Micocept

Mycophenolate mofetil

In combination w/ ciclosporin & corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Renal transplant Adult & elderly 1 g bd (2 g daily) initiated w/in 72 hr following transplantation. Childn & adolescent 2-18 yr 600 mg/m² bd. Max: 2 g daily. BSA >1.5 m² 1 g bd (2 g daily). BSA 1.25-1.5 m² 750 mg bd (1.5 g daily). Severe chronic renal impairment outside the immediate post-transplant period Max: 1 g bd. Cardiac transplant Adult & elderly 1.5 g bd (3 g daily) initiated w/in 5 days following transplantation. Hepatic transplant Adult & elderly 1.5 g bd (3 g daily) initiated after IV mycophenolate mofetil as soon as it can be tolerated.

May be taken with or without food: Swallow whole, do not crush/open.

Hypersensitivity to mycophenolate mofetil & mycophenolic acid. Women of childbearing potential not using highly effective contraception & w/o pregnancy test result ruling out unintended use in pregnancy. Pregnancy & lactation.

Increased risk of developing lymphomas & other malignancies, particularly of the skin; opportunistic infections, fatal infections & sepsis. Reports of hypogammaglobulinaemia, bronchiectasis, ILD & pulmonary fibrosis; pure red cell aplasia. Exposure to sunlight & UV light should be limited. Monitor for neutropenia. Vaccinations may be less effective. Avoid live attenuated vaccines. Associated w/ increased incidence of digestive system adverse events including infrequent cases of GIT ulceration, haemorrhage, perforation. Avoid use in patients w/ rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Caution when switching combination therapy from regimens containing immunosuppressants, which interfere w/ mycophenolic acid (MPA) enterohepatic recirculation eg, ciclosporin to other devoid of this effect eg, sirolimus, belatacept, or vice versa. Caution w/ drugs of other classes which interfere w/ MPA enterohepatic cycle eg, cholestyramine. Do not administer concomitantly w/ azathioprine. Risk-benefit w/ tacrolimus or sirolimus has not been established. Genotoxic & teratogenic potential. Women of childbearing potential, sexually active men & their female partners should use highly effective contraception. Patients should not donate blood during therapy or for at least 6 wk following discontinuation of therapy. Men should not donate semen during therapy or for 90 days following discontinuation of therapy. Not recommended in childn <2 yr. Increased risk of adverse events in elderly patients.

Sepsis, GI candidiasis, UTI, herpes simplex or zoster; leucopenia, thrombocytopenia, anaemia; vomiting, abdominal pain, diarrhoea, nausea. Pneumonia, flu, resp tract infection, resp moniliasis, GI infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vag candidiasis, rhinitis; skin cancer, benign neoplasm of skin; pancytopenia, leucocytosis; acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphatemia, hyperuricaemia, gout, anorexia; agitation, confusional state, depression, anxiety, thinking abnormal, insomnia; convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysguesia; tachycardia; hypotension, HTN, vasodilatation; pleural effusion, dyspnoea, cough; GI haemorrhage, peritonitis, ileus, colitis, gastric & duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation; hepatitis, jaundice, hyperbilirubinaemia; skin hypertrophy, rash, acne, alopecia; arthralgia; renal impairment; oedema, pyrexia, chills, pain, malaise, asthenia; increased hepatic enzyme, blood creatinine, blood LDH, blood urea, & blood alkaline phosphatase, decreased wt.

In presence of renal impairment, potential exists for mycophenolate mofetil & aciclovir/ganciclovir, or its prodrugs, to compete for tubular secretion & further increases in conc for both substances may occur. Decreased MPA exposure w/ antacids (eg, Mg & Al hydroxides) & PPIs (eg, lansoprazole & pantoprazole); rifampicin; sevelamer; combined administration of norfloxacin & metronidazole. Reduced efficacy w/ cholestyramine & drugs that interfere w/ enterohepatic circulation. Increased MPA AUC if concomitant treatment w/ ciclosporin A is stopped. Decreased MPA conc w/ telmisartan. Reductions in pre-dose (trough) MPA conc w/ oral ciprofloxacin or amoxicillin + clavulanic acid. Increased AUC of tacrolimus in hepatic transplant patients. Other substances known to undergo renal tubular secretion may compete w/ MPAG (phenolic glucuronide of mycophenolic acid) & thereby raise plasma conc of MPAG or the other substance undergoing tubular secretion. Diminished Ab response to other vaccines.

Immunosuppressants

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

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