Division of nuclear medicine procedure protocol university. Novantrone is a cytotoxic agent that produces dosedependent myelosuppression. Mitoxantrone is a chemotherapy drug that is sometimes used in ms as a disease modifying drug dmd to reduce the number of relapses a person is experiencing. Novantrone mitoxantrone hydrochloride is a synthetic antineoplastic anthracenedione for intravenous use. Please consult a qualified health professional for more detailed information. Novantrone mitoxantrone for injection concentrate warning. Novantrone fda prescribing information, side effects and. Stable if stored in accordance with information listed on the product insert. Find patient medical information for mitoxantrone intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Defined as treatment to progression or unacceptable toxicity.
Information for the patient mitoxantrone 2 mgml concentrate for solution for infusion mitoxantrone read all of this leaflet carefully before you start using this medicine because it contains important information for you. It is used alone or in combination with other antineoplastic medications to treat many types of cancer. The mean alpha halflife of mitoxantrone is 6 to 12 minutes, the mean beta halflife is 1. Mitoxantrone may cause dangerous effects on your heart. Although it is not licensed for ms in the uk, it is sometimes used in some specialist centres for people with highly active relapsing ms whose level of disability is developing. Visiting standards have been updated to allow only two legal guardians at the bedside during a patients stay. 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. Tourmaline mm1 clinical trial design ninlaro ixazomib. Highlights of prescribing information these highlights do not include all the information needed to use hydrea safely and effectively. Record any hydromorphone demerol, fentanyl, or morphine used in last 12 hours. Mitoxantrone is a prescription medicine used alone or with other medicines to treat people with. Mitoxantrone 2 mgml solution in combination regimens is indicated in the remissioninduction treatment of blast crisis in chronic myeloid leukaemia. Toxicological information the toxicological effects of this product have not been thoroughly studied. Mitoxantrone also interferes with ribonucleic acid rna and is a potent inhibitor of topoisomerase ii, an enzyme responsible for uncoiling and repairing damaged dna.
Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. A global, phase 3, doubleblind, placebocontrolled study of patients with relapsed andor refractory multiple myeloma n722 1. Ibm micromedex it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. These include certain types of leukemia cancer of the white blood cells, breast cancer. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If you think someone in your family has been exposed to covid19, stay home and contact your health care provider for next steps. User guide on how to generate pdf versions of the product. Pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by. Phosphotec kit for the preparation of technetium tc 99m pyrophosphate is supplied in a kit containing 10 reaction vials 5 ml size, 10 pressuresensitive labels, and 1 package insert. The pdfpages package makes it easy to insert pages of external pdf. Annex i, conditions of the marketing authorisation annex ii, labelling annex iiia, package leaflet. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Full prescribing information 1 indications and usage avonex is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Mitoxantrone hydrochloride mitoxantrone hydrochloride this product information is intended only for residents of the united states.
Nov 21, 2019 novantrone mitoxantrone is a cancer medication used to treat prostate cancer and certain types of leukemia. Jun 26, 2012 study to evaluate the reduction of cardiac problems in multiple sclerosis patients with mitoxantrone and dexrazoxane in combination mscardiopro the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Mitoxantrone is also used to treat the symptoms of relapsing multiple sclerosis. Highlights of prescribing information these highlights. 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. Mitoxantrone uses, dmf, dossier, manufacturer, supplier. It is supplied as a concentrate that must be diluted prior to injection. Mitoxantrone belongs to the group of cancerfighting medications known as antineoplastics. Mitoxantrone hydrochloride mitoxantrone hydrochloride pfizer. Mitoxantrone injection, usp concentrate is a synthetic antineoplastic anthracenedione for intravenous use. Mitoxantrone intravenous route precautions mayo clinic.
However, it is very important that you continue to receive the medicine, even if your stomach is upset. Mitoxantrone injection usp by hospira brand name mitoxantrone injection usp by hospira common name mitoxantrone in this drug factsheet. Side effects of novantrone mitoxantrone for injection. The molecular formula is c 22 h 28 n 4 o 6 2hcl and the molecular weight is 517. Storage store the phosphotec kit for the preparation of technetium tc 99m pyrophosphate refrigerated at 28c 3646f. For patients taking mitoxantrone to treat ms multiple sclerosis. Campath and mitoxantrone drug interactions a study of fda. The pdfpages package makes it easy to insert pages of external pdf documents. The number of anomalies was also significantly increased over the control group. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated.
Side effects, drug interactions, dosage, and pregnancy safety information is included. Dec 01, 2019 mitoxantrone, a dnareactive agent that intercalates into deoxyribonucleic acid dna through hydrogen bonding, causes crosslinks and strand breaks. Pediatric use safety and effectiveness in pediatric patients have not been established. 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. Intravenous cladribine therapy requires an experienced clinician who is proficient in the use of chemotherapy. Find out what health conditions may be a health risk when taken with mitoxantrone intravenous. Mitoxantrone 2 mgml solution is indicated in combination with corticosteroids for palliation e. Antineoplastic, immune modifier pregnancy risk category d fda box warning administer slowly into freeflowing i. Mitoxantrone injection is used to adults with various forms of multiple sclerosis ms. Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means. Webmd provides common contraindications for mitoxantrone intravenous. Use birth control that you can trust to prevent pregnancy while taking mitoxantrone. Mitoxantrone hydrochloride definition of mitoxantrone.
Dec 24, 2019 you may need to have a pregnancy test while taking mitoxantrone. If you are pregnant or you get pregnant while taking mitoxantrone, call your doctor right away. 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. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. Mitoxantrone may cause potentially serious infections or heart problems in some people. Mitoxantrone 2 mgml concentrate for solution for infusion. When administered to patients intravenously every three weeks, white blood cell wbc and platelet nadirs occurred between days 8. The product catalog provides you with a full listing of tevas brand and generic product lines. It kills cancer cells by interfering with their growth and reproduction. Study to evaluate the reduction of cardiac problems in. Prozac fluoxetine hydrochloride capsules label fda.
Pharmacokinetics of mitoxantrone in patients following a single intravenous administration of novantrone can be characterized by a threecompartment model. Division of nuclear medicine procedure protocol university hospital and the american center page 3 of 11 morphine use in hepatobiliary scans. Pharmacokinetic studies of the interaction of novantrone with concomita ntly. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2. Otn mitoxantrone mitoxantrone intravenous route drugs. Nov 21, 2019 novantrone mitoxantrone hydrochloride is a synthetic antineoplastic anthracenedione for intravenous use.
If you encounter technical difficulties in viewing our product information please contact. See what the interactions are and for which people. Mitoxantrone injection usp by hospira uses, side effects. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. See full prescribing information for complete boxed warning. The brand name novantrone is discontinued in the u. Tourmalinemm1 is the first clinical trial using an alloral, pibased treatment to progression or unacceptable toxicity 1,5. Highlights of prescribing information these highlights do. Mitoxantrone novantrone is an injection medication prescribed to treat ms, some forms of leukemia and pain with certain prostate cancer. Mitoxantrone fda prescribing information, side effects and uses.
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