CellCept

CellCept

mycophenolic acid

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Mycophenolate mofetil
Indications/Uses
Concomitant use w/ cyclosporin & corticosteroids for prophylaxis of acute organ rejection in patients receiving allogeneic renal, cardiac & hepatic transplants. Concomitant use w/ corticosteroids for induction & maintenance treatment of lupus nephritis.
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
Avoid use in avoided in patients w/ hypoxanthine-guanine phosphoribosyl-transferase deficiency eg, Lesch-Nyhan & Kelley-Seegmiller syndrome; incidence of digestive system adverse events. Increased risk of lymphomas & other malignancies; avoid exposure to sunlight & UV light. Pure red cell aplasia (PRCA); immunosuppressed patients. Monitor blood counts wkly during 1st mth, twice mthly for 2nd & 3rd mth & mthly through 1st year; neutropenia. Not to be used concomitantly w/ azathioprine; switching combination therapy from regimens containing immunosuppressants; drugs interfering MPA's enterohepatic cycle. Avoid use of live attenuated vaccines & doses >1 g bd to renal transplant patients w/ severe chronic renal impairment. May affect ability to drive & use machines. Severe renal impairment. Women of childbearing potential should use highly effective contraception prior to, during & for 6 wk after last dose. Elderly.
Adverse Reactions
Bacterial, viral & fungal infections; benign skin neoplasm, neoplasm, skin cancer; anemia, ecchymosis, leukocytosis, leukopenia, pancytopenia, thrombocytopenia; acidosis, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipidemia, hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia, decreased wt; confusional state, depression, insomnia; dizziness, headache, hypertonia, paresthesia, somnolence, tremor; tachycardia; HTN, hypotension, venous thrombosis; cough, dyspnea, pleural effusion; abdominal pain, colitis, constipation, decreased appetite, diarrhea, dyspepsia, esophagitis, flatulence, gastritis, GI hemorrhage & ulcer, ileus, nausea, stomatitis, vomiting; increased blood alkaline phosphatase, lactate dehydrogenase & hepatic enzyme, hepatitis; alopecia, rash; arthralgia, muscular weakness; increased blood creatinine & urea, hematuria; asthenia, chills, edema, hernia, malaise, pain, pyrexia.
Drug Interactions
Higher MPAG & acyclovir plasma conc. Increased MPAG & ganciclovir conc. Decreased MPA exposure w/ Mg & Al hydroxides antacids, PPIs eg, lansoprazole, pantoprazole; rifampicin, ciclosporin A. Reduced MPA AUC w/ cholestyramine, norfloxacin, metronidazole. Increased MPA exposure w/ isavuconazole. Decreased MPA conc w/ telmisartan. 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
Immunosuppressants
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
CellCept cap 250 mg
Packing/Price
100's
Form
CellCept tab 500 mg
Packing/Price
50's
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