mycophenolate sodium / Generic mfg. - LARVOL DELTA

Pharmacokinetics of mycophenolic acid in plasma and peripheral blood mononuclear cells and its relationship with activity of inosine monophosphate dehydrogenase in Chinese adult kidney allograft recipients. (PubMed, Front Pharmacol) - "Plasma and PBMC samples were collected 0-12 h after administration of mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS) 2 weeks after initiation of immunosuppressive therapy. The IC50 of plasma and PBMC MPA on IMPDH activity were 2.76 μg/mL and 0.023 ng/106 cells for MMF, 3.34 μg/mL and 0.052 ng/106 cells for EC-MPS, respectively. Measurement of MPA concentration and IMPDH activity in PBMCs serves as a complementary method to routine clinical therapeutic drug monitoring, which provide basis for the individual therapy of MPA in Chinese kidney allograft recipients."

Journal • PK/PD data

Orthotopic liver transplant recipient with Enteric-coated Mycophenolate Sodium induced small bowel ulcers: two case reports. (PubMed, BMC Surg) - No abstract available

Journal • Gastrointestinal Disorder • Transplantation

Autoimmune Hepatitis Profiles After Liver Transplantation in Latin American Patients: A Cluster Analysis of Clinical Outcomes. (PubMed, Hepatol Res) - "This analysis identifies key predictors that define high-risk clusters for early and long-term outcomes in Latin American AIH patients post-LT, highlighting potential region-specific factors."

Clinical data • Journal • Autoimmune Hepatitis • Immunology • Inflammation • Rare Diseases • Transplantation

Pharmacokinetics and abbreviated AUC model of enteric-coated mycophenolate sodium in early kidney transplant recipients receiving tacrolimus. (PubMed, Sci Rep) - "Enteric-coated mycophenolate sodium (EC-MPS) is used in kidney transplant recipients (KTRs) as an alternative to mycophenolate mofetil for improved gastrointestinal tolerability. A practical three-point abbreviated AUC model provides accurate estimation and may improve TDM in tacrolimus-treated recipients. Validation in larger, more diverse cohorts is warranted."

Journal • PK/PD data • Transplantation

A Case of Atypical Hemolytic Uremic Syndrome and Scleroderma Renal Crisis Successfully Treated with Ravulizumab (KIDNEY WEEK 2025) - "She was initially treated with eculizumab then ravulizumab leading to remission...For her scleroderma maintenance therapy, she remains on Rituximab and myfortic with close monitoring by her rheumatologist...Scleroderma renal crisis is typically treated with ACE inhibitors, and more experimental therapies include plasma exchange therapy, bosentan, and prostacyclin. Given that scleroderma renal crisis and aHUS are both likely triggered by an overactive complement system, it is reasonable that these conditions can be associated with one another and treated with complement inhibitors. This case illustrates yet another example of safe long-term maintenance therapy on a long-acting C5 complement inhibitor in a case of scleroderma renal crisis and aHUS."

Clinical • Acute Kidney Injury • Anemia • Atypical Hemolytic Uremic Syndrome • Cardiovascular • Complement-mediated Rare Disorders • Congestive Heart Failure • Fatigue • Heart Failure • Hematological Disorders • Hypertension • Immunology • Nephrology • Renal Disease • Rheumatology • Scleroderma • Systemic Sclerosis

A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications (clinicaltrials.gov) - P3 | N=102 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Dec 2033 ➔ Jun 2034

Trial completion date • Transplantation

Adverse Gastrointestinal Symptoms and Inflammatory Bowel Disease Secondary to Enteric Coated Mycophenolate Sodium (ACG 2025) - "Introduction: Gastrointestinal symptoms are a common side effect of the immunosuppressant drug mycophenolate mofetil (MMF), prompting the development of enteric coated mycophenolate sodium (MPS)...Here we present a novel case of persistent diarrhea and histological mimicry of inflammatory bowel disease due to use of MPS.Case Description/ 22 yo female with history of linear morphea and irritable bowel syndrome (IBS) who was on treatment with methotrexate and prednisone developed worsening of her morphea in October 2024...After discussion with her dermatologist, the MPS was discontinued with plan to switch to upadacitinib...Biopsies showed histology mimicking inflammatory bowel disease, a known sequelae of MMF, during use of MPS. This case demonstrates that while rare, MPS may cause colitis similar to that caused by MMF."

Cardiovascular • Dermatology • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Inflammation • Inflammatory Bowel Disease

Mycophenolate-Induced Multifocal Colonic Strictures: A Rare Presentation of Drug-Associated Colitis (ACG 2025) - "Introduction: Mycophenolate mofetil (MMF) is an inosine monophosphate inhibitor that selectively suppresses lymphocyte proliferation and is thus widely used in transplant medicine to prevent graft rejection. Management typically includes discontinuation or dose reduction, though this can be difficult in transplant patients with high immunologic risk. Our highly sensitized patient was switched to lower-dose enteric-coated mycophenolate sodium and scheduled for sequential colonic dilatations.Figure: Coronal (left) and sagittal (right) views of descending colon stricture.Figure: Colonic stricture seen on colonoscopy prior to dilation (left) and stricture seen through balloon dilator (right)"

Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Nephrology • Pediatrics • Transplant Rejection

HYPERCALCEMIA, A RARE MANIFESTATION OF A PNEUMOCYSTIS JIROVECII PNEUMONIA (PJP) INFECTION IN RENAL TRANSPLANT PATIENT: A CASE REPORT (CHEST 2025) - "CASE PRESENTATION: A 73-year-old male with a history of ESRD status post two DDKTs, prostate cancer treated with prostatectomy, and an 80-pack-year smoking history was immunosuppressed with cyclosporine, prednisone, belatacept, and Myfortic...He was treated with loop diuretics, calcitonin, and zoledronic acid...He was initially treated with Bactrim, later transitioned to Atovaquone for 21 days, with plans for long-term PJP prophylaxis... PJP-associated hypercalcemia can present subtly. In this case, it was repeatedly treated and investigated, ultimately becoming a diagnosis of exclusion after BAL samples tested positive for PJP. While PJP typically presents with respiratory symptoms such as cough and shortness of breath, this case was unique, with initial symptoms of fatigue, generalized weakness, and hypercalcemia.Therefore, in patients with respiratory symptoms, concerning imaging findings, and/or hypercalcemia, it is essential to not only evaluate the hypercalcemia..."

Case report • Clinical • Anorexia • Chronic Kidney Disease • Cough • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Human Immunodeficiency Virus • Immunology • Infectious Disease • Metabolic Disorders • Pneumonia • Prostate Cancer • Rare Diseases • Renal Disease • Respiratory Diseases • Sarcoidosis • Solid Organ Transplantation • Solid Tumor • Transplantation

Optimizing Mycophenolate Therapy in Renal Transplant Patients Using Machine Learning and Population Pharmacokinetic Modeling. (PubMed, Med Sci (Basel)) - "This study demonstrates the potential of integrating machine learning with population pharmacokinetic modeling to improve the understanding of MPA variability and support individualized dosing strategies in renal transplant recipients. The developed PopPK/ML models provide a methodological foundation for future research toward more personalized immunosuppressive therapy."

Journal • PK/PD data • Nephrology • Transplantation

Identification of Drugs Associated With Oral Ulcers Based on Pharmacovigilance. (PubMed, Int Dent J) - "This study systematically identified approximately 289 drugs significantly associated with oral ulcer risk, including immunosuppressants, cardiovascular drugs and bronchodilators. Based on pharmacovigilance signal detection and regression analysis, patients on long-term treatment with these drugs should receive enhanced oral monitoring. As this is an observational study, further prospective and experimental research is needed to confirm causality."

Adverse events • Journal • Cardiovascular • Pain

A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications (clinicaltrials.gov) - P3 | N=102 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Dec 2031 ➔ Dec 2033 | Trial primary completion date: Dec 2030 ➔ Dec 2032

Trial completion date • Trial primary completion date • Transplantation

Real world effectiveness of Mycophenolate-sodium therapy in patients at risk with Graves' orbitopathy. (PubMed, Thyroid Res) - "While inactivation is most often achieved, the severity of the disease in form of fibrosis (lid retraction, motility) and proptosis is not reversed. Further rehabilitative surgery is needed and patients should still be closely monitored for DON. Other immunosuppressants could be more effective even in IVMP resistant GO and should be subject to randomized head-to-head trials."

Journal • Real-world evidence • Fibrosis • Immunology • Inflammation • Ophthalmology • Thyroid Eye Disease

A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants. (PubMed, J Zhejiang Univ Sci B) - "Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety."

Journal • Solid Organ Transplantation • Transplantation

Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Sep 2026 | Trial primary completion date: Jan 2027 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Managing a Paradox: Exacerbation of Pemphigus Vulgaris Following Rituximab Infusion (EADV 2025) - "He had previously completed three cycles of rituximab over the past year without complications and had discontinued oral prednisolone shortly after the third cycle...Prior treatments with systemic corticosteroids, mycophenolate sodium, and azathioprine had failed to achieve adequate disease control before the initiation of rituximab... This case highlights a rare but clinically significant complication—paradoxical exacerbation of pemphigus vulgaris following rituximab infusion. Although the underlying mechanism remains unclear, such flares have been observed with both the original rituximab drug and biosimilars. The absence of previous adverse reactions does not eliminate the risk of future flares, nor does a prior exacerbation necessarily predict recurrence."

Dermatology • Hematological Disorders • Immunology • Obesity • Osteoporosis • Pemphigus Vulgaris • Rheumatology • CD20

A Case Series of Ruptured Fungal Mycotic Pseudoaneurysms in Renal Transplant Patients. (PubMed, Ann Vasc Surg) - "All patients underwent immunosuppression induction with rabbit anti-thymocyte globulin and high-dose steroids, and following transplant, were managed with a triple therapy immunosuppression regimen of mycophenolate sodium, a prednisone taper, and tacrolimus, as well as an infection prophylaxis regimen of valganciclovir, clotrimazole, and sulfamethoxazole-trimethoprim. MPs in immunocompromised transplant patients may not present with infectious symptoms before rupture, but infection should be considered in acutely bleeding transplant patients. Open and endovascular approaches can be employed to control hemorrhage; however, infection risk must be considered with prosthetics."

Journal • Candidiasis • Cardiovascular • Hematological Disorders • Infectious Disease • Transplantation

Pharmacokinetics and Bioequivalence of Mycophenolate Sodium Enteric-Coated Tablets Under Fasting and Fed Conditions: A Single-Dose, Open-Label, Four-Period Replicated Crossover Study in Healthy Chinese Male Subjects. (PubMed, Drug Des Devel Ther) - P=N/A | "Both formulations were well tolerated in healthy Chinese males. http://www.chictr.org.cn/, Registration No: ChiCTR2300075403."

Clinical • Journal • PK/PD data • Transplantation

Published population pharmacokinetic models of mycophenolate sodium: a systematic review and external evaluation in a Chinese sample of renal transplant recipients. (PubMed, Front Pharmacol) - "To advance individualized medication for MPS based on popPK, future research must prioritize the investigation of potential covariates. This will enable identification of key factors influencing MPS model predictability and facilitate the development of a popPK model suitable for patients in our hospital."

Journal • PK/PD data • Transplantation

Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis (clinicaltrials.gov) - P=N/A | N=72 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

To evaluate the short and long term outcomes of renal transplant recipients with low dose Everolimus, Tacrolimus - based minimal quadruple immunosuppressive regimen. (PubMed, Immunopharmacol Immunotoxicol) - "Group-I (n = 25) comprised of low dose everolimus (0.5 mg/bd) (EVR), low dose Tacrolimus (1mg/bd), low dose mycophenolate sodium (360mg/bd) and prednisolone. Proteinuria and hyperlipidemia were comparable between the groups. The low dose quadruple immunosuppression protocol was a better option for long-term graft survival with fewer complications."

Journal • Dyslipidemia • Nephrology • Transplantation

Diet and Diagnosis: Unveiling Secondary Oxalate Nephropathy in a Kidney Transplant Recipient (WTC 2025) - "Her post-transplant course had been complicated by nausea, vomiting, dysphagia, and poor oral intake with Helicobacter pylori confirmed by an upper endoscopy two weeks prior to presentation; she was treated with famotidine, omeprazole, metronidazole, and tetracycline, leading to resolution of symptoms and normalization of her nutritional intake. Upon admission, tacrolimus levels were overall therapeutic (5-12 ng/ml); she remained on prednisone 5 mg daily and mycophenolate sodium 360 mg BID... Excessive dietary oxalate is the second most common cause of SON. In addition to high oxalate intake, recent H. pylori treatment could have contributed through altered gut microbiome, leading to hyper-absorption of oxalate. Outcomes in SON are poor, with over 50% of cases requiring renal replacement therapy, most remaining dialysis dependent."

Clinical • Chronic Kidney Disease • Diabetic Nephropathy • Gastrointestinal Disorder • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • Transplantation

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

Expression of CD40 on Monocytes and Lymphocytes in Kidney Transplant Patients (WTC 2025) - "Forty-seven KTIP were under standard maintenance immunosuppression therapy (SMIT) including calcineurin inhibitors, purine pathway inhibitors (mycophenolate sodium or azathioprine), and 16 patients were under steroid-free immunosuppression (SFI). Overall, these results show differences in CD40 expression on B cells and monocytes in renal transplant patients. Furthermore, different immunosuppression maintenance protocols affect CD40 expression on monocytes rather than B cells."

Clinical • IO biomarker • Inflammation • Transplantation • CD40 • CD40LG

Haplo Peripheral Blood Sct In GVHD Prevention (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Zachariah Michael DeFilipp | Active, not recruiting ➔ Completed

Trial completion • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Graft versus Host Disease • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Leukemia • Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-B • HLA-C