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Prophylaxis of organ rejection in patients receiving renal transplants. Unlabeled Uses Treatment of psoriasis.


Standard considerations.

Adverse reactions:

Cardiovascular Hypertension (49%); tachycardia, venous thromboembolism including deep vein thrombosis and pulmonary embolism (3% to less than 20%); pericardial effusion. CNS Headache (34%). Dermatologic Acne (22%); rash (20%); basal cell carcinoma, melanoma, squamous cell carcinoma (3% to less than 20%); exfoliative dermatitis. GI Constipation (38%); diarrhea (35%); nausea (31%); stomatitis (3% to less than 20%); pancreatitis (less than 3%). Genitourinary UTI (33%); pyelonephritis (3% to less than 20%); azoospermia, nephrotic syndrome, proteinuria. Hematologic-Lymphatic Anemia (33%); thrombocytopenia (30%); leukopenia, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (3% to less than 20%); lymphoma/posttransplant lymphoproliferative disorder (less than 3%); lymphedema, neutropenia, pancytopenia. Hepatic Abnormal liver function tests, hepatotoxicity including fatal hepatic necrosis, increased ALT and AST. Hypersensitivity Anaphylactic/anaphylactoid reactions, angioedema, hypersensitivity vasculitis. Lab Tests Increased creatinine (40%). Metabolic-Nutritional Hypertriglyceridemia (57%); hypercholesterolemia (46%); abnormal healing, including fascial dehiscence, incisional hernia, and anastomosis disruption, hypokalemia, increased LDH (3% to less than 20%); hyperglycemia, hypophosphatemia. Musculoskeletal Arthralgia (31%); bone necrosis (3% to less than 20%). Respiratory Epistaxis, pneumonia (3% to less than 20%); interstitial lung disease including bronchiolitis obliterans organizing pneumonia, pneumonitis and pulmonary fibrosis, pleural effusion, pulmonary hemorrhage. Miscellaneous Peripheral edema (58%); abdominal pain (36%); fever (34%); pain (33%); edema (20%); herpes simplex, herpes zoster, lymphocele, sepsis (3% to less than 20%); cytomegalovirus, Epstein-Barr virus, mycobacterial infection including Mycobacterium tuberculosis (less than 3%); tuberculosis .


ACE inhibitors (eg, captopril) Risk of angioedema may be increased. Calcineurin inhibitor Risk of hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, and thrombotic microangiopathy may be increased. Cyclosporine Sirolimus plasma concentrations may be increased; administer sirolimus 4 h after cyclosporine. CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. John’s wort) Sirolimus concentrations may be reduced, decreasing the efficacy. CYP3A4 inhibitors (eg, atorvastatin, bromocriptine, cimetidine, cisapride, clarithromycin, danazol, diltiazem, erythromycin, fluconazole, grapefruit juice, indinavir, itraconazole, ketoconazole, metoclopramide, nicardipine, ritonavir, telithromycin, verapamil, voriconazole) Sirolimus concentrations may be elevated, increasing the risk of adverse reactions. Tacrolimus Tacrolimus blood concentrations may be reduced by sirolimus. Vaccination Response to vaccination may be less effective. Verapamil Concentrations may be elevated by sirolimus, increasing the pharmacologic effects and risk of adverse reactions.


Pregnancy Category C . Lactation Undetermined. Children Safety and efficacy not established in children younger than 13 yr of age. Elderly Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy. Hypersensitivity Hypersensitivity, including anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis, has been reported. Renal Function Dosage adjustment is not necessary in patients with renal function impairment. However, decreased renal function may occur; monitor closely. Hepatic Function Reduce the dosage in patients with hepatic function impairment. Antimicrobial prophylaxis Pneumocystis carinii pneumonia has occurred in patients not receiving antimicrobial prophylaxis. Administration of antimicrobial prophylaxis for 1 yr following transplantation is recommended. Cytomegalovirus prophylaxis for 3 mo after transplantation is recommended. Cyclosporine The safety and efficacy of de novo use of sirolimus without cyclosporine have not been established in renal transplant patients. Interstitial lung disease Cases of interstitial lung disease (including pneumonitis and, infrequently, bronchiolitis fibrosa obliterans organizing pneumonia and pulmonary fibrosis), some fatal, have occurred in patients receiving immunosuppressive regimens, including sirolimus. In some cases, interstitial lung disease resolved upon discontinuation of sirolimus. The risk may be increased as the sirolimus trough level increases. Lipids Increased serum cholesterol and triglycerides requiring treatment may occur. Lymphocele Lymphocele, a surgical complication of renal transplantation, has occurred more often in a dose-related fashion in sirolimus-treated patients. Proteinuria Increased urinary protein excretion has been reported from 6 to 24 mo after conversion to sirolimus from calcineurin inhibitors. Skin cancer Patients on immunosuppressive therapy are at increased risk for skin cancer. Instruct patients to limit exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor. Wound healing Impaired or delayed wound healing has been reported in patients receiving sirolimus.



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