【缺藥訊息】 公告日期：2022/11/2。 缺藥品項：Immufine Cap 250mg。 缺藥原因：國內生產供應不及。 替代藥品：國內有同成分規格藥品可供替代。 配套方式：用罄關檔停用，將採購同成分規格品項 (Cellcept 膠囊 250mg) 替代。

Cardiac transplant rejection, Concomitantly with cyclosporine and corticosteroids; Prophylaxis.
Liver transplant rejection, Concomitantly with cyclosporine and corticosteroids; Prophylaxis.
Renal transplant rejection, Concomitantly with cyclosporine and corticosteroids; Prophylaxis.

MPA exhibits a cytostatic effect on T and B lymphocytes. It is an inhibitor of inosine monophosphate dehydrogenase (IMPDH) which inhibits de novo guanosine nucleotide synthesis. T and B lymphocytes are dependent on this pathway for proliferation.

Absorption:
Bioavailability, Oral: 94%
Distribution:
Vd: approximately 4 L/kg (mycophenolic acid)
Metabolism:
Liver: rapid and extensive via esterases
Excretion:
Renal: 93%; approximately 88% as metabolites
Dialyzable: No (hemodialysis) ; No (peritoneal dialysis)
Elimination Half Life:
17.9 hours (mycophenolic acid)

Hypersensitivity to mycophenolate mofetil, mycophenolic acid, or any other component of the product.

D (FDA) (AUS)

Infant risk cannot be ruled out.(MDX)

Common:
Cardiovascular: Hypertension (renal transplant, 28.2% to 32.4%; heart transplant, 77.5%; liver transplant, 62.1% ), Peripheral edema (renal transplant, 27% to 28.6%; heart transplant, 64%; liver transplant, 48.4% ) Endocrine metabolic: Hypercholesterolemia (heart transplant, 41.2% ), Hyperglycemia (heart transplant, 46.7%; liver transplant, 43.7% ), Hypocalcemia (liver transplant, 30% ), Hypokalemia (heart transplant, 31.8%; liver transplant, 37.2% ), Hypomagnesemia (liver transplant, 39% )
Gastrointestinal: Abdominal pain (renal transplant, 24.7% to 27.6%; heart transplant, 33.9%; liver transplant, 62.5% ), Constipation (renal transplant, 18.5% to 22.9%; heart transplant, 41.2%; liver transplant, 37.9% ), Diarrhea (renal transplant, 31% to 36.1%; heart transplant, 45.3%; liver transplant, 51.3% ), Nausea (renal transplant, 19.9% to 23.6%; heart transplant, 54%; liver transplant, 54.5% ), Vomiting (heart transplant, 33.9%; liver transplant, 32.9% )
Musculoskeletal: Backache (heart transplant, 34.6%; liver transplant, 46.6% )
Neurologic: Anxiety, Asthenia (heart transplant, 43.3%; liver transplant, 35.4% ), Dizziness, Headache (renal transplant, 16.1% to 21.1%; heart transplant, 54.3%; liver transplant, 53.8% ), Insomnia (heart transplant, 40.8%; liver transplant, 52.3% ), Paresthesia, Tremor (heart transplant, 24.2%; liver transplant, 33.9% )
Renal: Serum blood urea nitrogen raised (heart transplant, 34.6% ), Serum creatinine raised (heart transplant, 39.4% ), Urinary tract infectious disease (renal, 37% to 37.2% )
Respiratory: Disorder of lung (heart transplant, 30.1%; liver transplant, 22% ), Dyspnea (heart transplant, 36.7%; liver transplant, 31% ), Increasing frequency of cough (heart transplant, 31.1% ), Respiratory tract infection (renal transplant, 22% to 23.9%; heart transplant, 37% )
Other: Fever (renal transplant, 21.4% to 23.3%; heart transplant, 47.4%; liver transplant, 52.3% ), Pain (renal transplant, 31.2% to 33%; heart transplant, 75.8%; liver transplant, 74% )
Serious:
Gastrointestinal: Gastric ulcer (infrequent ), Gastrointestinal hemorrhage (1.7% to 5.4% ), Gastrointestinal perforation (rare )
Hematologic: Anemia (renal transplant, 25.6% to 25.8%; cardiac transplant, 42.9%; liver transplant, 43% ), Leukopenia (23.2% to 45.8% ), Neutropenic disorder (Severe) (2% to 3.6% ), Thrombocytopenia (23.5% to 38.3% )
Immunologic: Malignant epithelial neoplasm of skin, non-melanoma (1.6% to 4.2% ), Malignant lymphoma (0.4% to 1% ), Opportunistic infection, Sepsis
Neurologic: Progressive multifocal leukoencephalopathy
Renal: Disease due to Polyomavirus
Respiratory: Pleural effusion (liver transplant, 34.3% ), Pulmonary fibrosis.

Renal transplant:
Oral: 1 g twice daily. Doses >2 g daily are not recommended.
Cardiac transplantation:
Oral: 1.5 g twice daily
Hepatic transplantation:
Oral: 1.5 g twice daily
Autoimmune hepatitis, refractory (off-label use): Oral: 2 g daily
Lupus nephritis (off-label use): Oral:
Induction: 1 g twice daily for 6 months in combination with a glucocorticoid or 2-3 g daily for 6 months in combination with glucocorticoids
Maintenance: 0.5-3 g daily or 1 g twice daily or 1-2 g daily
Myasthenia gravis (off-label use): Oral: 1 g twice daily (range: 1-3 g daily)
Psoriasis, moderate-to-severe (off-label use): Oral: 2-3 g daily.(UTD)

Renal transplant: Oral:
Infants ?3 months, Children, and Adolescents: Cellcept suspension: 600 mg/m2/dose twice daily; maximum dose: 1 g twice daily
Alternatively, may use Cellcept solid dosage forms according to BSA as follows:
BSA 1.25 to 1.5 m2: 750 mg capsule twice daily
BSA >1.5 m2: 1 g capsule or tablet twice daily

Renal impairment, renal transplant patients, GFR less than 25 mL/min/1.73 m(2) outside immediate posttransplant period: Maximum dose, 1 g orally twice daily.
Renal impairment, renal transplant with delayed graft function: No dosage adjustment necessary.

Hepatic impairment, renal transplant patients with severe hepatic parenchymal disease: No dosage adjustment necessary .