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Ask your doctor if you have questions.Tacrolimus is always used together with other medicines. If PRCA is diagnosed, discontinuation of Tacrolimus should be considered Gastrointestinal perforation has been reported in patients treated with Tacrolimus Capsules, USP; all reported cases were considered to be a complication of transplant surgery or accompanied by infection, diverticulum, or malignant neoplasm. Increased risk for developing serious infections and malignancies with tacrolimus extended-release or other immunosuppressants that may lead to hospitalization or death. The 12-month post-transplant information from this trial is presented below.The most common adverse reactions (≥ 30%) observed in Prograf-treated kidney transplant patients are:Based on reported adverse reaction terms related to decreased renal function, nephrotoxicity was reported in approximately 52% of kidney transplantation patients.Adverse reactions that occurred in ≥ 15% of kidney transplant patients treated with Prograf in conjunction with azathioprine are presented below:Two trials were conducted for Prograf-based immunosuppression in conjunction with MMF and corticosteroids. Approximately 63% and 55% of these MMF dose reductions were because of adverse reactions in the Tacrolimus/MMF group and the cyclosporine/MMF group, respectively Key: Time-averaged MMF dose=(total MMF dose)/(duration of treatment)The safety and efficacy of Tacrolimus-based immunosuppression following orthotopic liver transplantation were assessed in two prospective, randomized, non-blinded multicenter trials. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Other side effects not listed may also occur in some patients. Observed whole blood trough concentrations can be found in Table 1. Most patients are stable when trough whole blood concentrations are maintained between 5 to 20 ng/mL. This information does not take the place of talking with your doctor about your medical condition or your treatment.•plan to receive any live vaccines•have or have had liver, kidney or heart problems•are pregnant or plan to become pregnant. In vitro, approximately 32% of the drug in plasma is protein bound. Monitoring of whole blood concentrations and appropriate dosage adjustments of Tacrolimus are recommended when St. John’s Wort and Tacrolimus are co-administered.Lansoprazole and omeprazole, as CYP2C19 and CYP3A4 substrates, may potentially inhibit the CYP3A4 metabolism of Tacrolimus and thereby substantially increase Tacrolimus whole blood concentrations, especially in transplant patients who are intermediate or poor CYP2C19 metabolizers, as compared to those patients who are efficient CYP2C19 metabolizers.Cimetidine may also inhibit the CYP3A4 metabolism of Tacrolimus and thereby substantially increase Tacrolimus whole blood concentrations.Coadministration with magnesium and aluminum hydroxide antacids increases Tacrolimus whole blood concentrations Bromocriptine, nefazodone, metoclopramide, danazol, ethinyl estradiol, amiodarone, methylprednisolone and herbal products containing schisandra sphenanthera extracts may inhibit CYP3A metabolism of Tacrolimus and increase Tacrolimus whole blood concentrations.
Monitoring of whole blood concentrations and appropriate dosage adjustments of Tacrolimus are recommended when these drugs and Tacrolimus are used concomitantly.Concomitant administration of phenytoin with Tacrolimus may also increase phenytoin plasma concentrations. Adjunct therapy with adrenal corticosteroids is recommended early post-transplant.The data in kidney transplant patients indicate that the Black patients required a higher dose to attain comparable trough concentrations compared to Caucasian patients Table 2.Tacrolimus injection should be used only as a continuous IV infusion and when the patient cannot tolerate oral administration of Tacrolimus capsules. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.•Take Tacrolimus exactly as your doctor tells you to take it.•Your doctor will tell you how many Tacrolimus to take and when to take them.•Your doctor may change your Tacrolimus capsules dose if needed. These include:The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:The incidence of adverse reactions was determined in three randomized Prograf-based immunosuppression in conjunction with azathioprine and corticosteroids following kidney transplantation was assessed in a trial where 205 patients received Prograf-based immunosuppression and 207 patients received cyclosporine-based immunosuppression. No significant irritation was observed and blood tacrolimus level was kept within a safe level (2.5 ng/mL). The highest dose used in the mouse was 3.0 mg/kg/day (0.9 to 2.2 times the AUC at clinical dose of 0.075 to 0.2 mg/kg/day) and in the rat was 5.0 mg/kg/day (0.265 to 0.65 times the AUC at clinical doses of 0.075 to 0.2 mg/kg/day) A 104-week dermal carcinogenicity study was performed in mice with Tacrolimus ointment (0.03% - 3%), equivalent to Tacrolimus doses of 1.1-118 mg/kg/day or 3.3-354 mg/m The implications of these carcinogenicity studies to the human condition are limited; doses of Tacrolimus were administered that likely induced immunosuppression in these animals impairing their immune system’s ability to inhibit unrelated carcinogenesis.No evidence of genotoxicity was seen in bacterial ( Tacrolimus given orally at 1.0 mg/kg (0.8 to 2.2 times the clinical dose range of 0.075 to 0.2 mg/kg/day based on body surface area) to male and female rats, prior to and during mating, as well as to dams during gestation and lactation, was associated with embryolethality and adverse effects on female reproduction.
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