Drug information for MITOXANTRONE HYDROCHLORIDE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone BEDFORD 76611
2007-04-09 Review
2006-04-13 Letter
INJECTABLE; INJECTION EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone BEDFORD   "
INJECTABLE; INJECTION EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone BEDFORD   "
INJECTABLE; INJECTION EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Prescription AP (Reference Drug) MITOXANTRONE HYDROCHLORIDE Mitoxantrone HOSPIRA 76871
2006-04-13 Letter
INJECTABLE; INJECTION EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Prescription AP (Reference Drug) MITOXANTRONE HYDROCHLORIDE Mitoxantrone HOSPIRA   "
INJECTABLE; INJECTION EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Prescription AP (Reference Drug) MITOXANTRONE HYDROCHLORIDE Mitoxantrone HOSPIRA   "
INJECTABLE; INJECTION EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone TEVA PARENTERAL 77356
2006-04-12 Letter
INJECTABLE; INJECTION EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone TEVA PARENTERAL   "
INJECTABLE; INJECTION EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone TEVA PARENTERAL   "
INJECTABLE; INJECTION EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone APP PHARMS 77496
2006-04-13 Letter
INJECTABLE; INJECTION EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone APP PHARMS   "
INJECTABLE; INJECTION EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone APP PHARMS   "
INJECTABLE; INJECTION EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone FRESENIUS KABI ONCOL 78606
INJECTABLE; INJECTION EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone FRESENIUS KABI ONCOL   "
INJECTABLE; INJECTION EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone FRESENIUS KABI ONCOL   "
INJECTABLE; INJECTION EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone MYLAN INSTITUTIONAL 78980
INJECTABLE; INJECTION EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Prescription AP  MITOXANTRONE HYDROCHLORIDE Mitoxantrone MYLAN INSTITUTIONAL   "

Drug Adverse Effects information for MITOXANTRONE HYDROCHLORIDE

Role code Indications Reaction # Reports
SS ACUTE LYMPHOCYTIC LEUKAEMIA ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA BILE DUCT CANCER 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA BLOOD CREATININE INCREASED 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA BLOOD UREA INCREASED 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA BONE MARROW TRANSPLANT 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA CARDIAC FAILURE CONGESTIVE 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA CARDIOTOXICITY 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA COLONIC POLYP 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA CONGESTIVE CARDIOMYOPATHY 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA DIARRHOEA 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA HEPATIC CIRRHOSIS 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA METASTASES TO LIVER 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA METASTASES TO LUNG 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA METASTASES TO STOMACH 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA NEUROPATHY PERIPHERAL 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA OSTEOSCLEROSIS 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA PLEURAL EFFUSION 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA RASH 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA RENAL CYST 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA RENAL IMPAIRMENT 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA RENAL MASS 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA THROMBOCYTOPENIA 9
SS ACUTE LYMPHOCYTIC LEUKAEMIA TOXICITY TO VARIOUS AGENTS 9
SS ACUTE MYELOID LEUKAEMIA CEREBRAL HAEMORRHAGE 4
SS ACUTE MYELOID LEUKAEMIA ENTEROCOCCAL SEPSIS 3
SS ACUTE MYELOID LEUKAEMIA GRANULOCYTOPENIA 3
SS ACUTE MYELOID LEUKAEMIA HYPOTENSION 5
SS ACUTE PROMYELOCYTIC LEUKAEMIA ANIMAL SCRATCH 1
SS ACUTE PROMYELOCYTIC LEUKAEMIA ERYTHEMA 1
SS ACUTE PROMYELOCYTIC LEUKAEMIA ESCHERICHIA INFECTION 2
SS ACUTE PROMYELOCYTIC LEUKAEMIA FEBRILE NEUTROPENIA 2
SS ACUTE PROMYELOCYTIC LEUKAEMIA NEUTROPENIA 1
SS ACUTE PROMYELOCYTIC LEUKAEMIA PYREXIA 1
SS ACUTE PROMYELOCYTIC LEUKAEMIA RASH PUSTULAR 1
SS ANTIFUNGAL PROPHYLAXIS ADENOVIRAL HAEMORRHAGIC CYSTITIS 2
SS ANTIFUNGAL PROPHYLAXIS MANTLE CELL LYMPHOMA 2
SS B-CELL LYMPHOMA CARDIAC DISORDER 4
SS B-CELL LYMPHOMA DYSPNOEA 4
SS B-CELL LYMPHOMA FATIGUE 4
SS B-CELL LYMPHOMA HEPATITIS B 4
SS B-CELL LYMPHOMA INFECTION 4
SS B-CELL LYMPHOMA MYALGIA 4
SS B-CELL LYMPHOMA MYELODYSPLASTIC SYNDROME 4
SS B-CELL LYMPHOMA NEOPLASM MALIGNANT 4
SS B-CELL LYMPHOMA NEUTROPENIA 8
SS B-CELL LYMPHOMA STEVENS-JOHNSON SYNDROME 4
SS B-CELL LYMPHOMA THROMBOCYTOPENIA 4
SS EMBOLISM VENOUS CEREBRAL HAEMORRHAGE 1
SS HYPERTENSION ADENOVIRAL HAEMORRHAGIC CYSTITIS 2
SS HYPERTENSION MANTLE CELL LYMPHOMA 2
SS HYPERURICAEMIA ADENOVIRAL HAEMORRHAGIC CYSTITIS 2
SS HYPERURICAEMIA MANTLE CELL LYMPHOMA 2
SS MANTLE CELL LYMPHOMA ADENOVIRAL HAEMORRHAGIC CYSTITIS 10
SS MANTLE CELL LYMPHOMA MANTLE CELL LYMPHOMA 10
SS OEDEMA ADENOVIRAL HAEMORRHAGIC CYSTITIS 2
SS OEDEMA MANTLE CELL LYMPHOMA 2
C ACUTE LYMPHOCYTIC LEUKAEMIA ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT 10
C ACUTE LYMPHOCYTIC LEUKAEMIA FEBRILE NEUTROPENIA 10
C ACUTE LYMPHOCYTIC LEUKAEMIA HERPES ZOSTER 10
C ACUTE LYMPHOCYTIC LEUKAEMIA LIVER DISORDER 10
C ACUTE MYELOID LEUKAEMIA ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 5
C ACUTE MYELOID LEUKAEMIA ACUTE MYELOID LEUKAEMIA 5
C ACUTE MYELOID LEUKAEMIA ENTEROCOCCAL SEPSIS 2
C ACUTE MYELOID LEUKAEMIA EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 5
C ACUTE MYELOID LEUKAEMIA GRAFT VERSUS HOST DISEASE IN INTESTINE 2
C ACUTE MYELOID LEUKAEMIA GRAFT VERSUS HOST DISEASE IN SKIN 2
C ACUTE MYELOID LEUKAEMIA HERPES ZOSTER DISSEMINATED 1
C ACUTE MYELOID LEUKAEMIA METASTASES TO LUNG 5
C ACUTE MYELOID LEUKAEMIA RESPIRATORY FAILURE 5
C ACUTE MYELOID LEUKAEMIA STAPHYLOCOCCAL SEPSIS 5
C ALLERGY PROPHYLAXIS ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 3
C ALLERGY PROPHYLAXIS ACUTE MYELOID LEUKAEMIA 3
C ALLERGY PROPHYLAXIS EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 3
C ALLERGY PROPHYLAXIS METASTASES TO LUNG 3
C ALLERGY PROPHYLAXIS RESPIRATORY FAILURE 3
C ALLERGY PROPHYLAXIS STAPHYLOCOCCAL SEPSIS 3
C ANTIFUNGAL PROPHYLAXIS ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 2
C ANTIFUNGAL PROPHYLAXIS ACUTE MYELOID LEUKAEMIA 2
C ANTIFUNGAL PROPHYLAXIS EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 2
C ANTIFUNGAL PROPHYLAXIS METASTASES TO LUNG 2
C ANTIFUNGAL PROPHYLAXIS RESPIRATORY FAILURE 2
C ANTIFUNGAL PROPHYLAXIS STAPHYLOCOCCAL SEPSIS 2
C ANTIVIRAL PROPHYLAXIS ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 2
C ANTIVIRAL PROPHYLAXIS ACUTE MYELOID LEUKAEMIA 2
C ANTIVIRAL PROPHYLAXIS EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 2
C ANTIVIRAL PROPHYLAXIS METASTASES TO LUNG 2
C ANTIVIRAL PROPHYLAXIS RESPIRATORY FAILURE 2
C ANTIVIRAL PROPHYLAXIS STAPHYLOCOCCAL SEPSIS 2
C BONE MARROW CONDITIONING REGIMEN ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 3
C BONE MARROW CONDITIONING REGIMEN ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT 1
C BONE MARROW CONDITIONING REGIMEN ACUTE MYELOID LEUKAEMIA 3
C BONE MARROW CONDITIONING REGIMEN ENTEROCOCCAL SEPSIS 5
C BONE MARROW CONDITIONING REGIMEN EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 3
C BONE MARROW CONDITIONING REGIMEN FEBRILE NEUTROPENIA 1
C BONE MARROW CONDITIONING REGIMEN GRAFT VERSUS HOST DISEASE IN INTESTINE 5
C BONE MARROW CONDITIONING REGIMEN GRAFT VERSUS HOST DISEASE IN SKIN 5
C BONE MARROW CONDITIONING REGIMEN HERPES ZOSTER 1
C BONE MARROW CONDITIONING REGIMEN LIVER DISORDER 1
C BONE MARROW CONDITIONING REGIMEN METASTASES TO LUNG 3
C BONE MARROW CONDITIONING REGIMEN RESPIRATORY FAILURE 3
C BONE MARROW CONDITIONING REGIMEN STAPHYLOCOCCAL SEPSIS 3
C BRAIN OEDEMA ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C BRAIN OEDEMA ACUTE MYELOID LEUKAEMIA 1
C BRAIN OEDEMA EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 1
C BRAIN OEDEMA METASTASES TO LUNG 1
C BRAIN OEDEMA RESPIRATORY FAILURE 1
C BRAIN OEDEMA STAPHYLOCOCCAL SEPSIS 1
C DIARRHOEA ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C DIARRHOEA ACUTE MYELOID LEUKAEMIA 1
C DIARRHOEA EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 1
C DIARRHOEA METASTASES TO LUNG 1
C DIARRHOEA RESPIRATORY FAILURE 1
C DIARRHOEA STAPHYLOCOCCAL SEPSIS 1
C HAEMORRHAGE PROPHYLAXIS ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 2
C HAEMORRHAGE PROPHYLAXIS ACUTE MYELOID LEUKAEMIA 2
C HAEMORRHAGE PROPHYLAXIS EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 2
C HAEMORRHAGE PROPHYLAXIS METASTASES TO LUNG 2
C HAEMORRHAGE PROPHYLAXIS RESPIRATORY FAILURE 2
C HAEMORRHAGE PROPHYLAXIS STAPHYLOCOCCAL SEPSIS 2
C INFECTION PROPHYLAXIS ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 7
C INFECTION PROPHYLAXIS ACUTE MYELOID LEUKAEMIA 7
C INFECTION PROPHYLAXIS ENTEROCOCCAL SEPSIS 2
C INFECTION PROPHYLAXIS EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 7
C INFECTION PROPHYLAXIS GRAFT VERSUS HOST DISEASE IN INTESTINE 2
C INFECTION PROPHYLAXIS GRAFT VERSUS HOST DISEASE IN SKIN 2
C INFECTION PROPHYLAXIS METASTASES TO LUNG 7
C INFECTION PROPHYLAXIS RESPIRATORY FAILURE 7
C INFECTION PROPHYLAXIS STAPHYLOCOCCAL SEPSIS 7
C NUTRITIONAL SUPPORT ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C NUTRITIONAL SUPPORT ACUTE MYELOID LEUKAEMIA 1
C NUTRITIONAL SUPPORT EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 1
C NUTRITIONAL SUPPORT METASTASES TO LUNG 1
C NUTRITIONAL SUPPORT RESPIRATORY FAILURE 1
C NUTRITIONAL SUPPORT STAPHYLOCOCCAL SEPSIS 1
C PAIN ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C PAIN ACUTE MYELOID LEUKAEMIA 1
C PAIN EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 1
C PAIN METASTASES TO LUNG 1
C PAIN RESPIRATORY FAILURE 1
C PAIN STAPHYLOCOCCAL SEPSIS 1
C PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED HERPES ZOSTER DISSEMINATED 2
C PREMEDICATION ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT 1
C PREMEDICATION FEBRILE NEUTROPENIA 1
C PREMEDICATION HERPES ZOSTER 1
C PREMEDICATION LIVER DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C PRODUCT USED FOR UNKNOWN INDICATION ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT 7
C PRODUCT USED FOR UNKNOWN INDICATION ACUTE MYELOID LEUKAEMIA 1
C PRODUCT USED FOR UNKNOWN INDICATION EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION FEBRILE NEUTROPENIA 7
C PRODUCT USED FOR UNKNOWN INDICATION HERPES ZOSTER 7
C PRODUCT USED FOR UNKNOWN INDICATION LIVER DISORDER 7
C PRODUCT USED FOR UNKNOWN INDICATION METASTASES TO LUNG 1
C PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY FAILURE 1
C PRODUCT USED FOR UNKNOWN INDICATION STAPHYLOCOCCAL SEPSIS 1
C PROPHYLAXIS ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 3
C PROPHYLAXIS ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT 3
C PROPHYLAXIS ACUTE MYELOID LEUKAEMIA 3
C PROPHYLAXIS ENTEROCOCCAL SEPSIS 1
C PROPHYLAXIS EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 3
C PROPHYLAXIS FEBRILE NEUTROPENIA 3
C PROPHYLAXIS GRAFT VERSUS HOST DISEASE IN INTESTINE 1
C PROPHYLAXIS GRAFT VERSUS HOST DISEASE IN SKIN 1
C PROPHYLAXIS HERPES ZOSTER 3
C PROPHYLAXIS LIVER DISORDER 3
C PROPHYLAXIS METASTASES TO LUNG 3
C PROPHYLAXIS RESPIRATORY FAILURE 3
C PROPHYLAXIS STAPHYLOCOCCAL SEPSIS 3
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT 3
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE ACUTE MYELOID LEUKAEMIA 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE ENTEROCOCCAL SEPSIS 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE FEBRILE NEUTROPENIA 3
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE GRAFT VERSUS HOST DISEASE IN INTESTINE 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE GRAFT VERSUS HOST DISEASE IN SKIN 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE HERPES ZOSTER 3
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE LIVER DISORDER 3
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE METASTASES TO LUNG 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE RESPIRATORY FAILURE 2
C PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE STAPHYLOCOCCAL SEPSIS 2
C PROPHYLAXIS OF NAUSEA AND VOMITING ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1
C PROPHYLAXIS OF NAUSEA AND VOMITING ACUTE MYELOID LEUKAEMIA 1
C PROPHYLAXIS OF NAUSEA AND VOMITING EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER 1
C PROPHYLAXIS OF NAUSEA AND VOMITING METASTASES TO LUNG 1
C PROPHYLAXIS OF NAUSEA AND VOMITING RESPIRATORY FAILURE 1
C PROPHYLAXIS OF NAUSEA AND VOMITING STAPHYLOCOCCAL SEPSIS 1
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