CellCept

CellCept

mycophenolic acid

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Mycophenolate mofetil
Indications/Uses
In combination w/ ciclosporin & corticosteroids for 1st or refractory organ rejection in patients receiving allogeneic renal transplants; prophylaxis of acute organ rejection in patients receiving allogeneic renal, cardiac, & hepatic transplants. Induction & maintenance therapy of patients w/ Class III-IV lupus nephritis.
Dosage/Direction for Use
Prophylaxis of renal rejection 1 g bid (daily dose of 2 g). 1st or refractory renal rejection; prophylaxis of cardiac rejection 1.5 g bid (daily dose of 3 g). Prophylaxis of hepatic rejection 1 g bid (daily dose of 2 g) or 1.5 g bid (daily dose of 3 g). Lupus nephritis patients Induction therapy 750 mg to 1.5 g bid (daily dose of up to 3 g). Maintenance therapy: 500 mg to 1 g bid.
Administration
May be taken with or without food: In stable renal transplant patients, may be administered w/ meals.
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 developing lymphomas & other malignancies. Limit exposure to sunlight & UV light in patients at an increased risk for skin cancer. Increased susceptibilty to infection including opportunistic infections, fatal infections & sepsis w/ immune system oversuppression. Progressive multifocal leukoencephalopathy. Reduce immunosuppression in patients who develop BK virus-associated nephropathy. Perform CBC wkly during the 1st mth of treatment, twice mthly for the 2nd & 3rd mth, then mthly through the 1st yr. Monitor patients for neutropenia. Absolute neutrophil count <1.3 x 103/microL. Do not donate blood during & for at least 6 wk following discontinuation of therapy. Avoid use of live attenuated vaccines during therapy. Active digestive system disease; hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) deficiency eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Switching combination therapy from regimens containing immunosuppressants, which interfere w/ MPA enterohepatic recirculation eg, ciclosporin. Concomitant use w/ cholestyramine, sevelamer, & antibiotics; azathioprine. Men should not donate semen during therapy & 90 days following discontinuation of treatment. Moderate influence on the ability to drive & use machines. Elderly.
Adverse Reactions
Bacterial & viral infections; anemia, leukopenia; headache; HTN; cough, dyspnea; abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting; asthenia, edema, pyrexia. Fungal infections; leukocytosis, thrombocytopenia; hypercholesterolemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypophosphatemia; confusional state, depression, insomnia; dizziness, paresthesia, tremor; tachycardia; hypotension; pleural effusion; decreased appetite, flatulence; increased hepatic enzyme; rash; increased blood creatinine & blood urea; chills, hernia, pain. Ecchymosis; hyperlipidemia, hypocalcemia; hypertonia, somnolence; arthralgia, muscular weakness; hematuria. Benign neoplasm of skin, neoplasm; decreased wt; venous thrombosis; colitis, esophagitis, gastritis, GI hemorrhage, GI ulcer, ileus, stomatitis; increased blood alkaline phosphatase; alopecia; malaise.
Drug Interactions
Increased MPAG & plasma conc of DNA polymerase inhibitors (eg, acyclovir, ganciclovir). Decreased MPA exposure w/ antacids eg, Mg & Al hydroxide & proton pump inhibitors eg, lansoprazole & pantoprazole; rifampicin. Reduced AUC w/ drugs that interfere w/ enterohepatic circulation eg, cholestyramine. Decreased Cmax & AUC0-12 w/ sevelamer. Increase AUC of tacrolimus in hepatic transplant patients. Reduced systemic MPA exposure w/ antibiotics eliminating β-glucuronidase-producing bacteria in the intestine eg, aminoglycoside, cephalosporin, fluoroquinolone & penicillins. Reduced pre-dose conc w/ ciprofloxacin or amoxicillin + clavulanic acid. Reduced AUC0-48 w/ norfloxacin & metronidazole combination. Increased AUC0-∞ w/ drugs inhibiting glucuronidation eg, isavuconazole. Decreased conc w/ telmisartan. Increased plasma conc w/ probenecid. 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
CellCept cap 250 mg
Packing/Price
100's
Form
CellCept tab 500 mg
Packing/Price
50's
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