Mycophenolate mofetil dispersible tablets

Pharmacological action: 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) and 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 reactions after renal transplantation and treating refractory rejection.

The main ingredient of this product is mycophenolate mofetil. Chemical name: 2-morpholinoethyl ester (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexene salt Molecular weight: C23H31NO7

This product is white or off-white tablets.

This product can be used to prevent rejection of allogeneic renal transplant patients and treat refractory rejection. This product can be used simultaneously with cyclosporine and adrenocortical hormones. It can also be used simultaneously with tacrolimus.

1. Oral administration 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). Oral administration of 2 grams/day is safer than oral administration of 3 grams/day. 2. 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). 3. If neutropenia occurs (absolute neutrophil count [1.3×10[sup]3[/sup]/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. Renal function after kidney transplantation

1. The occurrence of side effects of immunosuppressants is often difficult to determine because of the presence of underlying diseases on the one hand and the combined use of multiple other drugs on the other. The main adverse reactions of taking mycophenolate mofetil or taking it together with cyclosporine and corticosteroids include diarrhea, leukopenia, sepsis and vomiting, as well as frequent infections of certain types (see Warnings). 2. The safety of using this product to treat refractory renal transplant rejection is the same as the safety observed in three controlled, 3-gram daily, rejection prevention trials. Compared with patients receiving intravenous cyclosporine, diarrhea and leukopenia, accompanied by anemia, abdominal pain, sepsis, nausea, vomiting and indigestion are the main side effects reported more frequently. 3. Patients receiving immunosuppressive regimens, including patients taking concomitant drugs, and patients receiving mycophenolate mofetil tablets as partial immunosuppression have an increased risk of lymphoma and malignant tumors, especially skin (see Warnings). Within 3 years after surgery, patients treated with mycophenolate mofetil tablets in an immunosuppressive regimen developed lymphoproliferative diseases or lymphoma. In a controlled trial to prevent renal transplant rejection, the incidence was 1.6% for patients taking 3 grams per day, 0.6% for patients taking 2 grams per day, 0% for the placebo group, and 0.6% for the azathioprine group. In a controlled trial to treat refractory renal transplants, the incidence of lymphoma was 3.9% with an average follow-up of 42 months. 4. The risk of opportunistic infections in all patients increases, and the risk increases with the immunosuppressive load (see Warnings). For renal transplant patients, the overall incidence of opportunistic infections in patients treated with mycophenolate mofetil tablets and azathioprine is similar. 5. Compared with young people, the elderly, especially those who receive mycophenolate mofetil as part of a combined immunosuppressive regimen, have an increased risk of some infections (including cytomegalovirus tissue invasion), possible gastrointestinal bleeding and pulmonary edema. 6. Other adverse reactions of this product after marketing are similar to those in controlled renal transplant studies.

1. Allergic reactions to this drug have been observed. Therefore, mycophenolate mofetil tablets are contraindicated in patients with hypersensitivity to mycophenolate mofetil and mycophenolic acid. 2. Patients receiving immunosuppressive therapy, including combined medication, who receive mycophenolate mofetil tablets as part of immunosuppressive therapy, have an increased risk of developing lymphoma and other malignant tumors, especially skin. (See [Adverse Reactions]). The risk is related to the intensity and efficacy of immunosuppression, but not to the specific immunosuppression. 3. Due to the increased risk of skin cancer in all patients, exposure to sunlight and ultraviolet rays should be limited by wearing protective clothing or high-protection factor sunscreen. 4. Excessive suppression of the immune system can increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis.

Precautions for children: The safety and effectiveness of this drug for children have not been confirmed. Pharmacokinetic data for children are limited, so more observation is necessary when using it. Precautions for pregnancy and lactation: 1. The use of this drug during organ formation in rats and rabbits during pregnancy may cause fetal malformation. Although adequate and well-controlled studies have not been conducted on pregnant women, this drug should only be used when its potential advantages outweigh the potential risks to the fetus. 2. This drug should be taken only after a negative pregnancy test. During the use of this drug, effective contraceptive measures should be taken, and if the patient becomes pregnant, the doctor should be consulted in a timely manner. 3. Studies on rats have found that MMF can be secreted through breast milk. It is not clear whether mycophenolate mofetil tablets are secreted in human milk. In addition, MMF may have potential serious side effects on breastfeeding infants, and a decision should be made based on the importance of MMF to the mother: stop breastfeeding or stop taking the drug. Precautions for the elderly: 1. Pharmacokinetics: The pharmacokinetic data of mycophenolate mofetil in the elderly have not been formally studied. 2. Usage and Dosage: Elderly (≥65 years old): For renal transplant patients, the recommended oral dose of 1g each time, twice a day is suitable for the elderly. 3. Precautions: Compared with young people, the risk of side effects in the elderly is increased.

1. Acyclovir: When MMF and acyclovir are taken at the same time, the plasma concentrations of MPAG and acyclovir are higher than when the two drugs are taken alone. When renal function is impaired, the plasma concentrations of MPAG and acyclovir both increase. The two drugs are competitively excreted through the renal tubules, which may further increase the blood concentrations of the two drugs. 2. Antacids and magnesium hydroxide and aluminum hydroxide: When antacids are taken at the same time, the absorption of MMF is reduced. 3. Cholestyramine: Healthy people first took 4 grams of cholestyramine three times a day. After four days, a single dose of MMF 1.5 grams was given, and the area under the curve of MPA decreased by 40%. 4. Cyclosporine A: The pharmacokinetics of CsA are not affected by MMF. 5. Ganciclovir: No pharmacokinetic interaction was observed between MMF and intravenous ganciclovir.

seal.

0.25g

24 months

Kunming Baker NORTON Pharmaceutical Co., Ltd.

• Founded in:

  1992-07-30

• Address:

  7km west of Wuhua District, Kunming City, Yunnan Province

• Tax NO.:

  915300006226003939

• Registered Funds:

  $8,527,898

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