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Drug Details

ONKOTRONE INJECTION

• Drug Class Description
  DNA-reactive cytotoxics (antineoplastic agents).
• Generic Name
  Mitoxantrone [mitozantrone]
• Presentation
  Infusion, mitoxantrone 2mg/mL.
• Description
  Concentrate for solution for infusion. Sterile, dark blue aqueous solution.
• Indications
  Treatment of advanced breast cancer, non-Hodgkin's lymphoma, adult acute non-lymphocytic leukaemia, non-resectable primary hepatocellular carcinoma.
• Adult Dosage
  

  Onkotrone should only be administered by experienced oncologists. It should not be given intrathecally.

  Advanced breast cancer, non- Hodgkin's lymphoma, hepatocellular carcinoma: during monotherapy, a dose of 14mg/m2 is recommended as the initial dose for the first cycle. This dose can be repeated after 21 days.

  In patients with diminished bone marrow reserves, initial dose marrow reserves, initial dose should be reduced to 12mg/m 2 or as appropriate for the haematological status. Refer to Summary of Product Characteristics. Adult acute non-lymphocytic leukaemia: for induction treatment in adults, recommended dose is 12mg/m 2 for five consecutive days (total dose 60mg/m 2).

• Child Dosage
  Not recommended.
• Contra Indications
  

  Known hypersensitivity to the active ingredient. Use in childhood malignancy. Severe hepatic insufficiency (defined as serum bilirubin 60micromol/L or greater). Pregnancy and lactation. Intrathecal route.

• Special Precautions
  

  Pancytopenia, septicaemia. Severe hepatic and/or renal insufficiency. Prior treatment with anthracyclines, prior mediastinal/thoracic radiotherapy, pre-existing heart disease - regular cardiac examinations recommended from initiation of treatment.

  Prolonged treatment (therapy exceeding a cumulative dose of 160mg/m 2 - cardiac examinations recommended. Monitor haematological blood parameters before each dose and at least once during each treatment cycle. Effective contraception should be used during treatment and for at least six months after cessation of treatment.

• Interactions
  Other neoplastic agents.
• Adverse Drug Reactions
  

  Bone marrow depression. Temporary nausea and vomiting. Cardiac effects including transient ECG alterations, acute arrhythmias, reduced left ventricular output, cardiac insufficiency.

  Occasionally, stomatitis and/or mucositis, loss of appetite, diarrhoea, abdominal pain, constipation, GI bleeding, tiredness and weakness, amenorrhoea, fever, dyspnoea, somnolence, confusion, anxiety, hypersensitivity reactions.

  Blue-green discolouration of urine one to two days after administration. Occasionally, blue-green discolouration of the nails and skin also. Very rarely, nail dystrophy or reversible blue colouration of the sclerae.