Mycophenolate mofetil tablets

Mycophenolate mofetil (MMF) is a 2-ethyl ester derivative of mycophenolic acid (MPA). MPA is a highly effective, selective, non-competitive, and reversible inhibitor of inosine mononucleotide dehydrogenase (IMPDH), which can inhibit the classical synthesis pathway of guanine nucleotides. MPA has a highly selective effect on lymphocytes. Mycophenolate mofetil tablets are extremely effective in preventing rejection after renal transplantation and treating refractory rejection.

The main ingredient of this product is mycophenolate mofetil

Pale purple film-coated tablets, appearing white or off-white after removing the film coating.

It can be used to prevent rejection of allogeneic renal transplant patients and treat refractory rejection. It can also be used simultaneously with cyclosporine and corticosteroids.

Dosage for prevention of rejection: should be started within 72 hours of transplantation. The recommended dose for renal transplant patients is 1 gram twice a day (2 grams a day). Taking 2 grams of sildenafil daily is safer than taking 3 grams orally a day. Dosage for the treatment of refractory rejection: In clinical trials, the recommended initial and maintenance dose for the treatment of refractory rejection is 1.5 grams twice a day (3 grams/day). Special dose: if neutropenia occurs (absolute neutrophil count < 1.3X103/microliter), the dose should be stopped or reduced. Severe renal impairment: for patients with severe chronic renal impairment (glomerular filtration rate < 25 ml/min 1.73 square meters), a dose exceeding 1 gram twice a day should be avoided (except for use immediately after transplantation). These patients should be carefully observed. No dose adjustment is required for patients with delayed recovery of renal function after transplantation.

Major adverse reactions include diarrhea, leukopenia, sepsis, and vomiting, and frequently certain types of infections.

Contraindicated in patients with hypersensitivity to mycophenolate mofetil and mycophenolic acid. Avoid concurrent use with azathioprine.

Precautions for children: Based on the pharmacokinetic and safety data of children after kidney transplantation, the recommended dose is 600 mg/m2 bid (up to 1 g bid) of mycophenolate mofetil orally (see [Pharmacology and Toxicology], [Clinical Trials], [Adverse Reactions] and [Dosage and Administration]). The safety and effectiveness of pediatric patients receiving heart or liver allogeneic transplants have not been established. Precautions for pregnancy and lactation: In pregnant rats and rabbits, the use of this drug during the organogenesis period has adverse effects on embryonic development (including teratogenicity). These reactions occurred at doses lower than those associated with maternal toxicity and lower than the clinically recommended dose for kidney transplantation. Adequate controlled studies have not been conducted in pregnant women. However, since this product has been shown to be teratogenic in animals, use by pregnant women may cause harm to the fetus. Therefore, the use of CellCet by pregnant women should be avoided unless the potential benefits to the fetus outweigh the potential risks. Women of childbearing age should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 1 week before starting treatment. Physicians are advised not to start CellCet treatment before obtaining a negative pregnancy test report. Patients must take effective contraceptive measures before starting treatment with Mycophenolate mofetil, during treatment, and for 6 weeks after discontinuation of treatment. This includes patients with a history of infertility. Patients who have undergone hysterectomy do not need to take contraceptive measures. Unless abstinence is used, patients must take two reliable methods of contraception at the same time (see [Drug Interactions]). If pregnancy occurs during treatment, the doctor and patient should discuss whether to continue the pregnancy. Lactation Studies on rats have found that this drug can be secreted in breast milk. However, it is not known whether it is secreted into breast milk in humans. Because many drugs can be secreted into breast milk and this drug can have potentially serious adverse reactions in breastfeeding newborns, a decision should be made to discontinue breastfeeding or discontinue the drug based on the importance of this drug to the nursing mother. Elderly precautions: Clinical trials of mycophenolate mofetil did not include enough elderly people aged 65 years or older to determine whether the effect in the elderly is different from that in younger people. Other reported clinical experience has not determined the difference in effect between the elderly and the young. In general, the dose selection for the elderly should be cautious because more elderly people have decreased kidney, heart and liver function and are more likely to use other drugs. Compared with young people, adverse reactions may be more common in the elderly.

Acyclovir: When MMF and acyclovir are taken simultaneously, the plasma concentrations of MPAG and acyclovir are higher than when either drug is taken alone. When renal function is impaired, the plasma concentrations of both MPAG and acyclovir increase. The two drugs are competitively excreted through the renal tubules, which may further increase the blood concentrations of both drugs. Antacids and magnesium hydroxide and aluminum hydroxide: The absorption of MMF is reduced when antacids are taken simultaneously. Cholestyramine: Healthy people first took cholestyramine 4 grams three times a day, and after four days, a single dose of MMF 1.5 grams was given, and the area under the curve of MPA decreased by 40%. Cyclosporine A: The pharmacokinetics of CsA are not affected by MMF. Ganciclovir: No pharmacokinetic cross-talk was observed between MMF and intravenous ganciclovir. Oral contraceptives: No interaction has been found between MMF and the oral contraceptive 1 mg norethindrone/35 micrograms ethinyl estradiol, but this is only a conclusion drawn from a single-dose study and does not rule out the possibility that long-term use of mycophenolate mofetil tablets will change the pharmacokinetics of oral contraceptives, which may lead to reduced efficacy of oral contraceptives. Sulfadimethoxazole: No effect on the bioavailability of MPA. Other interactions: Giving monkeys probenecid and MMF at the same time can increase the area under the curve of plasma MPAG by 3 times. For this reason, other drugs excreted through the renal tubules can compete with MPAG, thereby increasing the concentration of plasma MPAG or these drugs. Patients with immune response disorders should not be vaccinated with live vaccines. Antibody responses to other vaccinations may be eliminated.

Keep in a dry place, sealed and protected from light. The validity period is tentatively 18 months.

0.5 g

36 months