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19 protocols using myfortic

1

Immunosuppressive Regimen for Organ Transplant

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Depending on routine induction medication, basiliximab was administered at a dose of 20 mg/day at the time of surgery and on the fourth postoperative day. All patients received triple immunosuppressive therapy regimens consisting of tacrolimus, mycophenolate mofetil, and methylprednisolone. Any patient who did not receive this regimen was excluded from the study. Tacrolimus (FK506, Prograf; Astellas Fujisawa, Osaka, Japan, and generic tacrolimus) was started on postoperative day 5 at 0.1 to 0.15 mg/kg/day and adjusted to maintain whole-blood trough level at 8 to 10 ng/mL for 1 month postoperatively and administered at 6 to 8 ng/mL until 3 months and tapered down thereafter. Mycophenolate mofetil (Myfortic; Novartis Pharma AG, Basel, Switzerland) was started at a dose of 500 to 1000 mg/day on postoperative day 3 and adjusted according to the general condition of the recipient considering the potential for opportunistic infection. Methylprednisolone was started on the day of surgery at an intravenous dose of 500 mg/day, administered for 2 days, and then tapered by half every day to 60 mg/day. Thereafter, oral methylprednisolone was administered at 32 mg/day for 7 days, at 16 mg/day for the next 2 weeks, at 8 mg/day for the next month, and at 4 mg/day for maintenance.
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2

Kidney Transplant Immunosuppressive Regimen

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The typical immunosuppressive regimen at our institute was described previously.[9 (link)] All kidney recipients receive basiliximab (Simulect, Novartis Pharmaceuticals Co., Basel, Switzerland) 20 mg on POD0 and 4 or antithymocyte globulin (ATG) (Thymoglobulin, Sanofi Genzyme, Cambridge, MA) 1.25 mg/kg from POD0 to 4 as induction immunosuppressants (in case of highly sensitized patients or expanded criteria deceased donor). Maintenance immunosuppression consists of tacrolimus (Tacrobell, Chong Kun Dang Pharmaceuticals Co., Seoul, Korea; Prograf, Astellas Pharma Inc., Toyama, Japan), corticosteroid, and either mycophenolate mofetil (Cellcept, Hoffmann-La Roche Inc., Nutley, NJ) or mycophenolate sodium (Myfortic, Novartis Pharmaceuticals Co.).
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3

Xenogeneic and Allogeneic Islet Transplantation

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Age-matched mice were used as no pre-vascularization controls, delivering the islet/collagen mixture (with HUVEC) using the PE90 tubing into the unmodified subcutaneous space.
Xenogeneic islet transplantations into the SCID/bg mouse did not require any immunosuppression. For allogeneic rat islet transplantations (Supplementary Figure 1B), the recipients were immunosuppressed using a combination of anti-lymphtocyte serum (ALS, Lot:
J2445 and J2546, Accurate Chemical Scientific Corporation), mycophenolic acid (Myfortic, Novartis) and FTY-720 (fingolimod, Biorbyt). ALS was administered as a single i.p. injection (0.5-0.75 mL, dosage determined by lot) 3 days prior to allogeneic islet transplantation. Starting on the day of islet transplantation and daily for the entire duration of the experiment, rats were administered MMF (20 mg/kg, which was tapered to 0 mg/kg between day 14 to 21) and FTY-720 (2 mg/kg) via oral gavage. For long term rat studies, an additional injection of ALS was given at day 21 post transplantation.
For mice, the non-fasting blood glucose (NFBG) levels were monitored until day 28 for animals in the unmodified subcutaneous space and day 42 for animals in the MAA-coated or uncoated groups. For rats, NFBG was monitored until day 21, or day 90 for long-term studies.
At experimental endpoints implants were removed and processed for histology.
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4

Kidney Transplantation Immunosuppressive Protocol

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The data of preoperative donors and recipients were obtained from the registry system of organ donation database and then evaluated and recorded in electronic medical record system by surgeons and anesthesiologists. Anesthesia management, surgery, and perioperative care followed standard institutional protocols. A triple immunosuppressive regimen with calcineurin inhibitors (CNIs), entericcoated mycophenolate sodium (EC-MPS; Myfortic, Novartis Pharma, Basel, Switzerland) and prednisone were treated all recipients. Cyclosporine A (CsA; Sandimmun Optoral, Novartis Pharma, Nuremberg, Germany) and tacrolimus (TAC; Prograf, Astellas Pharma, Deerfield, IL, United States) composed the CNIs. The initial dosages of CsA, TAC, EC-MPS and prednisone were 4.0–4.5 and 0.06–0.08 mg/kg/day, 1,080–1,440 and 10–20 mg/day, respectively. Rabbit anti-thymocyte globulin (rATG; thymoglobulin, Genzyme Ireland, Waterford, Ireland) at a dosage of 1.25–1.50 mg/kg/day as induction therapy during the surgery were given to all recipients in a total of 4–6 days after kidney transplantation.
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5

Triple Immunosuppression in Kidney Transplant

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All of the recipients were given a triple immunosuppressive regimen with calcineurin inhibitors (CNIs), enteric-coated mycophenolate sodium (EC-MPS; Myfortic, Novartis Pharma, Basel, Switzerland), and prednisone. The CNIs included cyclosporine A (CsA; Sandimmun Optoral, Novartis Pharma, Nuremberg, Germany) and tacrolimus (TAC; Prograf, Astellas Pharma, Deerfield, IL, USA). The initial dosages of CsA, TAC, EC-MPS, and prednisone were 4.0-4.5 mg/kg/day, 0.06-0.08 mg/kg/day, 1080–1440 mg/day, and 10–20 mg/day, respectively. All of the recipients were treated with rabbit anti-thymocyte globulin (rATG; thymoglobulin, Genzyme Ireland, Waterford, Ireland) at a dosage of 1–1.25 mg/kg/day as induction therapy during the surgery, and for a total of 4–6 days after kidney transplantation.
Anti-infective prophylaxis included oral intake of sulfamethoxazole/trimethoprim for 6 months and intravenous administration of valganciclovir for 2 weeks, which was initiated immediately and after 2 months post-transplantation, respectively. This was followed by maintenance therapy with oral ganciclovir for at least 3 months, depending on donor and recipient cytomegalovirus (CMV) serological status.
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6

Immunosuppressive Regimen for Kidney Transplant

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A triple immunosuppressive regimen of enteric-coated- mycophenolate sodium (EC-MPS; myfortic®, Novartis, Basel, Switzerland), tacrolimus (Tac), and prednisone (pred) was the initial maintenance immunosuppressive regimen used in all patients. The initial EC-MPS dose was 1440 mg/d administered within 24 h posttransplantation; Tac was administered at 0.06 mg·kg−1·d−1 beginning on the 3rd day after transplantation. The target Tac C0 level was 4–10 ng/ml from the beginning of transplantation. Oral pred was administered at 10 mg/d after transplantation. The dosage of immunosuppressive agents was adjusted according to clinical experience, biochemical results, and effective exposure of the drug. All recipients were induced with rabbit antithymocyte globulin (ATG; Thymoglobulin®; Genzyme, Waterford, Ireland; 1.25 mg·kg−1·d−1 between days 0 and 4 after transplantation).
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7

Comparing MPA Forms in Kidney Transplant

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The cross‐sectional study was conducted within adult kidney transplant recipients who had been treated in the Clinic of Nephrology, University Clinical Centre of Nis, Nis, Serbia, in period of 6 months from the beginning of October 2018. Inclusion criteria were post‐transplant period at least 12 months, stable graft function and MPA as part of immunosuppressive protocol based mostly on tacrolimus and low prednisone levels. In addition, the study included patients without clinical significant hypoalbuminemia (serum albumin levels above 25 g/L).9 Two oral pharmaceutical formulation of MPA were used, MMF (Cellcept®, Roche, 500–1000 mg twice daily) or EC‐MPS (Myfortic®, Novartis Pharma, 360–720 mg twice daily). In order to compare different MPA forms, MMF dose were multiplied with a conversion factor of 0.72. Exclusion criteria were unstable graft function and graft rejection in previous 3 months. Informed consent was obtained from all 77 patients. A study protocol has been carried out in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Faculty of Medicine, University of Nis (No: 12–10 580‐2/6).
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8

Immunosuppressive Protocol for Organ Transplant

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Standard immunosuppression included induction therapy with a single dose of 8 mg per kg bodyweight antithymocyte globulin (ATG) (ATG‐Fresenius®; Fresenius Biotech, Gräfelfing, Germany); tacrolimus (Prograf®; Astellas Pharma, Vienna, Austria) with trough levels of 12–15 ng/ml for the first 3 months, aiming at 3–5 ng/ml at 2 years after transplantation; mycophenolate mofetil (CellCept®; Roche Austria, Vienna, Austria) at a dose of 1 g twice daily, or enteric coated mycofenolic acid (Myfortic®; Novartis Austria, Vienna, Austria) at a dose of 720 mg twice daily; and a steroid taper with an attempt to wean steroids at 1 year.
Perioperative antimicrobial prophylaxis consisted of tazobactam/piperacillin (Tazonam®; Pfizer Austria, Vienna, Austria) and ciprofloxacin (Ciproxin®; Bayer Austria, Vienna, Austria) for 3 days. Fluconazole (Diflucan®; Pfizer Austria) was given for 7 days. In the event of a CMV mismatch (D+/R–), antiviral prophylaxis consisted of valganciclovir (Valcyte®; Roche Austria) for 3 months.
Octreotide acetate (Sandostatin®; Novartis Austria) was administered for 7 days. Blood glucose levels were kept below 120 mg/dl in the ICU. In the general ward, levels exceeding 150 mg/dl were treated with subcutaneous insulin. Grafts were monitored closely by daily ultrasound examination17.
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9

Immune Suppression Regimen for Transplant

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The immune suppression regimen consisted of induction therapy with anti-thymocyte globulin (ATG-Fresenius®, Fresenius, HemoCare, Redmond,WA) and maintenance therapy with mycophenolate mofetil (MMF, Cellcept®, Roche, Basel, Switzerland, n=46) or mycophenolic acid (Myfortic®, Novartis, Basel,
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10

Triple Immunosuppressive Regimen in Kidney Transplant

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All recipients were given a triple immunosuppressive regimen with calcineurin inhibitors (CNIs), enteric-coated mycophenolate sodium (EC-MPS; Myfortic, Novartis Pharma, Basel, Switzerland) and prednisone. The CNIs included cyclosporine A (CsA; Sandimmun Optoral, Novartis Pharma, Nuremberg, Germany) and tacrolimus (TAC; Prograf, Astellas Pharma, Deerfield, IL, USA). The initial dosages of CsA, TAC, EC-MPS and prednisone were 4.0–4.5 mg/kg/day, 0.06–0.08 mg/kg/day, 1080–1440 mg/day and 10–20 mg/day, respectively. All the recipients were treated with rabbit anti-thymocyte globulin (rATG; thymoglobulin, Genzyme Ireland, Waterford, Ireland) at a dosage of 1.25–1.50 mg/kg/day as induction therapy during the surgery, and a total of 4–6 days after kidney transplantation.
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