Cellcept

Cellcept

mycophenolic acid

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Mycophenolate mofetil
Indications/Uses
Prophylaxis of acute organ rejection in patients receiving allogeneic renal, cardiac & hepatic transplants, concomitantly w/ cyclosporin & corticosteroids. Induction & maintenance treatment of lupus nephritis, concomitantly w/ corticosteroids.
Dosage/Direction for Use
Renal transplant; induction & maintenance treatment of lupus nephritis 1 g bd. Cardiac & hepatic transplant 1.5 g bd.
Administration
Should be taken on an empty stomach: In stable renal transplant patients, may be administered w/ meals if necessary. Swallow whole, do not chew/crush/open.
Contraindications
Hypersensitivity to mycophenolate mofetil or mycophenolic acid (MPA). Women of childbearing potential not using highly effective contraceptive methods. Pregnancy & lactation.
Special Precautions
Increased risk of lymphomas & other malignancies. Immunosuppressed patients. Pure red cell aplasia (PRCA). Monitor complete blood & absolute neutrophil count. Increased incidence of digestive system adverse events. Avoid use of live attenuated vaccines & doses >1 g bd to renal transplant patients. Avoid exposure to sunlight & UV light. Switching combination therapy from regimens containing immunosuppressants. Severe renal impairment. Elderly.
Adverse Reactions
Diarrhoea, leucopenia, anaemia, nausea, abdominal pain, sepsis, vomiting, dyspepsia.
Drug Interactions
Higher MPAG & acyclovir plasma conc. Decreased MPA exposure w/ antacids eg, Mg & Al hydroxides & proton-pump inhibitors eg, lansoprazole & pantoprazole; rifampicin, ciclosporin A. Reduced MPA AUC w/ cholestyramine, norfloxacin & metronidazole. Decreased MPA conc w/ telmisartan. Increased MPAG & ganciclovir conc. Increased MPA exposure w/ isavuconazole. Reduced pre-dose MPA conc w/ ciprofloxacin or amoxicillin + clavulanic acid. Raised MPAG plasma AUC w/ probenecid. Decreased MPA Cmax & AUC w/ sevelamer.
MIMS Class
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Cellcept tab 500 mg
Packing/Price
50's
Form
Cellcept cap 250 mg
Packing/Price
100's
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