Renocell

A white film-coated tablet, capsule-shaped, plain on one side and bisected on the other side.
Each film-coated tablet contains: Mycophenolate Mofetil 500 mg.
Mycophenolate mofetil is a morpholinoethyl derivative of mycophenolic acid. It is an immunosuppressive derived from Penicillium stoloniferum. It is a reversible inhibitor of inosine monophosphate dehydrogenase and thus inhibits purine synthesis, with potent cytostatic effects on both T- and B-lymphocytes. Mycophenolate mofetil also acts by preventing cell division of lymphocytes in transplantation.

Pharmacology: Pharmacodynamics: Mycophenolate mofetil (MMF) has been demonstrated in experimental animal models to prolong the survival of allogeneic transplants (kidney, heart, liver, intestine, limb, small bowel, pancreatic islets, and bone marrow). MMF has also been shown to reverse ongoing acute rejection in the canine renal and rat cardiac allograft models. MMF also inhibited proliferative arteriopathy in experimental models of aortic and heart allografts in rats, as well as in primate cardiac xenografts. MMF was used alone or in combination with other immunosuppressive agents in these studies. MMF has been demonstrated to inhibit immunologically mediated inflammatory responses in animal models and to inhibit tumor development and prolong survival in murine tumor transplant models. MMF is rapidly absorbed following oral administration and hydrolyzed to form MPA, which is the active metabolite. MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways, MPA has potent cytostatic effects on lymphocytes. MPA inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. Addition of guanosine or deoxyguanosine reverses the cytostatic effects of MPA on lymphocytes. MPA also suppresses antibody formation by B-lymphocytes. MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. MMF did not inhibit early events in the activation of human peripheral blood mononuclear cells, such as the production of interleukin-1 (IL-1) and interleukin-2 (IL-2), but did block the coupling of these events to DNA synthesis and proliferation.
Pharmacokinetics: Mycophenolate mofetil is rapidly and extensively absorbed from the gastrointestinal tract, and undergoes presystemic metabolism to active mycophenolic acid. It undergoes enterohepatic recirculation. Mycophenolic acid is metabolized by glucuronidation and excreted primarily in the urine; about 6% of a dose is recovered in faeces. Mycophenolic acid is 97% bound to plasma albumin. The half-life of mycophenolic acid after oral administration of mycophenolate is about 18 hours.

For the prevention of graft rejection, and also been tried in various diseases with an auto-immune or immune-mediated inflammatory components.

For acute renal graft rejection: 1 g twice daily.
For prophylaxis of cardiac graft: 1.5 g twice daily or as prescribed by the physician.

It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression. If neutropenia develops, dosing with mycophenolate mofetil should be interrupted or the dose be reduced.

Mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product.

Mycophenolate mofetil may have a moderate influence on the ability to drive and use machines. Patients should be advised to use caution when driving or using machines if they experience adverse drug reactions such as somnolence, confusion, dizziness, tremor or hypotension during treatment with mycophenolate mofetil.

Should be given with care to patients with severe renal impairment or active disorders of the gastrointestinal tract.

Mycophenolate mofetil is contraindicated during pregnancy due to its mutagenic and teratogenic potential.
Mycophenolate mofetil is contraindicated in women of childbearing potential not using highly effective contraceptive methods and without providing a pregnancy test result.
Mycophenolate mofetil is contraindicated in women who are breastfeeding.

Reported adverse drug reactions include asthenia, fever, pain, headache, anaemia, thrombocytopenia, renal tubular necrosis, hematuria, hyperglycaemia, disturbances of electrolytes and blood lipids, peripheral oedema, dyspnea, cough, acne, dizziness, insomnia, and tremor. Hypersensitivity reactions have occurred. Mycophenolate is teratogenic in animals.

Mycophenolate mofetil may compete with other drugs that undergo active renal tubular secretion, resulting in increased concentrations of either drug. Concomitant administration with antacids, or to patients receiving cholestyramine, may result in reduced absorption of mycophenolate.

Store at temperatures not exceeding 30°C.

Immunosuppressants

L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.

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