Tagrab Capsule (Tacrolimus Hydrate)

Adult dose

Suppression of rejection in kidney transplantation Usually, the initial oral dose for adults is 0.10~0.15mg/kg per dose twice daily as tacrolimus, followed by gradual dose reduction. The maintenance dose should be adjusted according to symptoms, with reference to the “recommended target trough blood concentration.” Suppression of rejection in liver transplantation Usually, the initial oral dose for adults is 0.05~0.10mg/kg per dose twice daily as tacrolimus, followed by gradual dose reduction. The maintenance dose should be adjusted 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 blood concentrations in each patient, together with clinical assessment of rejection and tolerability (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 concentration for kidney and liver transplantation (whole blood trough level) 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). During the initial 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 adjusting the dose, changing immunosuppressive therapy, or coadministering drugs that may affect tacrolimus whole-blood concentrations (see “Interactions”). Recommended target trough blood concentrations: In clinical practice, initial 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 per dose of tacrolimus is administered orally twice daily. During the initial period after transplantation, 0.06mg/kg per dose of tacrolimus is administered orally twice daily, followed by gradual dose reduction. If treatment with this drug is initiated after the onset of graft-versus-host disease, the usual dose is 0.15mg/kg per dose of tacrolimus orally twice daily. The dose should also be adjusted as appropriate according to symptoms. Chronic rheumatoid arthritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. Patients who develop adverse reactions require regular monitoring. The usual dose for elderly patients is 1.5mg orally once daily after the evening meal; this 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 response was considered insufficient at 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, after which the dose was 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 In adults, 3mg of tacrolimus is administered orally once daily after a meal.

Child dose

Suppression of rejection in kidney transplantation: In children, administer 0.15mg/kg per dose orally twice daily Suppression of rejection in liver transplantation: In children, administer 0.15mg/kg per dose orally twice daily

This medication suppresses immune function, which increases the risk of infections and malignancies like lymphoma. Therefore, it should be used cautiously under the supervision of a physician with experience in transplant patients or immunosuppressive therapy, and patients require thorough observation and management by healthcare professionals. Additionally, this medication can affect kidney function, potentially causing acute or chronic kidney impairment; thus, dosage adjustments and regular kidney function tests are necessary for patients with compromised kidney function. Hyperkalemia may occur frequently, necessitating regular checks of serum potassium levels, and it should not be taken with potassium-sparing diuretics. It may affect the nervous system leading to symptoms such as headache, tremors, seizures, coma, and confusion; if abnormalities arise, immediate consultation with healthcare professionals is required. During treatment, there is an increased risk of malignancies such as lymphoma or skin cancer, necessitating regular check-ups and vigilance. Moreover, with the immune system suppressed, there is a heightened risk of latent viral infections or other infections, requiring prompt treatment when infection symptoms appear. When taking this medication, do not mix different formulations (immediate and extended release), and any changes in formulation must be done under professional supervision. Diabetes may develop post-transplant, so regular monitoring of blood glucose levels is important; consult a physician if diabetes symptoms appear. This medication should be used cautiously in patients with hepatic or renal issues, the elderly, those with infections, and women who are pregnant or capable of becoming pregnant. It has numerous drug interactions; inform healthcare professionals of all concomitant medications, particularly with those that cause nephrotoxicity or affect CYP3A4 enzymes. Pregnant or breastfeeding women should consult about risks to the fetus or neonate when taking this medication. Safety in children, especially those under 12 years or 16 years of age, has not been established, so caution is warranted in use. During treatment, various tests should be conducted regularly, including blood pressure, kidney function, blood glucose, and electrolyte levels, and report any adverse symptoms to a physician immediately. In cases of overdose, serious kidney and pancreatic impairment, neurological abnormalities, and cardiovascular diseases may arise, so strict adherence to the prescribed dosage is vital. This medication is best taken on an empty stomach for optimal absorption, and capsules should be taken with water; do not arbitrarily change the packaging or container of the medication. Finally, avoid exposure to sunlight or ultraviolet rays during treatment, and use sunscreen for skin protection.

Infection, Lymphoma, Renal impairment, Increased serum creatinine, Hyperkalemia, Decreased urea excretion, Hyperuricemia, Chronic kidney disease, Tremors, Headache, Changes in motor function, Changes in mental state, Changes in sensory function, Seizures, Coma, Delirium, Posterior reversible encephalopathy syndrome (PRES), Seizures, Visual disturbance, Hypertension, Lymphoproliferative disorder (LPD), BK virus nephropathy, JC virus-related progressive multifocal leukoencephalopathy (PML), CMV infection, Transplant rejection, Insulin-dependent post-transplant diabetes, Hyperglycemia, Myocardial impairment, Decreased cardiac function, Cardiac chamber enlargement, Ventricular wall hypertrophy, Heart failure, Ventricular arrhythmia, Supraventricular arrhythmia, Myocardial infarction, Angina pectoris, Pericardial effusion, QT prolongation, Torsades de pointes, Acute renal failure, Nephrotic syndrome, Thrombotic microangiopathy, Hemolytic-uremic syndrome, Thrombotic thrombocytopenic purpura, Pancytopenia, Thrombocytopenic purpura, Pure red cell aplasia, Agranulocytosis, Hemolytic anemia, Intestinal obstruction, Bacterial infection, Viral infection, Fungal infection, Protozoal infection, Chest pain, Abdominal distension, Gastrointestinal motility disorders, Loss of appetite, Diarrhea, Abdominal pain, Gastric ulcer, Duodenal ulcer, Colitis, Stomatitis, Nausea, Vomiting, Melena, Hemorrhage, Gastrointestinal perforation, Elevated 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 levels, 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, Chylothorax, Thrombophlebitis, Thrombosis, Vasculitis, Sensation of a foreign body in the throat, Pain, Ocular pain, Redness, Excessive sweating, Thirst, Temperature changes, Optic neuropathy, Febrile neutropenia, Insomnia, Dysesthesia, Dizziness, Dyspepsia, Chest pain, Edema, Tachycardia, Palpitations, Increased blood pressure, Decreased blood pressure, Bradycardia, Ataxia, Hallucinations, Anxiety, Delirium, Paresthesia, Eye twitching, Limb rigidity, Paralysis, Drowsiness, Clouding of consciousness, Localized sensory loss, Confabulation, Depression, Agitation, Sleep disturbances, Agitation, Worry, Confusion, Sense of relief, Sense of luck, Dreams, Unusual thoughts, Loss of reflexes, Emotional instability, Hypertonia, Disharmony, Interstitial muscle twitching syndrome, Neurological disorder, Psychosis, Inability to think, Amnesia, Encephalopathy, Hemorrhagic stroke, Distal muscle weakness, Nerve compression, Nervousness, Neuralgia, Flaccid paralysis, Incomplete paralysis of the limbs, Ataxia, Aphasia, Visual impairment, Amblyopia, Tinnitus, Cataract, Photophobia, Hearing loss, Ear pain, Otitis media, Cholangitis, Cholestatic jaundice, Gastrointestinal bleeding, Hepatitis, Increased appetite, Liver damage, Oral candidiasis, Dysphagia, Esophagitis, Gastritis, Gastroesophageal reflux, Gastrointestinal disorder, Granulomatous hepatitis, Duodenitis, Air in the gastro-intestinal tract, Eosinophilic esophagitis, Pancreatic pseudocyst, Abnormal ECG, Hypotension, Angina pectoris, Severe vascular venous inflammation, Orthostatic hypotension, Peripheral vascular disease, Atrial fibrillation, Slow pulse, Cardiac tremors, Cardiac arrest, Increased heart rate, Syncope, Thrombosis, Vasodilation, Hematuria, Renal failure, Cystitis, Dysuria, Hydronephrosis, Renal tubular necrosis, Nocturia, Pyuria, Toxic renal disease, Acute renal failure, 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, 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, Coagulation disorders, Petechial hemorrhage, Hypochromic anemia, Thrombocytopenia, Increased erythrocytes, Decreased prothrombin, Decreased plasma iron, Increased hematocrit, Abnormal hemoglobin, Arthralgia, Generalized seizures, Limb seizures, 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, Decreased lung function, Hair loss, Herpes simplex, Hypertrichosis, Skin disease, Sweating, Acne, Fungal dermatitis, Skin discoloration, Skin ulcer, Desquamative dermatitis, Shingles, Benign skin neoplasm, Abdominal enlargement, Abscess, Chills, Hernia, Peritonitis, Phototoxic reaction, Allergic reaction, Cellulitis, Influenza-like syndrome, Sepsis, Accidental injury, Back pain, Soft tissue infection, Falls, Dysesthesia, Temperature intolerance, Ulcer, Heartburn, Epigastric discomfort, Retinopathy, Cardiac arrest, Cold

This medication can be sensitive to air or moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius to effectively preserve the medication's efficacy.

Appearance

White hard capsule containing white powder

Package unit

100 capsules (10 capsules/PTP × 10)