mycophenolic acid




Concise Prescribing Info
Mycophenolate mofetil
In concomitant use w/ cyclosporin & corticosteroids, for refractory organ rejection & prophylaxis of acute organ rejection in patients receiving allogeneic renal transplants; prophylaxis of acute organ rejection & increased graft & patient survival in patients receiving allogeneic cardiac transplants; prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants.
Dosage/Direction for Use
Oral/IV Prophylaxis of renal rejection 1 g bd. Prophylaxis of cardiac rejection 1.5 g bd. Prophylaxis of hepatic rejection 1 g IV bd or 1.5 g orally bd. Oral Refractory renal rejection 1.5 g bd.
Should be taken on an empty stomach: Take on an empty stomach. In stable renal transplant patients, may be administered w/ meals if necessary. Swallow whole, do not open/chew/crush.
Hypersensitivity to mycophenolate mofetil or mycophenolic acid (MDA); polysorbate 80. Women of childbearing potential not using highly effective contraceptive methods. Pregnancy & lactation.
Special Precautions
Increased risk of developing lymphomas & other malignancies, particularly of the skin. 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. Potentially fatal progressive multifocal leukoencephalopathy associated w/ JC virus. BK virus-associated nephropathy; hypogammaglobulinaemia associated w/ recurrent infections; bronchiectasis during combination therapy w/ other immunosuppressants. Potential pure red cell aplasia during combination therapy w/ other immunosuppressants; perform complete blood count wkly during the 1st mth of treatment, twice mthly for the 2nd & 3rd mth, then mthly through the 1st yr. Monitor patients for neutropenia; interrupt or reduce dose if absolute neutrophil count is <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; not to be given in immune response impaired patients. Patients w/ active 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 immunosuppressant-containing regimen. Do not administer concomitantly w/ azathioprine. Men should not donate semen during therapy & 90 days following discontinuation. Avoid doses >1 g bd in renal transplant patients w/ severe chronic renal impairment. 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, hypokalemia, hypomagnesemia, hypophosphatemia; confusional state, depression, insomnia; dizziness, paresthesia, tremor; tachycardia; hypotension; pleural effusion; decreased appetite, flatulence; increased hepatic enzyme; rash/pruritus; increased blood creatinine; chills, hernia, pain. Ecchymosis; acidosis, hyperlipidemia, hypocalcemia; hypertonia, somnolence; arthralgia, muscular weakness; hematuria. Benign neoplasm of skin, neoplasm; decreased wt; venous thrombosis; colitis, esophagitis, gastritis, GI hemorrhage & ulcer, ileus, stomatitis; increased blood alkaline phosphatase; alopecia; malaise. Increased blood urea; skin cancer, pancytopenia; increased blood lactate dehydrogenase, hepatitis; pseudolymphoma.
Drug Interactions
Increased phenolic glucuronide of MPA (MPAG) & plasma conc of acyclovir & ganciclovir. Decreased MPA exposure w/ antacids eg, Mg & Al hydroxide & proton pump inhibitors (including lansoprazole & pantoprazole), & rifampicin. Reduced MPA AUC w/ drugs that interfere w/ enterohepatic circulation eg, cholestyramine. MPA exposure may be increased w/ drugs affecting glucuronidation. Decreased MPA conc w/ telmisartan. Increased tacrolimus AUC 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 MPA conc w/ immediate commencement of ciprofloxacin or amoxicillin + clavulanic acid in renal transplant recipients. Reduced MPA AUC0-48 w/ norfloxacin & metronidazole combination. Increased MPAG plasma conc w/ probenecid. Decreased Cmax & AUC0-12 w/ sevelamer. Ab response to other vaccines may be diminished w/ co-administration of live vaccines. Mutual potential bone marrow suppression in concomitant use w/ azathioprine.
MIMS Class
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
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