Atajec

Atajec

mycophenolic acid

Manufacturer:

Sandoz

Distributor:

Cathay YSS
Concise Prescribing Info
Contents
Mycophenolate mofetil
Indications/Uses
In combination w/ ciclosporin & corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Dosage/Direction for Use
Adult Renal transplant 1 g bid. Initiate w/in 72 hr following transplantation. Cardiac transplant 1.5 g bid. Initiate w/in 5 days following transplantation. Hepatic transplant 1.5 g bid. Initiate as soon as tolerated after the 1st 4 days of IV mycophenolate mofetil following transplant. Childn 2-18 yr Renal transplant 600 mg/m2 bid. Max: 2 g daily. Patient w/ BSA >1.5 m2 1 g bid (2 g daily). Elderly Renal transplant 1 g bid. Cardiac/hepatic transplant 1.5 g bid.
Administration
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.
Contraindications
Hypersensitivity to mycophenolate mofetil or mycophenolic acid. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Increased risk of developing lymphomas & other malignancies particularly of the skin; for opportunistic/fatal infection & sepsis. Limit sunlight & UV light exposure. Measure serum Ig in patients on therapy who develop recurrent infections. Patients who develop persistent pulmonary symptoms eg, cough & dyspnoea. Monitor CBC wkly during the 1st mth, twice mthly for the 2nd & 3rd mth of treatment, then mthly through the 1st yr. Discontinue use if neutropenia develops. Avoid use of live attenuated vaccines. Patients w/ active serious digestive system disease. Avoid in patients w/ rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Switching combination therapy from regimens containing immunosuppressants, which interfere w/ enterohepatic recirculation eg, ciclosporin to others devoid of this effect eg, sirolimus, belatacept, or vice versa. Concomitant use w/ cholestyramine; azathioprine; tacrolimus or sirolimus. Do not donate blood during therapy or for at least 6 wk following discontinuation of therapy; & semen (for men) during therapy or for 90 days following discontinuation of therapy. Use 2 reliable forms of contraception simultaneously before starting, during, & for 6 wk after stopping the therapy in women w/ childbearing potential. Use condoms during & for at least 90 days after cessation of treatment in sexually active men. Pregnancy. Not recommended in childn <2 yr. Elderly.
Adverse Reactions
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 neoplasm of skin; 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, dyspepsia; 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, blood lactate dehydrogenase, blood urea & blood alkaline phosphatase, decreased wt.
Drug Interactions
Higher plasma conc of aciclovir. Decreased exposure w/ antacids eg, Mg & Al hydroxides, proton pump inhibitors including lansoprazole & pantoprazole; rifampicin; sevelamer; norfloxacin & metronidazole. Potential to reduce efficacy w/ cholestyramine & medicinal products that interfere w/ enterohepatic circulation. Increased AUC w/ ciclosporin A. Decreased conc w/ telmisartan; ciprofloxacin & amoxicillin + clavulanic acid. Increased conc w/ ganciclovir. Increased AUC of tacrolimus in hepatic transplant patients. Raised plasma AUC & conc w/ probenecid or other substances undergoing renal tubular secretion. Diminished Ab response to live vaccines.
MIMS Class
Immunosuppressants
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Atajec FC tab 500 mg
Packing/Price
50's
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