Aljoša Kandus Renal Transplant Center, Department of Nephrology, University Medical Center Ljubljana, Slovenia
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1 Aljoša Kandus Renal Transplant Center, Department of Nephrology, University Medical Center Ljubljana, Slovenia
2 Immunosuppression in kidney transplantation Aljoša Kandus Renal Transplant Center, Department of Nephrology, University Medical Center Ljubljana NIŠ,
3 Immunosuppression Prevention of rejection. Ideal immunosuppression: selective, adjusted to immune response. Gradual decrease of immune response after Tx. Reduction of immunosuppression from its highest level in early period to maintenance long-term therapy.
4 Immunosuppression Increase of imm.: infections, malignancies, specific side effects. Decrease of imm.: rejection.
5 Calcineurin inhibitors Cyclosporine (e.g. Sandimmun Neoral) Tacrolimus (Prograf, Advagraf) Mechanism: inhibition of IL-2 production inhibition of T lymphocyte proliferation. Backbone of preventive immunosuppression.
6 Characteristics of calcineurin inhibitors Cyclosporine Tacrolimus Ch. structure polypeptide macrolide Route of administration o., iv. o., iv. Effectiveness + ++ Interactions similar similar
7 Side effects of calcineurin inhibitors Cyclosporine Tacrolimus Nephrotoxiticy + + Cosmetic ++ + Hypertension ++ + Hypercholesterolemia ++ + Glucose intolerance + ++ Neurotoxiticy + ++ Gastrointestinal + ++
8 Drugs that increase C.I. blood levels Calcium-channel blockers (diltiazem, verapamil, amlodipine, nicardipine), Antifungal agents (ketoconazole, fluconazole, itraconazole, voriconazole), Antibiotics (erythromycin, clarithromycin), Grapefruit juice.
9 Drugs that decrease C.I. blood levels Antibiotics (rifampin), Anticonvulsants (barbiturates, phenytoin, carbamazepine), St. John s wort (antidepressant herbal preparation).
10 Calcineurin inhibitors and statins Statins + cyclosporine rhabdomyolysis. Rosuvastatin; max. 10 mg/day. Lovastatin, simvastatin; max. 20 mg/day. Atorvastatin; max. 20 mg/day. Pravastatin; max. 40 mg/day. Fluvastatin; max. 80 mg/day.
11 Mycophenolate mofetil (MMF, CellCept) Synthetic ester of mycophenolic acid (MPA). Prevention of rejection. Main adjunctive immunosuppressive drug. MMF is more effective than azathioprine (reduction in incidence of acute rejections from app. 40% to 20%).
12 Mycophenolate mofetil (MMF) MMF inhibits IMPDH blocks de novo synthesis of guanosine nucleotides in T and B ly. MMF inhibits proliferation of T and B ly., antibody formation. Relatively selective effect on lymphocytes.
13 Side effects of MMF Gastrointestinal: diarrhea, abdominal pain, nausea, vomiting, esophagitis, gastroenteritis, GI hemorrhage. Leukopenia, anemia, thrombocytopenia. MMF should be discontinued before pregnancy!
14 MMF - drug interactions MMF + azathioprine hematologic toxicity (should not be administered concomitantly!), MMF + tacrolimus concentration of MPA (adjustment of MMF dose), MMF + allopurinol can be administered without dose adjustment.
15 Mycophenolate sodium (Myfortic) Pharmacodynamic proprerties equal to that of MMF. Clinical efficacy comparable to MMF. Myfortic 360 mg = CellCept 500 mg. GI side effects not significantly different from MMF. Could be administered simultaneously with PPI.
16 Sirolimus (rapamycin, Rapamune) Macrolide antibiotic Prevention of rejection. Adjunctive immunosuppressive drug. More effective than azathioprine.
17 Sirolimus (S.) S. blocks TOR (G 1 S phase of cell-division cycle) and proliferative response of cells to IL-2. S. inhibits proliferation of T and B lymphocytes, synthesis of Ig. S. inhibits proliferation of arterial smooth muscle cells (chronic rejection).
18 Sirolimus - drug interactions Drugs that increase S. blood levels: Cyclosporine, Calcium-channel blockers (diltiazem), Antifungal agents (ketoconazole). Drugs that decrease S. blood levels: Antibiotics (rifampin), Anticonvulsants (barbiturates, carbamazepine, phenytoin).
19 Side effects of Sirolimus Nephrotoxicity with standard doses of c. i., De novo proteinuria, limb edema, angioedema, Hypercholesterolemia, hypertrigliceridemia, Wound healing impairment, lymphoceles, mouth ulcers, Thrombocytopenia, leukopenia, anemia, Oligospermia, pneumonia.
20 Sirolimus It probably has antineoplastic potential (Kaposi s., skin c.,...?); Monaco AP. Transplantation 2009; 87: 157. Appropriate in pts. at high risk for post-transplant. mlg., For pts. who develop de novo mlg. after transplantation.
21 Everolimus (Certican) Pharmacodynamic properties equal to that of sirolimus ( TOR inhibitor ). Shorter half-life. Similar side effects. It allows calcineurin inhibitor reduction without loss of efficacy. (Tedesco Silva H Jr et al. Am J Transplant 2010; 10: 1401.)
22 Azathioprine (Imuran) Thiopurine Prevention of rejection (since 1961). Adjunctive immunosuppressive drug. Azathioprine 6-mercaptopurine 6-thioinosinic acid.
23 Azathioprine A. inhibits synthesis of purine nucleotides, DNA and RNA, A. inhibits proliferation of lymphocytes.
24 Side effects of Azathioprine Bone marrow suppression: leukopenia, thrombocytopenia, anemia, Hepatitis, Alopecia, Pancreatitis.
25 Azathioprine - drug interactions Azathioprine + allopurinol (xanthine oxidase inhibitor) immunosuppression and side effects (hematologic toxicity). 25% of initial dose + allopurinol!
26 Glucocorticoids Prednisone, Prednisolone, Methylprednisolone Treatment of a. rejection (high doses, since 1960). Prevention of rejection (low doses, since 1962).
27 Glucocorticoids Specific actions on macrophages and T cells; inhibit production of IL-1, -2, -3, -6, TNF-, IFN-. Nonspecific immunosuppressive and antiinflammatory effects.
28 Side effects of glucocorticoids Hypertension, glucose intolerance, hyperlipidemia, osteoporosis, osteonecrosis, muscle weakness. Growth impairment, impaired wound healing and resistance to infection, obesity, Cushingoid habitus, skin thinning and bruising, acne, cataract, psychiatric and gastrointestinal disturbances.
29 Steroid withdrawal / avoidance Within the first week; KDIGO... Am J Transplant 2009; 9 (Suppl 3): S10. After 3 to 6 months; Pascual J et al. Transplantation 2010; 90: 343. No earlier than 6 months; Opelz G et al. Am J Transplant 2005; 5: 720. Steroid avoidance; Cantarovich D et al. Transpl Int 2010; 23: 313.
30 Polyclonal antibodies Antithymocyte globulin (ATG); Atgam (immunization of horses), Thymoglobulin and ATG Fresenius (immunization of rabbits). Induction immunosuppression. Treatment of acute rejection.
31 Polyclonal antibodies Lymphopenia: opsonization of T ly. (RES), lysis of T ly. (complement activation).
32 Monoclonal antibodies Muromonab-CD3 (Orthoclone OKT3) - murine a. Basiliximab (Simulect) - chimeric antibody. Daclizumab (Zenapax) - humanized antibody. Rituximab (MabThera) - chimeric antibody. Alemtuzumab (MabCampath) - humanized a.
33 OKT3 Induction immunosuppression Treatment of acute rejection. Anti-CD3 deactivation of CD3 endocytosis of TCR T ly. become ineffectual RES.
34 Side effects of OKT3 Cytokine release syndrome: chills, fever, noncardiogenic pulmonary edema, nephrotoxicity, Neurologic complications (aseptic meningitis), Rejection recurrence, allograft thrombosis, TMA, infection (CMV), malignancy (lymphoma). Use of OKT3 administration protocol!
35 Basiliximab (Simulect) and Daclizumab *(Zenapax) Induction immunosuppression Binding to alpha chain (CD25) of IL-2R on activated T lymphocytes. Prevention of IL-2 binding and proliferation of activated T lymphocytes. * Zenapax production was discontinued in 2009.
36 Basiliximab (Simulect) and Daclizumab. (Zenapax) Basiliximab (chimeric) and Daclizumab (humanized) reduce incidence of acute rejections in combination with cyclosporine and steroids. Absence of significant side effects.
37 Rituximab (MabThera) Directed against CD20 antigen on B lymphocytes. Rapid and sustained depletion of circulating and tissue-based B cells. Treatment of acute humoral rejection.
38 Alemtuzumab (MabCampath) Directed against CD52 antigen on B and T lymphocytes. Rapid and sustained depletion of lymphocytes. Induction immunosuppression. Minimization of maintenance immunosuppression without steroids?
39 Immunosuppressive protocol drugs (Renal Transplant Center of University Medical Center Ljubljana, 2011) Basiliximab Cyclosporine Mycophenolate mofetil Methylprednisolone Diltiazem, antimicrobial prophylaxis (amoxicillin/clavulanate, miconazole, TMP-SMX, valganciclovir, isoniazid, lamivudine)
40 Immunosuppressive protocol (1) (Renal Transplant Center of University Medical Center Ljubljana, 2011) (1) Basiliximab (Simulect, Novartis): 20 mg infusion on day 0 and on day 4. (2) CyA (Novartis): continuous infusion (0.08mg/kg/h) started at operation, replaced by CyA-Neoral (3mg/kg b.i.d.) on day 2.
41 Immunosuppressive protocol (2) (Renal Transplant Center of University Medical Center Ljubljana, 2011) (3) Mycophenolate mofetil (CellCept, Roche): 750 mg t.i.d. orally (500mg t.i.d. in patients with b.w. < 50kg) started on day 1. (4) Methylprednisolone: 0.4mg/kg iv. at operation, and from day 1 through day 3.
42 Immunosuppressive protocol (3) (Renal Transplant Center of University Medical Center Ljubljana, 2011) CyA-Neoral dose adjustment to maintain blood trough levels of ng/ml in first 3 months, and ng/ml (EIA) thereafter. Oral methylprednisolone started on day 4 at 0.4 mg/kg/day and tapered by 4mg per week to achieve maintenance dose of 0.08mg/kg/day.
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