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Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone is not indicated in the treatment of patients with primary progressive multiple sclerosis. The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability. Mitoxantrone in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormonerefractory prostate cancer. Mitoxantrone in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.


Mitoxantrone is contraindicated in patients who have demonstrated prior hypersensitivity to it.

Adverse reactions:

Multiple Sclerosis: Mitoxantrone has been administered to 149 patients with multiple sclerosis in two randomized clinical trials, including 21 patients who received Mitoxantrone in combination with corticosteroids. In Study 1, the proportion of patients who discontinued treatment due to an adverse event was 9.7% (n = 6) in the 12 mg/m2 Mitoxantrone arm (leukopenia, depression, decreased LV function, bone pain and emesis, renal failure, and one discontinuation to prevent future complications from repeated urinary tract infections) compared to 3.1% (n = 2) in the placebo arm (hepatitis and myocardial infarction). The following clinical adverse experiences were significantly more frequent in the Mitoxantrone groups: nausea, alopecia, urinary tract infection, and menstrual disorders, including amenorrhea. General: Allergic Reaction - Hypotension, urticaria, dyspnea, and rashes have been reported occasionally. Anaphylaxis/anaphylactoid reactions have been reported rarely. Cutaneous - Extravasation at the infusion site has been reported, which may result in erythema, swelling, pain, burning, and/or blue discoloration of the skin. Extravasation can result in tissue necrosis with resultant need for debridement and skin grafting. Phlebitis has also been reported at the site of the infusion. Hematologic - Topoisomerase II inhibitors, including Mitoxantrone, in combination with other antineoplastic agents, have been associated with the development of acute leukemia. Leukemia - Myelosuppression is rapid in onset and is consistent with the requirement to produce significant marrow hypoplasia in order to achieve a response in acute leukemia. The incidences of infection and bleeding seen in the U.S. trial are consistent with those reported for other standard induction regimens. Hormone-Refractory Prostate Cancer - In a randomized study where dose escalation was required for neutrophil counts greater than 1000/mm3, Grade 4 neutropenia (ANC < 500/mm3) was observed in 54% of patients treated with Mitoxantrone + low-dose prednisone. In a separate randomized trial where patients were treated with 14 mg/m2, Grade 4 neutropenia in 23% of patients treated with Mitoxantrone + hydrocortisone was observed. Neutropenic fever/infection occurred in 11% and 10% of patients receiving Mitoxantrone + corticosteroids, respectively, on the two trials. Platelets < 50,000/mm3 were noted in 4% and 3% of patients receiving Mitoxantrone + corticosteroids on these trials, and there was one patient death on Mitoxantrone + hydrocortisone due to intracranial hemorrhage after a fall. Gastrointestinal - Nausea and vomiting occurred acutely in most patients and may have contributed to reports of dehydration, but were generally mild to moderate and could be controlled through the use of antiemetics. Stomatitis/mucositis occurred within 1 week of therapy. Cardiovascular - Congestive heart failure, tachycardia, EKG changes including arrhythmias, chest pain, and asymptomatic decreases in left ventricular ejection fraction have occurred. Pulmonary - Interstitial pneumonitis has been reported in cancer patients receiving combination chemotherapy that included Mitoxantrone.


No Information is Available.


WARNING Mitoxantrone Injection, USP (concentrate) should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents. Mitoxantrone Injection, USP (concentrate) should be given slowly into a freely flowing intravenous infusion. It must never be given subcutaneously, intramuscularly, or intra-arterially. Severe local tissue damage may occur if there is extravasation during administration. (See ADVERSE REACTIONS, General, Cutaneous and DOSAGE AND ADMINISTRATION, Preparation and Administration Precautions). NOT FOR INTRATHECAL USE. Severe injury with permanent sequelae can result from intrathecal administration. (See WARNINGS, General) Except for the treatment of acute nonlymphocytic leukemia, Mitoxantrone therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving Mitoxantrone. Cardiotoxicity: Congestive heart failure (CHF), potentially fatal, may occur either during therapy with Mitoxantrone or months to years after termination of therapy. Cardiotoxicity risk increases with cumulative Mitoxantrone dose and may occur whether or not cardiac risk factors are present. Presence or history of cardiovascular disease, radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or use of other cardiotoxic drugs may increase this risk. In cancer patients, the risk of symptomatic CHF was estimated to be 2.6% for patients receiving up to a cumulative dose of 140 mg/m2. To mitigate the cardiotoxicity risk with Mitoxantrone, prescribers should consider the following: All Patients: All patients should be assessed for cardiac signs and symptoms by history, physical examination, and ECG prior to start of Mitoxantrone therapy. All patients should have baseline quantitative evaluation of left ventricular ejection fraction (LVEF) using appropriate methodology (ex. Echocardiogram, multi-gated radionuclide angiography (MUGA), MRI, etc.). Multiple Sclerosis Patients: MS patients with a baseline LVEF below the lower limit of normal should not be treated with Mitoxantrone. MS patients should be assessed for cardiac signs and symptoms by history, physical examination and ECG prior to each dose. MS patients 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 multiple sclerosis patients 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. MS patients should not receive a cumulative Mitoxantrone dose greater than 140 mg/m2. MS patients should undergo yearly quantitative LVEF evaluation after stopping Mitoxantrone to monitor for late occurring cardiotoxicity. For additional information, see WARNINGS, Cardiac Effects, and DOSAGE AND ADMINISTRATION. Secondary acute myelogenous leukemia (AML) has been reported in multiple sclerosis and cancer patients treated with Mitoxantrone. In a cohort of Mitoxantrone treated MS patients followed for varying periods of time, an elevated leukemia risk of 0.25% (2/802) has been observed. Postmarketing cases of secondary AML have also been reported. In 1774 patients with breast cancer who received Mitoxantrone concomitantly with other cytotoxic agents and radiotherapy, the cumulative risk of developing treatment-related AML, was estimated as 1.1% and 1.6% at 5 and 10 years, respectively (see WARNINGS section). Secondary acute myelogenous leukemia (AML) has also been reported in cancer patients treated 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. General: Therapy with Mitoxantrone should be accompanied by close and frequent monitoring of hematologic and chemical laboratory parameters, as well as frequent patient observation. Systemic infections should be treated concomitantly with or just prior to commencing therapy with Mitoxantrone. Information for Patients: Mitoxantrone may impart a blue-green color to the urine for 24 hours after administration, and patients should be advised to expect this during therapy. Bluish discoloration of the sclera may also occur. Patients should be advised of the signs and symptoms of myelosuppression. Patients with multiple sclerosis should be provided with the Patient Package Insert at the time that the decision is made to treat with Mitoxantrone and prior to and in close temporal proximity to each treatment. In addition, the physician should discuss the issues addressed in the Patient Package Insert with the patient. Laboratory Tests: A complete blood count, including platelets, should be obtained prior to each course of Mitoxantrone and in the event that signs and symptoms of infection develop. Liver function tests should also be performed prior to each course of therapy. Mitoxantrone therapy in multiple sclerosis patients with abnormal liver function tests is not recommended because Mitoxantrone clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments. In leukemia treatment, hyperuricemia may occur as a result of rapid lysis of tumor cells by Mitoxantrone. Serum uric acid levels should be monitored and hypouricemic therapy instituted prior to the initiation of antileukemic therapy. Women with multiple sclerosis who are biologically capable of becoming pregnant, even if they are using birth control, should have a pregnancy test, and the results should be known, before receiving each dose of Mitoxantrone (see WARNINGS, Pregnancy). Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis - Intravenous treatment of rats and mice, once every 21 days for 24 months, with Mitoxantrone resulted in an increased incidence of fibroma and external auditory canal tumors in rats at a dose of 0.03 mg/kg (0.02 fold the recommended human dose, on a mg/m2 basis), and hepatocellular adenoma in male mice at a dose of 0.1 mg/kg (0.03 fold the recommended human dose, on a mg/m2 basis). Intravenous treatment of rats, once every 21 days for 12 months with Mitoxantrone resulted in an increased incidence of external auditory canal tumors in rats at a dose of 0.3 mg/kg (0.15 fold the recommended human dose, on a mg/m2 basis). Mutagenesis - Mitoxantrone was clastogenic in the in vivo rat bone marrow assay. Mitoxantrone was also clastogenic in two in vitro assays; it induced DNA damage in primary rat hepatocytes and sister chromatid exchanges in Chinese hamster ovary cells. Mitoxantrone was mutagenic in bacterial and mammalian test systems (Ames/ Salmonella and E. coli and L5178Y TK+/-mouse lymphoma). Drug Interactions: Mitoxantrone and its metabolites are excreted in bile and urine, but it is not known whether the metabolic or excretory pathways are saturable, may be inhibited or induced, or if Mitoxantrone and its metabolites undergo enterohepatic circulation. To date, post-marketing experience has not revealed any significant drug interactions in patients who have received Mitoxantrone for treatment of cancer. Information on drug interactions in patients with multiple sclerosis is limited. Following concurrent administration of Mitoxantrone with corticosteroids, no evidence of drug interactions has been observed. Special Populations: Hepatic Impairment - Patients with multiple sclerosis who have hepatic impairment should ordinarily not be treated with Mitoxantrone. Mitoxantrone should be administered with caution to other patients with hepatic impairment. In patients with severe hepatic impairment, the AUC is more than three times greater than the value observed in patients with normal hepatic function. Pregnancy: Pregnancy Category D (see WARNINGS). Nursing Mothers: Mitoxantrone is excreted in human milk and significant concentrations (18 ng/mL) have been reported for 28 days after the last administration. Because of the potential for serious adverse reactions in infants from Mitoxantrone, breast feeding should be discontinued before starting treatment. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Multiple Sclerosis: Clinical studies of Mitoxantrone did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Hormone-Refractory Prostate Cancer: One hundred forty-six patients aged 65 and over and 52 younger patients (<65 years) have been treated with Mitoxantrone in controlled clinical studies. These studies did not include sufficient numbers of younger patients to determine whether they respond differently from older patients. However, greater sensitivity of some older individuals cannot be ruled out. Acute Nonlymphocytic Leukemia: Although definitive studies with Mitoxantrone have not been performed in geriatric patients with ANLL, toxicity may be more frequent in the elderly. Elderly patients are more likely to have age-related comorbidities due to disease or disease therapy.



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