Unilory Capsule 1 mg (Tacrolimus Hydrate)

Adult dose

Suppression of rejection in kidney transplantation Usually, the initial dose for adults is 0.10~0.15mg/kg of tacrolimus per dose, administered orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted as appropriate according to symptoms, with reference to the “recommended target trough blood concentration.” Suppression of rejection in liver transplantation Usually, the initial dose for adults is 0.05~0.10mg/kg of tacrolimus per dose, administered orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted as appropriate according to symptoms, with reference to the “recommended target trough blood concentration.” General considerations for kidney and liver transplantation The initial doses presented above are intended only as guidelines. Administration of this drug should be based primarily on measurement of the blood concentration in each patient, together with clinical assessment of rejection and tolerability (see “recommended target trough blood concentration” below). If clinical symptoms of rejection are evident, a change in the immunosuppressive treatment regimen should be considered. Recommended target trough blood concentrations in kidney and liver transplantation (whole blood trough level) Several immunoassay methods, including semi-automated microparticle enzyme immunoassay (MEIA), are available for monitoring tacrolimus whole blood concentrations (whole blood level) to optimize the dosage. Comparisons between blood concentrations reported in the literature and those measured in actual clinical practice should be made with detailed knowledge of the assay method used. In recent clinical practice, whole blood concentrations are monitored using immunoassay methods. Tacrolimus trough blood concentrations should be monitored continuously. When this drug is administered orally, the tacrolimus trough blood concentration should be measured immediately before the next dose (approximately 12 hours after the previous dose). The frequency of blood concentration measurements should be determined according to clinical need. Because tacrolimus has low clearance, changes in blood drug concentrations may take several days to appear after adjustment of the dose. During the early period after transplantation, monitoring should be performed approximately twice a week; during the maintenance period, monitoring should be performed regularly. Trough blood concentrations should be monitored when the dose is adjusted, immunosuppressive treatment is changed, or this drug is coadministered with drugs that may affect tacrolimus whole blood concentrations (see “Interactions”). According to the results of clinical trial analyses, successful outcomes were obtained in most patients when tacrolimus trough blood concentrations were maintained below 20ng/mL. The patient’s clinical condition should be considered when interpreting blood concentrations. Recommended target trough blood concentrations: In clinical practice, early post-transplant trough blood concentrations were 5~20ng/mL in liver transplant recipients and 10~20ng/mL in kidney transplant recipients. Thereafter, during the maintenance period, trough blood concentrations were 5-15ng/mL in both liver and kidney transplant recipients. Bone marrow transplantation: Prevention of tissue graft rejection and graft-versus-host disease following bone marrow transplantation Usually, 0.06mg/kg of tacrolimus per dose is administered orally twice daily, starting 1 day before transplantation. During the early post-transplant period, 0.06mg/kg of tacrolimus per dose is administered orally twice daily, followed by gradual dose reduction. If administration of this drug is initiated after the onset of graft-versus-host disease, the usual dose is 0.15mg/kg of tacrolimus per dose, administered orally twice daily. The dose should also be adjusted as appropriate according to symptoms. Because absorption of this product after oral administration is variable and differs between patients, blood concentrations should be measured according to the patient’s condition, and the dose adjusted with reference to the trough level, in order to prevent adverse effects when blood concentrations are high and rejection or onset of graft-versus-host disease when blood concentrations are low. Blood concentrations should be measured frequently, particularly immediately after transplantation or shortly after starting treatment. Also, use caution because adverse effects are likely to recur when the trough blood concentration remains above 20ng/mL for a prolonged period. Chronic rheumatoid arthritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. Regular monitoring is required in patients who develop adverse reactions. The usual dose for elderly patients is 1.5mg orally once daily after the evening meal, and may be increased to 3mg according to symptoms. Lupus nephritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. In clinical trials, when the effect was insufficient 12 weeks after starting treatment and there were no safety concerns, this drug was administered at 4 mg/day for 4 weeks to confirm safety, and then increased to 5 mg/day. If adverse reactions occurred, the dose was appropriately reduced by 0.5 mg or 1 mg, taking the patient’s condition into consideration. In addition, when an adequate effect on lupus nephritis was achieved, this drug was reduced to the dose that maintained that effect. Myasthenia gravis Adults should receive 3mg of tacrolimus orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: In children, administer 0.15mg/kg per dose orally twice daily, then gradually reduce the dose. Prevention of rejection in liver transplantation: In children, administer 0.15mg/kg per dose orally twice daily, then gradually reduce the dose.

This medication is used to suppress immune function in transplant patients or for the treatment of certain autoimmune diseases. Increased risk of infection should be noted, so attention must be paid to signs of infection, and it should be administered under the supervision of a physician experienced in treatment. It can affect kidney and liver function, so renal and hepatic functions should be regularly monitored, as well as blood concentration. Blood pressure, blood sugar, and potassium levels may rise, therefore they need to be checked frequently. Neurological symptoms such as headaches, tremors, seizures, and changes in mental status may occur, so immediate consultation with a doctor is necessary if any abnormal symptoms arise. Like other immunosuppressants, there may be an increased risk of malignancies such as lymphoma and skin cancer, thus regular check-ups are essential. This drug has many interactions with certain medications, so discussing any concurrent medications with a doctor or pharmacist is mandatory, especially avoiding concurrent use with cyclosporine and potassium-sparing diuretics. Pregnant women or women of childbearing potential must consult a doctor before using this medication and should use appropriate contraception during treatment. It is recommended to discontinue breastfeeding when this medication is in use as it may transfer into breast milk. Greater monitoring and dose adjustments are necessary for children and the elderly when administering this medication. In the case of overdose, damage can be caused to the kidneys, pancreas, and heart, so the dosage must be strictly adhered to, and regular clinical tests and medical instructions must be thoroughly followed during usage.

Increased susceptibility to infections, possibility of lymphoma development, vasoconstriction effect, toxic acute tubular necrosis, interstitial nephritis effect, acute and chronic renal impairment, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal impairment, increased blood urea, proteinuria, tremors, headache, changes in motor function, changes in mental state, sensory changes, seizures, coma, delirium, reversible posterior leukoencephalopathy syndrome, convulsions, visual impairment, hypertension, lymphoma, malignant tumors, lymphoproliferative disorders, BK virus nephropathy, JC virus-related progressive multifocal leukoencephalopathy, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocarditis, cardiac function decline, cardiac chamber enlargement, ventricular wall hypertrophy, heart failure, ventricular arrhythmias, supraventricular arrhythmias, myocardial infarction, angina, pericardial effusion, QT prolongation, Torsades de pointes, acute renal failure, nephrotic syndrome, thrombotic microangiopathy, pancytopenia, thrombocytopenic purpura, pure red cell aplasia, agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infections, viral infections, fungal infections, protozoan infections, chest pain, abdominal distension, gastrointestinal motility disorders, loss of appetite, diarrhea, abdominal pain, gastric ulcers, duodenal ulcers, colitis, stomatitis, nausea, vomiting, melena, gastrointestinal bleeding, gastrointestinal perforation, elevated amylase, liver function abnormalities, jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphocytopenia, pruritus, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, fever, weight loss, flushing, general malaise, menorrhagia, myalgia, arthralgia, taste disturbances, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, hyperreflexia, thrombotic phlebitis, thrombosis, vasculitis, a sensation of a foreign body in the throat, pain, eye pain, redness, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, hypertension, insomnia, sensory disturbances, dizziness, dyspepsia, chest pain, frequent urination, hyperlipidemia, edema, low back pain, limb edema, pleural effusion, atelectasis, dyspnea, rash, sleep disturbances, mood swings, worry, confusion, depression, dysphoria, dreams, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, hallucinations, excessive tension, discordant, hypertrophy of the muscle spindle nerves, neuropathy, psychosis, inability to think, amnesia, encephalopathy, hemorrhagic stroke, hemiplegia, nerve compression, irritability, neuralgia, flaccid paralysis, incomplete paralysis of limbs, circumstantial disorder, aphasia, visual impairment, amblyopia, tinnitus, cataracts, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestatic jaundice, gastrointestinal bleeding, gastrointestinal perforation, hepatitis, increased appetite, liver damage, oropharyngeal candidiasis, dysphagia, esophagitis, granulomatous hepatitis, duodenitis, intragastric and intestinal air retention, pancreatic pseudocysts, abnormal ECG, hypotension, tachycardia, angina, severe vascular phlebitis, orthostatic hypotension, peripheral vascular disorders, arrhythmias, atrial fibrillation, bradycardia, heart flutter, cardiopulmonary failure, heart function loss, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, nephron necrosis, nocturia, pyuria, toxic nephropathy, acute renal impairment, proteinuria, BK nephropathy, bladder spasms, decreased urination, urgency incontinence, frequent urination, urinary incontinence, urinary retention, vulvovaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing wounds, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hypoglycemia, increased lactate dehydrogenase, weight gain, edema, gout, hypercholesterolemia, peripheral edema, Cushing's syndrome, coagulopathy, petechial hemorrhage, hypochromic anemia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, generalized seizures, limb convulsions, myalgia, myasthenia gravis, osteoporosis, joint disease, painful muscle spasms, reduced movement, asthma, bronchitis, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory distress, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, reduced lung function, hair loss, herpes simplex, hypertrichosis, skin disease, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, shingles, benign skin tumors, abdominal distention, abscess, chills, hernia, peritonitis, phototoxic reactions, allergic reactions, cellulitis, influenza-like syndrome, sepsis, accidental injury, back pain, soft tissue inflammation, falls, sensation abnormalities, intolerance to temperature, ulcers, heartburn, epigastric discomfort, retinopathy, cardiac arrest, back pain, hoarse voice, cold, shingles, autoimmune antibody response, soft tissue inflammation, thrombocytopenia, pneumonia, uterine leiomyoma, cardiac arrest, cytomegalovirus infection, dysphagia, hyperglycemia, diabetes, leukocytosis, diarrhea, glycosuria, lymphocytopenia, hypercholesterolemia, chest pain, leg pain, back pain, cytomegalovirus infection, cytomegalovirus gastrointestinal infection, secondary malignancies, dry skin, skeletal pain, gastroesophageal reflux, ulcerative stomatitis, biliary stricture, viral hepatitis, hepatic venous thrombosis, biliary disorders, decreased high-density lipoprotein, increased low-density lipoprotein, hypocholesterolemia, hemorrhagic cystitis, pyelonephritis, leg pain, hyperpyrexia, hepatic failure due to reactivation of hepatitis B, premature birth, congenital malformations, low birth weight, fetal distress, preterm labor, neonatal hyperkalemia, renal impairment, eclampsia, placental passage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. Maintaining a storage temperature between 1 degree and 30 degrees Celsius is preferable. This will help keep the medication effective for a longer time.

Appearance

White hard capsule filled with white powder

Package unit

100 capsules/box [(10 capsules/PTP x 10)]