MyRept Capsule 250 Milligrams (Mycophenolate Mofetil)

Adult dose

Oral administration of this medication should be initiated as soon as possible after kidney, heart, or liver transplantation. Adult kidney transplant recipients: Administer 1 g of mycophenolate mofetil orally twice daily. In clinical trials, a daily dose of 3 g (1.5 g twice daily) demonstrated efficacy and safety, but a benefit in efficacy has not been established in kidney transplant recipients. Adult heart transplant recipients: Administer 1.5 g of this medication orally twice daily (daily dose of 3g). Adult liver transplant recipients: Administer 1.5 g of this medication orally twice daily (daily dose of 3g). Patients with severe renal impairment: In patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), do not administer more than 1 g of this medication twice daily, except immediately after transplantation. No dose adjustment is necessary in patients with delayed graft function after transplantation. There are no data in heart transplant recipients with severe chronic renal impairment. In these patients, use this medication only when the expected benefit outweighs the potential risk. Elderly patients: Elderly patients may be treated with the recommended doses of 1 g twice daily after kidney transplantation and 1.5g twice daily after heart transplantation. However, the risk of adverse reactions may generally be increased in these elderly patients. The risk of adverse reactions may also be increased in patients receiving this medication concomitantly with other immunosuppressants (see Adverse Reactions). No dose adjustment is necessary in kidney transplant recipients with severe hepatic parenchymal disease; however, there are no data in heart transplant recipients with severe hepatic parenchymal disease. If neutropenia (ANC [absolute neutrophil count] < 1.3 x 103/㎕) is observed, stop or reduce the dose of this medication, perform appropriate diagnostic tests, and provide necessary treatment. Kidney transplant rejection does not alter the pharmacokinetics of MPA; discontinuation or dose reduction of this medication is not required.

Child dose

Children and adolescents (2~18 years): This medication should be administered to patients with a body surface area of at least 1. 25 m2. 1.25 ～ 1.5 m2: Administer 750 mg of this medication orally twice daily (daily dose of 1.5g). Greater than 1.5 m2: Administer 1.0 g of this medication orally twice daily (daily dose of 2g). Compared with adults, adverse reactions occur more frequently in children and adolescents, so temporary dose reduction or interruption may be necessary. Do not open or crush the capsules (see Precautions for Use). Infants under 2 years: Use of this medication is not recommended because safety and efficacy data in patients under 2 years of age are limited.

Women who may become pregnant must use effective contraception while taking this drug, as the risk of miscarriage and congenital malformations greatly increases if taken during pregnancy. Due to immunosuppressive effects, the risk of infection may increase, and the risk of tumor occurrence, such as lymphoma, is also heightened; therefore, it must be administered under strict supervision by the prescribing physician. This drug is used for immunosuppressive therapy in kidney, heart, and liver transplant patients and must be prescribed by a specialist with extensive relevant experience and managed in an appropriate medical facility. Patients with hypersensitivity to this drug, with certain genetic disorders, pregnant or breastfeeding women should avoid this medication. Patients with severe renal failure, severe gastrointestinal diseases, or delayed recovery of organ function after transplantation should be administered with caution and consult healthcare professionals immediately in case of adverse reactions. During use, various side effects such as diarrhea, leukopenia, infections, vomiting etc. may occur, therefore regular blood tests and health checks are necessary. Especially in children and the elderly, the risk of side effects is somewhat higher, so careful monitoring is required. This drug may interact with other medications; therefore, any medications currently being taken must be reported to healthcare professionals, and concurrent use with oral contraceptives may require additional contraceptive measures. In case of overdose, the risk of infection due to excessive immunosuppression and bone marrow suppression may arise, so the dosage must be strictly adhered to. If any unusual symptoms occur, visit a medical institution immediately. Crushing the capsule or direct contact with its contents is dangerous and precautions should be taken; if contact occurs, wash immediately with clean water and soap. Store in a closed container to protect from air and moisture, and keep in a cool place below 30 degrees Celsius, out of reach of children.

Diarrhea, leukopenia, sepsis, vomiting, tuberculosis, atypical mycobacterial infection, meningitis, infectious endocarditis, lymphoma, skin malignancy, mucocutaneous candidiasis, cytomegalovirus viremia, herpes simplex, anemia, infection, gastrointestinal bleeding, pulmonary edema, asthenia, fever, headache, chest pain, abdominal pain, lumbar pain, dysmenorrhea, edema, peripheral edema, hypochromic anemia, leukocytosis, thrombocytopenia, urinary tract infection, hematuria, renal tubular necrosis, renal function decline, oliguria, hypertension, arrhythmia, bradycardia, hypotension, acute heart failure, pericardial effusion, cardiovascular disease, tachycardia, hypercholesterolemia, hyperglycemia, hyperkalemia, hypokalemia, hypophosphatemia, hyperbilirubinemia, elevated BUN, elevated creatinine, increased enzyme levels, hyperlipidemia, hyperuricemia, hypervolemia, hypomagnesemia, hyponatremia, weight gain, constipation, dyspepsia, oral candidiasis, nausea, increased cough, dyspnea, pharyngitis, bronchitis, pneumonia, acne, herpes simplex infection, shingles infection, rash, sweating, dizziness, sleep disturbances, tremor, anxiety, agitation, confusion, depression, hypertonia, paresthesia, somnolence, delirium, insomnia, leg cramps, myalgia, myasthenia, amblyopia, petechiae, polycythemia, purpura, increased prothrombin, prolonged thromboplastin time, dysuria, erectile dysfunction, urinary urgency, proteinuria, hydronephrosis, pyelonephritis, angina, atrial fibrillation, orthostatic hypotension, thrombosis, vasodilation, palpitations, cardiac arrest, chronic heart failure, pulmonary hypertension, syncope, vasospasm, elevated venous pressure, dehydration, alkalosis, gout, hypochloremia, reduced blood volume, hypoxemia, respiratory acidosis, thirst, weight loss, anorexia, gingivitis, gingival hyperplasia, gastroenteritis, esophagitis, stomatitis, enteritis, gastrointestinal bleeding, gastritis, intestinal obstruction, dysphagia, jaundice, hematochezia, dysphagia, oral ulcer, rectal abnormalities, gastric ulcer, pulmonary edema, apnea, epistaxis, hemoptysis, hiccups, tumors, pneumothorax, increased sputum, voice changes, benign skin tumors, skin cancer, fungal skin diseases, skin hyperplasia, skin ulcers, hair loss, hirsutism, seizures, emotional instability, hallucinations, neuropathy, thought disorders, agitation, convulsions, delirium, xerostomia, sensory impairment, psychosis, arthralgia, osteoporosis, conjunctivitis, visual disturbances, hearing loss, ear pain, ocular hemorrhage, tinnitus, diabetes, parathyroid dysfunction, Cushing's syndrome, hypothyroidism, candidiasis, prostate disease, congestive heart failure, taste disorders, enuresis, toothache, external genital itching, perineal edema, liver failure due to reactivation of hepatitis B, intestinal villous atrophy, colitis, pancreatitis, agranulocytosis, aplastic anemia, bone marrow suppression, progressive multifocal leukoencephalopathy, angioedema, anaphylaxis, pulmonary fibrosis, bronchiectasis, lymphangioma

This drug should be stored in a closed container to protect it from air and moisture, and it is recommended to store it in a cool place below 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness over a longer period.

Appearance

A hard capsule filled with white to off-white powder, with a light blue upper part and a light brown lower part.

Package unit

Domestic: 100 capsules (10 capsules/PTP × 10), Export: 50 capsules (10 capsules/PTP × 5)