Myfortic 360mg is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Myfortic 360mg should be used concomitantly with cyclosporine and corticosteroids.
Novartis India Ltd
Myfortic 360mg (inactive form) is a prodrug of Mycophenolic acid (MPA) and it is an immunosuppressive drug. Following oral administration, mycophenolate mofetil is fastly absorbed and hydrolysed (converted) to Mycophenolic acid.
Mycophenolic acid (MPA) is the active metabolite which has pharmacological activity.
Myfortic 360mg is a prescription drug provided under the supervision of doctors.
Mechanism of action
Myfortic is the 2-morpholinoethyl ester of MPA. MPA (Mycophenolic acid) is a potent, selective, uncompetitive and reversible prohibitor of inosine monophosphate dehydrogenase, and thereby prevents the de novo pathway of guanosine nucleotide development without fusion into DNA.
Because T- and B-lymphocytes are mortally weak for their replication on de novo synthesis of purines although another cell types can utilise salvage pathways, Mycophenolic acid has more potent cytostatic effects on lymphocytes than on other cells.
In oral administration, rapidly absorbed and bioavailability are 94% for oral Mycophenolate mofetil relative Mycophenolate mofetil intravenous.
The active metabolite MPA bounded to plasma protein is 98%.
Mainly metabolised by glucuronic transferase to form inactive phenolic glucuronide of MPA.
Myfortic 360mg is completely recovered with 93% dose in urine and 6% via feces and 87% administrated dose excreted via urine as MPAG.
Half-life of myfortic is 13-17 hours
Myfortic is mainly required for preventions of organ transplant of kidney, heart and liver, the dosage as follows :
For Adult the prescribed dose is 1 g given orally or intravenously (over no less than 2 hours) twice a day.
For paediatric (3 months to 18 years of age) the prescribed dose of the oral suspension is 600 mg/m2 given twice daily (maximum daily dose of 2 g/10 ml).
Dosage also calculated according to body surface area
Patients with a body surface area of 1.25 m2 to 1.5 m2 may be taken capsules at a dose of 750 mg twice daily.
Patients with a body surface area >1.5 m2 may be administrated with capsules or tablets at a 1 g dose twice daily.
For Adults the usual dose is 1.5 g given twice daily intravenously over no less than 2 hours or 1.5 g administrated orally twice daily.
For Adults the prescribed dose is 1 g twice daily given via intravenously over no less than 2 hours or 1.5 g orally twice daily.
For Geriatrics (elderly patients) the prescribed orally is 1 g dose twice daily for renal transplant patients, 1.5 g dose given twice daily for heart transplant patients, and 1 g dose twice in a day administered intravenously or 1.5 g dose twice in a day administered orally in liver transplant patients.
Common side effects :
Diarrhoea, Vomiting, Pain, Abdominal pain, Hypertension, Swelling of the ankles or feet, lower legs.
Serious side effects
Infection, Infection in blood, Pharyngitis, Low RBC, and WBC, thrombocytopenia
Embryofoetal Toxicity :
Mofortic 180mg can leads risk to foetal when administered to a pregnant female. While Use of mofilet during pregnancy is along with an increased risk of first trimester pregnancy loss and have high risk of congenital malformations, Lymphoma and Malignancy
Patients administrating immunosuppressive drug containing combinations of drugs, involves Myfortic 180mg, as part of an immunosuppressive regimen have high risk of developing lymphomas and other malignancies, specifically effect the skin Pregnancy Exposure Prevention and Planning
Females of reproductive probably should be made aware of the high risk of first trimester pregnancy loss and congenital malformations and must be advise about pregnancy prevention and planning
Combination with Other Immunosuppressive Agents :
Myfortic 360mg has been given in co administration with the following agents in clinical trials: antithymocyte globulin(ATGAM®), OKT3 (Orthoclone OKT® 3), cyclosporine (Sandimmune®, Neoral®) and corticosteroids should be avoided.