Unless used within 15 minutes of reconstitution, the diluted. Decitabine fda prescribing information, side effects and uses. Pdf decitabine in the treatment of myelodysplastic syndromesj. Trial of decitabine in patients with acute myeloid leukemia. Cure leukemia, lymphoma, hodgkins disease and myeloma, and improve the quality of life of patients and their families. Decitabine dosing for mds is 15 mgm 2 via a 3hour continu ous infusion three times a day for 3 days for the. Decitabine has also been investigated in the treatment of aml. Gattex teduglutide for subcutaneous injection is a prescription medicine used in adults and children 1 year of age and older with short bowel syndrome sbs who need additional nutrition or fluids from intravenous iv feeding parenteral support. Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. Dacogen decitabine showed an overall survival advantage. 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 also being studied in the treatment of other conditions and types of cancer.
For more detail, see how decitabine works section below. Decitabine is a prodrug that has to be converted into a nucleoside triphosphate to become an active drug. Decitabine dacogen mds myelodysplasia chemoexperts. Dacogen decitabine for injection, for intravenous use. Based on its mechanism of action, decitabine alters dna synthesis and is expected to result in adverse reproductive effects see clinical pharmacology 12. Decitabine is not approved in the united states us for acute myeloid. Dacogen decitabine chemotherapy, side effects navigating care. Decitabine dosing for mds is 15 mgm 2 via a 3hour continuous. You may be given other medications to prevent nausea or vomiting while you are receiving decitabine. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. Pdf decitabine is more cost effective than cytarabine and. Decitabine is an anticancer antineoplastic or cytotoxic chemotherapy drug. Combine or merge files into a single pdf, adobe acrobat dc.
Dacogen can cause fetal harm when administered to a pregnant woman. The health professional information portion of the product monograph may also be made available as a package insert. Action inhibits dna methyltransferase, causing apoptosis. Side effect videos nausea and vomiting diarrhea fatigue constipation pain anemia see dailymed package insert. As in any fire, wear selfcontained breathing apparatus pressuredemand niosh approved or. The deoxycytidine analog prodrug decitabine and the cytidine. Decitabine side effects, dosage, interactions drugs. Along with its needed effects, decitabine may cause some unwanted effects. Besides 5azacytidine azacitidine, vidaza, 5aza2deoxycytidine decitabine, dacogen is the most widely used inhibitor of dna methylation, which triggers demethylation leading to consecutive reactivation of epigenetically silenced tumor suppressor genes in vitro and in vivo.
It must neverbe given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. In vitro studies demonstrated dosage and timedependent incorporation of decitabine into myeloid leukemia cell dna that correlated with. Side effects of dacogen decitabine injection, warnings, uses. Decitabine is a potent inhibitor of dna methylation with ic50 of 438 nm and 4. Decitabine fda prescribing information, side effects and.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for buspar buspirone. Decitabine is a cancer medication that interferes with the growth and spread of cancer cells in the body. These statements are typically preceded by words such as believes, expects. Highlights of prescribing information age group dosage. Dacogen decitabine for injection description dacogen decitabine for injection contains decitabine 5aza2deoxycytidine, an analogue of the natural nucleoside 2deoxycytidine. This treatment period is called a cycle, and the cycle may be repeated every 6 weeks for as long as your. However, the us food and drug administration fda rejected decitabine for elderly aml earlier. The majority of patients with acute myeloid leukemia aml are elderly and have a poor prognosis despite induction therapy. Dacogen decitabine for injection contains decitabine 5aza2deoxycitidine, an analogue of the natural nucleoside 2deoxycytidine. The median duration of treatment for patients on decitabine arm was 4. Decitabine definition of decitabine by medical dictionary. Dacogen decitabine for injection is a cancer antineoplastic medication used to treat myelodysplastic syndromes certain types of blood or bone marrow cancer. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient.
If a drug has been approved for one use, physicians. Decitabine is used to treat myelodysplastic syndromes certain types of blood or bone. Decitabine can cause fetal harm when administered to a pregnant woman. Mar 01, 2020 decitabine can cause fetal harm when administered to a pregnant woman. Pdf decitabine in the treatment of acute myeloid leukemia. This medicine is available only with your doctors prescription. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. This 3day treatment is usually repeated every 6 weeks at least 4 times. 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. Alternatively, you can rightclick a page and select insert pages to get the insert options.
Highlights of prescribing information these highlights do not. Decitabine for acute myeloid leukemia in a patient. Discard any unused portion of the reconstituted solution. The total body clearance 27 mean sd was 124 19 lhrm2, and the terminal phase elimination halflife was 0. Therapeutic effects improved hematologic and clinical. Medlineplus information on decitabine a lay language summary. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor or intermediaterisk cytogenetics. Targets dna methyltransferase hl60 dna methyltransferase kg1a ic50 100 ngml 1 ngml 1 in vitro decitabine inhibits cell growth in a dose and timedependent manner with ic50 of approximately 438.
Decitabine is classified as an antimetabolite and a demethylation agent. Decitabine has shown activity in some hematologic disorders including myelodysplastic. Dailymed dacarbazine injection, powder, for solution. In the insert pages dialog box, specify where to insert the document before or after the first or last page, or a designated page. No formal clinical drug interaction studies with decitabine have been conducted. Decitabine is designed to help the bone marrow produce more healthy and normal functioning cells. 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. Side effects requiring immediate medical attention. Discussion of clinically important adverse reactions. Colonystimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Final package leaflet in msword format and pdf format of.
Decitabine injection is used to treat myelodysplastic syndromes, a group of cancers in which immature blood cells in the bone marrow do not mature and do not become healthy blood cells. Decitabine is used in treatment of myelodysplastic syndrome mds. Recommended vial diluent, dilution solutions, and storage following reconstitution and dilution differ among products. See below for a comprehensive list of adverse effects. In the controlled trial using decitabine dosed at 15 mgm2, administered by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days, the highest incidence of grade 3 or grade 4 adverse events in the decitabine arm were neutropenia 87%, thrombocytopenia 85%, febrile neutropenia 23% and leukopenia 22%.
Decitabine in the treatment of myelodysplastic syndromesj. Structured product labeling for decitabine for injection is enclosed in this section. There are no adequate and wellcontrolled studies of dacogen in pregnant women. Decitabine is an antineoplastic cancer medicine this medicine is available only with your doctors prescription. Females using this medication should ask about reliable forms of birth control while using this medication and for at least 6 months after stopping treatment. Decitabine in the treatment of myelodysplastic syndromes.
Decitabine is approved for the treatment of myelodysplastic syndromes in more than 30 countries. No information is available on the pharmacokinetics of decitabine at the indicated dosage of 15 mgm. Patients treated with cytarabine received 20 mgm 2 subcutaneously once daily 10 consecutive days every 4 weeks. Tracking decitabine incorporation into malignant myeloid cell dna. Aseptically transfer the required dose of reconstituted dalbavancin solution from the vials to an intravenous bag or bottle containing 5% dextrose injection, usp. For outlook, click inside of the body of an item, such as an email message or calendar event. D indications treatment of various myelodysplastic syndromes mds. This portion should therefore be provided in connection with the promotion or advertisement of the drug or included in reference manuals distributed or sponsored by the sponsor. In preclinical studies in mice and rats, decitabine was teratogenic, fetotoxic, and embryotoxic. Click on the decitabine dacogen package insert below for reported side effects and possible drug interactions. 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 complete drug information, side effects and. Decitabine dacogen is a chemotherapy regimen for myelodysplastic syndromes mds weve made it easy for you to learn more. Azacitidine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed, and decrease the risk of bleeding. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Aug, 2019 commonly reported side effects of decitabine include. Dacogen approved for patients with all fab classifications of mds commercial. Click the orange links and well show you extra information. 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 is available as a singleuse 50mg lyophilized powder vial from multiple manufacturers. Nov 09, 2018 decitabine is a cancer medication that interferes with the growth and spread of cancer cells in the body. The diluted solution must have a final dalbavancin concentration of 1 mgml to 5 mgml. 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. Resistance to decitabine and 5azacytidine emerges from. As a consequence, tumor suppressor genes aberrantly silenced after methylation can be reactivated and expressed. It is not known if gattex is safe and effective in children under 1 year of age. Another multicenter phase ii trial of decitabine as firstline therapy for older. Alternate approaches should be discussed in advance with the relevant program area to avoid. Highlights of prescribing information these highlights do not include all the information needed to use cubicin safely and effectively. Decitabine with gclam for adults with newly diagnosed.
Patients treated with decitabine received a 1hour infusion, once daily for 5 consecutive days every 4 weeks. Dacogen decitabine for injection description e 59 66. A healthcare provider will give you this injection. Decitabine is a cytosine analogue and an intravenously administered antineoplastic agent used in the therapy of myelodysplastic syndromes. Decitabine trade name dacogen, or 5aza2deoxycytidine, acts as an nucleic acid synthesis inhibitor. Decitabine, a dnahypomethylating agent that induces differentiation and. Decitabine approved for elderly aml in europe medscape. Immediately after reconstitution, the solution should be further diluted with 0. Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells.
Decitabine, filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride may work better in treating patients with acute myeloid leukemia and myelodysplastic syndrome. Your doctor may also need to delay your treatment and reduce your dose if you experience certain side effects. Based on its mechanism of action, dacogen is expected to result in adverse reproductive effects. In the controlled trial using decitabine dosed at 15 mgm2, administered by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days, the highest incidence of grade 3 or grade 4 adverse events in the decitabine arm were neutropenia 87%, thrombocytopenia 85%, febrile neutropenia 23% and. Highlights of prescribing information these highlights do.
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