部份中文霉酚酸酯处方资料（仅供参考）
英文名: Mycophenolate Mofetil
商品名：Cellcept polvo
中文名: 霉酚酸酯粉末注射剂
生产商：罗氏制药
药品简介
CellCept（Mycophenolat mofetil）是一种免疫抑制剂，与皮质类固醇和环孢素或他克莫司联合使用，用于预防接受肾脏、心脏或肝脏移植的患者的器官排斥反应。
作用机制
霉酚酸酯是MPA的2-吗啉乙酯。MPA是IMPDH的一种选择性、无竞争性和可逆的抑制剂，因此在不掺入DNA的情况下抑制鸟苷核苷酸合成的从头途径。由于T和B淋巴细胞的增殖严重依赖于嘌呤的从头合成，而其他细胞类型可以利用挽救途径，因此MPA对淋巴细胞的细胞抑制作用比对其他细胞的作用更大。除了抑制IMPDH和由此产生的淋巴细胞剥夺外，MPA还影响负责淋巴细胞代谢程序的细胞检查点。使用人类CD4+T细胞已经表明，MPA将淋巴细胞的转录活性从增殖状态转移到与代谢和存活相关的分解代谢过程，从而导致T细胞的无能状态，从而使细胞对其特定抗原没有反应。
适应症
CellCept 500mg粉末浓缩液用于输液，与环孢素和皮质类固醇联合用于预防接受同种异体肾或肝移植的患者的急性移植排斥反应。
用法与用量
CellCept的治疗应由合格的移植专家开始并维持。
注意：CELLCEPT静脉注射溶液不得通过快速或大剂量静脉注射给药。
剂量
用于输注溶液的浓缩液的500 mg CellCept粉末是可给药长达14天的CellCept口服形式（胶囊、片剂和口服混悬剂粉末）的替代剂型。CellCept 500 mg粉末的初始剂量应在移植后24小时内给药，作为输注溶液的浓缩物。
肾移植
肾移植患者的推荐剂量为1g，每日两次（2g每日剂量）。
肝移植
肝移植患者输注CellCept的推荐剂量为1g，每日两次（2g每日剂量）。肝移植后的前4天应继续静脉注射（IV）CellCept，并在可耐受的情况下尽快开始口服CellCept。肝移植患者口服CellCept的推荐剂量为1.5克，每日两次（每日3克）。
在特殊人群中使用
儿科人群
CellCept用于儿科患者输液的安全性和有效性尚未确定。目前尚无儿童肾移植患者输注CellCept的药代动力学数据。目前尚无肝移植后儿科患者的药代动力学数据。
老年人
肾或肝移植患者每天两次服用1g的推荐剂量适合老年人。
肾功能损害
在患有严重慢性肾功能损害（肾小球滤过率<25 ml/min/1.73m2）的肾移植患者中，在移植后即刻以外，应避免每天两次给药剂量大于1g。还应仔细观察这些患者。术后肾移植功能延迟的患者无需调整剂量。没有关于患有严重慢性肾功能损害的肝移植患者的数据。
严重肝损伤
对于患有严重肝实质疾病的肾移植患者，无需调整剂量。
排斥反应期间的治疗
麦考酚酸（MPA）是麦考酚酯的活性代谢产物。肾移植排斥反应不会导致MPA药代动力学的变化；不需要减少剂量或中断CellCept。在肝移植排斥反应期间没有可用的药代动力学数据。
儿科人群
目前尚无治疗儿科移植患者首次或难治性排斥反应的数据。
给药方法
在重构至6mg/ml的浓度后，必须通过外周静脉或中心静脉缓慢静脉输注2小时来给药CellCept 500mg用于输注溶液的浓缩物粉末。
处理或服用药品前应采取的预防措施由于霉酚酸酯对大鼠和兔子具有致畸作用，因此应避免直接接触干燥粉末或配制的CellCept 500mg末浓缩液溶液，以供皮肤或粘膜输液。如果发生这种接触，请用肥皂和水彻底清洗；用清水冲洗眼睛。
有关给药前药品的重组和稀释说明。
禁忌症
•对霉酚酸酯、霉酚酸或所列任何赋形剂过敏的患者不应服用CellCept。已观察到对CellCept的超敏反应。对聚山梨酯80过敏的患者禁止使用CellCept 500mg粉末作为浓缩液用于输液。
•不应将CellCept用于未使用高效避孕措施的有生育潜力的妇女。
•在没有提供妊娠测试结果以排除在怀孕期间意外使用的情况下，不应在有生育潜力的妇女中开始使用CellCept治疗。
•除非没有合适的替代治疗方法来防止移植排斥反应，否则不应在妊娠期使用CellCept。
•哺乳期妇女不应服用CellCept。
保质期
输液浓缩液用粉末：
3年。
重构溶液和输注溶液：如果输注溶液没有在给药前立即制备，则应在药物重构和稀释后3小时内开始给药。
储存的特殊注意事项
输液浓缩液用粉末：储存温度不得超过30°C。
重组溶液和输液：储存于15-30°C。
容器的性质和内容物
20毫升I型透明玻璃瓶，带灰色丁基橡胶塞和带塑料翻盖的铝制密封件。CellCept 500mg粉末用于浓缩液，用于输液，可提供4瓶装的包装。
请参阅随附的CellCept完整处方信息：
https://www.medicines.org.uk/emc/medicine/1681
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CellCept(mycophenolate mofetil)
Indication
CellCept® (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets, and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication.
Important Safety Information Including BOXED WARNINGS
WARNING: EMBROYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning.
Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients should prescribe Cellcept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
CONTRAINDICATIONS
CellCept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. CellCept Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
WARNINGS
•Pregnancy category D: Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant female. Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning
•Patients receiving immunosuppressive regimens involving combinations of drugs, including CellCept, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin
•CellCept has been administered in combination with the following agents in clinical trials: antithymocyte globulin, OKT3, cyclosporine, and corticosteroids. The efficacy and safety of the use of CellCept in combination with other immunosuppressive agents have not been determined
•Because of the danger of oversuppression of the immune system which can increase susceptibility to infection, which may lead to serious, including fatal outcomes, combination immunosuppressant therapy should be used with caution
•Polyomavirus associated nephropathy (PVAN), JC virus associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including CellCept. Reduction in immunosuppression should be considered for patients who develop evidence of new or reactivated viral infections. Physicians should also consider the risk that reduced immunosuppression represents to the functioning allograft
•Monitor patients for neutropenia. If neutropenia develops [absolute neutrophil count (ANC)
•Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressive agents
•CAUTION: CELLCEPT INTRAVENOUS SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION
PRECAUTIONS
•Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning
◦Pregnancy Testing: a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL must be administered immediately before starting CellCept. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. In the event of a positive pregnancy test, females should be counseled with regard to whether the maternal benefits of mycophenolate treatment may outweigh the risks to the fetus in certain situations, please report the pregnancy to Mycophenolate Pregnancy Registry (1-800-617-8191)
◦Contraception: Patients taking CellCept must receive contraceptive counseling and use acceptable contraception (see Table 8 of the full Prescribing Information for acceptable contraception methods). Patients must use acceptable birth control during entire CellCept therapy, and for 6 weeks after stopping CellCept, unless the patient chooses abstinence
•CellCept may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks
•A higher incidence of opportunistic infections was observed in cardiac transplant patients treated with CellCept than in those receiving azathioprine therapy
•CellCept should not be administered concomitantly with azathioprine and used with caution when used in the concomitant administration with drugs that interfere with enterohepatic recirculation
•CellCept should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome
•Gastrointestinal bleeding (requiring hospitalization) has been observed
•During treatment with CellCept, avoid the use of live attenuated vaccines and advise patients that vaccinations may be less effective
•Care should be taken if CellCept Oral Suspension is administered to patients with phenylketonuria
ADVERSE REACTIONS
•The principal adverse reactions associated with the administration of CellCept include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections, eg, opportunistic infections (see WARNINGS in full Prescribing Information). Phlebitis and thrombosis have been reported with intravenous administration. Please refer to the full Prescribing Information for additional ADVERSE REACTIONS.