What should i discuss with my health care provider before receiving decitabine dacogen. Of the 83 decitabinetreated patients, 8 permanently discontinued therapy for adverse events. Decitabine dacogen mds myelodysplasia chemoexperts. Myelodysplastic syndromes mds are a heterogenous spectrum of hematopoietic stem cell disorders affecting older adults, with a median age of 60 to 80 years at the time of diagnosis. If you have an allergy to decitabine or any other part of this drug. Decitabine is available as a singleuse 50mg lyophilized powder vial from multiple manufacturers. Side effect videos nausea and vomiting diarrhea fatigue constipation pain anemia see dailymed package insert. What are the possible side effects of decitabine dacogen. Decitabine in the treatment of acute myeloid leukemia in. Tracking decitabine incorporation into malignant myeloid. What is the most important information i should know about decitabine dacogen. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalvance can be administered without regard to the timing of.
A healthcare provider will give you this injection. Dailymed dacarbazine injection, powder, for solution. Decitabine induced hypomethylation in neoplastic cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation. Refractory anemia ra or refractory anemia with ringed sideroblasts rars if accompanied by neutropenia or thrombocytopenia or requiring. Decitabine is associated with a low rate of transient serum enzyme elevations during therapy, but has not been implicated in causing clinically apparent liver injury with jaundice. Decitabine is an anticancer antineoplastic or cytotoxic chemotherapy drug. A recent phase i study of oral azacitidine suggested that lower drug. Easytoread drug name and dosage strength to aid in identifying the right product. Decitabine is classified as an antimetabolite and a demethylation agent. Recommended vial diluent, dilution solutions, and storage following reconstitution and dilution differ among products. Decitabine is an analogue of the natural nucleoside 2deoxycytidine. In vitro studies demonstrated dosage and timedependent incorporation of decitabine into myeloid leukemia cell dna that correlated with. Decitabine fda prescribing information, side effects and. Decitabine inhibits dna methylation in vitro, which is achieved at concentrations that do not cause major suppression of dna synthesis.
Follow applicable special handling and disposal procedures. Decitabine api manufacturers suppliers drug master files. Decitabine medicare coverage and copay details goodrx. The deoxycytidine analog prodrug decitabine and the cytidine analog. Does this mean it is trying to come back or just that the lower dose of decitabine chemo is not working as well as the stronger. Learn more about medicare prescription drug plans and savings with goodrx. Be sure to tell your doctor how you are feeling during your treatment with decitabine. Stability indicating rphplc method for the estimation of. It does not inhibit the progression of cells from the g1 to s phase. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Fda staff says decitabine no help in aml medpage today. Each 20 ml, single dose, glass vial contains 50 mg decitabine, 68 mg. Mar 06, 2020 dacogen decitabine for injection contains decitabine 5aza2deoxycitidine, an analogue of the natural nucleoside 2deoxycytidine. Each vial also contains anhydrous citric acid and mannitol.
Her doctor at mda did increase the dose again and she had wanted to wait until after her daughters wedding on sept. You may be given other medications to prevent nausea or vomiting while you are receiving decitabine. To characterize the safety and tolerability of 1 mbg453 as a single agent or in combination with pdr001 or 2 pdr001 andor mbg453 in combination with decitabine in aml and high risk mds patients, and to identify recommended doses for future studies. Pdf decitabine in the treatment of acute myeloid leukemia. In a treatment cycle, dacogen is administered at a dose of 20 mgm2 bodysurface area by intravenous. The decitabine manufacturing companies are offering top quality products. Despite encouraging clinical results, a direct correlation among drug. The majority of patients with acute myeloid leukemia aml are elderly and have a poor prognosis despite induction therapy. Decitabine in the treatment of myelodysplastic syndromes.
Treatment of newly diagnosed acute myeloid leukaemia in patients over 65 years of age who are not candidates for standard induction chemotherapy. Find patient medical information for decitabine intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Pdf efficacy and safety of decitabine in treatment of. Decitabine is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into dna and inhibition of dna methyltransferase, causing hypomethylation of dna and cellular differentiation or apoptosis. Bar codes included on the vial and carton for ease of scanning. Dalvance is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg table see 1. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. To work with importing pdf data autocad 2019 autodesk. Decitabine comes as a powder to be to be added to fluid and injected slowly over 3 hours intravenously into a vein by a doctor or nurse in a medical office or hospital outpatient clinic. Decitabine uses, dmf, dossier, manufacturer, supplier. Decitabine is a fine, white to almost white powder with the molecular formula of c 8 h 12 n 4 o 4 and a molecular weight of 228.
This treatment period is called a cycle, and the cycle may be repeated every 6 weeks for as long as your. Of the 83 decitabine treated patients, 8 permanently discontinued therapy for adverse events. Your doctor may also need to delay your treatment and reduce your dose if you experience certain side effects. Dacogen has been approved in the 2006 for the treatment of usa since odysplastic may myel syndrome. This drug may interact with other drugs or health problems. In a singlearm mds study n99 decitabine was dosed at 20 mgm2 intravenous, infused over one hour daily for 5 consecutive days of a 4 week cycle. Dacogen decitabine for injection, for intravenous use. Decitabineinduced hypomethylation in neoplastic cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation. Otsuka acquires rights to hematological cancer treatment.
Tell your doctor about the allergy and what signs you had. Highlights of prescribing information these highlights do. No information is available on the pharmacokinetics of decitabine at the indicated dosage of 15 mgm. Decitabine api manufacturers suppliers drug master. Vidaza is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following fab myelodysplastic syndrome mds subtypes. The top countries of suppliers are india, china, from which the percentage of decitabine supply is 1%, 99% respectively. Dacogen decitabine injection side effects, images, uses. Tracking decitabine incorporation into malignant myeloid cell dna. Import the data from a pdf file click insert tabimport panelpdf import. The management of patients with low or intermediaterisk myelodysplastic syndrome mds includes supportive care, azacitidine, decitabine, lenalidomide, and immunosuppressive agents such as antithymocyte globulin and cyclosporine. Decitabine is a cytosine analogue and an intravenously administered antineoplastic agent used in the therapy of myelodysplastic syndromes.
Dacogen decitabine dose, indications, adverse effects. I have been on decitabine treatments for 6 months, my blasts are at about 5% they were close to 3% when i started. Dacogen decitabine showed an overall survival advantage. Study of pdr001 andor mbg453 in combination with decitabine. Dacogen decitabine for injection description e 59 66. Medicare coverage and pricing details for decitabine. Fda approves dacogen decitabine for injection 3 may 2006 in 2006, news by webadmin. Find here huge list of decitabine cas 2353335, decitabine manufacturers, decitabine suppliers and decitabin exporters. The incorporation of decitabine into dna or rna inhibits methyltransferase thereby causing demethylation in that sequence. Cells in the presence of decitabine incorporate it into dna during replication and rna during transcription. Exclusive rights to the development and sale of dna methylation inhibitor dacogen, an intravenous formulation of decitabine generic name, in the u. Immediately after reconstitution, the solution should be further diluted with 0. Click on the decitabine dacogen package insert below for reported side effects and possible drug interactions.
Decitabine is associated with a low rate of transient serum enzyme elevations during therapy, but has not been implicated. Decitabine is indicated for treatment of patients with myelodysplastic syndrome mds. Decitabine, a dnahypomethylating agent that induces differentiation and. Decitabine is cell cycle specific and acts peripherally in the s phase of the cell cycle. For more detail, see how decitabine works section below. Do not save any unused portions for later administration. Decitabine is a prodrug that has to be converted into a nucleoside triphosphate to become an active drug. In vitro studies demonstrated dosage and time dependent incorporation of decitabine into myeloid leukemia cell dna that. Decitabine complete drug information, side effects and. Dacogen fda prescribing information, side effects and uses. Discard unused portions of each vial properly see how suppliedstorage and handling 16. Aug 11, 2017 the management of patients with low or intermediaterisk myelodysplastic syndrome mds includes supportive care, azacitidine, decitabine, lenalidomide, and immunosuppressive agents such as antithymocyte globulin and cyclosporine. Symptomatic patients often receive either azacitidine or decitabine, but which of these agents is the better choice.
Decitabine trade name dacogen, or 5aza2deoxycytidine, acts as an nucleic acid synthesis inhibitor. Listing a study does not mean it has been evaluated by the u. Dacogen decitabine dosing, indications, interactions. Unique label design to help products stand out on the shelf. Decitabine is a cytosine nucleoside analogue which inhibits dna methyltransferase and is intended for the treatment of acute myeloid leukaemia aml. Pdf decitabine induced delayed cardiomyopathy in hematologic. Decitabine should usually be given for at least four cycles but may be continued if your doctor decides that you will benefit from additional treatment. It is a chemical analogue of cytidine, a nucleoside present in dna and rna. Enhanced packaging and labeling designed to promote safety and help reduce the risk of medication errors. Pdf decitabine is a pyrimidine analogue of nucleoside cytidine, used for the treatment of. Dacogen decitabine for injection is a white to almost white sterile lyophilized powder supplied in a clear colorless glass vial. Decitabine is used in treatment of myelodysplastic syndrome mds.
Decitabine cas 2353335 manufacturers, suppliers, exporters. The total body clearance 27 mean sd was 124 19 lhrm2, and the terminal phase elimination halflife was 0. Dacogen decitabine package insert 2010 esai woodcliff lake, nj eisai. This 3day treatment is usually repeated every 6 weeks at least 4 times. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Decitabine inhibits cell growth in a dose and timedependent manner with ic50 of approximately 438 nm and 43. Resistance to decitabine and 5azacytidine emerges from. Dec 02, 2005 trial of decitabine in patients with acute myeloid leukemia the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Trial of decitabine in patients with acute myeloid leukemia the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. She has been going through treatment since january 2014 and she is tired and ready to be done but she has at least 6 more months of chemo to go. Each 20 ml, single dose, glass vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate potassium dihydrogen phosphate and 11. No formal clinical drug interaction studies with decitabine have been conducted.
In most cases, a decitabine injection is given every 8 hours for 3 days. It differs from deoxycytidine by the substitution of nitrogen for carbon at the 5position of the pyrimidine ring figure 1. If the pdf has multiple pages, choose the page to import by clicking a thumbnail image. Trial of decitabine in patients with acute myeloid leukemia. It is a drug for the treatment of myelodysplastic syndromes, a class of conditions where certain blood cells are dysfunctional, and for acute myeloid leukemia aml. Decitabine in myelodysplastic syndromes sciencedirect.
Efficacy and safety of decitabine in treatment of elderly patients with acute myeloid leukemia. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Characterization of in vitro and in vivo hypomethylating effects of. Fda approves dacogen decitabine for injection astex. Dacogen decitabine for injection is supplied as a sterile, lyophilized white to almost white powder, in a singledose vial, packaged in cartons of 1 vial.