Mitoxantrone Baxter Adverse Reactions

Bone marrow depression can occur during Mitoxantrone treatment even in the therapeutical dose range. In such a case, a drop in the leucocyte count is observed in the first place. In patients who have previously undergone chemotherapy and/or radiation therapy as well as in patients in a generally poor state of health, marked bone marrow depression can occur. The lowest leucocyte count is generally observed between 6 and 15 days after Mitoxantrone administration. Subsequently, the bone marrow recovers and haematological parameters normalise which, as a rule, is completed by 21 days after administration. A severe thrombocytopenia and, even more rarely, a very low erythrocyte count are seldom observed.
Nausea and vomiting can occur temporarily. They are in most cases of mild to moderate severity. Loss of hair was observed in about 20% of the patients treated with Mitoxantrone, which was reversible in most cases when the treatment was discontinued.
Cardiac side effects such as transient ECG alterations, acute arrhythmia, reduced left ventricular ejection fraction as well as cases of cardiac insufficiency can occur after administration of Mitoxantrone. These cardiac phenomena are observed particularly in high risk patients (see Contraindications).
Patients with cardiac insufficiency generally respond well to supportive treatment with digitalis and/or diuretic agents.
Occasionally, a stomatitis and/or mucositis - in most cases of lower degree - can occur (in some cases more frequently and pronounced during treatment of leukaemia).
Occasionally, hypersensitivity reactions (hyperergias) are possible, which may appear as acute general allergic reactions (anaphylaxis) in exceptional cases.
Side effects such as loss of appetite, diarrhoea, abdominal pain, constipation, gastrointestinal bleeding, tiredness and debility, amenorrhoea, fever, dyspnea and nonspecific neurological disorders are occasionally observed. However, a connection between neurological disorders and the administration of Mitoxantrone could not be established so far.
Liver enzyme, serum creatinine and blood urea values may temporarily change in individual cases. Marked pathological alterations of the liver enzyme values and an impairment of liver function can occasionally occur in patients with acute leukaemia.
Mitoxantrone causes a blue-green coloration of the urine for 1 to 2 days after administration. In rare cases, reversible blue coloration of the sclera, veins and perivenous tissue as well as the nails (including onycholysis) were observed.
In case of intrapleural instillation, pain and side effects similar to those after systemic application may occur. The patient is requested to inform his doctor about all side effects not mentioned within this monograph.
Treatment in case of side effects: Bone marrow depression: Due to the severity of bone marrow depression, a consequent infection prophylaxis with antibiotics has to be initiated. To counteract agranulocytosis and thrombocytopenia, whole blood transfusions, leucocyte and thrombocyte concentrates are suitable. (Refer to Dosage & Administration for further information.)
Cardiac side effects: Patients with cardiac insufficiency generally respond well to a supportive treatment with digitalis and/or diuretic agents.
Post-marketing Adverse Reactions: Infections and Infestations: Sepsis, Infection.
Neoplasm Benign and Malignant (Including Cysts and Polyps): Acute myeloid leukemia, Myelodysplastic syndrome.
Blood and Lymphatic System Disorders: Bone marrow failure, Pancytopenia, Thrombocytopenia, Febrile neutropenia, Neutropenia, Leukopenia, Anemia.
Immune System Disorders: Hypersensitivity reactions.
Metabolism and Nutrition Disorders: Tumor lysis syndrome.
Psychiatric Disorders: Confusional state.
Cardiac Disorders: Cardiomyopathy, Cardiac failure, Left ventricular failure, Myocardial infarction, ECG alterations, Arrhythmia.
Vascular Disorders: Phlebitis.
Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonitis, Dyspnea.
Gastrointestinal Disorders: Nausea, Vomiting, Stomatitis, Abdominal pain, Abdominal tenderness, Diarrhea.
Hepatobiliary Disorders: Hepatotoxicity.
Skin and Subcutaneous Tissue Disorder: Alopecia, Nail disorder, Onycholysis including nail discoloration.
Pregnancy, Puerperium and Perinatal Conditions: Fetal growth restriction.
Reproductive System and Breast Disorders: Amenorrhea, Oligospermia.
General Disorders and Administration Site Conditions: Injection site necrosis, Injection site discoloration, Injection site erythema, Injection site pain, Injection site warmth, Asthenia, Chest pain, Mucosal inflammation, Pain, Pyrexia.
Investigations: Ejection fraction decreased, Hepatic enzyme increased, Blood bilirubin increased.