Cellcept 250mg Roche Drugs prevent acute transplantation (10 blisters x 10 tablets)

mycophenolate mofetil (MMF) is the form of ester 2-morpholinethyl of mycophenolic acid (MPA).

MPa is an Inosine monophosphate dehydrogenase inhibitor (IMPDH) with strong, selective, non -competitive and recovery inhibitors, so the DE NOVO road inhibitors of Guanosine Nucleotide synthesis.

MPa has a stronger effect on lymphocytes for other cell lines because T -lymphocytes and B lymphocytes are dependent on their proliferation in the De Novo path of the Purines synthesis, while other cell lines can take advantage of other regenerative paths.

Clinical effects

In clinical trials on preventive treatment of pieces of pieces in kidney, heart and liver transplantation, cellcept has been used in combination with thymus gland cell globulin, OKT3, Ciclosporin and Corticosteroids to treat kidney transplant stages that are hard to treat.

Before treatment with cellcept, the patient has been used globulin anti -lymphocytes, globulin gland cell gland cell and OKT3. After that, the cellcept was used with Daclizumab and Tacrolimus in these clinical trials.

Room pregnancy transplant

Adult patient:

Safety and effectiveness of cellcept when used in combination with corticosteroid and ciclosporin to treat organ transplantation prophylaxis have been assessed in patients with kidney transplantation in three random, blind, multicolored tests; In patients with heart transplantation in a random, blind, multicolored test; And in patients with liver transplant in a random, double, multicolored test.

Pediatric:

Safety, pharmacokinetics, effectiveness of Cellcept treatment in coordination of treatment with corticosteroids and ciclosporin in the prevention of transplantation in kidney transplantation is assessed in open label research, multi -central centers over 100 patients (aged 3 months - 18 years old)

kidney transplant

Adult patient:

Three tests compare two oral dose levels of Cellcept (1g x 2 times daily and 1.5g x 2 times daily) in combination with azathioprine (2 tests) or placebo (1 test) and used in combination with ciclosporin and corticosteroids for backup treatment for acute transplant stages.

The main ending of the effectiveness of the drug is that the proportion of patients in each group of therapeutic therapy failed with treatment within the first 6 months after the organ transplantation (failure with treatment is determined when: there is a transplantation during the treatment process is confirmed through a biopsy; or when the patient's death or loss of organ transplant; or when the patient must end early, not to follow the test for any reason, there is no assertion through any assertion, there is no assertion through the transplant. that).

Cellcept is studied in the following three treatments: (1) For the use of globulin globulin/then use MMF or Azathioprine/Ciclosporin/Corticosteroids, (2) MMF or Azathioprine/Ciclosporin/Corticosteroids, and (3) MMF or placebo/Ciclosporin

Cellcept, when coordinated with corticosteroids and ciclosporin, reduces (significantly statistically significantly at

The table below summarizes the results of these tests.

Patients who have to stop early treatment have been monitored about death or losing organ transplantation, and people have summarized separately the accumulation rate of organ loss and death.

Patients who have to stop early treatment have not been monitored about acute transplantation after stopping the drug.

The number of patients in the cellcept group must stop treatment (there is no affirmation of transplantation through the previous biopsy, death or loss of organ transplantation) more than the number of patients who have to stop treatment in the control group, with the highest rate in the 3G/3G Cellcept group. Therefore, the acute transplant ratio can be improperly assessed, especially in the group using 3G Cellcept/Day.

The main outcome of effectiveness measured by the proportion of patients occurring acute transplantation in the first 6 months after transplantation.

The ratio of grafted evidence is similar to other groups (3 months to 6 years old, 6 years old to

The ratio of transplant organs (5%) and death (2%) in patients 12 months of age after kidney transplant is similar to the rate of observation in adult patients with kidney transplant.

Heart transplant

A double, random, comparative, equivalent, multi -center test has been conducted in heart transplant patients for the first time. The total number of patients participating in the test is 650, of which 72 have never been treated with testing and 578 people treated with testing.

Patients who are used for Cellcept 1.5g x 2 times daily (n = 289) or Azathioprine 1.5-3mg/kg/day (n = 289) in combination with Ciclosporin and Corticosteroids are immunosuppressive maintenance therapy. The two main ending endings are:

(1) The percentage of patients after a heart transplant has at least one incidental disposal has been confirmed through the muscular biopsy in the heart muscle with hemodynamic damage, or re -grafted or mortality, within the first 6 months; and (2) The rate of patients died or re -allowed within 12 months after heart transplant.

Patients who have to end early treatment are monitored for heterozygous removal within 6 months and death within 1 year.

1. Grafting: There is no difference between cellcept and azathioprine (AZA) on a state of transplantation that is confirmed through biopsy, with hemodynamic damage, as shown in the following table:

For patients taking immunosuppressive drugs, doctors should pay attention to the case of PML when diagnosis is distinguished in patients with neurological symptoms and need to consult with specialists.

Kidney disease related to the BK virus has been recorded during the use of cellcept in patients after kidney transplant. This infection can lead to serious consequences, sometimes leading to kidney failure. Monitoring patients helps detect patients at risk of kidney disease associated with BK virus. It is necessary to consider reducing immunosuppressive in patients with evidence of kidney disease related to BK virus.

Blood and immunity system:

Patients who use Cellcept should be tested for total blood recipe, once a week for the first month, twice a month in the 2nd and 3rd month, then check monthly until the end of the first year.

In particular, patients who use Cellcept should be monitored to detect neutrophils of neutrophils. Multi -neutral leukopenia may be involved in the use of cellcept, combined drugs, virus infections or due to the combination of these causes.

If there is a neutrophils of neutropenia (the number of absolute neutrophils

It is advisable to let patients know that during the cellocpt treatment, the effectiveness of vaccination may be reduced and should avoid the use of live vaccines that have reduced toxicity. Influenza can be vaccinated. Doctors should refer to the national instructions on Influenza vaccination.

Due to the increase in the proportion of adverse events occurring in the digestive system, including rare cases such as gastrointestinal ulcers, hemorrhage and perforation, caution should be cautious when taking cellcept for patients with the disease of the digestive system.

Cellcept is an Inosine monophosphate dehydrogenase inhibitor (IMPDH), so it should not be used for patients with hypoxanthin-guaninephosphosyl-gansferase (HGPRT) (HGPRT) such as Lesch -nyhan and Kelley-seegmiller syndrome.

Interactive:

Be careful when changing the treatment regimen from therapy containing immunosuppressants that can inhibit the intestinal circulation of MPA such as Ciclosporin to other drugs that do not have this effect such as Sirolimus, Belatacept, or vice versa, due to the change of treatment regimen can change MPa level.

Be careful with drugs that can inhibit the MPA's intestinal cycle such as cholestyramin, antibiotics due to the ability to reduce plasma concentrations and effectiveness of cellcept.

It is recommended that the cellcept should not be used with azathioprine because both of these drugs can inhibit bone marrow and this combination has not been studied.

Special cases:

The risk of adverse events may increase in older patients such as infections (including tissue invasive virus) and gastrointestinal bleeding and pulmonary edema when compared to younger patients. Contraindicated use of cellcept for pregnant women and nursing mothers.

Should avoid using the dose exceeding 1g, twice daily in patients with chronic renal function.

No dose adjustment in patients after organ transplant has a slow recovery kidney function, but must monitor patients carefully. There are no data in patients with heart transplant or liver transplant with severe kidney failure.

Oral cellcept cells containing aspartame, the origin of phenylamine (equivalent to 2.78 mg/ 5 ml of oral fluid). Therefore, it is necessary to be cautious when using the oral cellcept for patients with phenylketonuria.

Drug interaction

acyclovir:

Plasma concentrations of acyclovir and mpag when used with mycophenolate mofetil with acyclovir are higher when used separately each drug. Because the mpag concentration in plasma as well as acyclovir concentration or its form of quality, valacyclovir, increases when the kidney failure, is capable of harmful drugs with competition elimination in the renal tubules and can cause more concentration of both drugs.

antacids and proton pump inhibitors (PPIS): When taking poor antacids such as hydroxide magnesium and aluminum hydroxide, and PPIS, such as Lansoprazole and Pantoprazole, the absorption of mycophenolate mofetil is reduced. When comparing the ratio of transplantation or the loss of organ losing the transplant between the Cellcept patients with PPLS and patients who do not take PPIS, do not observe the significant difference.

These data help foreign conclusions for all antacids due to reduced absorption when using Cellcept with hydroxide Magne and aluminum hydroxide are considered lower when using cellCept.

cholestyramine:

In normal healthy people, 4G cholestyramine three times a day for 4 days then use a single dose of 1.5 g Mycophenolate mofetil, the area under the MPa curve is reduced by 40%. Should be cautious when used with drugs that limit the re-circulating ring.

ciclosporin A:

The pharmacokinetics of Ciclosporin A (CSA) is not affected by Mycophenolate Mofetil. However, CSA inhibits MPA's intestinal circulation, reduces MPa levels from 30-50% in kidney transplant patients with Cellcept and CSA treatment when compared with patients using syrolimus or belatacept and cellcept with the same dose as cellcept.

In contrast, the changes in the concentration of MPa should be expected when transferred to patients from CSA to other immunosuppressive drugs that do not affect the gut liver cycle of MPA.

telmisartan:

Simultaneous use of Telmisartan and Cellcept reduces about 30% of mycophenolic acid level (MPA). Telmisartan changes the excretion of MPA due to activation of PPAR Gamma (Peroxisome Proliferator activating gamma receptors) that increases the activity of UGT1A9.

When comparing the ratio of transplantation, the ratio of organ damage or adverse events between patients using Cellcept simultaneously and not simultaneously with Telmisartan, there is no clinical conclusion about DDI pharmacokinetics observed.

ganciclovir:

Based on the results of the single dose research of the dosage of the use of Mycophenolate Mofetil oral and ganciclovir intravenously; And the known kidney failure for pharmacokinetics of Mycophenolate Mofetil and Ganciclovir, when used simultaneously, these drugs have competition in the mechanism of renal excretion) will increase the concentration of MPAG and Ganciclovir.

There is no significant change in the pharmacokinetics of MPA and no need to adjust the dose of mycophenolate mofetil. In patients with renal failure, simultaneously using Mycophenolate Mofetil and Ganciclovir or its precursors, for example Valganciclovir, should monitor patients carefully.

Oral contraceptive pills:

A study on the use of cellcept (1g twice daily) with oral contraceptives containing ethinylelestradiol (0.02-0.04mg) and levonorgestrel (0.05-0.20mg), Desogestrel (0.15mg) or Gestode (0.05-0.10mg), which is conducted in 18 women with psed pale Cellcept does not affect clinical effects on the concentrations of progesterone, LH and FSH, so the cellcept does not affect the inhibition of ovulation of oral contraceptives.

The pharmacokinetics of oral contraceptives are not affected at the level of clinical when used simultaneously with Cellcept.

rifampicin:

After adjusting the dose correctly, it is still observed that there is a 70% reduction in MPA (AUC-P) concentration when used in combination with rifampicin in a heart-pitcher patient. Therefore, it is advised to closely monitor MPA levels and need to adjust the Cellcept concentration accordingly to maintain clinical effect when using these two drugs simultaneously.

tacrolitis:

Using Tacrolimus simultaneously with cellcept does not affect the area under the AUC curve as well as the MPA's CMAX peak concentration in patients with liver transplantation. In a recent study, it was found that this happened in patients with kidney transplant.

In patients with kidney transplantation, the concentration of Tacrolimus does not seem to be changed by the cellocpt. However, in patients with stable liver transplantation, there is a phenomenon of increasing the AUC value of Tacrolimus about 20% when using multiple doses of cellcept (1.5g x 2 times/day) in combination with Tacrolimus.

Antibiotics kill bacteria producing b-glucuronidase in the intestine (for example, aminoglycoside, cephalosporin, fluoroquinolon, and penicillin group antibiotics) can affect the mpag/mpa liver circulatory cycle thus led to reduced mpa levels (see warning and caution, drug interaction)

Information related to antibiotics are as follows:

ciprofloxacin or amoxicillin in collaboration with clavulanic acid: reduced 54% of MPA (sunken) level before the dose was recorded in kidney transplant patients right after the beginning of drinking ciprofloxacin and amoxicillin in combination with clavulanic acid.

Norfloxacin and Metronidazole: Norfloxacin combined with Metronidazole reduces the AUC0-48 of MPa 30% after taking the single doses of Cellcept. There is no effect on MPa concentration with one of the two antibiotics when they are used separately.

trimethoprim/sulphamethoxazole: MPA concentration (AUC, CMAX) is not affected when combined with trimethoprim/sulfamethoxazole

Other interactions:

Use a propeller combination with mycophenolate mofetil when increasing the area below the curve of MPAG 3 times. Thus, other drugs are known to be excreted through the renal tubules that can compete with MPAG and thus increased plasma concentrations of MPEG or removal drugs through the renal tubules.

Using SEVELAMER combination with cellcept in adults and in children will reduce the CMAX peak concentration of MPa by 30% and reduce the AUC0-12 value of MPa by about 25%. From this fact, it is suggested that after using a new 2 -hour cellcept, SEVELAMER and calcium drugs have a binding force associated with other free phosphate roots to minimize the impact of these drugs on the absorption of MPA.

Living vaccine: Living vaccine should not be used for patients with impaired immune response. Antibody response to other vaccines may be reduced (see items note and caution).

Cavalry

Cellcept uses intravenous lines that are not compatible with other intravenous solutions, except for the Dextrose intravenous solution. Do not mix or simultaneously cellcept with other intravenous drugs through the same transmission line.