{"id":"fluvastatin-tacrolimus-mycophenolat-mofetil","rwe":[],"tags":[],"safety":{"boxedWarnings":["Increased risk of infection and malignancy (Tacrolimus, Mycophenolate Mofetil)"],"drugInteractions":[{"drug":"Cyclosporine","interaction":"Increased risk of nephrotoxicity"},{"drug":"Aspirin","interaction":"Increased risk of bleeding"},{"drug":"Antacids","interaction":"Reduced absorption of Tacrolimus"}],"commonSideEffects":[{"effect":"Headache","drugRate":"10%","severity":"Mild"},{"effect":"Nausea","drugRate":"8%","severity":"Mild"},{"effect":"Diarrhea","drugRate":"12%","severity":"Moderate"},{"effect":"Fatigue","drugRate":"7%","severity":"Mild"},{"effect":"Increased liver enzymes","drugRate":"5%","severity":"Moderate"},{"effect":"Tremor","drugRate":"4%","severity":"Mild"},{"effect":"Anemia","drugRate":"6%","severity":"Moderate"},{"effect":"Leukopenia","drugRate":"3%","severity":"Moderate"}],"contraindications":["Hypersensitivity to any component of the drug (all)","Severe hepatic impairment (Fluvastatin)","Pregnancy (Tacrolimus, Mycophenolate Mofetil)"],"specialPopulations":{"Geriatric":"Increased sensitivity to side effects; monitor closely.","Pediatric":"Use in pediatric patients is generally safe but requires dose adjustments.","Renal Impairment":"Dose reduction may be necessary.","Hepatic Impairment":"Contraindicated in severe hepatic impairment (Fluvastatin)."}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"drug":"Fluvastatin","expiry":"2023","patentNumber":"US5006528A"},{"drug":"Tacrolimus","expiry":"2022","patentNumber":"US4888399A"},{"drug":"Mycophenolate Mofetil","expiry":"2024","patentNumber":"US5286730A"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1994","type":"Approval","milestone":"FDA approval of Fluvastatin","regulator":"FDA"},{"date":"1994","type":"Approval","milestone":"FDA approval of Tacrolimus","regulator":"FDA"},{"date":"1995","type":"Approval","milestone":"FDA approval of Mycophenolate Mofetil","regulator":"FDA"},{"date":"2023","type":"Generic Entry","milestone":"Generic entry for Fluvastatin","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Fluvastatin, Tacrolimus, and Mycophenolate Mofetil are immunosuppressive and lipid-lowering drugs primarily used in transplant patients and for managing hypercholesterolemia. Fluvastatin is a statin that reduces cholesterol by inhibiting HMG-CoA reductase. Tacrolimus is an immunosuppressant that prevents organ rejection by inhibiting T-cell activation. Mycophenolate Mofetil is another immunosuppressant that works by inhibiting purine synthesis in lymphocytes. These drugs are prescribed in combination therapy to manage the complex needs of transplant patients and those with autoimmune conditions. Each drug has distinct mechanisms and side effect profiles, requiring careful monitoring and management.","ecosystem":[],"mechanism":{"target":["HMG-CoA reductase","T-cell activation","IMP dehydrogenase"],"novelty":"These drugs represent established treatments with well-characterized mechanisms and extensive clinical use.","modality":["Oral","Oral/Intravenous","Oral"],"drugClass":["Statins","Immunosuppressants","Immunosuppressants"],"explanation":"Fluvastatin lowers cholesterol by inhibiting HMG-CoA reductase, while Tacrolimus and Mycophenolate Mofetil suppress the immune system to prevent organ rejection.","oneSentence":"Fluvastatin, Tacrolimus, and Mycophenolate Mofetil work through different mechanisms to manage hypercholesterolemia and prevent organ rejection in transplant patients.","technicalDetail":"Fluvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis. Tacrolimus binds to FKBP12, forming a complex that inhibits calcineurin, preventing T-cell activation. Mycophenolate Mofetil is converted to mycophenolic acid, which inhibits IMP dehydrogenase, a key enzyme in the de novo purine synthesis pathway in lymphocytes."},"_scrapedAt":"2026-03-27T23:30:50.931Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"5%","launchDate":"1994 (Fluvastatin), 1994 (Tacrolimus), 1995 (Mycophenolate Mofetil)","annualCostUS":"$10,000 - $20,000 per patient per year","currentRevenue":"$150 million","patientPopulation":"Approximately 100,000 transplant patients and 500,000 hypercholesterolemia patients","peakSalesEstimate":"$500 million"},"references":[],"biosimilars":[],"competitors":["Simvastatin (hypercholesterolemia)","Sirolimus (immunosuppression)","Azathioprine (immunosuppression)"],"indications":{"approved":["Hypercholesterolemia (Fluvastatin)","Prevention of organ rejection in kidney, liver, and heart transplants (Tacrolimus)","Prevention of organ rejection in kidney transplants (Mycophenolate Mofetil)"],"offLabel":["Management of autoimmune diseases (Tacrolimus, Mycophenolate Mofetil)"],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00223015","phase":"PHASE4","title":"Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation","status":"COMPLETED","sponsor":"University Hospital Schleswig-Holstein","startDate":"2004-05","conditions":"Renal Transplantation","enrollment":15}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[{"drug":"Fluvastatin","company":"Teva Pharmaceuticals"},{"drug":"Tacrolimus","company":"Sandoz Inc."},{"drug":"Mycophenolate Mofetil","company":"Apotex Inc."}],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Fluvastatin, Tacrolimus, Mycophenolat Mofetil","genericName":"Fluvastatin, Tacrolimus, Mycophenolat Mofetil","companyName":"University Hospital Schleswig-Holstein","companyId":"university-hospital-schleswig-holstein","modality":"Small molecule","firstApprovalDate":"1994 (Fluvastatin), 1994 (Tacrolimus), 1995 (Mycophenolate Mofetil)","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"patentsNormalised":[{"patent_number":"US4888399A","territory":"US","patent_type":"","expiry_date":"2022-06-01T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"US5006528A","territory":"US","patent_type":"","expiry_date":"2023-06-01T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"US5286730A","territory":"US","patent_type":"","expiry_date":"2024-06-01T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}