Decitabine is a cytosine analogue and an intravenously administered antineoplastic agent used in the therapy of myelodysplastic syndromes. Decitabine is used to treat myelodysplastic syndromes certain types of blood or bone marrow cancer. D indications treatment of various myelodysplastic syndromes mds. Medlineplus information on decitabine a lay language summary of important information about this drug that may include the. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. The information on dosage adjustments in renal impairment given in this book is based on cockcroftgault creatinine clearance and not egfr, since the majority. Polyethylene glycol 3350 powder for oral solution can be administered at any time of day. Derythropentofuranosyl1,3,5triazin21 hone and it has the following structural formula. Mar 06, 2020 dacogen decitabine for injection contains decitabine 5aza2deoxycitidine, an analogue of the natural nucleoside 2deoxycytidine. Action inhibits dna methyltransferase, causing apoptosis. Decitabine dosing schedules md anderson cancer center. 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 may also be used for purposes not listed in this medication guide.
Decitabine is classified as an antimetabolite and a demethylation agent. In initial phase i testing, the maximum tolerated dose was 15002250 mgm 2, which caused prolonged myelosuppression. Alterations for special populations because azacitidine, decitabine, andor their metabolites are primarily excreted by the kidneys, caution is needed in patients with renal impairment. Clinical trials look at new ways to prevent, detect, or treat disease. For oncedaily dosing, draw a single random level 8 to 12 hours after dose given adjustments are made based on a published hartford nomogram. The renal drug handbook the st georges hospital, adult critical. How i treat acute myeloid leukemia presenting with preexisting. Medscape myelodysplastic syndromes dosing for dacogen decitabine, frequencybased adverse effects.
Decitabine trade name dacogen, or 5aza2deoxycytidine, acts as an nucleic acid synthesis. Decitabine is available as lyophilized powder in a single dose vial, 50 mgvial. For elderly patients with aml, decitabine and lowdose cytarabine should be chosen based on the patients choice and affordability. While the advice and information in this book are believed to be true and accurate at the date of publication, neither. Guidelines for chemotherapy dosage adjustment hematology. This information sparked further clinical trials using a lower dosing schedule since the original studies using higher doses were associated with significant myelosuppression and induction toxicity. Dacogen decitabine dosing, indications, interactions. Median of simplified costeffectiveness ratio was 0. The optimal dosing schedule for decitabine is still unclear. Decitabine for acute myeloid leukemia in a patient undergoing. This guide succeeds at providing busy healthcare providers with updated and evidencebased information on dosing and monitoring commonly used medications in patients with renal dysfunction. Decitabine is associated with a low rate of transient serum enzyme elevations during therapy, but has not been implicated. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. This cycle was repeated every 6 weeks, depending on the patients clinical response and toxicity.
Pediatric drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. Decitabine was approved by the fda for the treatment of myelodysplastic syndromes in 2006. The fifth edition of 2007 has been significantly expanded by dosage tables for children. In most cases, a decitabine injection is given every 8 hours for 3 days. The total body clearance 27 mean sd was 124 19 lhrm2, and the terminal phase elimination halflife was 0.
New drug toxicities in the onconephrology world kidney. Treatment of myelodysplastic syndrome and acute myeloid. Decitabine can harm an unborn baby or cause birth defects if the mother or the father is using this medicine. Azacitidine, decitabine, myelodysplastic syndrome, serum creatinine. Azacitidine and its deoxy derivative, decitabine also known as 5aza2. March 15, 2010 the us food and drug administration fda has approved a 5day dosing regimen for decitabine dacogen, eisai, inc for injection in the treatment of patients with. The pharmacists will automatically adjust the doses of any of the antimicrobials included in the protocol according to the estimated creatinine clearance generally using the cockroftgault equation for patients. Decitabine is used in treatment of myelodysplastic syndrome mds. However, decitabine shows promising clinical activity and good tolerance with the lower dosing schedules.
Administer dacogen at a dose of 15 mgm 2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. This 3day treatment is usually repeated every 6 weeks at least 4 times. Decitabine compared with lowdose cytarabine for the. In renal impairment and patients on chronic haemodialysis, dose adjustment is. Jul 01, 2005 decitabine dosing schedules decitabine dosing schedules kantarjian, hagop m issa, jeanpierre j. This medicine is available only with your doctors prescription. Dosing guidelines for varying degrees of renal impairment are stated accordingly.
This medication is given by injection into a vein by a health care professional in a hospital or infusion clinic the dosage is based on your medical condition, body size. Side effects of dacogen decitabine injection, warnings, uses. Emtriva, emtricitabine dosing, indications, interactions. Decitabine side effects, uses, dosage, overdose, pregnancy. In patients with chronic kidney disease, batty and colleagues reported the first case series. Abacavir abacavir lamivudine abacavir lamivudine zidovudine acarbose acebutolol acetaminophen acetazolamide acetohexamide acetohydroxamic acid acetylsalicylic acid aspirin acrivastine acyclovir adefovir adenosine albuterol inhaled albuterol oral alfentanil alfentanil allopurinol alprazolam alteplase tissuetype plasminogen activator. Although the prevalence of an elevated serum creatinine is low in cancer patients renal dose adjustments of chemotherapy drugs. Decitabine is soluble in dimethyl sulphoxide and sparingly soluble in water. Low dose decitabine, low dose azacitidine, or standard. Severe renal insufficiency was defined as an estimated gfr. Decitabine side effects, dosage, interactions drugs. Feb 10, 2020 recovery requiring more than 6, but less than 8 weeks delay decitabine for injection dosing for up to 2 weeks and reduce the dose temporarily to 11 mgm 2 every 8 hours 33 mgm 2 day, 99 mgm 2 cycle upon restarting therapy. Some clinicians prefer decitabine because it is given intravenously over acute myeloid leukemia.
Successful treatment with lowdose decitabine in acute. Our dacogen decitabine for injection side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this. Renal insufficiency at the initiation of treatment was defined as an estimated gfr. Feasibility of therapy with hypomethylating agents in. Measure dosage with the calibrated cap provided with the bulk product, or, open the 17gram packet if packet dosing is appropriate. Although no dose adjustment is recommended in patients with renal failure.
The clinical trials on this list are studying decitabine. Highlights of prescribing information these highlights do not. An advantage of the low dosing schedule is that patients could be treated on either inpatient or outpatient basis. The drugs which are in bold, details of dose reductions are mentioned below table, scroll down. Clinical trials are research studies that involve people. The renal drug handbook 5th edition medicina interna. Xeloda capecitabine dosing, indications, interactions. Renal drug handbook 3rd edition general intensive care unit. Oct 15, 2014 phase i, dose escalation study of decitabine the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Get the latest treatment regimens for acute myeloid leukemia aml, such as induction therapy, consolidation therapy, and more. Clinical trials using decitabine national cancer institute. A pilot study suggested decitabine could potentially activate gamma globin gene management of primary myelofibrosis view in chinese while the remainder received nonintensive chemotherapy eg, low dose cytarabine, azacitidine, decitabine or supportive care.
If your institution subscribes to this resource, and you dont have a myaccess profile, please contact your librarys reference desk for information on how to. Decitabine definition of decitabine by medical dictionary. The starting dose of decitabine is 20 mgm 2 by iv into the vein infusion over 1 hour repeated daily for 5 days. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose. Breastfeeding while receiving dacogen is not recommended. Dacogen decitabine dosing, indications, interactions, adverse. Escalation study to determine bioavailability of a single. For those drugs in which renal excretion is an important determinant of elimination of the intact drug or an active metabolite, dose adjustment is often required if renal function is impaired. Decitabine is a prodrug that has to be converted into a nucleoside triphosphate to become an active drug. Dacogen, mgi pharma, inc, bloomington, mn is a cytidine analog that inhibits dna methyltransferases resulting in loss of dna methylation with subsequent gene reexpression. Renal dosage adjustment guidelines for antimicrobials. You may be given other medications to prevent nausea or vomiting while you are receiving decitabine.
Dailymed decitabine injection, powder, lyophilized, for. Aml outcomes with decitabine not dependent on dosing. 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. Dacogen decitabine dose, indications, adverse effects. If any of the following nonhematologic toxicities are present, decitabine treatment should not be restarted until the toxicity is resolved. Both drugs were first synthesized in czechoslovakia as potential chemotherapeutic agents for cancer. For renally excreted drugs with a narrow therapeutic index, the total daily maintenance dose may be reduced either by decreasing the dose or by increasing the dosing interval, or sometimes by a combination of both.
Find patient medical information for decitabine intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Fda approves 5day dosing regimen for decitabine in. Feasibility of therapy with hypomethylating agents in patients with. Dacogen is supplied as a a sterile lyophilized white to almost white powder, for reconstitution in sterile water and dilution for intravenous injection. A catalogue record for this book is available from the british library. Thus at optimal doses, decitabine blocks this type of methylation and has an. This is not a complete list of side effects and others may occur. Two approved dosage regimens are recommended for a minimum of 4 treatment cycles.
The incidence of acute myelogenous leukemia aml in patients over 80 years old is 20 times greater than that observed in younger patients. Mar 06, 2020 decitabine is a white to off white coloured powder with the molecular formula of c 8 h 12 n 4 o 4 and a molecular weight of 228. This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newlydiagnosed acute myeloid leukemia aml in older patients. Dosing andor duration may be adjusted according to adverse effects that. Decitabine is used to treat myelodysplastic syndromes certain types of blood or bone. It works by helping the bone marrow produce normal blood cells and by killing. Decitabine and midostaurin in treating older patients with. Decitabine trade name dacogen, or 5aza2deoxycytidine, acts as an nucleic acid synthesis inhibitor. This randomized phase ii trial studies how well low dose decitabine, low dose azacitidine, or standard dose azacitidine works in treating patients with myelodysplastic syndrome mds who need blood transfusion transfusiondependent compared to best supportive care in patients with mds who do not need blood transfusion transfusionindependent. Renal dosage adjustment guidelines for antimicrobials the pharmacists will automatically adjust the doses of any of the antimicrobials included in the protocol according to the estimated creatinine clearance generally using the cockroftgault equation for patients.
Aml outcomes with decitabine not dependent on dosing schedule san diego, californiaolder patients with newly diagnosed acute myeloid leukemia aml had similar outcomes and early mortality regardless of whether they received decitabine in a 5 or 10day schedule, results from a recent study by nicholas j. For hd, draw trough prehd, and peak 30 min after end of each infusion streptococci, streptococcus bovis, strep. Decitabine fda prescribing information, side effects and uses. Administer dacogen at a dose of 20 mgm repeat cycle every 4 weeks. 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. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Thus, all patients received the same 100 mgm2 total decitabine dose in each. The need for dose adjustment in patients with renal impairment has not been evaluated see section 4. Jul 17, 2009 escalation study to determine bioavailability of a single oral dose of decitabine in patients with myelodysplastic syndrome mds the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Mar 06, 2020 our dacogen decitabine for injection side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. A healthcare provider will give you this injection.
Decitabine is also being studied in the treatment of other conditions and types of cancer. Indications and dose treatment of newly diagnosed acute myeloid leukaemia in patients over 65 years of age who are not candidates for standard induction chemotherapy. Recovery requiring more than 8, but less than 10 weeks perform bone marrow aspirate to assess for disease. Drug dosing adjustments in patients with chronic kidney. Hold decitabine therapy until nephrotoxicity resolves in patients who develop renal impairment i. Herein, we report the first use of decitabine in a patient on hemodialysis. Therapeutic effects improved hematologic and clinical. 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. May 10, 20 decitabine plasma pharmacokinetics remained unchanged upon repeated dosing and even from cycle to cycle. Recommended initial dosing is 15 mgm2 via continuous 3hour intravenous infusion, once every 8 hours for 3 days.
Drug dosing adjustments in patients with chronic kidney disease myrna y. Each 20 ml, single dose, glass vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate potassium dihydrogen phosphate and 11. Miralax polyethylene glycol 3350 dose, indications, adverse. Dosing andor duration may be adjusted according to adverse effects that may occur. Official title a phase 2 study of decitabine in combination with midostaurin pkc412 for elderly patients with newly diagnosed flt3itdtkd positive acute myeloid leukemia. Nevertheless, this is clearly an area of flux in the era of novel therapies for hcv. Nov 14, 2018 provides accurate and independent information on more than 24,000 prescription drugs, overthecounter medicines and natural products. Previously, no standard treatment protocol for elderly patients with aml existed, however the development of hypomethylating agents, including decitabine, has brought about promising results in aml. Phase i, dose escalation study of decitabine full text view. Decitabine is eliminated by cytidine deaminase which is found intracellularly in.
General renal dosing guidelines agents not listed below click here for a specialized list of other renal medication dosing not listed in the alphabetical main section simple renal dosing guidelines. All trials on the list are supported by nci ncis basic information about clinical trials explains the types and phases of trials and how they are carried out. For more detail, see how decitabine works section below. Listing a study does not mean it has been evaluated by the u. The use of decitabine in patients with renal disease has not been studied. To our knowledge, the feasibility of therapy with hypomethylating agents has in patients with renal insufficiency ri has not been examined. Decitabine also has activity in the treatment of acute myeloid leukemia in patients aged over 60 years 24 c. Decitabine is in a class of medications called hypomethylation agents. Patients with renal or severe hepatic impairment treatment with dacogen has not been studied in patients with preexisting renal or hepatic impairment. Providing clinical nephrology services to patients in the louisville metro area including daily outpatient services in the kidney disease program office.
Decitabine for injection contains decitabine 5aza2deoxycitidine, an analogue of the natural nucleoside 2deoxycytidine. Decitabine dosing schedules, seminars in hematology 10. If you are a woman, do not use decitabine if you are pregnant. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Dacogen decitabine for injection is a white to almost white sterile lyophilized powder supplied in a clear colorless glass vial. The renal drug handbook third edition edited by caroline ashley and aileen currie uk renal pharmacy group foreword by. For patients with preexisting renal or hepatic impairment, consider the potential risks and benefits before initiating treatment with dacogen. Fda approves fiveday dosing regimen for dacogen r decitabine for injection, offering a new outpatient dosing option for myelodysplastic syndromes mds news provided by eisai inc. Each 20 ml, single dose, glass vial contains 50 mg decitabine, 68 mg. Bennetts drug prescribing in renal failure has been the best pocket book for drug prescribing in patients with renal insufficiency and dialysis since the first edition in 1987. At high doses decitabine is cytotoxic, while lower doses are associated with demethylating activity. This new book addresses the persistent and challenging problem of dosing medications for patients with renal insufficiency and dysfunction. In the absence of progression, delay decitabine for injection dosing for up to 2 more weeks and reduce the dose to 11 mgm 2 every 8 hours 33 mgm 2 day, 99 mgm 2 cycle upon restarting therapy, then maintain or increase dose in subsequent cycles as clinically indicated. Patients randomized to the decitabine for injection arm received decitabine for injection intravenously infused at a dose of 15 mgm 2 over a 3hour period, every 8 hours, for 3 consecutive days.
996 1224 488 1587 1407 597 1442 179 157 705 693 108 1504 198 1070 310 1280 1246 1537 224 1109 1582 1334 1453 481 533 864 1370 448 904 1244 1076 1457