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CytarabineDaunorubicinIdarubicinLeukemia, Myeloid, AcuteRemission InductionMitoxantroneAntineoplastic Combined Chemotherapy ProtocolsConsolidation ChemotherapyAntibiotics, AntineoplasticLeukemia, MyeloidAntimetabolites, AntineoplasticThioguanineEtoposideArabinonucleosidesNaphthacenesVincristineDrug Administration ScheduleDoxorubicinInduction ChemotherapyMethotrexatePrecursor Cell Lymphoblastic Leukemia-LymphomaTreatment OutcomeAsparaginaseP-GlycoproteinAnthracyclinesDrug AgonismAcute DiseaseAclarubicin6-MercaptopurineLeukemia, Myelomonocytic, AcuteMeningeal CarcinomatosisDrug Resistance, NeoplasmInjections, SpinalLeukemic InfiltrationDisease-Free SurvivalDrug Resistance, MultipleLymphoma, Non-HodgkinAntineoplastic AgentsAmsacrineSurvival AnalysisCyclophosphamideCyclosporinsCytidine MonophosphateLeukemiaSurvival RateCarmustineDrug ResistanceRecurrenceDeoxycytidine KinaseTeniposideArabinonucleotidesLeukemia P388Leukemia, Myeloid, Accelerated PhaseVerapamilCentral Nervous System NeoplasmsHL-60 CellsLiposomesSalvage TherapyVidarabineArabinofuranosylcytosine TriphosphateTransplantation, AutologousDose-Response Relationship, DrugCombined Modality TherapyLeukemia, Myelogenous, Chronic, BCR-ABL PositivePrednisoneInfusions, IntravenousBlast CrisisAnemia, Refractory, with Excess of BlastsMyelodysplastic SyndromesDrug Screening Assays, AntitumorPrognosisLeukemia, Promyelocytic, AcuteDexamethasoneCarcinoma, Ehrlich TumorDrug SynergismMeningitisRazoxaneMelphalanPodophyllotoxinCladribineLeukemia, Myeloid, Chronic-PhaseAdenine NucleotidesAminoglycosidesTumor Cells, CulturedDioxolanesPolyradiculopathyHarringtoninesStreptomycesActuarial AnalysisHematopoietic Stem Cell TransplantationCytogenetic AnalysisBurkitt LymphomaMeningesPrednisoloneGranulocyte Colony-Stimulating FactorBenzamidesEquilibrative Nucleoside Transporter 1PyrimidinesGene Expression Regulation, LeukemicMultidrug Resistance-Associated Proteins
VyxeosLiposomeEtoposideLiposomalChemotherapy drugsIdarubicinChemotherapiesHydrochlorideVenetoclaxGemtuzumabInjectionIntravenouslyAllergicPatientsMedicationsLeukemiaTreatmentDrugPhaseStandardDaysGrowth of cancer cellsSide effectsVYXEOSLiposomalDoxorubicinAnthracyclineIdarubicinAcuteDrugsCerubidineMedicationDoseRegimenMolar ratioLeukemiaCombinationRemissionConsolidationAntimetaboliteEfficacyFormulationInhibitorInhibits
Vyxeos13
  • Patients who have a history of serious hypersensitivity to daunorubicin, cytarabine or any component of the formulation should not use Vyxeos. (lls.org)
  • The prescribing information for Vyxeos includes a boxed warning not to interchange Vyxeos with other daunorubicin- and/or cytarabine-containing products. (lls.org)
  • VYXEOS is a combination of 2 chemotherapies, daunorubicin and cytarabine, into tiny, bubble-like carriers called liposomes. (vyxeos.com)
  • WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. (vyxeos.com)
  • Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products. (vyxeos.com)
  • VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients. (vyxeos.com)
  • VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. (vyxeospro.com)
  • As a result, Jazz obtained the rights to breakthrough therapy Vyxeos (liposomal daunorubicin and cytarabine) for treatment of acute myeloid leukemia. (wikipedia.org)
  • Presentations include clinical data from trials of Vyxeos ® (daunorubicin and cytarabine). (lls.org)
  • Among future therapies, the researchers called CPX-351 (Vyxeos), a liposome formulation of cytarabine and daunorubicin, promising. (ajmc.com)
  • Median OS improved by almost 8 months among patients with AML and myelodysplasia-related changes (AML-MRC) treated with liposomal cytarabine-daunorubicin (CPX-351, Vyxeos) versus conventional 7 + 3 induction therapy, as reported at the Transplantation and Cellular Therapy Meetings . (medpagetoday.com)
  • This tiny market cap biotech recently surprised investors with bullish phase 3 trial results for Vyxeos, a nano-scale liposome encased mash-up of the chemotherapy drugs cytarabine and daunorubicin, that sent shares surging 450%, and on Monday, the company updated investors on its timeline for regulatory filings for Vyxeos approval. (foxbusiness.com)
  • In trials, overall survival in secondary acute myeloid leukemia (AML) patients receiving Vyxeos was 9.56 months and that was significantly better than the 5.95 months experienced within the control arm of the study, which was given the standard combination of cytarabine and daunorubicin. (foxbusiness.com)
Liposome1
Etoposide2
Liposomal3
  • www.drugguide.com/ddo/view/Davis-Drug-Guide/110585/all/daunorubicin_cytarabine_liposomal. (drugguide.com)
  • Vallerand AHA, Sanoski CAC, Quiring CC. Daunorubicin/cytarabine liposomal. (drugguide.com)
  • This liposomal formulation has 2 major benefits: kinetic advantages provided by the liposomes, and the ability to deliver these drugs in a defined 1:5 molar ratio [daunorubicin to cytarabine] to the target cells," Young said. (pharmacytimes.com)
Chemotherapy drugs1
Idarubicin5
  • Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. (nih.gov)
  • Pharmacokinetic studies have been performed in adult leukemia patients with normal renal and hepatic function following intravenous administration of 10 to 12 mg/m 2 of idarubicin daily for 3 to 4 days as a single agent or combined with cytarabine. (nih.gov)
  • The elimination rate of idarubicin from plasma is slow with an estimated mean terminal half-life of 22 hours (range, 4 to 48 hours) when used as a single agent and 20 hours (range, 7 to 38 hours) when used in combination with cytarabine. (nih.gov)
  • This phase III trial comparing idarubicin with high-dose daunorubicin as part of induction therapy in AML did not find significant differences in complete remission rates, relapse, or survival. (ascopost.com)
  • A significant interaction between the treatment arm and the FLT3-ITD mutation was found, and high-dose daunorubicin was more effective than idarubicin in patients with FLT3-ITD mutation. (ascopost.com)
Chemotherapies1
Hydrochloride1
Venetoclax1
  • The Company is also conducting a series of studies to evaluate ziftomenib in combination with current standards of care, beginning with venetoclax/azacitidine and standard induction cytarabine/daunorubicin chemotherapy in NPM1-mutant and KMT2A-rearranged newly diagnosed and relapsed/refractory AML (KOMET-007). (abc4.com)
Gemtuzumab2
  • Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients. (fda.gov)
  • Patients were randomized (1:1) to receive induction therapy consisting of daunorubicin (60 mg/m2 on days 1 to 3) and cytarabine (200 mg/m2 on days 1 to 7) with (n=135) or without (n=136) gemtuzumab ozogamicin 3 mg/m2 (up to maximum of one vial) on days 1, 4, and 7. (fda.gov)
Injection1
  • CYTARABINE INJECTION Faulding Antileukemic Action And Clinical Pharmacology: Cytarabine is converted intracellularly to the nucleotide, cytarabine triphosphate. (rxmed.com)
Intravenously2
  • Daunorubicin and cytarabine lipid complex comes as a powder to be mixed with liquid and injected intravenously (into a vein) by a doctor or nurse in a medical facility. (medlineplus.gov)
  • Consolidation therapy consisted of cytarabine intravenously every 12 hours for 3 days. (fda.gov)
Allergic1
Patients3
Medications4
  • Daunorubicin and cytarabine lipid complex is different than other products containing these medications and should not be substituted for one another. (medlineplus.gov)
  • Daunorubicin is in a class of medications called anthracyclines. (medlineplus.gov)
  • Cytarabine is in a class of medications called antimetabolites. (medlineplus.gov)
  • Many other medications may also interact with daunorubicin and cytarabine lipid complex, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. (medlineplus.gov)
Leukemia2
Treatment3
  • You should use birth control to prevent pregnancy in yourself or your partner during your treatment with daunorubicin and cytarabine lipid complex and for 6 months after your final dose. (medlineplus.gov)
  • You should not breastfeed during your treatment with daunorubicin and cytarabine lipid complex and for at least 2 weeks after your final dose. (medlineplus.gov)
  • Cytarabine is also being studied in the treatment of other types of cancer . (cancer.gov)
Drug1
  • This page contains brief information about cytarabine and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. (cancer.gov)
Phase1
  • Administration of low-dose cytarabine results in immediate S-phase arrest and subsequent activation of cell cycling in murine stem cells. (rug.nl)
Standard1
Days1
Growth of cancer cells1
Side effects1
VYXEOS18
Liposomal8
  • This phase I/II trial studies the side effects and best dose of liposomal cytarabine-daunorubicin CPX-351 (CPX-351) when given with fludarabine phosphate, cytarabine, and filgrastim and to see how well they work in treating younger patients with acute myeloid leukemia that has come back after treatment (relapsed) or is not responding to treatment (is refractory). (mayo.edu)
  • Liposomal cytarabine-daunorubicin CPX-351 is made up of two chemotherapy drugs, cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking the cells from dividing. (mayo.edu)
  • Giving liposomal cytarabine-daunorubicin CPX-351 followed by fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common effect of other chemotherapy treatments for acute myeloid leukemia. (mayo.edu)
  • Purpose CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin that delivers a synergistic 5:1 drug ratio into leukemia cells to a greater extent than normal bone marrow cells. (escholarship.org)
  • 2. Persistent cytarabine and daunorubicin exposure after administration of novel liposomal formulation CPX-351: population pharmacokinetic assessment. (nih.gov)
  • 5. CPX-351: a nanoscale liposomal co-formulation of daunorubicin and cytarabine with unique biodistribution and tumor cell uptake properties. (nih.gov)
  • 7. First-in-man study of CPX-351: a liposomal carrier containing cytarabine and daunorubicin in a fixed 5:1 molar ratio for the treatment of relapsed and refractory acute myeloid leukemia. (nih.gov)
  • a nano-scale liposomal fixed molar ratio formulation of cytarabine:daunorubicin, in patients with advanced leukemia. (nih.gov)
Doxorubicin1
  • Generic chemotherapy drugs are in particularly tight supply at the nation's hospitals, including mainstay cancer treatments such as cisplatin, doxorubicin, cytarabine and leucovorin. (nih.gov)
Anthracycline5
  • The most common induction regimen for AML includes cytarabine and an anthracycline drug, such as daunorubicin or idarubicin . (lls.org)
  • This is called the "7 + 3" regimen, because cytarabine is most often given by continuous intravenous (IV) infusion over 7 days, while the anthracycline drug is given by an IV infusion in a single dose for 3 days during the first week of treatment. (lls.org)
  • The patient is started on induction therapy with cytarabine and an anthracycline using the standard 7+3 protocol (7 days cytarabine + 3 days an-thracycline). (medpagetoday.com)
  • CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. (yale.edu)
  • Cerubidine (daunorubicin) is an anthracycline, which inhibits DNA replication and repair. (jax.org)
Idarubicin4
  • Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. (nih.gov)
  • Pharmacokinetic studies have been performed in adult leukemia patients with normal renal and hepatic function following intravenous administration of 10 to 12 mg/m 2 of idarubicin daily for 3 to 4 days as a single agent or combined with cytarabine. (nih.gov)
  • The elimination rate of idarubicin from plasma is slow with an estimated mean terminal half-life of 22 hours (range, 4 to 48 hours) when used as a single agent and 20 hours (range, 7 to 38 hours) when used in combination with cytarabine. (nih.gov)
  • 7+3 may be given using idarubicin , instead of daunorubicin. (chemoexperts.com)
Acute6
  • Prior clinical studies demonstrated a sustained drug ratio and exposure in vivo and prolonged survival versus standard-of-care cytarabine plus daunorubicin chemotherapy (7+3 regimen) in older patients with newly diagnosed secondary acute myeloid leukemia (sAML). (escholarship.org)
  • We performed a retrospective analysis of 9 patients with acute myeloid leukemia (AML) treated with gemtuzumab ozogamicin (GO) plus cytarabine as a salvage regimen (GO reinduction) for patients who did not achieve complete remission (CR) after the first cycle of induction chemotherapy or at first relapse. (scirp.org)
  • 4. CPX-351 daunorubicin-cytarabine liposome: a novel formulation to treat patients with newly diagnosed secondary acute myeloid leukemia. (nih.gov)
  • 6. Daunorubicin and Cytarabine Liposome in Newly Diagnosed Therapy-Related Acute Myeloid Leukemia (AML) or AML With Myelodysplasia-Related Changes. (nih.gov)
  • 10. CPX-351 versus 7+3 cytarabine and daunorubicin chemotherapy in older adults with newly diagnosed high-risk or secondary acute myeloid leukaemia: 5-year results of a randomised, open-label, multicentre, phase 3 trial. (nih.gov)
  • A Phase 1 study of imatinib mesylate in combination with cytarabine and daunorubicin for c-kit positive relapsed acute myeloid leukemia. (bdbiosciences.com)
Drugs4
  • Drugs used in chemotherapy, such as fludarabine phosphate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. (mayo.edu)
  • Patients with favorable risk factors are often given intensive chemotherapy with high-dose cytarabine and other drugs for their consolidation therapy. (lls.org)
  • Daunorubicin is part of a group of drugs called anthracyclines and cytarabine is classified as an antimetabolite. (rxwiki.com)
  • Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. (yale.edu)
Cerubidine1
Medication1
  • The chemotherapy medication cytarabine was first approved by the Food and Drug Administration in 1969. (nih.gov)
Dose7
  • You should use birth control to prevent pregnancy in yourself or your partner during your treatment with daunorubicin and cytarabine lipid complex and for 6 months after your final dose. (medlineplus.gov)
  • You should not breastfeed during your treatment with daunorubicin and cytarabine lipid complex and for at least 2 weeks after your final dose. (medlineplus.gov)
  • The chemo drug most often used for MDS is cytarabine (ara-C) . It can be given by itself at a low-dose, which can often help control the disease, but doesn't often put it into remission. (cancer.org)
  • 100-fold dose reduction of cytarabine in both AML cell lines and primary T-ALL cells. (nih.gov)
  • Each dose is calculated based on the daunorubicin dose (mg/m2) using body surface area. (standardofcare.com)
  • For the first induction cycle, the recommended dose is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome via intravenous infusion over 90 minutes on days 1, 3, and 5. (standardofcare.com)
  • Daunorubicin ends when the third dose is given on Day 3. (chemoexperts.com)
Regimen1
  • Standard approaches in patients who can tolerate intensive therapy include the 7+3 combination regimen of cytarabine and daunorubicin, and stem-cell transplantation. (fda.gov)
Molar ratio1
  • 11. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. (nih.gov)
Leukemia1
  • Biological evaluation of our isoform-selective inhibitors revealed a high degree of synergistic drug action in combination with the clinical leukemia therapeutics daunorubicin and cytarabine in in vitro cellular models of AML and primary patient-derived T-ALL cells. (nih.gov)
Combination4
  • SB: Abhi, this drug is a nanoscale liposome-encapsulated combination of daunorubicin and cytarabine. (fda.gov)
  • SB: Common side effects are similar to those seen with the traditional cytarabine and daunorubicin combination, including those related to the delayed recovery of marrow progenitors. (fda.gov)
  • Liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor prognosis AML. (standardofcare.com)
  • The standard combination is the 7+3, with a 7-day continuous infusion of cytarabine at the dosage of 100 or 200 mg/m 2 per day on days 1 to 7 and daunorubicin at 60 mg/m 2 per day on days 1 to 3. (medpagetoday.com)
Remission1
Consolidation1
  • Based on these encouraging outcomes, midostaurin was looked into in a big, randomized stage III trial where it had been added to regular induction therapy (cytarabine and daunorubicin induction and cytarabine loan consolidation, also called 7+3 routine) in individuals with newly-diagnosed FLT3-positive AML, where it had been discovered to improve patient survival considerably. (2011globalhealth.org)
Antimetabolite1
  • Cytarabine is an antimetabolite specific for cells in the S-phase of the cell cycle. (medscape.com)
Efficacy1
  • AN: So in this case, the company had to perform clinical trials, but their application could reference additional safety and efficacy information from previously-approved daunorubicin and cytarabine data. (fda.gov)
Formulation1
Inhibitor1
  • Daunorubicin is a topoisomerase-II inhibitor. (medscape.com)
Inhibits1
  • Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair ( PMID: 32524309 ). (jax.org)