Mycophenolate Mofetil Capsules

The mechanism of action of this product has the following specificity: (1) It selectively inhibits the classical guanine synthesis pathway of lymphocytes and has no toxic effects on non-lymphocytes and/or organs; (2) It directly inhibits B cell proliferation, while cyclosporine has no effect on inhibiting antibody formation; (3) It effectively reduces the activity of adhesion molecules, inhibits the proliferation of vascular smooth muscle cells, and can prevent and treat vascular rejection reactions and reduce the occurrence of chronic rejection reactions.

Chemical name: 2-morpholinoethyl (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 a hard capsule containing white or off-white powdery granules.

This product is used to prevent acute organ rejection and treat refractory rejection after allogeneic renal transplantation. This product should be used simultaneously with cyclosporine and corticosteroids.

Dosage for preventing renal transplant rejection: The first dose of this product should be taken orally within 72 hours after transplantation. For renal transplant patients, 1 gram each time, twice a day (daily dose of 2 grams) is recommended. Although 1.5 grams each time, twice a day (daily dose of 3 grams) has been used in clinical trials and is safe and effective, it has no advantage in effectiveness. Patients who receive 2 grams of this product per day have better overall safety than patients who receive 3 grams. This product should be used simultaneously with standard doses of cyclosporine and corticosteroids. Dosage for treating refractory renal transplant rejection In clinical practice, the treatment and maintenance dose for refractory rejection is 1.5 grams per day, twice a day (daily dose of 3 grams). Therefore, a dose of 3 grams per day is recommended for clinical use. This product should be used simultaneously with standard doses of cyclosporine and corticosteroids.

1. Clinical experience: 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 to taking mycophenolate mofetil or taking mycophenolate mofetil, cyclosporine and corticosteroids together include diarrhea, leukopenia, sepsis and vomiting, and frequent certain types of infections. (See Warnings) 2. The safety of using mycophenolate mofetil to treat refractory renal transplant rejection is the same as the safety observed in three controlled groups of 3 grams per day. Prevention of rejection trials. Compared with patients receiving intravenous cyclosporine, diarrhea and leukopenia, accompanied by anemia, nausea, abdominal pain, sepsis, nausea and vomiting, indigestion and other adverse reactions are the main side effects that are reported more frequently. 3. Patients receiving immunosuppressants

Allergic reactions to Cellcept have been found. Therefore, patients who have allergic reactions to MMF or MPA should not use Cellcept.

Precautions for children: 1. 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. 2. The safety and effectiveness of pediatric patients receiving heart or liver allogeneic transplants have not been determined. Precautions for pregnancy and lactation: Pregnancy category C has adverse effects on embryonic development (including teratogenicity) in pregnant mice and rabbits after the use of this drug during the organogenesis period. The dose at which these reactions occur is lower than the dose associated with maternal toxicity and is lower than the dose recommended clinically for kidney transplantation. There are no adequate controlled studies in pregnant women. However, since this product has been shown to have teratogenic effects in animals, it may cause fatal harm to pregnant women. Therefore, this product should be avoided in pregnant women unless the potential benefits to the fetus outweigh the potential risks. It is recommended that the pregnancy test before using this drug should be negative. Effective contraceptive methods should be adhered to before, during and within 6 weeks after the treatment of this drug. Even for patients with a history of infertility, unless a hysterectomy has been performed. Unless abstinence is used, two effective geriatric precautions must be taken: Clinical trials of mycophenolate mofetil did not include enough elderly people aged 65 years or older to determine whether the effects in the elderly are different from those in younger people. Other reported clinical experience has also not determined the difference in effects between the elderly and the young. In general, dose selection in the elderly should be cautious because more elderly people have decreased kidney, heart, and liver function and are more likely to use other drugs. Adverse reactions may be more common in the elderly than in the young.

1. Acyclovir: When mycophenolate mofetil and acyclovir are taken simultaneously, the plasma concentrations of MPAG and acyclovir are increased compared with when the drugs are taken alone. 2. Antacids containing magnesium hydroxide and aluminum hydroxide: The absorption of mycophenolate mofetil is reduced when antacids are taken simultaneously. 3. Cholestyramine: It is recommended that mycophenolate mofetil should not be used in combination with cholestyramine or other drugs that affect enterohepatic circulation. 4. Cyclosporine A: The pharmacokinetics of cyclosporine A (CsA) are not affected by mycophenolate mofetil. However, in renal transplant patients, the combined use of sirolimus and cyclosporine A can reduce MPA by 30-50% compared with patients taking sirolimus and similar doses of cyclosporine. 5. Ganciclovir: In patients with renal impairment, mycophenolate mofetil is combined with ganciclovir or its prodrugs, such as valganciclovir.

Keep away from light and store in sealed container.

250mg

36 months

PKU HealthCare Corp., Ltd.

• Founded in:

  1993-05-18

• Address:

  No. 21, Fangzheng Avenue, Shuitu Town, Beibei District, Chongqing

• Tax NO.:

  91500000450533779H

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  595.987425 yuan

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