Mitoxantrone 2 mg/mL
MITOXANTRONE HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Mitoxantrone is a injection, solution containing mitoxantrone hydrochloride at 2 mg/mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Mitoxantrone
- Generic Name
- MITOXANTRONE HYDROCHLORIDE
- NDC Code (Product)
63323-132- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA077496
- Marketing Start
- 04/11/2006
Recall History
Hospira Inc.
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Teva North America
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Mitoxantrone injection, USP (concentrate) 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 injection, USP (concentrate) 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 injection, USP (concentrate) in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. Mitoxantrone injection, USP (concentrate) in combination with other approved drug(s) is indicated in the initial th…
Dosage & Administration
DOSAGE AND ADMINISTRATION (See also WARNINGS .) Multiple Sclerosis The recommended dosage of mitoxantrone injection (concentrate) is 12 mg/m 2 given as a short (approximately 5 to 15 minutes) intravenous infusion every 3 months. Left ventricular ejection fraction (LVEF) should be evaluated by echocardiogram or MUGA prior to administration of the initial dose of mitoxantrone injection (concentrate) and all subsequent doses. In addition, LVEF evaluations are recommended if signs or symptoms of congestive heart failure develop at any time during treatment with mitoxantrone injection (concentrate). Mitoxantrone injection (concentrate) should not be administered to multiple sclerosis patients with an LVEF < 50%, with a clinically significant reduction in LVEF, or to those who have received a cumulative lifetime dose of > 140 mg/m 2 . Complete blood counts, including platelets, should be monitored prior to each course of mitoxantrone injection (concentrate) and in the event that signs or symptoms of infection develop. Mitoxantrone injection (concentrate) generally should not be administered to multiple sclerosis patients with neutrophil counts less than 1500 cells/mm 3 . Liver function t…
Warnings
WARNINGS WHEN MITOXANTRONE INJECTION IS USED IN HIGH DOSES (> 14 mg/m 2 /d × 3 days) SUCH AS INDICATED FOR THE TREATMENT OF LEUKEMIA, SEVERE MYELOSUPPRESSION WILL OCCUR. THEREFORE, IT IS RECOMMENDED THAT MITOXANTRONE INJECTION BE ADMINISTERED ONLY BY PHYSICIANS EXPERIENCED IN THE CHEMOTHERAPY OF THIS DISEASE. LABORATORY AND SUPPORTIVE SERVICES MUST BE AVAILABLE FOR HEMATOLOGIC AND CHEMISTRY MONITORING AND ADJUNCTIVE THERAPIES, INCLUDING ANTIBIOTICS. BLOOD AND BLOOD PRODUCTS MUST BE AVAILABLE TO SUPPORT PATIENTS DURING THE EXPECTED PERIOD OF MEDULLARY HYPOPLASIA AND SEVERE MYELOSUPPRESSION. PARTICULAR CARE SHOULD BE GIVEN TO ASSURING FULL HEMATOLOGIC RECOVERY BEFORE UNDERTAKING CONSOLIDATION THERAPY (IF THIS TREATMENT IS USED) AND PATIENTS SHOULD BE MONITORED CLOSELY DURING THIS PHASE. MITOXANTRONE INJECTION ADMINISTERED AT ANY DOSE CAN CAUSE MYELOSUPPRESSION. General Patients with preexisting myelosuppression as the result of prior drug therapy should not receive mitoxantrone injection unless it is felt that the possible benefit from such treatment warrants the risk of further medullary suppression. The safety of mitoxantrone injection (concentrate) in patients with hepatic insuffi…
Contraindications
CONTRAINDICATIONS Mitoxantrone injection (concentrate) is contraindicated in patients who have demonstrated prior hypersensitivity to it.
Drug Interactions
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, postmarketing experience has not revealed any significant drug interactions in patients who have received mitoxantrone injection for treatment of cancer. Information on drug interactions in patients with multiple sclerosis is limited. Following concurrent administration of mitoxantrone injection with corticosteroids, no evidence of drug interactions has been observed.
Adverse Reactions
ADVERSE REACTIONS Multiple Sclerosis Mitoxantrone injection has been administered to 149 patients with multiple sclerosis in two randomized clinical trials, including 21 patients who received mitoxantrone injection 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/m 2 mitoxantrone injection 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 injection groups: nausea, alopecia, urinary tract infection, and menstrual disorders, including amenorrhea. Table 4a summarizes clinical adverse events of all intensities occurring in ≥ 5% of patients in either dose group of mitoxantrone injection and that were numerically greater on drug than on placebo in Study 1. The majority of these events were of mild to moderate intensity, and nausea was the only adverse event that occurred wi…
Frequently Asked Questions
What is Mitoxantrone used for?
Mitoxantrone contains MITOXANTRONE HYDROCHLORIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Mitoxantrone a controlled substance?
Mitoxantrone is not classified as a controlled substance by the DEA.
What is the generic name for Mitoxantrone?
The generic name for Mitoxantrone is MITOXANTRONE HYDROCHLORIDE. There are no other listed brand versions of MITOXANTRONE HYDROCHLORIDE.
What is the NDC code for Mitoxantrone 2 mg/mL?
The NDC (National Drug Code) for Mitoxantrone 2 mg/mL is 63323-132, listed by Fresenius Kabi USA, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)