tacrolimus XR / Generic mfg. - LARVOL DELTA

COMPARATIVE EFFICACY, SAFETY, AND ADHERENCE OF ONCE-DAILY VERSUS TWICE-DAILY TACROLIMUS IN ADULT KIDNEY TRANSPLANT RECIPIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS (ISN-WCN 2026) - "Qualitative synthesis of adherence outcomes indicated better dose implementation with once-daily prolonged-release in at least one RCT, with overall evidence favoring improved adherence but limited by small numbers and heterogeneous measuresConclusion In adult kidney transplant recipients, once-daily prolonged-release tacrolimus provides efficacy, safety, and pharmacokinetic exposure comparable to twice-daily immediate-release tacrolimus. While graft and renal outcomes appear equivalent, the once-daily regimen may confer an adherence advantage."

Adherence • Retrospective data • Review • Transplant Rejection • Transplantation

AASLD AST Practice Guideline on adult liver transplantation: Diagnosis and management of graft-related complications (AASLD) - "In the absence of contraindications, tacrolimus monotherapy should be considered as maintenance immunosuppression in patients at low risk for rejection (eg, non-immune–mediated liver disease), as it has similar graft survival when compared with combination therapy. (Strong, Level 3)...The addition of or conversion to a mammalian target of rapamycin inhibitor-based immunosuppression may be considered in adult liver transplant recipients transplanted for hepatocellular carcinoma within the Milan criteria to improve recurrence-free survival up to 3 years post-liver transplant. (Weak, Level 3)"

Clinical guideline • Metabolic Dysfunction-Associated Steatohepatitis • Transplantation

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=97 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • ABL1 • ANPEP • BCR • CD22 • CD5 • CD7 • CD79A • MME • MPO

Clinical Practices for the Surveillance of Stable Lung Transplant Recipients Beyond the First Year After Transplant (ISHLT 2026) - "65 (90.3%) of centers used immediate release tacrolimus as their first line calcineurin inhibitor, whereas 7 (9.7%) used extended-release tacrolimus...Most centers agree that standardization of monitoring may benefit patient care and research implementation and design. A consensus statement regarding monitoring of stable recipients may be helpful moving forward."

Clinical • Nephrology • Renal Disease • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Jun 2026 ➔ Oct 2015

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Astellas Pharma Europe Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2016 ➔ Jun 2026

Enrollment closed • Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Nov 2015 ➔ Dec 2016

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Jun 2015 ➔ Nov 2015

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Dec 2014 ➔ Jun 2015

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial completion date: May 2026 ➔ Dec 2025

Trial completion date • Pediatrics • Transplantation

Establishment of accurate estimation equations for area under the concentration curves using simultaneous limited sampling for extended-release tacrolimus and mycophenolic acid in kidney transplant recipients. (PubMed, Front Immunol) - "This study demonstrated that LSS using C0-C1-C3-C6 reliably and accurately estimated both the actual TAC-ER AUC0-24 and MPA AUC0-12 simultaneously in kidney transplant recipients. These equations can be feasibly implemented in outpatient clinical settings to reduce time and cost."

Journal • Retrospective data • Nephrology • Transplantation

Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Transplantation

Financial burden of once daily extended-release tacrolimus and twice daily immediate-release tacrolimus for kidney transplant recipients. (PubMed, Explor Res Clin Soc Pharm) - "No additional financial burden was placed on patients taking LCPT. However, patients with high copay or deductible primary insurance are at risk for high out-of-pocket costs for both IR-Tac and LCPT."

Journal • Transplantation

Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Oncology • Transplantation • UGT1A1

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Stanford University | Trial completion date: Dec 2025 ➔ Nov 2027 | Trial primary completion date: Dec 2025 ➔ Nov 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • Transplantation • HLA-B • HLA-C • HLA-DRB1

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Suspended ➔ Recruiting

Enrollment open • Myelofibrosis • Transplantation

Transition of Immediate Release (IR) to Extended Release (XR) Tacrolimus in Pediatric Renal Transplant Patients – An Analysis of Pharmacokinetic and Clinical Outcomes (ASHP 2025) - No abstract available

Clinical • Clinical data • PK/PD data • Pediatrics • Transplantation

Early Conversion to Once-Daily MeltDose® Extended-Release Tacrolimus (LCPT) in Liver Transplant Patients. (PubMed, J Clin Med) - "Self-reported treatment adherence was good and consistent throughout the study. The early switch from IR-Tac to LCPT was safe and effective in our cohort and may be particularly beneficial for patients with suboptimal liver and renal function following LT."

Journal • Dermatology • Fatigue • Metabolic Disorders • Movement Disorders • Nephrology • Transplant Rejection • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=81 | Completed | Sponsor: Astellas Pharma Europe Ltd. | Active, not recruiting ➔ Completed

Trial completion • Pediatrics • Transplantation

Tacrolimus Conversion in CYP3A5*1 Expressers: From Immediate-Release to LCP Formulation. (PubMed, Ther Drug Monit) - "These results suggest that CYP3A5 genotype should be considered when adjusting the tacrolimus dose during conversion from Tac-IR to Tac-LCP. C0 values may not adequately reflect the higher exposure observed in CYP3A5*1 expressers, highlighting the importance of AUC0-24h in guiding dose adjustment."

Journal • Solid Organ Transplantation • Transplantation • CYP3A5

Managing Delayed or Missed Doses of Prolonged-Release Tacrolimus in Transplant Recipients: Implications for Drug Exposure and Recovery Strategies. (PubMed, Basic Clin Pharmacol Toxicol) - "For delays shorter than 12 h, the full dose should be taken immediately; for delays between 12 and 24 h, half the dose should be administered; for a missed dose, 150% should be given at the next intake. These strategies may help maintain therapeutic exposure and preserve transplant outcomes."

Journal • Transplantation

Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center

New P2 trial • Hematological Malignancies • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Transplantation

Red Is Not Always Bad: Vin Rosé Urine in a Kidney Transplant Patient with Sickle Cell Crisis (KIDNEY WEEK 2025) - "His treatment included Tacrolimus ER, Cellcept, Prednisone, Hydroxyurea, Deferiprone, Apixaban, Pregabalin, Nifedipine and Methadone. However, as urinalysis experts nephrologists should be aware of it. Figure 1: Vin rosé urine"

Clinical • Anemia • Chronic Kidney Disease • CNS Disorders • Epilepsy • Genetic Disorders • Glomerulonephritis • Infectious Disease • Lupus Nephritis • Nephrology • Renal Calculi • Renal Disease • Sickle Cell Disease • Transplantation

Plasmapheresis as Rescue Therapy for Early Recurrent Lupus Nephritis After Kidney Transplantation (KIDNEY WEEK 2025) - "She was not sensitized and received rabbit antithymocyte globulin for induction and maintenance immunosuppression with extended-release tacrolimus, mycophenolate, and low-dose steroids...Low-level CMV viremia (552 IU/mL) developed, prompting valganciclovir initiation. Due to worsening function and concern for CMV, plasmapheresis was initiated in lieu of cyclophosphamide...Low-level CMV may have contributed to collapsing glomerulopathy in the absence of APOL1 risk variants. Early LN recurrence requires nuanced management balancing aggressive immunosuppression and infection risk, and alternative therapies such as plasmapheresis should be considered."

Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Transplantation

Two Step Haplo With Radiation Conditioning (clinicaltrials.gov) - P2 | N=63 | Recruiting | Sponsor: Thomas Jefferson University | Suspended ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Adult T-Cell Leukemia-Lymphoma • Anemia • Aplastic Anemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Essential Thrombocythemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Polycythemia Vera • Small Lymphocytic Lymphoma • Thrombocytosis • Transplantation