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DaunorubicinLiposomesAntibiotics, AntineoplasticNaphthacenesDoxorubicinCytarabineDrug CarriersIdarubicinAmphotericin BP-GlycoproteinAnthracyclinesLeukemia P388Leukemia, Myeloid, AcuteDrug Resistance, MultipleVerapamilPolyethylene GlycolsDrug ResistanceThioguanineDrug Delivery SystemsCyclosporinsVincristineMitoxantroneRemission InductionAntineoplastic AgentsAclarubicinAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ehrlich TumorRazoxaneAntifungal AgentsLeukemia, MyeloidDrug Resistance, NeoplasmStreptomycesTumor Cells, CulturedAsparaginaseNystatinHL-60 CellsDose-Response Relationship, DrugPyrazolonesAnthraquinonesDrug Screening Assays, AntitumorDrug AgonismTreatment OutcomeConsolidation ChemotherapyK562 CellsChemistry, PharmaceuticalGenes, MDRLeukemia L1210EtoposideMultidrug Resistance-Associated ProteinsDeoxycholic AcidRhodamine 123Tissue DistributionNeutropeniaCell SurvivalDrug Administration ScheduleBenzylisoquinolinesNanomedicineLeukemia, ExperimentalMucormycosisAcute DiseaseAspergillosisAntiprotozoal AgentsPrecursor Cell Lymphoblastic Leukemia-LymphomaPhosphatidylcholinesCell Line, TumorLeukemia
DoxorubicinDaunoXomeVyxeosCytarabine-daunorubicinAnthracyclinesChemotherapyFormulationConventionalToxicityDrugsSide effectsDeliveryInductionAnthracyclineLiposome for injectionVyxeos LiposomalIdarubicinHydrochlorideVincristine2017InjectionEfficacyIntravenouslyChemotherapy drugsLiposomesMolar ratioRegimenClin OncolAcute leukemiaSynergisticAchieved with conventionalDoseVialLocal tissueVitro releaseConsolidationMedicationGenericTherapyCombinationTrialDrugTreatmentStudiesCells
Doxorubicin7
DaunoXome2
  • Liposomal daunorubicin (trade name DaunoXome) is a chemotherapy drug that is FDA approved to treat AIDS related Kaposi's sarcoma. (wikipedia.org)
  • A configuration I dose-escalating investigation of DaunoXome, liposomal daunorubicin, in metastatic tit cancer. (upb.ro)
Vyxeos3
  • On the flip side, the SMC did approve NHS funding for Jazz Pharmaceuticals' chemotherapy Vyxeos (liposomal daunorubicin/cytarabine) and MSD's antiviral Prevymis (letermovir). (pharmatimes.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)
  • CPX-351 (Vyxeos) is a liposomal formulation of daunorubicin plus cytarabine and was recently approved by the FDA for use in adults and children in the treatment of AML. (healthtree.org)
Cytarabine-daunorubicin1
  • Cost-effectiveness of liposomal cytarabine/daunorubicin in patients with newly diagnosed acute myeloid leukemia. (bvsalud.org)
Anthracyclines3
Chemotherapy2
  • As pegylated liposomal formulation: In patients who failed 1st-line platinum-based chemotherapy regimen: 50 mg/m 2 via infusion over 60 minutes once every 4 weeks. (azurewebsites.net)
  • As pegylated liposomal formulation: In patients with low CD4 counts and extensive visceral or mucocutaneous disease, or after failure of or intolerance to previous systemic chemotherapy: 20 mg/m 2 via infusion over 30 or 60 minutes once every 2-3 weeks. (azurewebsites.net)
Formulation2
  • As pegylated liposomal formulation: In combination with bortezomib for the treatment of progressive cases in patients who have undergone or are unsuitable for a bone marrow transplant and who have received at least 1 prior therapy: 30 mg/m 2 on day 4 of the bortezomib 3 week regimen given via infusion over 60 minutes immediately after bortezomib infusion. (azurewebsites.net)
  • As pegylated liposomal formulation: Monotherapy in patients with increased cardiac risk: 50 mg/m 2 via infusion over 60 minutes once every 4 weeks. (azurewebsites.net)
Conventional2
  • It utilizes the liposomal carrier system that provides a favorable pharmacokinetic profile at the site of KS lesions resulting in a 10-fold increase in concentrations compared to that which is achieved with conventional preparations. (wikipedia.org)
  • Patients treated with CPX-351 had a median OS of 19.15 months as compared with 11.58 months for conventional formulations of cytarabine and daunorubicin. (medpagetoday.com)
Toxicity1
  • Liposomal drugs have high encapsulation capacity, hence shows a significant anticancer activity with decreased toxicity preferentially cadiotoxicity. (ijpsr.com)
Drugs1
  • This liposomal drug delivery also developed for delivery of various drugs. (ijpsr.com)
Side effects1
  • To overcome these problems and side effects liposomal treatment is useful. (ijpsr.com)
Delivery1
  • The liposomal delivery reduces the penetration into the tight capillary junctions of the heart. (healthtree.org)
Induction7
  • In general, standard induction therapy in children and adults with AML consists of 3 days of anthracycline (daunorubicin ≥60 mg/m², idarubicin 10 to 12 mg/m², or the anthracenedione mitoxantrone 10 to 12 mg/m²) and 7 to 10 days of cytarabine (100 to 200 mg/m² per day), the authors explain. (medscape.com)
  • Induction: VYXEOS (daunorubicin 44 mg/m 2 and cytarabine 100 mg/m 2 ) liposome via intravenous infusion over 90 minutes on days 1, 3, and 5 and on days 1 and 3 for subsequent cycles of induction, if needed. (nih.gov)
  • Daunorubicin is given intravenously, typically in a regimen of once daily for 3 days during induction and for two days of subsequent courses. (nih.gov)
  • They were randomized 1 to 1 to first induction with the standard 7+3 regimen, where daunorubicin and cytarabine are given separately over three and seven days, respectively, or to first induction with (daunorubicin and cytarabine) liposome for injection given every other day for three infusions. (fda.gov)
  • Vyxeos liposomal dosing is based on the patient's body surface area (BSA) according to the following schedule: 1st induction: daunorubicin 44 mg/m2 & cytarabine 100 mg/m2 on days 1, 3, and 5. (bjh.be)
  • We present a 65-year-old woman who developed a diffuse pruritic papular eruption after receiving induction chemotherapy with daunorubicin and cytarabine for newly diagnosed acute myelomonocytic leukemia. (bvsalud.org)
  • Patients aged 1-18 years with newly diagnosed AML were randomized to two cycles of induction chemotherapy with daunorubicin and ara-C (DA) or two cycles of ara-C, daunorubicin, and etoposide (ADE). (bvsalud.org)
Anthracycline4
  • VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. (nih.gov)
  • Daunorubicin is an anthracycline antibiotic that has antineoplastic activity and is used in the therapy of acute leukemia and AIDS related Kaposi sarcoma. (nih.gov)
  • There is no information on cross sensitivity to hepatic injury between daunorubicin and other antineoplastic agents, including anthracycline antibiotics. (nih.gov)
  • VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). (cancermedicinesnetwork.com)
Liposome for injection7
Vyxeos Liposomal9
  • As of April 1st 2023, Vyxeos liposomal is officially reimbursed in Belgium for the treatment of patients aged 60-75 years with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). (bjh.be)
  • 1 Regulatory approval was based on the results of a phase III randomised trial of Vyxeos liposomal versus the 7+3 regimen in patients with untreated high-risk AML. (bjh.be)
  • 6,7 Vyxeos liposomal (CPX-351) is a dual-drug liposomal encapsulation of cytarabine and daunorubicine at a fixed 5:1 synergetic molar ratio. (bjh.be)
  • The regulatory approval of CPX-351 was based on the analysis of the primary endpoint of a randomised phase III trial, in which Vyxeos liposomal was evaluated and compared to conventional chemotherapy (the '7+3' regimen), demonstrating superior survival for Vyxeos liposomal. (bjh.be)
  • 9 The pre-specified follow-up at 5 years (median follow-up of 60.91 months) demonstrated that the improvement in overall survival (OS) with Vyxeos liposomal compared to conventional chemotherapy was maintained. (bjh.be)
  • Of note, as Vyxeos liposomal has a different dosing schedule than daunorubicin injection and cytarabine injection, it should not be confused with other products containing daunorubicin and/or cytarabine. (bjh.be)
  • The pharmaceutical form of Vyxeos liposomal is 44 mg/100 mg powder for solution for infusion. (bjh.be)
  • 1. Vyxeos Liposomal. (bjh.be)
  • Vyxeos liposomal has a different posology than daunorubicin injection and cytarabine injection and it must not be interchanged with other daunorubicin and/or cytarabine containing products. (bjh.be)
Idarubicin1
Hydrochloride2
Vincristine1
  • Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, we expect a grantee to conduct in vitro release studies under multiple conditions, perform in vivo pharmacokinetics and biodistribution studies in animal model, collect literature report on human pharmacokinetics data, and establish an in silico platform to explore the in vivo in vitro correlation of liposomal drug products. (nih.gov)
20171
Injection2
  • For injection: 44 mg daunorubicin and 100 mg cytarabine encapsulated in liposomes as a lyophilized cake in a single-dose vial for reconstitution. (nih.gov)
  • Daunorubicin is available as a solution or a powder for injection in 20 and 50 mg vials [5 mg/mL] generically and under the brand name Cerubidine. (nih.gov)
Efficacy2
  • 11. Efficacy of liposomal daunorubicin and cytarabine as reinduction chemotherapy in relapsed acute lymphoblastic leukaemia despite expression of multidrug resistance-related proteins. (nih.gov)
  • 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)
Intravenously1
Chemotherapy drugs1
  • Liposomal therapy uses chemotherapy drugs that have been packaged inside liposomes (synthetic fat globules). (medkonect.com)
Liposomes1
Molar ratio1
Regimen2
  • 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)
  • 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)
Clin Oncol1
Acute leukemia1
  • Daunorubicin has potent activity in acute leukemia and was approved for this indication in the United States in 1979. (nih.gov)
Synergistic1
Achieved with conventional1
  • It utilizes the liposomal carrier system that provides a favorable pharmacokinetic profile at the site of KS lesions resulting in a 10-fold increase in concentrations compared to that which is achieved with conventional preparations. (wikipedia.org)
Dose3
  • 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)
  • Chemotherapy with daunorubicin in combination with other agents is associated with serum enzyme elevations in a proportion of patients depending upon the dose and other agents used. (nih.gov)
  • ALT elevations during daunorubicin therapy are usually asymptomatic and transient and may resolve without dose modification. (nih.gov)
Vial1
Local tissue2
  • Tissue Necrosis: Daunorubicin has been associated with local tissue necrosis at the site of drug extravasation. (nih.gov)
  • Local extravasation of daunorubicin causes severe local tissue injury. (nih.gov)
Vitro release2
  • The development of generic liposomal drug products face challenges because of a lack of compendial or bio-relevant in vitro release methods. (nih.gov)
  • The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications. (nih.gov)
Consolidation1
  • Consolidation: VYXEOS (daunorubicin 29 mg/m 2 and cytarabine 65 mg/m 2 ) liposome via intravenous infusion over 90 minutes on days 1 and 3. (nih.gov)
Medication1
Generic1
  • Results from this study will advance the regulatory review process and ultimately improve public access to quality generic liposomal drug products. (nih.gov)
Therapy3
  • Daunorubicin is associated with a low rate of transient serum enzyme and bilirubin elevations during therapy, but has not been implicated in cases of clinically apparent acute liver injury with jaundice. (nih.gov)
  • There have been no convincing instances of acute, clinically apparent idiosyncratic liver injury with jaundice associated with daunorubicin therapy. (nih.gov)
  • AML treatment, including Vyxeos (CPX-351, liposomal cytarabine and daunorubicin), gemtuzumab ozogamicin, or any other prohibited concomitant AML therapy previously received or anticipated to start during the study. (researcherprofiles.org)
Combination3
  • However, high doses of daunorubicin given in combination with other antineoplastic agents have been linked to cases of sinusoidal obstruction syndrome, typically presenting with right upper quadrant pain 10 to 30 days after the infusion, followed by weight gain, ascites and liver test abnormalities. (nih.gov)
  • 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)
Trial1
  • SB: This liposomal product was evaluated in a clinical trial of 309 patients with newly-diagnosed treatment-related AML or AML with myelodysplasia-related changes. (fda.gov)
Drug2
  • Liposomal daunorubicin was approved by the US Food and Drug Administration in 1996 as first-line treatment for HIV-associated Kaposi's sarcoma, Dr. Creutzig told Medscape Medical News . (medscape.com)
  • The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. (nih.gov)
Treatment1
  • 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)
Studies1
Cells2
  • 12. P-glycoprotein and multidrug resistance-associated protein, but not lung resistance protein, lower the intracellular daunorubicin accumulation in acute myeloid leukaemic cells. (nih.gov)
  • Daunorubicin (daw" noe roo' bi sin) is a parenterally administered, cytotoxic antibiotic which is believed to act by intercalating between DNA base pairs and uncoiling the DNA helix, which results in inhibition of DNA synthesis and apoptosis of rapidly dividing cells. (nih.gov)