Indications:

1. Is structurally related to doxorubicin; it is used for metastatic breast cancer. Mitoxantrone is also licensed for treatment of non- Hodgkin's lymphoma, adult acute non- lymphocytic leukaemia, and non- resectable primary hepatocellular carcinoma.

It is given intravenously and is well tolerated, but myelosuppression and dose-related cardiotoxicity occur; cardiac examinations are recommended after a cumulative dose of 160 mg/ m2.

2. Secondary Progressive Multiple Sclerosis

3. Prostate Cancer

Cautions: The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to manage complications Administer slowly into a freely flowing intravenous infusion and never administer IM, SC, or intra-arterially or intrathecally.

Severe injury with permanent sequelae can result from intrathecal administration. Severe local tissue damage can occur if extravasation occurs during administration.

Do not administer therapy to patients with baseline neutrophil counts <1, 500 cells/ mm³. Perform peripheral blood cell counts to monitor the occurrence of bone marrow suppression, primarily neutropenia, that may be severe and result in infection.

Cardiotoxicity

●Potentially fatal CHF may occur either during therapy or months to years after termination of therapy. The risk increases with cumulative doses and may occur whether or not cardiac risk factors are present. History of cardiovascular disease, radiotherapy to the mediastinal/ pericardial area, previous therapy with other anthracyclines or anthracenediones, or the use of other cardiotoxic drugs may increase the risk

●To mitigate the cardiotoxicity risk with this agent, prescribers should consider the following.

● All patients should be assessed for cardiac signs and symptoms by history, physical examination, ECG prior to the start of therapy, and have a baseline evaluation of left ventricular ejection fraction (LVEF) using appropriate methodology (eg, echocardiogram, multi-gated radionuclide angiography [MUGA]).

● Patients with multiple sclerosis (MS) should be assessed for cardiac signs and symptoms by history, physical examination, and ECG prior to each dose. Patients with a baseline LVEF below the lower limit of normal should not be treated with mitoxantrone. Patients with MS should undergo quantitative reevaluation of LVEF prior to each dose using the same methodology that was used to assess baseline LVEF.

● Additional doses of mitoxantrone should not be administered to patients with MS who have experienced either a drop in LVEF to below the lower limit of normal or a clinically significant reduction in LVEF during mitoxantrone therapy. These patients should not receive a cumulative dose >140 mg/sq.meter and should undergo yearly quantitative LVEF evaluation after stopping mitoxantrone to monitor for late occurring cardiotoxicity Secondary acute myelogenous leukemia.

● Secondary AML has been reported in patients with MS and cancer who treated with mitoxantrone. Also seen when patients are treated concurrently with anthracyclines. Mitoxantrone is an anthracenedione, a related drug.

● The occurrence of refractory secondary leukemia is more common when anthracyclines are given in combination with DNA- damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated.

-Not indicated for primary progressive MS

-Risk of cardiotoxicity & secondary AML

-If extravasation occurs, stop immediately & restart in another vein

Hepatic impairment: use with caution.

Pregnancy: avoid manufacturer advises effective contraception during and for at least 6 months after treatment in men or women. Most cytotoxic drugs are teratogenic and should not be administered during pregnancy, especially during the first trimester. Exclude pregnancy: before treatment with cytotoxic drugs.

Considerable caution is necessary if a pregnant woman presents with cancer requiring chemotherapy, and specialist advice should always be sought.Contraceptive advice should be given to men and women before cytotoxic therapy begins (and should cover the duration of contraception required after therapy has ended).Regimens that do not contain an alkylating drug or procarbazine may have less effect on fertility, but those with an alkylating drug or procarbazine carry the risk of causing permanent male sterility (there is no effect on potency). Pretreatment counselling and consideration of sperm storage may be appropriate. Women are less severely affected, though the span of reproductive life may be shortened by the onset of a premature menopause. No increase in fetal abnormalities or abortion rate has been recorded in patients who remain fertile after cytotoxic chemotherapy.

Breast-feeding: discontinue breast- feeding

Contra-indications: Hypersensitivity

Side Effects: Extravasation of intravenous drugs, Oral Tumour lysis syndrome, mucositis, Hyperuricaemia, Bone-marrow suppression, Thromboembolism, Nausea and vomiting, Upper respiratory infection, Alopecia Urinary tract infection, Amenorrhea, Diarrhea, Stomatitis, Constipation, Headache, Back pain, Frequency Not Defined, Decreased left ventricular ejection fraction, Cardiotoxicity, Myelosuppression, Hepatotoxicity, Abnormal LFT's.

Dose: injectable solution 2mg/Ml For adult: Secondary Progressive Multiple Sclerosis 12 mg/m² short IV (5-15 minutes) infusion q3Months Not to exceed lifetime cumulative dose of 140 mg/m² Acute Nonlymphocytic Leukemia Induction.

●12 mg/m²/day IV on days 1-3 with cytarabine 100 mg/m²/day IV continuous infusion on days 1-7.

●Second induction with same doses of mitoxantrone for 2 days & cytarabine for 5 days may be given if incomplete antileukemic response & no severe non hematologic toxicity in first induction.

●Consolidation: 12mg/m²/day for 2 days, repeat in 4 weeks For pediatric: <12 years old: Safety and efficacy not established For Geriatric: Secondary progressive multiple sclerosis 12 mg/m² short IV (5-15 minutes) infusion q3Months Acute nonlymphocytic leukemia.

Induction:

●12 mg/m²/day IV on days 1-3 with cytarabine 100 mg/m²/day IV continuous infusion on days 1-7.

●Second induction with same doses of mitoxantrone for 2 days & cytarabine for 5 days may be given if incomplete antileukemic response & no severe non hematologic toxicity in first induction.

Consolidation: 12 mg/m²/day for 2 days, repeat in 4 weeks Prostate cancer 12-14 mg/m² q21Days every 3 weeks in combination with corticosteroids.