Tarimus Capsule 0.5 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 appropriately 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 appropriately 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 clinical assessment of rejection and tolerability for each patient, together with measurement of blood concentrations (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 concentration (whole blood trough level) in kidney and liver transplantation Several immunoassay methods, including semi-automated microparticle enzyme immunoassay (MEIA), are available for monitoring tacrolimus whole blood concentrations (whole blood level) to optimize the dose. Comparisons between blood concentrations reported in the literature and those measured in clinical practice must be made with detailed knowledge of the assay method used. In current clinical practice, immunoassay methods are used to monitor whole blood concentrations. Tacrolimus trough blood concentrations must 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 depends on clinical need. Because tacrolimus has low clearance, it may take several days for changes in blood concentrations to appear after a dose adjustment. Monitoring should be performed approximately twice a week during the initial period after transplantation and regularly during the maintenance period. Trough blood concentrations should be monitored when the dose is adjusted, immunosuppressive treatment is changed, or the drug is coadministered with drugs that may affect tacrolimus whole blood concentrations (see “Interactions”). According to clinical trial analyses, successful outcomes were achieved 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, the trough blood concentration during the initial period after transplantation was 5~20ng/mL in liver transplant patients and 10~20ng/mL in kidney transplant patients. During the subsequent maintenance period, the trough blood concentration was 5-15ng/mL in liver and kidney transplant patients. Bone marrow transplantation: Prevention of tissue graft rejection and graft-versus-host disease following bone marrow transplantation Usually, starting 1 day before transplantation, 0.06mg/kg of tacrolimus per dose is administered orally twice daily. During the initial period after transplantation, 0.06mg/kg of tacrolimus per dose is administered orally twice daily, followed by gradual dose reduction. In addition, if treatment with 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 appropriately according to symptoms. Furthermore, because absorption of this preparation after oral administration is variable and differs among 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 graft-versus-host disease when blood concentrations are low. Blood concentrations should be measured frequently, particularly immediately after transplantation or just after starting treatment. Also, use caution because adverse effects are more likely to recur when the trough blood concentration remains above 20ng/mL for an extended period. Chronic rheumatoid arthritis Usually, adults are administered 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; it may be increased to 3mg according to symptoms. Lupus nephritis Usually, adults are administered 3mg of tacrolimus orally once daily after the evening meal. In clinical trials, when the effect was considered insufficient at 12 weeks after starting treatment and there were no safety concerns, 4 mg/day of this drug was administered for 4 weeks to confirm safety before increasing the dose to up 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. Also, when a sufficient effect on lupus nephritis was achieved, this drug was reduced to the dose that maintained that effect. Myasthenia gravis Adults are administered 3mg of tacrolimus orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: Administer 0.15mg/kg per dose orally twice daily to children. Prevention of rejection in liver transplantation: Administer 0.15mg/kg per dose orally twice daily to children.

This drug suppresses immune function, making the body more susceptible to infections. Therefore, patients using this drug need to be vigilant for infection symptoms and should receive treatment under thorough observation by healthcare professionals. This drug may affect kidney function, potentially causing kidney damage or dysfunction; thus, frequent kidney function tests should be performed and the condition should be closely monitored. If kidney function deteriorates, dosage adjustments or temporary discontinuation may be necessary. There is a risk of elevated potassium levels in the blood, so potassium levels should be checked regularly, and it should not be used with potassium-sparing diuretics. This drug can affect the nervous system, causing symptoms such as headaches, tremors, changes in mental state, and seizures, so if these symptoms occur, immediate consultation with medical staff is necessary. Long-term use may increase the risk of malignant tumors including lymphoma or skin cancer, hence regular check-ups and caution are needed. As immune function is suppressed, the risk of various infections by viruses, bacteria, and fungi increases, necessitating prompt treatment if infection symptoms appear. This drug may interact with other immunosuppressants or specific medications, especially if there is increased renal toxicity, requiring careful monitoring and dosage adjustments when co-administered. During pregnancy, it may affect the fetus; therefore, it should only be used in special cases, and women of childbearing potential should use appropriate contraceptive methods. Moreover, breastfeeding should be avoided due to the risk of drug transfer to the baby through breast milk. Elderly patients and those with decreased liver or kidney function may experience delayed metabolism and excretion of this drug, necessitating more cautious dosage adjustments and monitoring of their condition. During treatment, various tests such as blood pressure, blood glucose, kidney function, liver function, and electrolyte levels should be conducted regularly, and any abnormal symptoms should be reported immediately to healthcare professionals for appropriate action. This drug can be taken regardless of meals; however, for maximal absorption, it is best taken one hour before a meal or in a fasting state two to three hours after a meal. When taking this drug, the prescribed dosage and method should be strictly adhered to, and it should not be arbitrarily stopped or changed in dosage. When handling this drug, care should be taken to avoid direct contact of the powder with the skin or mucous membranes, and if contact occurs, it should be washed off immediately. Finally, caution is needed while driving or operating machinery during the ingestion of this drug, and immediate consultation with medical staff is necessary if changes in vision or neurological symptoms occur.

Increased susceptibility to infection, potential for lymphoma development, renal vascular constriction, toxic tubulopathy, interstitial nephritis, acute and chronic renal dysfunction, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal dysfunction, increased blood urea, proteinuria, tremor, headache, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, encephalopathy syndrome (PRES), convulsions, visual disturbances, hypertension, lymphoma, malignant tumors, lymphoproliferative disorders (LPD), BK virus nephropathy, JC virus-related PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, decreased cardiac function, cardiac chamber enlargement, ventricular wall thickening, heart failure, ventricular arrhythmia, supraventricular arrhythmia, myocardial infarction, angina, pericardial effusion, QT prolongation, Torsades de pointes, acute renal failure, nephrotic syndrome, thrombotic microangiopathy, pancytopenia, thrombocytopenic purpura, pure red cell aplasia (PRCA), agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infection, viral infection, fungal infection, protozoan infection, systemic infection, localized infection, chest pain, abdominal distension, gastrointestinal motility disorders, anorexia, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, gastrointestinal bleeding, gastrointestinal perforation, elevated amylase, abnormal liver function, jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphocyte depletion, pruritus, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, fever, weight loss, flushing, systemic malaise, heavy menstrual bleeding, myalgia, arthralgia, taste disturbance, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, hyperlipidemia, thrombotic venous thrombosis, thrombosis, vasculitis, foreign body sensation in the throat, pain, eye pain, redness, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, insomnia, dysesthesia, anxiety, delirium, paresthesia, eye twitching, limb rigidity, paralysis, drowsiness, decreased consciousness, localized sensory loss, hallucinations, depression, agitation, ataxia, hallucinations, palpitations, hypertension, edema, tachycardia, hypotension, bradycardia, dizziness, dyspepsia, cholangitis, cholestatic jaundice, gastrointestinal bleeding, hepatitis, increased appetite, liver damage, oral candidiasis, dysphagia, esophagitis, gastritis, duodenitis, pneumatosis intestinalis, gastroesophageal reflux disease, gastrointestinal disorders, granulomatous hepatitis, pancreatic pseudocyst, chest pain, abnormal ECG, hemorrhage, hypotension, angina, severe vascular venous thrombosis, orthostatic hypotension, peripheral vascular disorders, arrhythmia, atrial fibrillation, bradycardia, heart palpitations, cardiac arrest, heart failure, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturnal polyuria, pyuria, toxic nephropathy, acute kidney function loss, proteinuria, BK nephropathy, bladder spasms, decreased urine output, urge incontinence, frequency of urination, incontinence, urinary retention, vulvitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hypoglycemia, increased lactic dehydrogenase, weight gain, edema, gout, hypercholesterolemia, peripheral edema, Cushing's syndrome, coagulopathy, purpura, hypochromic anemia, thrombocytopenia, erythrocytosis, decreased prothrombin, reduced plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, generalized seizures, limb convulsions, myalgia, myasthenia, osteoporosis, joint disorders, muscle cramps, decreased mobility, asthma, bronchitis, pulmonary diseases, pulmonary edema, pharyngitis, pneumonia, respiratory distress, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, decreased lung function, hair loss, herpes simplex, hypertrichosis, skin disorders, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, shingles, benign skin neoplasms, abdominal distension, abscess, chills, hernia, peritonitis, photosensitivity reaction, allergic reaction, cellulitis, influenza-like syndrome, sepsis, incidental injury, back pain, soft tissue inflammation, falls, altered sensation, inability to tolerate temperature changes, ulcers, epigastric discomfort, retinopathy, cold, heartburn, low back pain, hoarseness, uterine smooth muscle tumor, cardiac arrest, cytomegalovirus infection, dysphagia

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This will help to preserve the drug's effectiveness for a longer period.

Appearance

It is a hard capsule with a yellow upper and lower part containing white powder.

Package unit

50 capsules/box [10 capsules/PTP x 5]