Prograf 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 the symptoms, with reference to the “recommended 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 the symptoms, with reference to the “recommended 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 trough blood concentration” below). If clinical symptoms of rejection are evident, a change to the immunosuppressive treatment regimen should be considered. Recommended trough blood concentration for 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 dose. Comparisons of blood concentrations reported in the literature with those measured in clinical practice should be made with detailed knowledge of the assay method used. In current 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 by clinical need. Because tacrolimus has a low clearance, changes in blood drug concentrations may take several days to appear after adjustment of the dose. Monitoring should be performed approximately twice weekly during the early period after transplantation and periodically during the maintenance period. Trough blood concentrations should be monitored when adjusting the dose, changing immunosuppressive treatment, or coadministering 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 trough blood concentration: In clinical practice, trough blood concentrations during the early period after transplantation were 5~20ng/mL in liver transplant patients and 10~20ng/mL in kidney transplant patients. Thereafter, during the maintenance period, trough blood concentrations were 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 early period after transplantation, 0.06mg/kg of tacrolimus per dose is administered orally twice daily, followed by gradual dose reduction. In addition, when 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 the symptoms. Because absorption of this product after oral administration is inconsistent and varies among patients, blood concentrations should be measured according to the patient’s condition, and the dose should be adjusted with reference to the trough level, to prevent adverse reactions when blood concentrations are high and rejection and graft-versus-host disease when blood concentrations are low. Blood concentrations should be measured frequently, particularly immediately after transplantation or immediately after starting treatment. Caution is also advised because adverse reactions are likely to recur when trough blood concentrations remain 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. For elderly patients, the usual dose is 1.5mg orally once daily after the evening meal, which may be increased to 3mg depending on symptoms. Lupus nephritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. In clinical trials, when the response was considered 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 up to 5 mg/day. If adverse reactions occurred, the dose was appropriately reduced in increments of 0.5 mg or 1 mg, taking the patient’s condition into consideration. In addition, when an adequate response was achieved for lupus nephritis, this drug was reduced to the dose that maintained the response. Myasthenia gravis For adults, 3mg of tacrolimus is administered orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: For children, administer 0.15mg/kg per dose orally twice daily, followed by gradual dose reduction. Prevention of rejection in liver transplantation: For children, administer 0.15mg/kg per dose orally twice daily, followed by gradual dose reduction.

This medication can suppress the immune system, making it easier to contract infections. Therefore, it should only be used by physicians experienced in immunosuppressive therapy, and patients should undergo regular monitoring by healthcare professionals. This medication can affect kidney function and may lead to acute or chronic kidney impairment; hence, kidney function should be monitored frequently and dosages adjusted as necessary. Additionally, it may increase blood potassium levels, so it should not be used with potassium-sparing diuretics, and blood potassium concentrations should be monitored regularly. It may affect the nervous system, causing symptoms such as headaches, tremors, seizures, and changes in mental status, so immediate consultation with a doctor is necessary if abnormal symptoms occur. There may be an increased risk of malignant tumors such as lymphoma while taking this medication, so regular check-ups are required. Due to immunosuppression, there is an increased risk of latent viral infections or other opportunistic infections, necessitating prompt treatment in case of infection symptoms. Caution is advised when used in combination with other immunosuppressants, particularly cyclosporine. Women who are pregnant or may become pregnant should consult a doctor prior to use, as it can affect the fetus. Blood concentrations of this medication need to be monitored regularly for dosage adjustments, and overdose may lead to side effects involving kidneys, pancreas, heart, etc. Careful administration is required for the elderly or patients with liver or kidney disorders, and any adverse reactions should be reported immediately to healthcare professionals. Various side effects such as elevated blood pressure, hyperglycemia, gastrointestinal disturbances, skin rashes, and alopecia may occur, necessitating periodic monitoring. Additionally, this medication may interact with specific drugs, so patients should inform their doctor if they are taking other medications. Prescription and dosage should be strictly followed; do not discontinue or change without consulting a physician. It is advisable to use sunscreen and avoid sun exposure during the course of this medication. Finally, caution is needed for specific patient groups such as children, pregnant women, and the elderly, and the instructions of the attending physician must be strictly followed.

Increased sensitivity to infections, potential for lymphoma occurrence, renal dysfunction, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal dysfunction, proteinuria, tremors, headache, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, delirium, posterior reversible encephalopathy syndrome (PRES), headache, changes in mental status, seizures, visual disturbances, hypertension, lymphoproliferative disorders, malignant tumors, BK virus-associated nephropathy, JC virus-related PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, decreased heart function, chamber enlargement, ventricular wall hypertrophy, heart failure, ventricular arrhythmias, supraventricular arrhythmias, myocardial infarction, angina, pericardial effusion, QT prolongation, Torsades de pointes, acute kidney failure, nephrotic syndrome, thrombotic microangiopathy, pancytopenia, thrombocytopenic purpura, pure red cell aplasia, agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infections, viral infections, fungal infections, protozoal infections, systemic infections, localized infections, reversible posterior encephalopathy syndrome, generalized seizures, consciousness disturbances, confusion, language disorders, hemiparesis, cerebral infarction, cerebral hemorrhage, epilepsy pneumonia, worsening diabetes, pancreatitis, mucocutaneous syndrome, Stevens-Johnson syndrome, dyspnea, acute respiratory distress syndrome, myasthenic crisis, hypertension, edema, tachycardia, palpitations, hypotension, bradycardia, ataxia, hallucinations, sensory disturbances, anxiety, delirium, insomnia, paresthesia, eyelid twitching, limb rigidity, paralysis, drowsiness, altered consciousness, localized sensory loss, nonsensical speech, depression, agitation, chest pain, abdominal distension, gastrointestinal motility disorders, loss of appetite, diarrhea, abdominal pain, gastric ulcers, duodenal ulcers, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, increased amylase, abnormal liver function, jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphocytopenia, itching, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, gigantism, thrombophlebitis, thrombosis, vasculitis, sensation of foreign body in the throat, pain, ocular pain, erythema, hyperhidrosis, thirst, temperature changes, optic nerve disease, febrile neutropenia, diarrhea, hypertension, nausea, headache, epigastric pain, dyspepsia, edema, rash, hair loss, increased SGPT, upper respiratory tract infections, increased SGOT, increased C-reactive protein, dizziness, dry mouth, constipation, tremors, palpitations, sleep disturbances, agitation, worries, confusion, depression, euphoria, elation, dreams, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, hypertonia, disharmony, myotonic syndrome, neurological disorders, psychosis, inability to think, amnesia, dizziness, encephalopathy, hemorrhagic stroke, monoparesis, nerve compression, irritability, neuralgia, flaccid paralysis, incomplete limb paralysis, split personality disorder, aphasia, visual impairment, amblyopia, tinnitus, cataracts, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestasis jaundice, dyspepsia, flatulence, gastrointestinal bleeding, increased γ-GTP, gastrointestinal perforation, hepatitis, increased appetite, jaundice, liver damage, oral moniliasis, dysphagia, esophagitis, gastritis, intestinal obstruction, abnormal liver function tests, rectal dysfunction, stomatitis, loss of appetite, duodenitis, pneumoperitoneum, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, nausea, vomiting, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, bleeding, hypotension, angina, severe vascular venous inflammation, orthostatic hypotension, peripheral vascular disorders, arrhythmias, atrial fibrillation, bradycardia, cardiac tremor, cardiac and respiratory failure, cardiovascular disorders, congestive heart failure, deep vein thrombosis, abnormal echocardiogram, abnormal QRS complex on ECG, abnormal ST complex on ECG, heart failure, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubule necrosis, nocturia, pyuria, toxic kidney disease, acute kidney failure, proteinuria, BK virus nephropathy, bladder spasms, reduced urine output, urinary urgency with incontinence, frequent urination, urinary incontinence, urinary retention, vulvitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, nonhealing, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hyperglycemia, hypoglycemia, increased lactate dehydrogenase, weight gain, increased BUN, edema, gout, hypercalcemia, hypercholesterolemia, hypophosphatemia, peripheral edema, Cushing's syndrome, coagulopathy, petechial hemorrhage, hypopigmented anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, generalized seizures, limb convulsions, myalgia, myasthenia, osteoporosis, joint disorders, muscle cramping pain, reduced movement, asthma, bronchitis, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory dysfunction, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, decreased lung capacity, hair loss, herpes simplex, hypertrichosis, skin disorders, sweating, acne, dermatophytosis, skin discoloration, skin ulcers, exfoliative dermatitis, herpes zoster, benign skin neoplasms, abdominal enlargement, abscesses, chills, hernia, peritonitis, phototoxic reactions, allergic reactions, cellulitis, influenza-like syndrome, sepsis, abdominal pain, incidental injury, myasthenia, back pain, soft tissue inflammation, falls, altered sensations, temperature intolerance, ulcers, heartburn, discomfort in the epigastric area, retinopathy, cardiac arrest, low back pain, hoarseness, cold, herpes zoster, autoimmune reactions, soft tissue inflammation, thrombocytopenia, pneumonia, pyelonephritis, warts, eczema, cholecystitis, chickenpox, amenorrhea, appendicitis, hyperpyrexia, uterine leiomyoma, cardiac arrest, cytomegalovirus infection, low back pain, chest pain, leg pain, hyperglycemia, diabetes, dysphagia

Store this medication in a tightly sealed container, as it may be sensitive to air or moisture. It is best kept at a moderate room temperature, away from extreme heat or cold.

Appearance

White hard capsule containing white powder

Package unit

100 capsules (10 capsules/PTP X 10) /box