Polyoma virus infections in transplant patients may have serious, and sometimes fatal, outcomes. ]•Take Tacrolimus at the same 12-hour intervals everyday to achieve consistent blood concentrations.•Take Tacrolimus consistently either with or without food because the presence and composition of food decreases the bioavailability of Tacrolimus.•Not to eat grapefruit or drink grapefruit juice in combination with Tacrolimus Inform patients they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression. Wear protective clothing and use a sunscreen.Tell your doctor if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of Tacrolimus. You should not become pregnant while using tacrolimus. Drink the dose immediately. Pediatric patients generally required higher doses of Tacrolimus to maintain blood trough concentrations of Tacrolimus similar to adult patients Clinical trials of Tacrolimus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Insulin dependence was reversible in 15% of these PTDM patients at one year and in 50% at 2 years post-transplant. Tacrolimus may harm an unborn baby. Do not save any of the mixture for later use.Tacrolimus is available in different formulations (such as immediate and extended-release). Patient monitoring may help detect patients at risk for CMV disease. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.

Chemically, Tacrolimus is designated asUSP Dissolution Test pending. Symptoms indicating PRES include headache, altered mental status, seizures, visual disturbances and hypertension. Further reductions in dose below the targeted range may be required The mean clearance of Tacrolimus was substantially lower in patients with severe hepatic impairment (mean Child-Pugh score: >10) compared to healthy volunteers with normal hepatic function.

Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use a sunscreen with a high protection factor [see Warnings and Precautions ( Inform patients they are at increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression and to contact their physician if they develop any symptoms of infection [see Warnings and Precautions ( Inform patients that Tacrolimus can cause diabetes mellitus and should be advised to contact their physician if they develop frequent urination, increased thirst or hunger Inform patients that Tacrolimus can have toxic effects on the kidney that should be monitored. Patients with impaired renal function should be monitored closely as the dosage of Tacrolimus may need to be reduced. 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. Tacrolimus is bound mainly to albumin and alpha-1-acid glycoprotein, and has a high level of association with erythrocytes. You may report side effects to Health Canada at 1-866-234-2345.This drug may make you more sensitive to the effects of alcohol. BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONSIncreased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppressionOnly physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Tacrolimus. Avoid tanning booths and sunlamps. In a patient receiving an IV infusion, the first dose of oral therapy should be given 8-12 hours after discontinuing the IV infusion.The observed trough concentrations described above pertain to oral administration of Tacrolimus only; while monitoring Tacrolimus concentrations in patients receiving Tacrolimus injection as a continuous IV infusion may have some utility, the observed concentrations will not represent comparable exposures to those estimated by the trough concentrations observed in patients on oral therapy.The recommended starting dose of Tacrolimus injection is 0.03-0.05 mg/kg/day in kidney and liver transplant and 0.01 mg/kg/day in heart transplant given as a continuous IV infusion. Additionally, a minimum of 122 pediatric patients were studied in an uncontrolled trial of Tacrolimus in living related donor liver transplantation. Tacrolimus, given orally to pregnant rats after organogenesis and during lactation at 1.0 and 3.2 mg/kg, 0.8 to 6.9 times the recommended clinical dose range was associated with reduced pup weights and pup viability (3.2 mg/kg only); among the high dose pups that died early, an increased incidence of kidney hydronephrosis was observed.Tacrolimus is excreted in human milk. Tacrolimus is in a class of medications called immunosupressants. In a randomized, open-label, multi-center trial (Study 1), 1589 kidney transplant patients received Tacrolimus (Group C, n=401), sirolimus (Group D, n=399), or one of two cyclosporine (CsA) regimens (Group A, n=390 and Group B, n=399) in combination with MMF and corticosteroids; all patients, except those in one of the two cyclosporine groups, also received induction with daclizumab.