, was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: convulsion. CLOFARABINE dosage: 38MG DAILY IV DRIP. During the same period patient was treated with CAMPATH, MELPHALAN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5195681-1
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Dec 19, 2006. Female patient, 68 years of age, weighting 142.9 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia recurrent, alopecia, appetite disorder, confusional state, dehydration, diarrhoea, febrile neutropenia. CLOFARABINE dosage: 40 MG/M2 QD X 5 IV. During the same period patient was treated with HIDAC, ACYCLOVIR, AMILORIDE HYDROCHLORIDE, ABELCET, TYLENOL, BENADRYL. Patient was hospitalized. Patient died on 11/18/2006.

Clofarabine Side Effects Report #5195682-3
Health Professional from UNITED STATES reported CLOFARABINE problem on Dec 19, 2006. Female patient, 26 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, cellulitis gangrenous, dialysis, electrocardiogram t wave amplitude decreased, febrile neutropenia, hyperbilirubinaemia, hypotension, myocardial ischaemia, pseudomonas infection. CLOFARABINE dosage: 60 MG QD X 3 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, BACTRIM DS, COMPAZINE, CYTARABINE, KEPPRA, MORPHINE SULPHATE, NEXIUM. Patient was hospitalized. Patient died on 12/20/2006.

Clofarabine Side Effects Report #5379035-0
CLOFARABINE problem was reported by a Physician from UNITED STATES on June 20, 2007. Male patient, 67 years of age, weighting 225.1 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: adrenal adenoma, aggression, aspiration, culture positive, deep vein thrombosis, depressed level of consciousness, hilar lymphadenopathy, lung consolidation. CLOFARABINE dosage: 30 MG/M2 IV. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5379040-4
Physician from UNITED STATES reported CLOFARABINE problem on June 20, 2007. Male patient, 75 years of age, weighting 171.7 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: adrenal disorder, bacterial sepsis, bronchopulmonary aspergillosis, febrile neutropenia, haematocrit increased, haemoglobin decreased, lung consolidation. CLOFARABINE dosage: 30 MG/M2 QD IV. Patient was hospitalized. Patient died on 06/06/2007.

Clofarabine Side Effects Report #5382049-8
CLOFARABINE problem was reported by a Physician from UNITED STATES on June 21, 2007. Female patient, child 11 years of age, weighting 74.96 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: blood bilirubin increased, caecitis, cardiomegaly, enteritis, febrile neutropenia, gastrointestinal oedema, hepatomegaly, hypotension. CLOFARABINE dosage: 35 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, BACTRIM, VORICONAZOLE, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5386089-4
Physician from FRANCE reported CLOFARABINE problem on June 26, 2007. Female patient, 19 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative, skin hyperpigmentation. CLOFARABINE dosage: 52 MG/M2 QD X 5 IV. During the same period patient was treated with CYTARABINE, PARCONAZOLE, BACTRIM, FASTURTEC. Patient recovered.

Clofarabine Side Effects Report #5389189-8
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on July 06, 2007. Female patient, 56 years of age, weighting 122.6 lb, was diagnosed with myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, blood bilirubin increased, blood culture positive, enterococcal bacteraemia, enterococcal infection, febrile neutropenia, fluid overload, lung disorder. CLOFARABINE dosage: 31 MG DAILY IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, PIPERACILLIN AND TAZOBACTAM, VALACYCLOVIR, POTASSIUM CHLORIDE, ACETAMINOPHEN, AMBISOME. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5389615-4
Health Professional from FRANCE reported CLOFARABINE problem on June 29, 2007. Male patient, 18 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, aplasia, arthritis bacterial, brain abscess, neutrophil count decreased, pyrexia. CLOFARABINE dosage: 52 MG QD IV. During the same period patient was treated with CYTARABINE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5391844-0
CLOFARABINE problem was reported by a Physician from UNITED STATES on July 12, 2007. Female patient, 56 years of age, weighting 122.6 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, bacteraemia, blood bilirubin increased, blood culture positive, disease progression, enterococcal infection, febrile neutropenia, fluid overload, hypoxia. CLOFARABINE dosage: 31 MG DAILY IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, PIPERACILLIN AND TAZOBACTAM, VALACYCLOVIR, POTASSIUM CHLORIDE, ACETAMINOPHEN, AMBISOME. Patient was hospitalized. Patient died on 07/10/2007.

Clofarabine Side Effects Report #5391845-2
Physician from UNITED STATES reported CLOFARABINE problem on July 06, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anorexia, atelectasis, bk virus infection, cytomegalovirus infection, depression, epistaxis, febrile neutropenia, haematocrit decreased, haemoglobin decreased. CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5402118-3
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on July 13, 2007. Female patient, 71 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, blood creatinine increased, lipase increased. CLOFARABINE dosage: 30 MG/M2 QD IV. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5422868-2
Pharmacist from UNITED STATES reported CLOFARABINE problem on June 01, 2007. Female patient, 24 years of age, was diagnosed with t-cell lymphoma and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: erythema. CLOFARABINE dosage: 42 MG/M2. During the same period patient was treated with CAMPATH, CYTARABINE. Patient recovered.

Clofarabine Side Effects Report #5404990-X
CLOFARABINE problem was reported by a Physician from UNITED STATES on July 18, 2007. Male patient, child 10 years of age, weighting 112.4 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: atelectasis, bacteraemia, beta haemolytic streptococcal infection, caecitis, enterococcal infection, febrile neutropenia, haematemesis, haematocrit decreased, haemoglobin decreased. CLOFARABINE dosage: 28 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5404991-1
Physician from UNITED STATES reported CLOFARABINE problem on July 26, 2007. Female patient, 66 years of age, weighting 144.1 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acidosis, aortic valve sclerosis, atelectasis, cognitive disorder, collapse of lung, dialysis, diarrhoea, hypotension. CLOFARABINE dosage: 67 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, VANCOMYCIN, ACYCLOVIR, AZTREONAM, CHLORHEXIDINE GLUCONATE, CIPROFLOXACIN, IMMUNE GLOBULIN, MICAFUNGIN. Patient was hospitalized. Patient died on 07/21/2007.

Clofarabine Side Effects Report #5404992-3
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on July 18, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cytomegalovirus infection, epistaxis, febrile neutropenia, haematocrit decreased, haemoglobin decreased, human herpes virus 6 serology positive, pancreatitis, platelet count decreased. CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5407906-5
Physician from UNITED STATES reported CLOFARABINE problem on July 30, 2007. Male patient, 39 years of age, was diagnosed with bone marrow conditioning regimen and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: catheter sepsis, diarrhoea, disease progression, haemoptysis, hallucination, lower gastrointestinal haemorrhage, mucosal inflammation, renal failure acute. CLOFARABINE dosage: unknown. During the same period patient was treated with MELPHALAN, THIOTEPA. Patient was hospitalized. Patient died on 07/22/2007.

Clofarabine Side Effects Report #5407908-9
CLOFARABINE problem was reported by a Physician from UNITED STATES on Apr 24, 2007. Male patient, 17 years of age, weighting 88.18 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bacteraemia, blast cell count increased, blast cells present, blood culture positive, blood glucose increased, blood phosphorus decreased, blood pressure decreased, bone marrow failure, caecitis. CLOFARABINE dosage: 42 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, BACTRIM, POTASSIUM CHLORIDE, VALTREX, COLACE, MYLANTA, OXYCONTIN. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5408399-4
Health Professional from SPAIN reported CLOFARABINE problem on July 23, 2007. Male patient, child 11 years of age, weighting 81.57 lb, was diagnosed with t-cell type acute leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, capillary leak syndrome, cardiac arrest, feeling abnormal, hypoalbuminaemia, migraine, nausea, no therapeutic response. CLOFARABINE dosage: 40 MG QD IV. During the same period patient was treated with PREDNISONE, MORPHINE, ELITEK, DEXAMETHASONE, FLUCONAZOLE, FAMCICLOVIR, IBUPROFEN, OMEPRAZOLE. Patient died on 07/21/2007.

Clofarabine Side Effects Report #5409230-3
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Aug 07, 2007. Female patient, 82 years of age, was diagnosed with lymphoma and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, febrile neutropenia, thrombocytopenia. CLOFARABINE dosage: 4MG/M2 QD X 5 IV. During the same period patient was treated with ACYCLOVIR, ALBUTEROL, ALLOPURINOL, BACITRACIN, CEFEPIME, DIGOXIN, FLUCONAZOLE, LIPITOR. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5409233-9
Consumer or non-health professional from UNITED STATES reported CLOFARABINE problem on Aug 08, 2007. Male patient, 83 years of age, was diagnosed with lymphoma and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: renal failure. CLOFARABINE dosage: 4MG/M2 QD X 5 DAYS IV. Patient recovered.

Clofarabine Side Effects Report #5409636-2
CLOFARABINE problem was reported by a Physician from UNITED STATES on July 31, 2007. Female patient, 60 years of age, weighting 159.8 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: asthenia, bone pain, capillary leak syndrome, chills, dry skin, feeling hot, flushing, hypotension. CLOFARABINE dosage: 30 MG/M2 QD IV. During the same period patient was treated with PROPOXYPHENE HYDROCHLORIDE, TYLENOL, BENADRYL, VALTREX, ZOFRAN, CALCIUM CARBONATE, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5417875-X
Physician from SPAIN reported CLOFARABINE problem on July 30, 2007. Male patient, child 11 years of age, weighting 81.57 lb, was diagnosed with adult t-cell lymphoma/leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, anorexia, anxiety, ascites, blood calcium increased, blood lactate dehydrogenase increased, blood phosphorus decreased, blood potassium decreased, capillary leak syndrome. CLOFARABINE dosage: 40 MG/M2 QD IV. During the same period patient was treated with PREDNISONE, MORPHINE, ELITEK, DEXAMETHASONE, FLUCONAZOLE, FAMCICLOVIR, IBRUPROFEN, OMEPRAZOLE. Patient died on 07/21/2007.

Clofarabine Side Effects Report #5417877-3
CLOFARABINE problem was reported by a Physician from FRANCE on July 30, 2007. Male patient, 58 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, stevens-johnson syndrome, toxic epidermal necrolysis. CLOFARABINE dosage: 30 MG/M2 QD X 5 IV. During the same period patient was treated with CYTARABINE, TAZOCILLINE, VANCOMYCIN, ONDANSETRON. Patient died on 12/19/2006.

Clofarabine Side Effects Report #5419205-6
Physician from UNITED STATES reported CLOFARABINE problem on Aug 08, 2007. Male patient, 83 years of age, was diagnosed with diffuse large b-cell lymphoma and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: renal failure. CLOFARABINE dosage: 4 MG/M2 QD X 5 IV. Patient recovered.

Clofarabine Side Effects Report #5419367-0
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 10, 2007. Female patient, 66 years of age, weighting 144.1 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acidosis, aortic valve sclerosis, atelectasis, bronchial secretion retention, cognitive disorder, dialysis, diarrhoea, diastolic dysfunction, hepatic enzyme increased. CLOFARABINE dosage: 67 MG QD X 5 IV. During the same period patient was treated with CYTARABINE, VANCOMYCIN, ACYCLOVIR, AZTREONAM, CHLORHEXIDINE GLUCONATE, CIPROFLOXACIN, IMMUNE GLOBULIN, MICAFUNGIN. Patient was hospitalized. Patient died on 07/21/2007.

Clofarabine Side Effects Report #5419373-6
Physician from UNITED STATES reported CLOFARABINE problem on Aug 08, 2007. Male patient, child 2 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: caecitis. CLOFARABINE dosage: 40 MG/M2 IV. During the same period patient was treated with CYTARABINE. Patient recovered.

Clofarabine Side Effects Report #5421826-1
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 06, 2007. Female patient, 80 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: asthenia, clostridial infection, diarrhoea, dysphagia, hypokalaemia, hypomagnesaemia, oral candidiasis. CLOFARABINE dosage: 30 MG/M2 QD X 5 IV. During the same period patient was treated with COLACE, PROTONIX, COREG, VALSARTAN, SENOKOT. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5422891-8
Physician from UNITED KINGDOM reported CLOFARABINE problem on Aug 06, 2007. Female patient, 15 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, back pain, bone marrow failure, depressed level of consciousness, haematemesis, hypotension, neutropenic sepsis, peripheral circulatory failure, renal failure. CLOFARABINE dosage: unknown. During the same period patient was treated with LIQUID PARAFFIN, ZOPICLONE, FENTANYL, HYOSCINE HYDROCHLORIDE, MIDAZOLAM, MAGNESIUM SULPHATE, GABAPENTIN, LEVOMEPROMAZINE. Patient died on 11/12/2006.

Clofarabine Side Effects Report #5423162-6
CLOFARABINE problem was reported by a Physician from FRANCE on Aug 14, 2007. Male patient, 58 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: erythema, multi-organ failure, toxic epidermal necrolysis. CLOFARABINE dosage: 30 MG/M2 QD X 5 IV. During the same period patient was treated with CYTARABINE, TAZOCILLINE, VANCOMYCIN, ONDANSETRON. Patient died on 12/19/2006.

Clofarabine Side Effects Report #5427846-5
Physician from UNITED STATES reported CLOFARABINE problem on Aug 10, 2007. Male patient, child 10 years of age, weighting 110.2 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: caecitis, cough, epistaxis, fatigue, febrile neutropenia, herpes zoster, hypokalaemia, lower respiratory tract infection fungal, lung disorder. CLOFARABINE dosage: 28 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5427853-2
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 17, 2007. Male patient, 39 years of age, was diagnosed with bone marrow conditioning regimen and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: catheter sepsis, confusional state, diarrhoea, haematemesis, haemoptysis, hallucination, hyperbilirubinaemia, hypotension. CLOFARABINE dosage: 20 MG/M2 QD X 5 IV. During the same period patient was treated with MELPHALAN, THIOTEPA, VANCOMYCIN, MYCOPHENOLATE MOFETIL, IPRATROPIUM, LEVOFLOXACIN, FILGRASTIM, MUPIROCIN. Patient was hospitalized. Patient died on 07/22/2007.

Clofarabine Side Effects Report #5428394-9
Consumer or non-health professional from UNITED STATES reported CLOFARABINE problem on Aug 09, 2007. Female patient, 71 years of age, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood magnesium decreased, blood potassium decreased, blood sodium decreased, blood urea increased, cholelithiasis, diarrhoea, glomerular filtration rate decreased, pancreatitis acute. CLOFARABINE dosage: 30 MG/M2 QD IV. During the same period patient was treated with BENAZEPRIL HYDROCHLORIDE, MECLIZINE, LOVASTATIN, RANITIDINE, MEGACE, ZANTAC. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5428396-2
CLOFARABINE problem was reported by a Pharmacist from UNITED STATES on Aug 10, 2007. Male patient, child 10 years of age, weighting 112.4 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, aspiration, atelectasis, bacteraemia, blister, blood fibrinogen increased, bronchial obstruction, bronchial secretion retention, caecitis. CLOFARABINE dosage: 28 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5441550-9
Consumer or non-health professional from UNITED KINGDOM reported CLOFARABINE problem on Aug 14, 2007. Male patient, 26 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: acute lymphocytic leukaemia, disease progression, fungal sepsis, mucormycosis, no therapeutic response, sputum culture positive. CLOFARABINE dosage: 52 MG/M2 QD X 5 IV. During the same period patient was treated with AMBISOME, POSACONAZOLE, MEROPENEM, CLARITHROMYCIN, LANSOPRAZOLE, ACYCLOVIR. Patient died on 05/25/2007.

Clofarabine Side Effects Report #5444087-6
CLOFARABINE problem was reported by a Physician from UNITED STATES on Aug 17, 2007. Female patient, weighting 159.8 lb, was diagnosed with acute myeloid leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: asthenia, capillary leak syndrome, chills, dry skin, feeling abnormal, feeling hot, flushing, headache. CLOFARABINE dosage: 30 MG/M2 QD IV. During the same period patient was treated with PROPOXYPHENE HYDROCHLORIDE, TYLENOL, BENADRYL, VALTREX, ZOFRAN, CALCIUM CARBONATE, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5444088-8
Physician from UNITED STATES reported CLOFARABINE problem on Aug 17, 2007. Female patient, child 8 years of age, weighting 42.99 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, bladder disorder, crystal urine present, heart rate increased, incontinence, nasal congestion, neutrophil count decreased. CLOFARABINE dosage: 32 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, ZOFRAN, ATIVAN, FILGRASTIM. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5447378-8
CLOFARABINE problem was reported by a Physician from SPAIN on Aug 21, 2007. Male patient, child 11 years of age, weighting 81.57 lb, was diagnosed with t-cell type acute leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, anuria, blood sodium decreased, capillary leak syndrome, cardiac arrest, feeling abnormal, migraine, nausea, pulmonary haemorrhage. CLOFARABINE dosage: 40 MGM2 QD IV. During the same period patient was treated with PREDNISONE, MORPHINE, ELITEK, DEXAMETHASONE, FLUCONAZOLE, FAMCICLOVIR, IBUPROFEN, OMEPRAZOLE. Patient died on 07/21/2007.

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Drug Information: Clofarabine Injection

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a607012.html

(kloe far' a been)

Why is this medication prescribed?

Clofarabine is used to treat acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in children and young adults 1-21 years old who have already received at least two other treatments. Clofarabine is in a class of medications called purine nucleoside antimetabolites. It works by killing existing cancer cells and limiting the development of new cancer cells.

How should this medicine be used?

Clofarabine comes as a solution to be injected into a vein. Clofarabine is administered by a doctor or nurse. It is usually given once a day for 5 days in a row. This dosing cycle may be repeated once every 2-6 weeks, depending on your response to the medication.

It will take at least 2 hours for you to receive each dose of clofarabine. Tell your doctor or other healthcare provider right away if you feel anxious or restless while you are receiving the medication.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using clofarabine,

tell your doctor and pharmacist if you are allergic to clofarabine or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention medications for high blood pressure and heart disease. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had kidney or liver disease.
tell your doctor if you are pregnant or plan to become pregnant. Clofarabine may harm the fetus. You should use birth control to prevent pregnancy during your treatment with clofarabine. Talk to your doctor about types of birth control that will work for you. If you become pregnant while using clofarabine, call your doctor.
tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with clofarabine.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving clofarabine.
you should know that clofarabine may cause a skin condition called hand-foot syndrome. If you develop this condition, you may experience tingling of the hands and feet, and then reddening, dryness, and flaking of the skin on the hands and feet. If this happens, ask your doctor to recommend a lotion that you can apply to these areas. You will need to apply the lotion lightly and avoid rubbing the areas forcefully. Your doctor may also prescribe medication to relieve these symptoms.

What special dietary instructions should I follow?

Drink plenty of fluids every day during your treatment with clofarabine, especially if you vomit or have diarrhea.

What side effects can this medication cause?

Clofarabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

nausea
vomiting
stomach pain
diarrhea
constipation
loss of appetite
weight loss
swelling of the inside of the mouth and nose
painful white patches in the mouth
headache
anxiety
depression
irritability
pain in the back, joints, arms, or legs
drowsiness
dry, itchy, or irritated skin
flushing

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

fast heartbeat
fast breathing
shortness of breath
dizziness
lightheadedness
fainting
decreased urination
sore throat, cough, fever, chills, and other signs of infection
pale skin
excessive tiredness
weakness
confusion
unusual bruising or bleeding
nosebleed
bleeding gums
blood in urine
small red or purple spots under the skin
yellowing of the skin or eyes
itching
red, warm, swollen, tender skin
uncontrollable shaking of a part of the body

Clofarabine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What storage conditions are needed for this medicine?

This medication will be stored in the hospital.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

yellowing of the skin or eyes
vomiting
rash

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to clofarabine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

Clolar®

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