voriconazole / Generic mfg. - LARVOL DELTA

Azole-adjusted venetoclax-based regimens in unfit AML patients: A real-world brazilian experience from a resource-limited setting (ASH 2025) - "After 2020, unfit patients were treated with Venetoclax-based regimens (n=54), either combined with Azacitidine 75 mg/m²/day SC for 7 days (AZA-VEN) or with low-dose Cytarabine 20 mg/m²/day SC for 10 days (LoDAC-VEN). All patients received, after ramp-up, azole-adjusted dosing of Venetoclax: 100 mg when combined with Voriconazole or 200 mg with Fluconazole... In this real-world study, Venetoclax-based regimens with azole-adjusted dosing showed better outcomes in unfit AML patients compared to LoDAC or BSC, reinforcing the applicability of such regimens in resource-limited settings. While overall survival in our cohort was lower than reported in pivotal trials, likely due to infectious complications and limited access to supportive care, response rates were comparable. These results support broader incorporation of this approach across diverse healthcare systems."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia

The effect of belumosudil on the therapeutic monitoring of tacrolimus and sirolimus in allogeneic hematopoietic transplantation (ASH 2025) - "Azoles were used concomitantly in 51.5% of patients (35/68), with 65.7% (23/35) on posaconazole, 31.4% (11/35) on isavuconazole, and 2.9% (1/35) on voriconazole. Four patients started an azole after starting belumosudil (2 on posaconazole, 1 on fluconazole, and 1 on isavuconazole)... Our study confirms the drug interaction between TAC/SIRO, with the increase in TAC/SIRO levels more pronounced with the second level after starting belumosudil. However, severe toxicities were rarely seen. Based on our data, we recommend close TDM of TAC and SIRO, but no dose adjustment is warranted when belumosudil is added."

Acute Kidney Injury • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Movement Disorders • Nephrology • Transplantation • CYP3A4

Dose modifications of mezigdomide when coadministered with CYP3A4 inhibitors for patients with relapsed/refractory multiple myeloma (ASH 2025) - P1/2 | "Introduction: Mezigdomide (MEZI), an oral CELMoD™ agent with potent antimyeloma and immunostimulatory effects, has demonstrated encouraging efficacy in relapsed/refractory multiple myeloma (RRMM) as monotherapy and in combination with dexamethasone/standard treatments (CC-92480-MM-001 [NCT03374085]; CC-92480-MM-002 [NCT03989414])...A phase 1 clinical drug–drug interaction (DDI) study in healthy participants evaluated MEZI as a substrate of cytochrome P450 3A4 (CYP3A4), using rifampin (strong inducer) and itraconazole (strong inhibitor)...Specifically, MEZI CL was reduced 0.15-, 0.11- and 0.38-fold when administered with posaconazole, voriconazole, and fluconazole, respectively... MEZI is a sensitive CYP3A4 substrate. Modeling and simulation provide a robust framework to guide dose adjustments and manage potential DDI risks while preserving efficacy. For pts requiring concomitant use of strong or moderate CYP3A4is, MEZI can be continued safely with dose..."

Clinical • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Thrombocytopenia

Reduced intensive chemotherapy combined with venetoclax in adult patients with Acute Myeloid Leukemia: A retrospective single-center analysis (ASH 2025) - "Methods A retrospective single-center analysis was conducted on 36 adult AML patients (≤65 years) treated with reduced intensiveIA (almost half dosage of 3+7 regimen)+ VEN (idarubicin 6 mg/m² on days 1–3, cytarabine 60 mg/m² on days 1–5, venetoclax 100 mg daily with voriconazole 200 mg q12h). Reduced intensive IA + VEN demonstrated efficacy comparable to that of standard regimen DA+VEN, but with reduced toxicity, especially lower cardiac toxicity, which would be benefit for long term survival in AML adult patients.Conclusion The reduced intensive IA + VEN regimen achieved high ORR and durable remissions in adult AML patients, including those with high-risk disease. This approach offers a promising strategy to improve outcomes in AML while reducing toxicity."

Retrospective data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia

Therapeutic drug monitoring-guided individualized dosing of multiple BTK inhibitors combined with voriconazole: Real-world evidence on managing drug-drug interactions (ASH 2025) - "The regimens included ibrutinib [560 mg once a day (QD), reduced to 140 mg QD], zanubrutinib (160 mg BID, reduced to 80 mg QD), orelabrutinib (150 mg QD, reduced to 50 mg QD), and acalabrutinib (100 mg BID, reduced to 100 mg QD). The study suggests that coadministration of BTKis with CYP3A inhibitors can significantly affect its pharmacokinetic properties, and TDM has been shown to optimize the individualized dose adjustments of BTKis in the presence of DDIs. We are currently conducting a prospective real-world study to further elucidate exposure-response relationships, aiming to transition BTKi therapy from empirical to precision medicine. These efforts will provide valuable insights for optimizing dosing regimens, guiding personalized treatment decisions, and improving clinical outcomes."

Clinical • HEOR • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Respiratory Diseases

Venetoclax pharmacokinetics with triazole prophylaxis in patients with Acute Myeloid Leukemia in India: Pilot study (ASH 2025) - "Limitations include the small sample size and incomplete recording of venetoclax dose and meal status (precluding dose-normalized analysis). Even so, these early data offer actionable guidance on venetoclax use in India: posaconazole-enabled dose reduction may safely achieve target exposures, while voriconazole may require additional dose adjustments."

Clinical • PK/PD data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia

Real world treatment outcome with azacytidine (AZA)-tocilizumab (TCZ) for reducing steroid dependence in vexas syndrome with myelodysplastic syndrome (MDS): A single-center, 1.5-year longitudinal observational study (ASH 2025) - "Treatment and outcome: The patient was initiated on high-dose prednisone (PRD) at 40 mg daily and Erythropoiesis-Stimulating Agent, leading to clinical improvement...Acyclovir, atovaquone and voriconazole were used for anti-microbial prophylaxis... As VEXAS syndrome is a novel disease, there is absence of standardized treatment guidelines. This case highlights the promise of AZA-TCZ combination therapy in steroid dependent VEXAS syndrome with MDS. Further investigation into targeted steroid-sparing regimens along with patient specific guidelines is warranted for durable disease control and improved outcomes."

Clinical • HEOR • Observational data • Real-world • Real-world evidence • Eosinophilia • Hematological Disorders • Hematological Malignancies • Inflammation • Leukopenia • Musculoskeletal Diseases • Myelodysplastic Syndrome • Neutropenia • Ocular Inflammation • Ophthalmology • Orthopedics • Renal Disease • Retinal Vein Occlusion • Uveitis

Comparative outcomes of posaconazole vs. voriconazole/isavuconazole for antifungal prophylaxis in neutropenic adults with Acute Myeloid Leukemia: A propensity-matched retrospective cohort study (ASH 2025) - "In this large, matched cohort of neutropenic AML patients, posaconazole prophylaxis was associated withimproved survival and reduced incidence of shock compared to voriconazole/isavuconazole, albeit at thecost of slightly increased hospitalization. These findings support the preferential use of posaconazole inselect high-risk AML populations, while highlighting the need for individualized risk–benefit assessmentin antifungal prophylaxis strategies."

Retrospective data • Acute Myelogenous Leukemia • Acute Respiratory Distress Syndrome • Candidiasis • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Ophthalmology • Respiratory Diseases

FLAG-mitoxantrone combined with low-dose venetoclax (7 Days): A highly efficient regimen and excellent bridge for allogeneic hematopoietic transplant for newly diagnosed and relapsed/refractory AML. (ASH 2025) - "Background FLAG (G-CSF, Fludarabine, Cytarabine) combined with either Idarubicin (Ida) or Mitoxantrone (Mitox) werereported to be effective and well tolerated regimens in newly diagnosed (ND) or relapsed/refractory (R/R)Acute Myeloblastic Leukemia (AML)...FLAG-Mitox +Ven regimen combined G-CSF (5μg/kg/d) on d1-7.Fludarabine (30mg/m2/d IV) and Cytarabine (1.5g/m2/d IV) on d2-5, Mitox (12mg/m2/d IV) d2,4 and Ven(100mg PO daily) given concomitantly with voriconazole d2-8...Among the 50 R/R pts, first induction therapy consisted of 7+3regimen in 32 pts (64%), FLAG-Ida in 15 pts (30%) and 5-Azacytidine+Ven in 3 pts (6%)...High survival outcomes were demonstrated across ELN 2022 riskgroups in ND AML pts. This regimen is also an effective bridge to AHSCT when feasible."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Pneumonia • Respiratory Diseases • Transplantation • FLT3

CYP3A4 inhibitors (CYP3A4i) and myelosuppression in patients (Pts) with newly diagnosed mutant isocitrate dehydrogenase 1 (mIDH1) Acute Myeloid Leukemia (AML) in the phase 3 AGILE study (ASH 2025) - P3 | "Introduction Ivosidenib (IVO) is an oral, targeted, small-molecule inhibitor of mIDH1 approved for the treatment of ptswith mIDH1 AML. In the pivotal AGILE study of IVO in combination with azacitidine (AZA) in newlydiagnosed AML (NCT03173248), the most common grade ≥3 adverse events (AEs) were hematologic inboth the IVO+AZA and placebo (PBO)+AZA arms (Montesinos, NEJM 2022)...Forexample, venetoclax requires dose reduction when administered concomitantly with CYP3A4i, yetincreased exposure and myelosuppression still occur (Kawedia, AJH 2025)...Population PK modeling predicted theAUC of IVO at SS to increase moderately (<2-fold) when coadministered with voriconazole, fluconazole,and posaconazole—by 48.7%, 60.8%, and 58.8%, respectively—compared with IVO alone...However, low rates of individual AEs limit the ability to draw firm conclusions.IVO exposure was predicted to increase <2-fold when given in combination with moderate/strongCYP3A4i. As concomitant use of..."

Clinical • P3 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Thrombocytopenia • CYP3A4 • IDH1 • TINCR

Improved outcomes with low-dose hypomethylating agent plus venetoclax as post-transplant maintenance in patients undergoing reduced intensity conditioning allogeneic hematopoietic stem cell transplantation for myeloid malignancies (ASH 2025) - "The use of low dosehypomethylating agents (HMAs) such as azacitidine (AZA) or decitabine (DEC) in combination withvenetoclax (VEN) has been shown to be a feasible post-HSCT maintenance strategy in myeloidmalignancies...Patients treated with post-HSCT HMA+VEN maintenance were matched in a 1:1 ratio to patients not receiving maintenancefollowing a hierarchal algorithm based on age at transplant, disease type (AML vs. MDS), risk stratification(ELN for AML and IPSS-M for MDS), disease status at transplant, donor type, Fludarabine/Melphalan(Flu/Mel) conditioning and year of diagnosis...The dose of VEN was reduced to 20mg when administered with voriconazole or posaconazoleor 100mg when administered with fluconazole or isavuconazium...More patients in the maintenancegroup received post-transplant cyclophosphamide-based graft versus host disease (GVHD) prophylaxis,compared to the no maintenance group (49% vs. 31%, p=0.03).Maintenance was initiated after a median of 58d (range..."

Clinical • Post-transplantation • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Neutropenia • Thrombocytopenia • Transplantation

Clinical and microbiological insights into invasive fusariosis following allogeneic hematopoietic stem cell transplantation: A 15-year single-center analysis (ASH 2025) - "Baseline characteristics betweenpatients with and without IF were compared using appropriate parametric and non-parametric tests.Overall survival (OS), and day 28, 84, and 1-year mortality were estimated using the Kaplan–Meiermethod, and univariate comparisons of clinical factors—including age, sex, performance status,conditioning intensity, prior HSCT, neutrophil recovery, monotherapy vs combination therapy withliposomal amphotericin B (L-AMB) and voriconazole (VRCZ), and steroid use—were conducted using thelog-rank test. Seventeen patients with proven IF and 2,342 without IF were analyzed...All patients received antifungalprophylaxis: micafungin (n = 10), posaconazole (n = 4), or VRCZ (n = 3)... Seventeen patients with proven IF and 2,342 without IF were analyzed. The incidence of IFamong allogeneic HSCT recipients was 7.2 cases per 1,000 transplants. Most cases occurred in patientstransplanted in non-complete remission (94.1% vs."

Clinical • Bone Marrow Transplantation • Cerebral Hemorrhage • CNS Disorders • Hematological Malignancies • Infectious Disease • Neutropenia • Septic Shock • Transplantation

A phase 1/2 study of GB3226, a novel dual inhibitor of ENL-yeats and FLT3, in patients with relapsed/refractory Acute Myeloid Leukemia (ASH 2025) - P1/2 | "Phase 2 of the study aims at assessing the efficacy of GB3226, measured by the rate of completeremission (CR) and CR with partial hematologic recovery (CRh).Additionally, the study will explore pharmacodynamic (PD) markers in peripheral blood and bone marrowto elucidate GB3226's biological effects and identify potential biomarkers predictive of clinical response. This open-label, multicenter, seamless Phase 1/2 study will enrol adult patients (aged ≥18years) with R/R AML, who have failed at least one prior line of therapy (e.g., chemotherapy, venetoclax-based regimens). Phase 1 employs a dose-escalation design across three cohorts to assess the impact of CYP3A4 inhibitorson GB3226 PK and safety and define the maximal tolerated dose (MTD).Cohort A: No CYP3A4 modifiersCohort B: Coadministration with strong CYP3A4 inhibitors (e.g., voriconazole, and posaconazole)Cohort C: coadministration with moderate CYP3A4 inhibitors (e.g., isavuconazole)GB3226 is administered..."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • CD14 • FLT3 • HEY1 • HOXA9 • ITGAM • MEIS1

Voriconazole (VCZ) therapeutic drug monitoring (TDM) for prophylaxis and treatment of invasive fungal diseases in hematology patients – daily clinical practice and evidence from clinical trials (ASH 2025) - "VCZ dosing in hematology pts remains complex in daily clinical practice, in particular inchildren and obese pts. While there is evidence supporting TDM to reduce toxicity (AI), there is no clearevidence that efficacy outcome is improved by TDM of VCZ for the management of IFD (BII). Subgroups ofhematology pts benefit from TDM to avoid either too low or excessively high VCZ levels, respectively (AI)."

Clinical • Hematological Malignancies • Infectious Disease • Obesity • Renal Disease • Respiratory Diseases • CYP3A4

Rare Case of Aspergillus fumigatus Isolated from Renal Stone in an Immunocompetent Patient. (PubMed, Int Med Case Rep J) - "The patient was treated with voriconazole intravenously with the loading dose of 6mg/Kg IV 12 hourly for 2 days followed by 4mg/Kg 12 hourly for 7 days...Post-operative follow-up and post-operative radiography did not show evidence of any recurrence. This rare case of fungal etiology in patient having renal stones reveals the importance of closely monitoring postoperative patients, even when typical infection risk factors are absent."

Journal • Infectious Disease • Nephrology • Pain • Pulmonary Disease • Renal Calculi • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Tracheobronchial Aspergillosis Mimicking Pseudotumoral Lesions in a Rare Presentation of a Known Disease. (PubMed, Clin Case Rep) - "The patient experienced marked clinical and endoscopic improvement following systemic voriconazole therapy and bronchoscopic intervention, with near-complete resolution of the lesion. This case highlights the need to consider fungal etiologies in the differential diagnosis of endobronchial masses and emphasizes the essential role of early bronchoscopy, microbiological cultures, and histopathologic evaluation in establishing a timely and accurate diagnosis."

Journal • Infectious Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Intrinsic resistance to short-tailed azoles in the basal fungus Mucor lusitanicus: functional analysis of Cyp51 isoforms and amino acid substitutions. (PubMed, Front Microbiol) - "The basal fungus Mucor lusitanicus (Mlu) is a cause of mucormycosis, with limited treatment options due to intrinsic resistance to short-tailed azoles (fluconazole, voriconazole) and echinocandins. Susceptibility to long-tailed azoles (e.g., posaconazole) remained unchanged for both isoforms. These findings demonstrate the functional expression of MluCyp51-F1 and MluCyp51-F5 isoforms in a phylogenetically distant host and confirm that conserved substitutions Y129F and V293A in MluCyp51-F5 confer intrinsic resistance to short-tailed azoles in M. lusitanicus."

Journal • Infectious Disease

GD06 Terbinafine-resistant Trichophyton indotineae: an analysis of confirmed cases in our regional National Health Service board. (PubMed, Br J Dermatol) - "Of the 10 positive mycological culture samples, three were terbinafine resistant (three of 10, 30%), 10 of 10 were itraconazole sensitive, seven of 10 were micoconazole sensitive, two of 10 were voriconazole sensitive and one of 10 was griseofulvin sensitive. Our findings confirm that terbinafine-resistant T. indotineae has been detected in our regional NHS board, and identified strains appeared to be sensitive in vitro to alternative antimycotics (although they may still be clinically resistant in practice). Globally, all dermatologists should be aware of this emerging organism, perform mycological testing if suspecting a dermatophytosis and liaise with local microbiology teams where terbinafine resistance is confirmed, to allow correct treatment and national monitoring."

Journal • Dermatology • Human Immunodeficiency Virus • Infectious Disease

Myco- and microbiological profiling of a human cadaver reveals drug-resistant strains and new fungal records. (PubMed, Appl Microbiol Biotechnol) - "Sensitivity tests for voriconazole and amphotericin B were also performed, to which several isolates were resistant...Moreover, the identification of drug-resistant strains underscores the importance of biosafety in forensic practice and raises awareness of the potential for pathogen dissemination from decomposing remains. KEY POINTS: • Twenty-six fungi and sixteen bacterial species were identified from the cadaver • New fungal records isolated from human remains, expanding forensic mycology knowledge • Antimicrobial susceptibility testing revealed the presence of drug-resistant fungal and bacterial isolates."

Journal

Species distribution, antifungal susceptibility, and clinical profiles of patients with osteoarticular fungal Infections: A retrospective study. (PubMed, New Microbes New Infect) - "Fungal identification was performed using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), followed by broth microdilution antifungal susceptibility testing for amphotericin B (AMB), fluconazole (FLC), voriconazole (VRC), and posaconazole (POS). Antifungal susceptibility testing revealed VRC and POS as potentially effective therapeutic options for OAFIs. These findings underscore the need for early detection of rare fungal pathogens, susceptibility-guided therapy, and continuous resistance surveillance in managing OAFIs in non-immunodeficient patients."

Journal • Retrospective data • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Musculoskeletal Diseases • Rheumatology

Non-Aspergillus molds. (PubMed, JHLT Open) - "In general, lipid preparations of amphotericin B or azole antifungals (voriconazole, posaconazole, isavuconazole) are frequently used for treatment. Investigational therapies such as fosmanogepix or olorofim are promising as future treatment modalities for some of these difficult-to-treat non-Aspergillus molds."

Journal • Review • Cardiovascular • Hematological Disorders • Infectious Disease • Neutropenia • Respiratory Diseases • Thrombosis • Transplantation

The Use of Antifungal Prophylaxis Is Associated with Worse Outcomes in Patients with Newly Diagnosed AML Treated with Venetoclax/HMA: A Retrospective Analysis of Patients in the Flatiron Health Database (ASH 2024) - "Among patients who received AFP, 172 (41%) received fluconazole, 128 (30%) received voriconazole, 52 (12%) received isavuconazole, and 68 (16%) received posaconazole. This further limited the ability to assess how venetoclax doses were modified. Finally, there may have been selection bias with some patients receiving antifungal prophylaxis because of additional patient or disease-related characteristics that could have impacted outcomes."

Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • ASXL1 • RUNX1 • TP53

Isavuconazole provides effective and tolerable antifungal prophylaxis for patients with acute myeloid leukemia. (PubMed, Leuk Res) - "Voriconazole has been a standard antifungal prophylactic (AFP) agent for patients with acute myeloid leukemia (AML) during neutropenia. Rates/classification of IFI, breakthrough IFI (bIFI) and IFI-free survival (IFI-FS) were comparable between azoles in both analyses. Isavuconazole is an effective AFP agent with a superior side-effect profile and should thus be considered as a promising AFP option for patients with AML."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology

Efficacy of natamycin monotherapy versus combination therapy with voriconazole for fungal keratitis: a randomised clinical trial. (PubMed, Br J Ophthalmol) - P2/3 | "Adjunctive topical voriconazole did not significantly improve clinical outcomes compared with natamycin monotherapy. Natamycin 5% remains an effective first-line treatment, particularly in non-Aspergillus keratitis. Further studies are warranted to explore targeted roles for combination therapy."

Journal • Monotherapy • Infectious Disease • Keratitis • Ocular Inflammation • Ophthalmology • Transplantation

ICG clearance as an indicator of augmented hepatic clearance and subtherapeutic drug concentrations in septic patients. (PubMed, BMC Anesthesiol) - "AHC is a prevalent phenotype in sepsis and identifies a patient subgroup at high risk for subtherapeutic concentrations of hepatically or partially cleared antibiotics. ICG-derived parameters, particularly ICG-PDR, are robust predictors of inadequate drug exposure, supporting the use of dynamic liver function monitoring to optimize antibiotic dosing in septic patients."

Journal • Critical care • Infectious Disease • Septic Shock