tacrolimus XR / Generic mfg. - LARVOL DELTA

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

Tacrolimus-Associated Tremor in Renal Transplant Patients: Potential Impact of the Galenic Formulation. (PubMed, Pharmaceuticals (Basel)) - "Extended-release tacrolimus (LCPT) has demonstrated efficacy in reducing tremor severity, as evidenced by studies employing quality of life (QoL) questionnaires, the Fahn-Tolosa-Marin (FTM) scale, and Accelerometer devices... The conversion to the LCPT formulation significantly reduced tremors in kidney transplant recipients without altering their immunological status, as confirmed through a panel of immunologic and pharmacodynamic biomarkers. The DyCare device enables a precise quantification of tremors in transplant recipients, allowing physicians to optimize treatment strategies."

Journal • Essential Tremor • Movement Disorders • Solid Organ Transplantation • Transplant Rejection • Transplantation • CXCL10 • IFNG • IL10 • MIR210

New-Onset Diabetes After Transplantation in Renal Recipients: A Pilot Comparative Study of Immediate vs. Extended-Release Tacrolimus Formulation. (PubMed, Pharmaceuticals (Basel)) - "The release-clinical outcome correlation requires validation in larger multicenter studies. These results contribute to the evidence base for tacrolimus formulation selection in renal transplant patients and other associated pathologies."

Journal • Diabetes • Metabolic Disorders • Nephrology • Transplantation

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis (clinicaltrials.gov) - P2 | N=20 | Suspended | Sponsor: Fred Hutchinson Cancer Center | Recruiting ➔ Suspended | Trial primary completion date: Aug 2026 ➔ Apr 2027

Trial primary completion date • Trial suspension • Myelofibrosis • Transplantation

Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2025 ➔ Sep 2026

Checkpoint inhibition • Trial completion date • Basal Cell Carcinoma • Colorectal Cancer • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation • BRAF • MSI

CSPC Pharmaceutical Group Limited…is pleased to announce that Tacrolimus Extended-release Capsules (0.5mg, 1mg) (the ‘‘Product’’) developed by the Group have obtained drug registration approval from the National Medical Products Administration of the People’s Republic of China and are deemed to have passed the consistency evaluation of quality and efficacy of generic drugs (HKEXnews) - "The Product is indicated for the prophylaxis of graft rejection after kidney transplantation, for the prophylaxis of graft rejection during the maintenance phase after liver transplantation..."

Generic launch • Transplant Rejection

Optimizing Dose Conversion from IR-Tac to LCP-Tac Formulations in Renal Transplant Recipients: A Population Pharmacokinetic Modeling Study. (PubMed, Pharmaceutics) - "The extended-release once-daily tacrolimus (LCP-Tac) formulation provides enhanced bioavailability and a sustained pharmacokinetic profile compared to the immediate-release twice-daily tacrolimus (IR-Tac) formulation...LCP-Tac's enhanced bioavailability requires dose reduction, greater in expressers when switching from IR-Tac. These genotype-specific recommendations provide clinically actionable guidance to complement therapeutic drug monitoring and support more individualized conversion protocols in renal transplantation."

Journal • PK/PD data • Nephrology • Transplantation • CYP3A5

Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant (clinicaltrials.gov) - P2 | N=63 | Suspended | Sponsor: Thomas Jefferson University | Recruiting ➔ Suspended

Trial suspension • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Adult T-Cell Leukemia-Lymphoma • Anemia • Aplastic Anemia • Bone Marrow Transplantation • 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

Evaluation of GLP-1 Receptor Agonists Use in Post-Kidney Transplant Recipients with Type 2 Diabetes Mellitus (WTC 2025) - "Exclusion criteria included history of other organ transplants or bariatric surgery, pregnant women, prisoners, and patients who were on sirolimus or belatacept...There was no difference in tacrolimus levels between immediate-release or extended-release tacrolimus formulations at all time points... GLP-1RAs did not significantly change tacrolimus levels within 28 days of initiation. GLP-1RAs did not significantly affect HbA1C but did have weight loss benefits in KT patients."

Clinical • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Genetic Disorders • Hypertension • Metabolic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease • Solid Organ Transplantation • Transplantation • Type 2 Diabetes Mellitus

Influence of Extended-Release Tacrolimus Metabolism Rate on BKV Infection in Renal Transplant Recipients (WTC 2025) - "Unlike TAC IR, the rapid metabolism of TAC XR was not associated with BKV post-renal transplantation."

Clinical • Infectious Disease • Nephrology • Transplantation

Extended-Release Tacrolimus Dosing in Obese Kidney Transplant Recipients (WTC 2025) - "Obese patients receiving TAC XR had a shorter time to therapeutic trough compared to non-obese patients and required a lower weight-based TAC XR dose. When initiating TAC XR, a lower starting dose should be utilized in obese patients, with additional considerations for age and race."

Clinical • Obesity • Solid Organ Transplantation • Transplantation

Improved Tacrolimus XR Dosing and Monitoring Outcomes with a Genotype-Based Dosing Algorithm vs. Weight Based Dosing (WTC 2025) - "This matched cohort analysis assessing a genotype-based dosing algorithm demonstrated improved tac XR dosing efficiency. Patients, on average, needed 2 fewer dose adjustments, spent longer time in therapeutic range and had significantly less time in concerning range. It is likely this algorithm is also cost effective."

Diabetes • Metabolic Disorders • Transplant Rejection • CYP3A5

Implementation of a Standardized Immunosuppression Protocol in an Established Kidney Transplant Program Produces Improved Results (WTC 2025) - "Pertinent protocol changes included lowering anti-thymocyte globulin goal dose to 4.5 mg/kg and initiating de novo weight-based tacrolimus extended-release 0.1 mg/kg on POD 1 for immunosuppression. All patients received mycophenolate sodium (1440 mg/day) with or without corticosteroids depending on risk stratification.* This was a retrospective, single-center cohort study of KTRs at our transplant center transplanted from 10/21/21 to 8/31/24... The implementation of a standardized immunosuppression protocol in kidney transplantation demonstrated favorable outcomes with stable graft function and rejection rates comparable to previous regimens, while utilizing lower doses of anti-thymocyte globulin for induction immunosuppression. This demonstrates improved quality with lower costs."

Clinical • Solid Organ Transplantation • Transplant Rejection • Transplantation

Impact of Immunosuppressive Drug Levels on Microvascular Inflammation in Kidney Transplant Recipients without DSA and C4d Deposition (WTC 2025) - "All recipients received induction therapy with basiliximab and maintenance immunosuppressive therapy consisting of extended-release tacrolimus, MMF, and/or everolimus, with or without steroids. The results indicate that lower trough levels of tacrolimus and everolimus are associated with a higher incidence of antibody-independent MVI, highlighting the need for tailored immunosuppressive regimens in kidney transplantation. Further research is warranted to optimize immunosuppressive drug concentrations to improve long-term graft outcomes."

Clinical • Inflammation • Transplantation • Urology

Changes in Renal Function After Switching to Extended-Release Tacrolimus in Heart Transplant Recipients (WTC 2025) - "In our study of cardiac transplant recipients, switching from IR to Tac-XR had no impact on short-term GFR or albuminuria at 4 weeks, nor on long-term GFR at 1 year."

Clinical • Chronic Kidney Disease • Renal Disease • Transplantation • CST3 • CYP3A5

Assessment of De Novo Extended-Release Tacrolimus Weight-Based Dosing Compared to Immediate-Release Tacrolimus in Kidney Transplant Recipients Leads to Improved Outcomes (WTC 2025) - "The use of de novo tacrolimus XR weight-based dosing in KTRs demonstrated a shorter time to therapeutic trough level and a higher percentage of trough levels within goal. Despite this observation, no difference in biopsy-proven acute rejection and graft function were identified. Tacrolimus XR was well tolerated and regardless of higher weight-based dosing, a lower incidence of DGF was observed."

Clinical • Solid Organ Transplantation • Transplant Rejection • Transplantation

Efficacy and Safety of De Novo Extended-Release Tacrolimus Weight-Based Dosing in Obese vs. Non-Obese Kidney Transplant Recipients (WTC 2025) - "Among KTRs, de novo tacrolimus XR weight-based dosing utilizing ABW yielded consistent trough concentrations and exposure among different BMI categories."

Clinical • Genetic Disorders • Obesity • Solid Organ Transplantation • Transplantation

Effect of CYP3A4 Methylation on Tacrolimus Pharmacokinetics. (PubMed, Ther Drug Monit) - "Increased methylation of 1 of the 10 methylation probes within the CYP3A4 gene region (cg19046783) was positively correlated with increased dose-normalized AUC0-24h, which explained 18% of the variation in the dose-normalized AUC0-24h using univariate linear regression."

Journal • PK/PD data • Transplantation • CYP3A4 • CYP3A5