Mitoxantrone Hydrochloride
Generic Name: mitoxantrone hydrochloride
Brand Names:
Mitoxantrone
DESCRIPTION: Mitoxantrone Injection, USP (concentrate) is a synthetic antineoplastic anthracenedione for intravenous use. It is supplied as a concentrate that MUST BE DILUTED PRIOR TO INJECTION. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2 mg/mL mitoxantrone free base, with the following inactive ingredients: sodium chloride (0.800% w/v), sodium acetate (0.005% w/v), acetic acid (0.046% w/v), and water for injection....
Overview
DESCRIPTION: Mitoxantrone Injection, USP (concentrate) is a synthetic antineoplastic anthracenedione for intravenous use. It is supplied as a concentrate that MUST BE DILUTED PRIOR TO INJECTION. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2 mg/mL mitoxantrone free base, with the following inactive ingredients: sodium chloride (0.800% w/v), sodium acetate (0.005% w/v), acetic acid (0.046% w/v), and water for injection....
Uses
INDICATIONS AND USAGE: Mitoxantrone Injection, USP 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 is not indicated in the treatment of patients with primary progressive multiple sclerosis.
Dosage
DOSAGE AND ADMINISTRATION: (see also WARNINGS ). Multiple Sclerosis The recommended dosage of Mitoxantrone Injection, USP 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, USP 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, USP.
Side Effects
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/m 2 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).
Warnings
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. WARNINGS: WHEN MITOXANTRONE IS USED IN HIGH DOSES (> 14 mg/m 2 /d x 3 days) SUCH AS INDICATED FOR THE TREATMENT OF LEUKEMIA, SEVERE MYELOSUPPRESSION WILL OCCUR. THEREFORE, IT IS RECOMMENDED THAT MITOXANTRONE 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. CONTRAINDICATIONS: Mitoxantrone Injection, USP is contraindicated in patients who have demonstrated prior hypersensitivity to it.
Storage
HOW SUPPLIED: Mitoxantrone Injection, USP (concentrate) is a sterile aqueous solution containing mitoxantrone hydrochloride at a concentration equivalent to 2 mg mitoxantrone free base per mL supplied in vials for multidose use as follows: Product No. NDC No. 132010 63323-132-10 10 mL fill in a 10 mL vial, 20 mg per 10 mL (2 mg per mL).
Frequently Asked Questions
What is Mitoxantrone Hydrochloride used for?▼
INDICATIONS AND USAGE: Mitoxantrone Injection, USP 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 is not indicated in the treatment of patients with primary progressive multiple sclerosis.
What are the side effects of Mitoxantrone Hydrochloride?▼
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/m 2 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).
What are the important warnings for Mitoxantrone Hydrochloride?▼
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. WARNINGS: WHEN MITOXANTRONE IS USED IN HIGH DOSES (> 14 mg/m 2 /d x 3 days) SUCH AS INDICATED FOR THE TREATMENT OF LEUKEMIA, SEVERE MYELOSUPPRESSION WILL OCCUR. THEREFORE, IT IS RECOMMENDED THAT MITOXANTRONE 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. CONTRAINDICATIONS: Mitoxantrone Injection, USP is contraindicated in patients who have demonstrated prior hypersensitivity to it.
Related Medications
Grindelia Hirsutula Flowering Top
grindelia hirsutula flowering top
Uses: See symptoms on front panel. Relieves fitful cough triggered by lying on the back *
Galium Aparine, Agnus Castus, Apis Mellifica, Capsicum Annuum, Chelidonium Majus, Taraxacum Officinale, Urtica Dioica, Xanthoxylum Fraxineum, Fucus Vesiculosus, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum, Sarsaparilla (smilax Regelii), Ubidecarenonum, Calcarea Carbonica, Graphites, Lycopodium Clavatum, Anacardium Orientale, Colchicum Autumnale, Nux Vomica, Phytolacca Decandra, Pulsatilla (pratensis), Histaminum Hydrochloricum
galium aparine, agnus castus, apis mellifica, capsicum annuum, chelidonium majus, taraxacum officinale, urtica dioica, xanthoxylum fraxineum, fucus vesiculosus, kali phosphoricum, magnesia phosphorica, natrum phosphoricum, sarsaparilla (smilax regelii), ubidecarenonum, calcarea carbonica, graphites, lycopodium clavatum, anacardium orientale, colchicum autumnale, nux vomica, phytolacca decandra, pulsatilla (pratensis), histaminum hydrochloricum
Standardized Insect Venom Allergenic Extract [EPC]
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, sluggish metabolism, headache, and fatigue.** **These statements are based upon homeopathic principles. They have not been approved by the Food and Drug Administration.
Anhydrous Base
anhydrous base
Dosage form: GEL. Active ingredients: HYDROXYPROPYL CELLULOSE (1 g/g); PROPYLENE GLYCOL (1 g/g). Category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.