Novantrone is a cytotoxic agent that produces dose. Mitoxantrone hydrochloride mitoxantrone hydrochloride this product information is intended only for residents of the united states. Hepatic impairment mitoxantrone clearance is reduced by hepatic impairment. Novantrone is a cytotoxic agent that produces dosedependent myelosuppression. When administered to patients intravenously every three weeks, white blood cell wbc and platelet nadirs occurred between days 8.
Antineoplastic, immune modifier pregnancy risk category d fda box warning administer slowly into freeflowing i. Mitoxantrone is also used to treat multiple sclerosis ms, most notably the subset of the disease known as secondaryprogressive ms. Mitoxantrone dihydrochloride is an antiviral, antibacterial, antiprotozoal, immunomodulating, and antineoplastic cytostatic anthraquinone derivative. Dec 01, 2019 mitoxantrone, a dnareactive agent that intercalates into deoxyribonucleic acid dna through hydrogen bonding, causes crosslinks and strand breaks. Identification of the substancemixture and of the companyundertaking. Novantrone mitoxantrone hydrochloride is a synthetic antineoplastic anthracenedione for intravenous use. If you have any questions, comments, or concerns about the content of this page, please click here. Jul 17, 2015 in march 2005, the labeling for mitoxantrone was changed to recommend that left ventricular ejection fraction lvef be evaluated before initiating treatment and prior to administering each dose. Test preparation transfer about 100 mg of mitoxantrone hydrochloride, accurately weighed, to a 5ml volumetric flask, add 2. Do not give by injection into a muscle, under the skin, or into the spinal cord. Identification of the substancemixture and of the companyundertaking 1.
This sds was prepared in accordance with 29 cfr 1910. Exposure of the product to direct sunlight for one month caused no change in its appearance or potency. The injection solution may also contain acetic acid, sodium acetate, sodium chloride, sodium. Other companies are charging thousands of dollars to set up.
Mitoxantrone must be given only by injection into a vein. Mitoxantrone novantrone, is an anthracenedione which in preclinical studies demonstrated a spectrum of antitumor activity similar to the anthracyclines, but with less cardiotoxicity. Mitoxantrone is further used for the manufacture of dosage form which is used in treatment of patients, especially those who have been diagnosed with cancer. In march 2005, the labeling for mitoxantrone was changed to recommend that left ventricular ejection fraction lvef be evaluated before initiating treatment and prior to administering each dose.
Mitoxantrone pharmacokinetics in patients with renal impairment are unknown. Mitoxantrone hydrochloride 2 mgml in h2o was purchased from. It is an anthracenedione not an anthracycline antineoplastic agent. Mitoxantrone 2 mgml solution is indicated in combination with corticosteroids for palliation e. Studies on the binding affinity of anticancer drug mitoxantrone to. Sonicate for 2 minutes and shake for 2 minutes, repeating these actions until the specimen is completely dissolved. Mitoxantrone hydrochloride safety data sheet section 2. Pain intensity was measured using the symptom distress scale sds pain item 2 a 5. Product identifier product name mechlorethamine hcl product number fm15516. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Mitoxantrone dihydrochloride cas 70476823 scbt santa. Mitoxantrone hydrochloride the production of the active pharmaceutical substance mitoxantrone hydrochloride at synthesia has more than 20 years of tradition.
When mitoxantrone injection is used to treat ms, it is usually given once every 3 months for about 2 to 3 years for a total of 8 to 12 doses. Mitoxantrone fda prescribing information, side effects and uses. When mitoxantrone injection is used to treat prostate cancer, it is usually. Mitoxantrone targets human ubiquitinspecific peptidase 11. Mitoxantrone is a cytostatic anthracenedione that intercalates in dna and increases the incidence of doublestrand breaks by stabilizing the cleavable complex of topoisomerase ii and dna. Mitoxantrone hydrochloride injection revision date.
It disrupts dna synthesis and dna repair in both healthy cells and cancer cells. Previous reports suggest that resistance to mitoxantrone in dif ferent tumor cell. Mitoxantrone is a type ii topoisomerase inhibitor with ic50 of 2. Mitoxantrone hydrochloride listed notice of intent to list mitoxantrone hydrochloride 2012 priority list for the development of proposition 65 nsrls for carcinogens and madls for chemicals causing reproductive toxicity. Dailymed mitoxantrone injection, solution, concentrate. Mitoxantrone hydrochloride mitoxantrone hydrochloride. Sep 29, 2014 register now and get a free online msds binder. The concentrate is a sterile, nonpyrogenic, dark blue aqueous. Mitoxantrone fda orange book approved drug product. Mitoxantrone injection msds mitoxantrone injection msds mitoxantrone cost of treatment site and would like to find out where you got this from or exactly what the theme is called make for mitoxantrone generic mitoxantrone rxlist mitoxantrone ms all goes well for u, fair play and best of luck x i know therer39. Mitoxantrone hydrochloride proposition 65 warnings website. Mitoxantrone hydrochloride national cancer institute. Chemical product and company information manufacturer name and address hospira, inc.
Mitoxantrone hcl pharmacology mitoxantrone has been shown in vitro to inhibit b cell, t cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, tnfa, and il2. Synonyms mitoxantrone hcl unii u6usw86rd0 cas number 70476823 weight average. The chemotherapeutic agent mitoxantrone was approved for use in multiple sclerosis ms in 2000. Mitoxantrone 2 mgml concentrate for solution for infusion. Posner le, dukart g, goldberg j, bernstein t, cartwright k.
Articles of mitoxantrone dihydrochloride are included as well. Mitoxantrone injection comes as a liquid to be given intravenously into a vein by a doctor or nurse in a hospital or clinic. Mitoxantrone inhibits division of tcells, bcells, and macrophages by preventing dna repair and synthesis, however, this also occurs in healthy cells. Mitoxantrone hydrochloride marketed as novantrone and. Mitoxantrone hydrochloride mitoxantrone hydrochloride pfizer.
If this medication accidentally leaks into the skin. Mitoxantrone also interferes with ribonucleic acid rna and is a potent inhibitor of topoisomerase ii, an enzyme responsible for uncoiling and repairing damaged dna. When administered to patients intravenously every three weeks, white blood cell wbc and. Jun 21, 2017 safety data sheet emergency telephone number. Induces dna damage by intercalating into dna and inhibiting topo ii topoisomerase ii. It is used as palliative treatment in patients with advanced disease that is hormonerefractory does not respond to hormone treatment. Pain intensity was measured using the symptom distress scale sds pain.
Mitoxantrone is used to treat certain types of cancer, mostly metastatic breast cancer, acute myeloid leukemia, and nonhodgkins lymphoma. Issued 102000 1 novantrone package insert 016609 novantrone mitoxantrone for injection concentrate warning novantrone mitoxantrone for injection concentrate should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents. Sigmaaldrich offers a number of mitoxantrone hydrochloride products. Mitoxantrone hydrochloride monograph for professionals. Mitoxantrone injection, usp concentrate should be given slowly into a freely. Mitoxantrone hydrochloride is approved to be used with other drugs to treat. It improves the survival rate of children suffering from acute lymphoblastic leukemia relapse the combination of mitoxantrone and prednisone is approved as a secondline treatment for metastatic hormonerefractory prostate. Mitoxantrone hydrochloride safety data sheet supersedes revision. Mitoxantrone hydrochloride is the common name for the dihydrochloride salt. Patients with severe hepatic dysfunction bilirubin 3. Safety data sheet mechlorethamine hcl according to regulation ec no 19072006, annex ii, as amended.
The purified usp11 enzyme was detected using sds page. Mitoxantrone hcl antineoplastic agents, analgesics, atc. Stable if stored in accordance with information listed on the product insert. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Synonyms mitoxantrone hcl product use pharmaceutical product classification antineoplastic agent supplier wyeth p. Toxicology and hazard communication pfizer global environment, health, and safety pfizer inc believes that the information contained in this material safety data sheet is accurate, and while it is provided in good faith, it. Mitoxantrone dihydrochloride induces interstrand dna crosslinks and dnaprotein crosslinks in cellular. Mitoxantrone injection is a potent drug and should be administered under the supervision of a qualified health care professional, who is experienced in the use of cancer chemotherapeutic drugs and in the management of carcinoma of the breast, relapsed adult leukemia, lymphoma. It is supplied as a concentrate that must be diluted prior to injection. In addition, mitoxantrone hcl at doses over 50 nm significantly increased the activity of caspases 37 and the level of puma, inducing dpscs and hdfs apoptosis. Mitoxantrone, a dnareactive agent that intercalates into deoxyribonucleic acid dna through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone is excreted in urine and feces as either unchanged drug or as inactive metabolites. Medication guide mitoxantrone mitoxantrone injection, usp.
Mitoxantrone hydrochloride definition of mitoxantrone. In human studies, 11% and 25% of the dose were recovered in urine and feces, respectively, as either parent drug or metabolite during the 5 day period following drug administration. Np regulatory information sara title iii information. Mitoxantrone also displays broad immunosuppressive activity inhibiting proliferation of all classes of lymphocytes and inducing apoptosis of antigen. The product catalog provides you with a full listing of tevas brand and generic product lines. List of approved drug products containing mitoxantrone in the fda orange book on. Mitoxantrone 2 mgml solution in combination regimens is indicated in the remissioninduction treatment of blast crisis in chronic myeloid leukaemia. In the absence of a cure, mitoxantrone is effective in slowing the progression of secondaryprogressive ms and extending the time between relapses in both relapsingremitting ms and progressiverelapsing ms. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Mitoxantrone fda prescribing information, side effects.
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