Mycophenolate mofetil (Mycophenolate mofetil).
Form of issue
Immunodepressant; selective and reversible inhibitor of inosine monophosphate dehydrogenase, blocks the synthesis of guanosine nucleotides. The cytotoxic effect is more pronounced in relation to lymphocytes.
Adults and children with a body surface area> 1.25 m2 (approximate age 12 years):
prevention of acute graft rejection in patients after allogeneic kidney transplantation.
treatment of the first or refractory to the treatment of transplant rejection in patients after allogeneic kidney transplantation;
prevention of acute graft rejection and improvement of its survival and survival of patients after allogeneic heart transplant;
prevention of acute graft rejection in patients after allogeneic liver transplantation.
CellCept is prescribed as a combination therapy with cyclosporine and corticosteroids.
Increased individual sensitivity to MMF, IFC and other components of the drug;
deficiency of hypoxanthine-guanine phosphoribosyltransferase;
simultaneous administration with azathioprine.
With caution: GI disease (in the phase of exacerbation), simultaneous administration of MMF with tacrolimus, sirolimus, with drugs that affect hepatic intestinal recirculation.
On the part of the digestive system: colitis (sometimes cytomegalovirus etiology), pancreatitis, individual cases of atrophy of intestinal villi.
On the part of the immune system: isolated cases of severe life-threatening infections (meningitis, infective endocarditis), an increase in the incidence of certain infections such as tuberculosis and atypical mycobacterial infections.
Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, were observed in patients taking CellCept. In reports on these cases, there is information about the presence of additional risk factors for the development of PML in patients, including immunosuppressive therapy and impairment of immunity.
In patients taking CellCept, there were cases of development of nephropathy associated with the BK virus (B virus-associated nephropathy). This infection can lead to serious consequences, sometimes to the death of a kidney transplant.
Cases of development of partial red cell aplasia (PKAA) were observed in patients taking CellCept in combination with other immunosuppressive drugs.
Developmental anomalies: cases of fetal development anomalies (including ear developmental defects) in patients taking MMP during pregnancy in combination with other immunosuppressants have been reported.
Other undesirable reactions: those observed with post-marketing use of the drug do not differ from undesirable reactions recorded in controlled clinical trials.
Antacids reduce absorption; colestyramine reduces the concentration of the active metabolite; tubular secretion blockers increase the concentration of the inactive metabolite.
With the simultaneous use of mycophenolate mofetil and acyclovir, both concentrations of plasma in the plasma increase.Cyclosporine A, ganciclovir, co-trimoxazole, oral contraceptives (single dose) do not affect the pharmacokinetic parameters
Impact on the ability to drive vehicles and manage mechanisms
When driving vehicles, working with cars and engaging in other potentially hazardous activities, it must be taken into account that the drug can cause dizziness and other side effects that can affect the concentration of attention and the speed of psychomotor reactions.
In case of violations of kidney function
In patients with severe chronic renal failure (glomerular filtration rate less than 25 ml/min / 1.73 m2) outside the nearest post-transplant period or after therapy for acute or refractory rejection, doses above 1 g 2 times/day should be avoided. Data on patients with severe renal failure who underwent a heart or liver transplant are not available.
Dose adjustments for patients with delayed renal transplant function are not required.
With violations of liver function
Patients who have undergone a kidney transplant and who have a severe lesion of the liver parenchyma, dose adjustment is not required. Data on patients with severe lesions of the liver parenchyma, who underwent a heart transplant, are absent.
Application in old age
In elderly patients, the risk of adverse events may be higher than in younger patients. In elderly and senile patients (≥65 years old) who underwent kidney transplantation, the recommended dose is 1 g 2 times/day, and after heart or liver transplantation – 1.5 g 2 times/day.
Application in childhood
Possible use according to the indications and in recommended doses.
In patients receiving mycophenolate mofetil as part of immunosuppressive therapy, the risk of developing lymphomas and other malignant tumors (particularly skin cancer) with prolonged treatment with high doses increases.
During therapy, it is necessary to monitor the picture of peripheral blood. Women of reproductive age need to use effective methods of contraception before, during treatment and for 6 weeks after discontinuation of the drug.
The drug should be stored out of reach of children at a temperature of no higher than 30 ° C, protect from light and moisture.
Shelf life – 3 years.