Imuscept Capsules (Mycophenolate Mofetil)

Adult dose

Oral administration of this medicine should begin as soon as possible after kidney, heart, or liver transplantation. Adult kidney transplant recipients: Administer 1 g of mycophenolate mofetil per dose orally twice daily. In clinical trials, 3 g daily (1.5 g twice daily) demonstrated efficacy and safety, but a benefit in efficacy was not established in kidney transplant recipients. Adult heart transplant recipients: Administer 1.5 g of this medicine per dose orally twice daily (daily dose 3g). Adult liver transplant recipients: Administer 1.5 g of this medicine per dose orally twice daily (3g daily). 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 medicine twice daily, except immediately after transplantation. No dose adjustment is necessary in patients with delayed graft function after transplantation. There are no data for heart transplant recipients with severe chronic renal impairment. Use this medicine in such patients only if the expected benefit outweighs the possible risks. 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 medicine 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 for heart transplant recipients with severe hepatic parenchymal disease. If neutropenia (ANC [absolute neutrophil count] < 1.3 x 103/㎕) is observed, discontinue this medicine or reduce the dose, perform appropriate diagnostic tests, and provide necessary treatment. Kidney transplant rejection does not alter the pharmacokinetics of MPA; discontinuation or dose reduction of this medicine is not necessary.

Child dose

Children and adolescents (2~18 years): This medicine should be administered to patients with a body surface area of 1. 25 m2 or greater. 1.25 ～ 1.5 m2: Administer 750 mg of this medicine per dose orally twice daily (1.5g daily). Over 1.5 m2: Administer 1.0 g of this medicine per dose orally twice daily (2g daily). Infants under 2 years: Use of this medicine is not recommended because safety and efficacy data in patients under 2 years are limited.

Women who may become pregnant must strictly use contraception when taking this drug, as there is a significantly increased risk of miscarriage or congenital anomalies during pregnancy. Due to its immunosuppressive effects, there may be an increased susceptibility to infections, and the risk of cancers, such as lymphoma, may be heightened. Therefore, it should only be used under the supervision of a specialist in kidney, heart, or liver transplant patients. This drug is contraindicated in patients who have had allergic reactions to it, patients with certain genetic disorders, and women who are pregnant or breastfeeding. Caution should also be exercised in patients with severe renal failure or active gastrointestinal disorders, and in those allergic to certain dyes. Major side effects include diarrhea, leukopenia, infections, and vomiting, with an increased risk of infections and tumor occurrence. There is also a heightened risk of side effects in children and the elderly; thus, caution is necessary. Regular blood tests and ongoing observation by a physician are essential during the course of treatment with this drug. Moreover, it may interact with other medications, so it is crucial to inform healthcare personnel about any other medications being taken. Women who are pregnant or planning to become pregnant and their partners must use effective contraception for a certain period before and after taking this drug. Capsules should not be split or crushed, and care should be taken to avoid contact of the contents with skin or eyes. When storing, it must be kept in a tightly closed container to avoid exposure to air or moisture, preferably in a cool place below 30 degrees Celsius, and out of the 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, weakness, fever, headache, chest pain, abdominal pain, back pain, dysuria, edema, peripheral edema, hypochromic anemia, thrombocytopenia, urinary tract infection, hematuria, 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, elevated enzyme levels, hyperlipidemia, hypervolemia, hypomagnesemia, hyponatremia, weight gain, constipation, dyspepsia, oropharyngeal candidiasis, increased cough, dyspnea, pharyngitis, bronchitis, pneumonia, asthma, rhinitis, pleural effusion, sinusitis, lung disease, acne, herpes simplex infection, shingles infection, rash, itching, sweating, dizziness, sleep disorders, tremor, anxiety, agitation, confusion, depression, tension, sensory abnormalities, drowsiness, delirium, insomnia, leg cramps, myalgia, myasthenia, amblyopia, angioedema, anaphylaxis, pulmonary fibrosis, bronchiectasis, lymphangioma, 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, bone marrow failure, pure red cell aplasia, hypogammaglobulinemia, angioedema, vasodilation, thrombosis, vasospasm, elevated venous pressure, angina, atrial fibrillation, orthostatic hypotension, cardiac arrest, chronic heart failure, pulmonary hypertension, syncope, dehydration, alkalosis, gout, hypochloremia, decreased blood volume, hypoxia, respiratory acidosis, thirst, weight loss, jaundice, hematochezia, oral ulcers, rectal abnormalities, gastric ulcer, gingivitis, gum hyperplasia, gastroenteritis, esophagitis, stomatitis, dysphagia, hematochezia, apnea, epistaxis, hemoptysis, whooping cough, pneumothorax, increased sputum, voice changes, skin cancer, fungal skin disease, skin thickening, skin ulcers, hair loss, hirsutism, skin benign tumors, vesicular rash, seizures, emotional instability, hallucinations, neuropathy, thought disorders, agitation, convulsions, delirium, dry mouth, sensory decrease, psychosis, arthralgia, osteoporosis, conjunctivitis, vision abnormalities, hearing loss, ear pain, eye hemorrhage, tinnitus, diabetes, parathyroid dysfunction, Cushing's syndrome, hypothyroidism

This drug should be stored in a tightly closed container to avoid exposure to air or moisture, preferably in a cool place below 30 degrees Celsius. This allows the efficacy of the drug to be maintained for a longer duration.

Appearance

Hard capsule filled with white to off-white powder, upper part light blue, lower part light brown

Package unit

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