The product information may be subsequently updated by the member state. For additional information, see warnings and dosage and administration. Mitoxantrone hydrochloride mitoxantrone hydrochloride pfizer. These highlights do not include all the information needed to use tysabri safely and effectively. If you have any questions or would like more information, please call 1. Plegridy peginterferon beta1a injection, for subcutaneous injection initial u. Our novantrone mitoxantrone side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
P834 final results from the registry to evaluate novantrone. Novantrone is an anticancer antineoplastic or cytotoxic chemotherapy drug. Novantrone mitoxantrone for injection concentrate should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents. Highlights of prescribing information patients at risk of. For additional information, see warnings and dosage and. Novantrone mitoxantrone hydrochloride is a synthetic antineoplastic anthracenedione for intravenous use. This emedtv segment includes a discussion on the safety concerns of using novantrone mitoxantrone during pregnancy. Jul 17, 2015 to report any unexpected adverse reactions or serious events associated with the use of this drug, please contact the fda medwatch program either online, by regular mail or by fax, using the.
See full prescribing information for complete boxed warning. Highlights of prescribing information these highlights do not include all the information needed to usegilenya safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use aubagio safely and effectively. Novantrone is a drug that works by suppressing the immune system to lessen its attack on the myelin sheath that surrounds nerves. Novantrone belongs to the general group of medicines called antineoplastics. Medicines are sometimes prescribed for purposes other than those listed in a medication guide. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated.
In some cases, health care professionals may use the trade name novantrone or other name dhad when referring to the generic drug name mitoxantrone. Novantrone mitoxantrone for injection concentrate is an intravenously delivered synthetic molecule for the treatment of multiple sclerosis ms. Mitoxantrone injection, usp prescribing information. Highlights of prescribing information these highlights do not. Novantrone has not been approved for the treatment of primaryprogressive ms characterized by progression from disease onset with no acute attacks or remissions. Some patientsmay benefit from a dosage of 140mg injected subcutaneously once monthly. The concentrate is a sterile, nonpyrogenic, dark blue aqueous. 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. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2. Novantrone and associated names see annex i 2 mgml concentrate for solution. Highlights of prescribing information urothelial carcinoma. Novantrone should be given slowly into a freely flowing intravenous infusion. Click here to read the novantrone prescribing information for healthcare professionals. The combination of mitoxantrone and prednisone is approved as a secondline treatment for.
Novantrone can reduce relapses and disability for patients with worsening forms of ms. Novantrone prescribing information pdf utorrentfab. Click here to read the novantrone medication guide for patients. Congestive heart failure chf, potentially fatal, may occur either during therapy with novantrone or months to years after termination of therapy. It can slow increases in disability and reduce the relapse rate in. Novantrone mitoxantrone hydrochloride is a synthetic anticancer agent for intravenous use. Novantrone fda prescribing information, side effects and uses.
This leaflet has information about using novantrone specifically for ms. Seattle, is the first therapy approved for this indication. Mitoxantrone 2 mgml concentrate for solution for infusion. The agencys committee for medicinal products for human use concluded that there is a need to harmonise the prescribing information for novantrone in the european union eu. Novantrone prescribing information this is ms multiple. 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. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Novantrone is a drug licensed to treat various conditions, such as multiple sclerosis and certain cancers. Novantrone mitoxantrone for injection concentrate fda. Novantrone fda prescribing information, side effects and.
Food and drug administration fda has approved novantrone mitoxantrone for injection concentrate for secondary progressive multiple sclerosis ms. It acts in ms by suppressing the activity of t cells, b cells, and macrophages that are thought to lead the attack on the myelin sheath. Find patient medical information for novantrone intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Mitoxantrone injection, usp concentrate should be administered under the supervision of a physician. Lemtrada causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and antiglomerular basement membrane disease. It is supplied as a concentrate that must be diluted prior to injection. Topics az slideshows images quizzes supplements medications. Serious side effects may happen right after or within. General information about the safe and effective use of mitoxantrone. Relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults primary progressive ms, in adults 2 dosage and administration. Ms patients should not receive a cumulative novantrone dose greater than. Gilenyafingolimod capsules, for oral use initial u.
Welcome to this is ms, the leading forum for multiple sclerosis research and support. Highlights of prescribing information these highlights. Highlights of prescribing information these highlights do not include all the information needed to use plegridy and symptsafely and effectively. Description mitoxantrone novantrone is a synthetic antineoplastic anthracenedione.
Reducing neurologic disability andor the frequency of clinical relapses in patients with secondary. Highlights of prescribing information extavia safely and. Full prescribing information 1 indicationsand usage aimovigis indicated for the preventive treatmentof migrainein adults. Aug 22, 2019 novantrone is used for other conditions besides ms. Fda approves novantrone for secondary progressive ms. It can slow the worsening of neurologic disability and reduce the relapse rate in patients with clinically worsening forms of relapsingremitting and secondary progressive ms. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Novantrone mitoxantrone hcl injection drug safety labeling changes. Diseasemodifying therapies dmts are currently the best way to slow the progression of multiple sclerosis ms, and there are several dmts available on the market which are listed in the table below.
Call your doctor at once if you have chest pain, fast or pounding heartbeats, shortness of breath even with mild exertion, swelling, or rapid weight gain. Tysabri natalizumab injection, for intravenous use initial u. The registry to evaluate novantrone effects in worsening multiple sclerosis renew was a 5year, phase iv, multicenter, openlabel, observational study designed to evaluate the safety of mitoxantrone. Drug information on novantrone mitoxantrone includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. Multiple sclerosis novantrone for cleveland clinic. Novantrone is not indicated for the treatment of patients with primary progressive multiple sclerosis. Important reminder at the end of this policy for important regulatory and legal information. Keytruda pembrolizumab injection, for intravenous use initial u. Full prescribing information 1 indications and usage extavia is indicated for the treatment of relapsing forms of multiple sclerosisms,to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Novantrone mitoxantrone is a medicine prescribed to treat multiple sclerosis and certain types of cancer.
Novantrone mitoxantrone for injection concentrate warning. Novantrone is a chemotherapy drug that works by suppressing the immune system. Highlights of prescribing information these highlights do not include all the information needed to use tarceva safely and effectively. Side effects of novantrone mitoxantrone for injection. Please see patient package insert for further information. Novantrone mitoxantrone uses, side effects, dosage. Autoimmunity, infusion reactions, stroke, and malignancies lemtrada causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and antiglomerular basement. A board to discuss the multiple sclerosis modifying drug novantrone. For additional information, see warnings, cardiac effects, and dosage and. Prior to its approval for use in ms, it was used only to treat certain forms of cancer.
Gilenya is a prescription medicine used to treat relapsing forms of multiple sclerosis. The brand name novantrone is discontinued in the u. Mitoxantrone is also used to treat the symptoms of relapsing multiple sclerosis. Clinical trial agreements a guide to key words and phrases pdf. It improves the survival rate of children suffering from acute lymphoblastic leukemia relapse. Novantrone and associated names european medicines agency. With the approval, the drug is now indicated for reducing neurologic disability andor the frequency of clinical relapses in patients with secondary progressive, progressive relapsing, or worsening relapsingremitting ms. It describes the complications that may occur and explains why women must use birth control during treatment with this drug. Novantrone may cause dangerous effects on your heart.
Progressive multifocal leukoencephalopathy see full prescribing information for complete boxed warning. This product information is intended only for residents of the united states. Highlights of prescribing information these highlights do. When considering which treatment is best, each individual should talk to their doctor about the treatment options that are right for their.
Highlights of prescribing information patients at risk. Mitoxantrone is the generic form of the brand name drug novantrone, which is an injection used to treat certain types of multiple sclerosis. Mitoxantrone hydrochloride marketed as novantrone and. The molecular formula is c 22 h 28 n 4 o 6 2hcl and the molecular weight is 517.
It may not be safe to use during pregnancy, as this drug may harm an unborn child. Novantrone is prescribed as a component of an akylator combination regimen e. See 17 for patient counseling information and fdaapproved medication guide re 32019 vised. What is the most important information i should know about novantrone. Full prescribing information 1 indications and usage gilenya is indicated for the treatment ofrelapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease,in patients 10 years of age and older. Novantrone is indicated for reducing neurologic disability andor the frequency of clinical relapses in patients with secondary chronic progressive, progressive relapsing, or worsening relapsingremitting multiple sclerosis ms. Jan 04, 2017 novantrone mitoxantrone hcl injection drug safety labeling changes. Side effects, drug interactions, dosage, and pregnancy safety information is included. The product catalog provides you with a full listing of tevas brand and generic product lines. This medication is classified as an antitumor antibiotic. Fda approved indications novantrone is indicated for. This emedtv page provides more details on this prescription drug, with information on how it works, dosing instructions, side effects, and more. Sections or subsections omitted from the full prescribing information are not. Aubagio teriflunomide is a prescription medicine used to treat relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults.
Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. To report any unexpected adverse reactions or serious events associated with the use of this drug, please contact the fda medwatch program either online, by regular mail or by fax, using the. This kind of ms is characterized by gradually increasing disability. If you are taking any of these, your doctor might need to prescribe an. Mitoxantrone is used to treat certain types of cancer, mostly acute myeloid leukemia. Cardiotoxicity risk increases with cumulative novantrone dose and may occur whether or not cardiac risk factors are present. Novantrone mitoxantrone prescribing information march 2012. Nov 21, 2019 novantrone mitoxantrone is a cancer medication used to treat prostate cancer and certain types of leukemia. Read the entire fda prescribing information for novantrone. Mitoxantrone novantrone is an injection medication prescribed to treat ms, some forms of leukemia and pain with certain prostate cancer. Highlights of prescribing information these highlights do not include all the information needed to use keytrudasafely and effectively. Reducing neurologic disability andor the frequency of clinical relapses in.
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