Mycophenolate Teva

Mycophenolate mofetil

In combination w/ ciclosporin & corticosteroids for prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Induction treatment of active lupus nephritis (class III, IV, V or mixed class) in combination w/ glucocorticoids. Maintenance treatment of lupus nephritis after induction treatment.

Renal transplant Elderly 1 g bid. Adult Initiate w/in 72 hr following transplant. Recommended dose: 1 g bid. Daily dose: 2 g. Paed patient 2-18 yr 600 mg/m² bid. Max: 2 g daily. Patient w/ BSA of >1.5 m² 1 g bid. Daily dose: 2 g, 1.25 to 1.5 m² 750 mg bid. Daily dose: 1.5 g. Severe chronic renal impairment (GFR <25 mL/min/1.73 m²) Max: 1 g bid. Cardiac transplant Elderly 1.5 g bid. Adult Initiate w/in 5 days following transplant. Recommended dose: 1.5 g bid. Daily dose: 3 g. Hepatic transplant Elderly 1.5 g bid. Adult IV mycophenolate mofetil should be administered for the 1st 4 days following transplant. Initiate w/ oral mycophenolate mofetil as soon after this can be tolerated. Recommended dose: 1.5 g bid. Daily dose: 3 g.

May be taken with or without food: Swallow whole, do not crush/open. In stable renal transplant patients, may be administered w/ meals if necessary.

Hypersensitivity. Women of childbearing potential who are not using highly effective contraception; do not initiate w/o providing a pregnancy test result to rule out unintended use in pregnancy. Pregnancy & lactation.

Do not donate blood during therapy & for at least 6 wk following discontinuation of therapy. Interrupt or discontinue if neutropenia develops (ANC <1.3 x 10³/microL). Avoid in patients w/ rare hereditary deficiency of hypoxanthine-guaninephosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Increased risk of developing lymphomas & other malignancies, particularly of the skin; opportunistic infections (bacterial, fungal, viral & protozoal), fatal infections & sepsis. Reactivation of hepatitis B or C. Bronchiectasis; ILD & pulmonary fibrosis. Pure red cell aplasia. Any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. Patients w/ active serious digestive system disease. Limit sunlight & UV light exposure by wearing protective clothing & using sunscreen w/ high protection factor. Measure serum Ig of patients who develop recurrent infections. Investigate patients who develop persistent pulmonary symptoms eg, cough & dyspnoea. Monitor for neutropenia. Perform CBC wkly during the 1st mth, twice mthly for 2nd & 3rd mth, then mthly through the 1st yr. Consider therapeutic drug monitoring for lupus nephritis patients w/ GFR <30 mL/min. Avoid use of live attenuated vaccines. Concomitant use w/ drugs which interfere w/ MPA's enterohepatic cycle eg, cholestyramine, antibiotics; sirolimus. Not to be administered concomitantly w/ azathioprine. Severe hepatic parenchymal disease in cardiac transplant & lupus nephritis patients. Severe chronic renal impairment in cardiac or hepatic transplant patients. Women of childbearing potential must use at least 1 form of reliable contraception before starting, during, & for 6 wk after stopping therapy. Men should not donate semen during therapy or for 90 days following discontinuation of therapy. High risk of spontaneous abortions & congenital malformations when used during pregnancy. Not recommended for renal transplant in childn <2 yr. Paed cardiac & hepatic transplant patients. Elderly.

Sepsis, GI candidiasis, UTI, herpes simplex, herpes 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 skin neoplasm; pancytopenia, leucocytosis; acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia; agitation, confusional state, depression, anxiety, abnormal thinking, insomnia; convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia; tachycardia; hypotension, HTN, vasodilatation; pleural effusion, dyspnoea, cough; GI haemorrhage, peritonitis, ileus, colitis, gastric ulcer, 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, LDH, urea & alkaline phosphatase, decreased wt.

Increased plasma conc of aciclovir. Decreased exposure w/ antacids (eg, Mg & Al hydroxides), & PPIs including lansoprazole & pantoprazole; rifampicin. Reduced efficacy w/ medicinal products interfering w/ enterohepatic circulation eg, cholestyramine, ciclosporin A, antibiotics (eg, aminoglycoside, cephalosporin, fluoroquinolone & penicillins). Reduced pre-dose conc w/ ciprofloxacin & amoxicillin + clavulanic acid. Reduced exposure w/ norfloxacin & metronidazole. Increased exposure w/ drugs inhibiting glucuronidation of mycophenolic acid eg, isavuconazole, telmisartan. Decreased conc w/ telmisartan. Increased conc w/ ganciclovir. Decreased C_max & AUC_0-12 w/ sevelamer. Increased AUC of tacrolimus. Concomitant use w/ live vaccines. Raised plasma AUC w/ probenecid.

Immunosuppressants

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

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