Advagraf Extended-Release Capsule 1 mg (Tacrolimus Hydrate)

Adult dose

Kidney transplantation Adults: The usual initial dose is 0.20 ∼ 0.30 mg/kg of tacrolimus orally once daily in the morning, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to symptoms, referring to the 'recommended target trough blood concentration.' Liver transplantation Adults: The usual initial dose is 0.10 ∼ 0.20 mg/kg of tacrolimus orally once daily in the morning, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to symptoms, referring to the 'recommended target trough blood concentration.' Method of administration It is recommended that this medicine be taken once daily in the morning. Take this medicine immediately after removing it from the blister. Instruct patients not to swallow the desiccant. Swallow the capsule with liquid, preferably water. In general, for maximum absorption, administer this medicine on an empty stomach, either 1 hour before a meal or 2 ∼ 3 hours after a meal. If a morning dose is missed, take it as soon as possible on the same day. Do not take a double dose the next morning. Recommended dose—Switching from immediate-release tacrolimus to this medicine When a transplant patient taking immediate-release tacrolimus (Prograf capsules) twice daily is switched to this medicine taken once daily, convert the total daily dose on a 1:1 (mg:mg) basis. This medicine should be taken in the morning. Measure the tacrolimus trough blood concentration for 2 weeks after the switch and adjust the dose if necessary to maintain similar systemic exposure. Dose adjustment in specific patient groups 1) Patients with hepatic impairment The dose may be reduced in patients with severe hepatic impairment to maintain the trough blood concentration within the recommended target range. 2) Patients with renal impairment No dose adjustment is necessary because the pharmacokinetics of tacrolimus are not affected by renal function. 3) Sex There is no evidence that different doses are required for men and women to achieve similar trough blood concentrations. 4) Elderly patients There is no evidence that dose adjustment is necessary in elderly patients. Recommended tacrolimus trough blood concentrations (whole blood trough level) after kidney and liver transplantation Tacrolimus trough blood concentrations should be monitored continuously. Measure the trough blood concentration of this medicine immediately before the next dose (approximately 24 hours after the previous dose). During the first 2 weeks after transplantation, measure trough blood concentrations frequently; regular monitoring is recommended thereafter during the maintenance period. Monitor trough blood concentrations when switching from immediate-release tacrolimus to this medicine, adjusting the dose, changing immunosuppressive therapy, or coadministering medicines that may affect whole-blood tacrolimus concentrations. The frequency of blood concentration measurements depends on clinical need. Because tacrolimus has low clearance, changes in blood concentrations may take several days to appear after a dose adjustment. According to clinical trial analyses, successful outcomes were achieved in most patients when tacrolimus trough blood concentrations were maintained below 20 ng/mL. In general clinical practice, early post-transplant trough blood concentrations were 5 ∼ 20 ng/mL in liver transplant patients and 10 ∼ 20 ng/mL in kidney and heart transplant patients. During the maintenance period, trough blood concentrations were 5 ∼ 15 ng/mL in liver, kidney, and heart transplant patients.

This medication suppresses the immune system and may increase susceptibility to infections. Patients using this medication are at a higher risk of developing serious conditions such as infections or cancer, so treatment should be conducted under the care of an experienced physician. It may place a burden on the kidneys and liver, so patients with compromised kidney function should be closely monitored, and dosage adjustments may be necessary. Blood pressure may increase, so regular monitoring and management of blood pressure are necessary. While taking this medication, potassium levels in the blood may increase, so it should not be taken with potassium-sparing diuretics. It may affect the central nervous system, leading to symptoms such as headaches, tremors, and seizures; if such symptoms arise, immediate notification is required. This medication can induce or worsen diabetes, so blood glucose levels should be checked periodically. There are many interactions with other medications, so if patients are taking other medications, they must inform their physician or pharmacist, especially regarding drugs metabolized in the liver to monitor potential changes in blood concentrations. Women who are pregnant or may become pregnant should consult a physician before using this medication, and breastfeeding women should discontinue breastfeeding. In children or elderly patients, administration should be cautious considering the potential decline in kidney and liver function. This medication is best taken on an empty stomach, either 1 hour before or 2 to 3 hours after a meal with water. Regular blood tests and clinical evaluations during the course of treatment should be conducted to monitor kidney function, liver function, glucose levels, electrolyte status, etc. In cases of overdose, abnormalities in renal and pancreatic functions or neurological issues may occur, so the prescribed dosage should be strictly adhered to.

Increased sensitivity to infections, possibility of lymphoma occurrence, renal function impairment, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, chronic kidney impairment, 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 diseases, malignant tumors, BK virus-related nephropathy, JC virus-related PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, pure red cell aplasia, cardiac disturbances, heart failure, arrhythmia, myocardial infarction, angina pectoris, pericardial effusion, QT interval prolongation, Torsades de pointes, acute kidney failure, nephrotic syndrome, thrombotic microangiopathy, pancytopenia, thrombocytopenic purpura, agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infection, viral infection, fungal infection, protozoal infection, systemic infection, localized infection, reversible posterior encephalopathy syndrome, cerebral infarction, cerebral hemorrhage, aspiration pneumonia, worsening of diabetes, hyperglycemia, pancreatitis, Stevens-Johnson syndrome, skin and mucosal syndrome, respiratory distress, acute respiratory distress syndrome, renal impairment, decreased urine output, polyuria, urinary frequency, residual urine sensation, glycosuria, hypomagnesemia, acidosis, hypercholesterolemia, hyperphosphatemia, hypophosphatemia, hypertriglyceridemia, hyperchloremia, hypercalcemia, hypocalcemia, hyponatremia, hypokalemia, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphocytopenia, itching, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, pleural effusion, ascites, asthma, fever, weight loss, flushing, general malaise, menorrhagia, myalgia, arthralgia, taste disturbance, aplastic anemia, cerebral infarction, colitis, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, hyperventilation, thrombotic venous inflammation, thrombosis, vasculitis, foreign body sensation in the throat, pain, ocular pain, redness, excessive sweating, thirst, temperature change, optic nerve pathology, febrile neutropenia, sleep disturbances, agitation, worry, confusion, depression, euphoria, good fortune, dreams, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, hallucinations, hypertonia, dyscoordination, muscular cramp neurosis, neurological disorder, psychosis, inability to think, forgetfulness, dizziness, encephalopathy, hemorrhagic stroke, monoplegia, nerve compression, irritability, neuralgia, flaccid paralysis, incomplete paralysis of limbs, thalamic disorder, aphasia, visual impairment, amblyopia, tinnitus, cataract, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestatic jaundice, dyspepsia, flatulence, gastrointestinal bleeding, increased γ-GTP, gastrointestinal perforation, hepatitis, increased appetite, jaundice, liver damage, oral candidiasis, dysphagia, esophagitis, gastritis, bowel obstruction, abnormal liver function tests, rectal disorders, stomatitis, duodenitis, pneumatosis intestinalis, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, bleeding, hypotension, tachycardia, angina pectoris, severe vasculitis, orthostatic hypotension, peripheral vascular disorder, arrhythmia, atrial fibrillation, bradycardia, heart palpitations, cardiac arrest, heart failure, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, pyuria, toxic kidney disease, acute renal failure, proteinuria, BK nephropathy, bladder spasms, reduced urine output, urgency urinary incontinence, frequent urination, urinary incontinence, urine accumulation, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing, 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, hyperkalemia, hypophosphatemia, peripheral edema, diabetes, Cushing's syndrome, coagulation disorders, petechiae, hypochromic anemia, leukopenia, thrombocytopenia, polycythemia, reduced prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, systemic seizures, limb seizures, myalgia, myasthenia gravis, osteoporosis, joint diseases, painful muscle cramping, reduced movement, asthma, bronchitis, increased cough, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory disorders, rhinitis, sinusitis, voice changes, pneumothorax, respiratory distress, hiccups, reduced lung function, pleural effusion, hair loss, herpes simplex, hirsutism, skin diseases, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, shingles, benign skin neoplasms, abdominal enlargement, abscess, chills, hernia, peritonitis, phototoxic reaction, allergic reaction, cellulitis, influenza-like syndrome, sepsis, abdominal pain, incidental injury, asthenia, back pain, soft tissue infection, falling, sensory abnormalities, fever, generalized swelling, intolerance to temperature, ulcers

This medication is sensitive to light, so it should be stored in a container that blocks light. Additionally, it is best to keep it in a dry place, at temperatures between 1 and 30 degrees Celsius. This way, the effectiveness of the medication can be well maintained.

Appearance

A hard capsule with a white upper half and an orange lower half, containing white powder.

Package unit

50 capsules (10 capsules/PTP x 5) / box