Neuromis Capsule 1mg (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 stated above are intended only as guidelines. Administration of this medicine should be based primarily on measurement of blood concentrations in each patient and clinical assessment of rejection and tolerance (see “Recommended target trough blood concentration” below). If clinical signs 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 the 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, whole blood concentrations are monitored using immunoassays. Tacrolimus trough blood concentrations should be monitored continuously. When this medicine 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 by clinical need. Because tacrolimus has low clearance, changes in blood drug concentration may take several days to appear after a dose adjustment. During the early period after transplantation, monitoring should be performed approximately twice a week, and regularly during the maintenance period. Trough blood concentrations should be monitored when the dose is adjusted, immunosuppressive treatment is changed, or this medicine is coadministered with drugs that may affect tacrolimus whole blood concentrations (see “Interactions”). According to 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 taken into account 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. During the subsequent maintenance period, trough blood concentrations were 5-15ng/mL in liver and kidney transplant recipients. 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 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 medicine 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. As absorption of this preparation is variable when administered orally 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, to prevent adverse effects when blood concentrations are high and rejection or onset of graft-versus-host disease when concentrations are low. Blood concentrations should be measured frequently, particularly immediately after transplantation or initiation of treatment. Also, use caution because adverse effects are more likely to recur when the period during which the trough blood concentration exceeds 20ng/mL is prolonged. Chronic rheumatoid arthritis The usual adult dose is 3mg of tacrolimus administered 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 administered orally once daily after the evening meal; it may be increased to 3mg according to symptoms. Lupus nephritis The usual adult dose is 3mg of tacrolimus administered orally once daily after the evening meal. In clinical trials, when the effect was insufficient 12 weeks after treatment initiation and there were no safety concerns, 4 mg/day of this medicine 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. When an adequate effect on lupus nephritis was achieved, the dose of this medicine was reduced to the dose that maintained the 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 2 times daily, then gradually reduce the dose. Adjust the maintenance dose as appropriate according to symptoms, referring to the ‘recommended target trough blood concentration.’ Prevention of rejection in liver transplantation: In children, administer 0.15mg/kg per dose orally 2 times daily, then gradually reduce the dose. Adjust the maintenance dose as appropriate according to symptoms, referring to the ‘recommended target trough blood concentration.’

This drug is used as an immunosuppressant, which may increase the risk of infection in transplant patients or those with certain autoimmune diseases. Frequent renal function tests are required as this medication can affect kidney function, and dosage adjustments may be necessary based on results. Since serum potassium levels may increase, potassium levels should be monitored regularly, and it should not be used in conjunction with potassium-sparing diuretics. Neurological side effects such as headache, tremors, and seizures may occur; if symptoms appear, consult a healthcare professional immediately. This drug may increase the risk of developing lymphoma or other malignancies, thus regular examinations are necessary with long-term use. Due to the immunosuppressive effect, the risk of opportunistic infections such as viral infections increases; patients should be vigilant for signs of infection and receive prompt treatment if infections occur. Caution is needed when used in conjunction with other immunosuppressants, particularly it should not be used simultaneously with cyclosporine. Use during pregnancy may pose risks to the fetus, so women capable of becoming pregnant should practice adequate contraception, and it should be administered with caution to pregnant women. This drug is secreted into breast milk; therefore, its use during lactation is not recommended. Elderly patients or those with reduced liver or kidney function are at higher risk for side effects, necessitating dosage adjustments and close monitoring of their condition. During administration, regular testing for blood pressure, blood glucose, kidney function, and liver function should be conducted to detect any adverse reactions early. In case of overdose, symptoms such as renal and pancreatic dysfunction, hyperkalemia, and hypertension may occur; caution is advised. It is recommended to take this medication on an empty stomach for better absorption, and it should be swallowed with plenty of water. Avoid direct contact with skin or mucous membranes, and avoid sun exposure while taking the drug, with the use of sunscreen encouraged. Live vaccinations should be avoided during the course of this medication, and patients should inform healthcare providers of any other medications they are taking due to numerous possible drug interactions.

Increased sensitivity to infection, possibility of lymphoma, nephrotoxicity, acute kidney injury, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, chronic kidney disease, tremors, headaches, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, confusion, posterior reversible encephalopathy syndrome (PRES), seizures, visual impairment, hypertension, lymphoproliferative disorders, BK virus-associated nephropathy, JC virus-related PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, heart failure, ventricular and 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 (PRCA), agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infections, viral infections, fungal infections, parasitic infections, systemic infections, localized infections, chest pain, abdominal distension, intestinal motility disorder, loss of appetite, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, gastrointestinal perforation, elevated amylase, abnormal liver function, jaundice, anemia, increase or decrease in platelet count, leukopenia, leukocytosis, lymphopenia, pruritus, alopecia, 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, dysgeusia, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, hyperreflexia, thrombophlebitis, thrombosis, vasculitis, globus sensation, headaches, insomnia, paresthesia, anxiety, delirium, numbness, eye twitching, limb rigidity, paralysis, drowsiness, clouding of consciousness, regional sensory loss, hallucinations, depression, agitation, ataxia, hallucinations, insomnia, inability to think, forgetfulness, dizziness, encephalopathy, hemorrhagic stroke, monoplegia, nerve compression, neurotic symptoms, neuralgia, flaccid paralysis, incomplete paralysis of limbs, reflex disorder, aphasia, visual impairment, amblyopia, tinnitus, cataracts, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestatic jaundice, dyspepsia, flatulence, gastrointestinal bleeding, increased γ-GTP, hepatitis, increased appetite, liver damage, oral moniliasis, dysphagia, esophagitis, gastritis, intestinal obstruction, abnormalities in liver function tests, rectal disorders, duodenitis, pneumoperitoneum, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, bleeding, hypotension, tachycardia, angina, severe vascular inflammation, orthostatic hypotension, peripheral vascular disorders, arrhythmia, atrial fibrillation, bradycardia, cardiac trembling, cardiopulmonary failure, heart function failure, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturia, pyuria, toxic nephropathy, acute renal function loss, proteinuria, BK nephropathy, bladder spasm, decreased urine output, urgency incontinence, frequent urination, urinary incontinence, urinary retention, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing wounds, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoalbuminemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hypoglycemia, increased lactate dehydrogenase, weight gain, edema, gout, hypercalcemia, hypercholesterolemia, peripheral edema, diabetes, Cushing's syndrome, coagulopathy, purpura, hypochromic anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, systemic seizures, limb seizures, myalgia, myasthenia gravis, osteoporosis, joint disorders, painful muscle cramps, 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, hirsutism, skin disorders, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, herpes zoster, benign skin tumors, abdominal enlargement, abscess, chills, hernia, peritonitis, photosensitivity reactions, allergic reactions, cellulitis, influenza-like syndrome, sepsis, accidental injury, asthenia, back pain, soft tissue inflammation, falls, sensory changes, fever, generalized edema, temperature intolerance, ulcers, heartburn, discomfort in the epigastric region, retinopathy, cardiac arrest, low back pain, hoarseness, cold, herpes zoster, warts, autoimmune response, soft tissue inflammation, thrombocytopenia, pneumonia, cytomegalovirus infection, uterine leiomyoma, cardiac arrest, dysphagia

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept at room temperature, between 1 to 30 degrees Celsius. Avoid storing it in excessively hot or cold places.

Appearance

White hard capsule containing white powder

Package unit

100 Capsules/PTP [10 Capsules/PTP X 10]