Sanofetil

Mycophenolate mofetil.

Each film-coated caplets contains 500 mg Mycophenolate mofetil.

PHARMACOLOGY: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). 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. MPA has more potent cytostatic effect on lymphocytes than on other cells. SANOFETIL is effective in the prophylaxis of organ rejection in patients receiving allogeneic renal transplants and in the prophylaxis of organ rejection in patients receiving allogeneic cardiac transplants.

SANOFETIL capsules are indicated for the prophylaxis of acute organ rejection and increased graft and patient survival in patients receiving allogeneic cardiac transplants.
SANOFETIL should be used concomitantly with cyclosporin and corticosteroids.

Standard dosage for prophylaxis of renal rejection: The initial dose of SANOFETIL should be given orally within 72 hours following transplantation. Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients.
Standard dosage for prophylaxis of cardiac rejection: The initial dose of SANOFETIL should given orally within 5 days following transplantation. A dose of 1.5 g administered twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
Special dosage instructions: Patients with neutropenia: If neutropenia develops (absolute neutrophil count < 1.3 x 10³/mcl), dosing with cellcept should be interrupted or the dose reduced (see Precautions).
Physician should perform appropriate diagnostic test, manage the patients appropriately.
Patients with severe renal impairment: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m²), outside of the immediate post-transplant period or after treatment of acute or refractory rejection, doses greater than 1 g administered twice a day should be avoided (see PRECAUTIONS). No data are available for cardiac transplant patients with severe chronic renal impairment.
Patients with severe hepatic impairment: No dose adjustments are needed for renal patients with severe hepatic parenchymal disease.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Elderly (≥65 years): The recommended oral doses of 1 g b.i.d. for renal transplant patients and 1.5 g b.i.d. for cardiac transplant patients area appropriate for elderly patients (see PRECAUTIONS).

There has been no reported experience of overdosage of mycophenolate mofetil in humans.

SANOFETIL is contraindicated in patients with hypersensitivity to mycophenolate mofetil or mycophenolic acid.

In some cases PRCA was found to be reversible with dose reduction cessation of SANOFETIL therapy. In transplant patients however reduced immunosuppression may place the graft at risk.
Increased risk of developing lymphomas and other malignancies, particularly of the skin (see Adverse Reactions).
Vaccinations maybe less effective and the use of live attenuated vaccines should be avoided (see Interactions). Influenza vaccination may be of value.
Because SANOFETIL is an inosine monophosphate dehydrogenase (IMPDH) inhibitor, on theoretical grounds it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
It is recommended that SANOFETIL should not be administered concomitantly with azathioprine because both have the potential to cause bone marrow suppression and such concomitant administration has not been studied.
Administration of doses greater than 1 g b.i.d. to renal patients with severe chronic renal impairment should be avoided (see Special dosage instructions under Dosage & Administration).
SANOFETIL should be avoided in pregnant woman unless the potential benefit outweighs the potential risk to the fetus.

When used in combination with cyclosporin and corticosteroids.
Renal transplant patients: Major effect: asthenia, fever, headache, infection, pain (includes abdominal, back and chest), edema, sepsis.
Minor effect: cysts (including lymphocele and hydrocele), enlarged abdomen, facial edema, flu syndrome, hemorrhage, hernia, malaise, pelvic pain.
Cardiac transplant patients: Major effect: asthenia, fever, chills, headache, infection, pain (includes abdominal, back and chest), edema, sepsis.
Minor effect: cellulitis, cysts (including lymphocele and hydrocele), enlarged abdomen, facial edema, flu syndrome, hemorrhage, hernia, malaise, pelvic pain, neck pain, pallor.
Disorders of immunosuppression: serious life threatening infections such as meningitis and infectious endocarditis have been reported occasionally, certain infection such as tuberculose and atypical bacterial have higher infection frequency.

Acyclovir: the potential exist for two drugs to compete for tubular secretion, further increasing the concentrations of both drugs.
Antacids with magnesium and aluminum hydroxides: absoption of mycophenolate mofetil was decreased when administered with antacids.
Cholestyramine: should be used during concomitant administration or with drugs that interfere with enterohepatic circulation (see Precautions).
Tacrolimus: for patients on tacrolimus, the dose of cellcept should not exceed 1 g twice a day.
Live vaccines: live vaccines should not be given to patients with an impaired immune response. The antibody response to other vaccines may be diminished (see Precautions).

Store below 30°C.

Immunosuppressants

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

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