CellCept

Mycophenolate mofetil

In combination w/ corticosteroids & either ciclosporin or tacrolimus for prophylaxis of acute organ rejection & treatment of 1st or refractory organ rejection in patients receiving allogeneic renal transplants; prophylaxis of acute organ rejection in patients receiving allogeneic cardiac/hepatic transplants. Induction & maintenance therapy of patients w/ class III-V lupus nephritis.

Prophylaxis of renal rejection Adult 1 g (over no <2 hr) bid (2 g daily). Childn 3 mth-18 yr w/ BSA >1.5 m² 1 g bid (2 g daily). Prophylaxis of cardiac rejection & treatment of 1st or refractory renal rejection Adult 1.5 g (over no <2 hr) bid (3 g daily). Prophylaxis of hepatic rejection Adult 1.5 g bid (3 g daily). Lupus nephritis Adult Induction therapy: 750 mg-1.5 g bid (up to 3 g daily). Maintenance therapy: 500 mg-1 g bid. Childn Induction therapy: 600 mg/m² bid (up to max: 2 g daily). Maintenance therapy: 300 mg/m² bid.

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.

Hypersensitivity to mycophenolate mofetil, mycophenolic acid or polysorbate 80. Women of childbearing potential not using highly effective contraception. Pregnancy & lactation.

Increased risk of developing lymphomas & other malignancies particularly of the skin. Limit sunlight & UV light exposure. Increased susceptibility to infection including opportunistic & fatal infections & sepsis. Hepatitis due to reactivation of hepatitis B or C; progressive multifocal leukoencephalopathy associated w/ JC virus. Consider dose reduction or discontinuation of use if evidence of BK virus-associated nephropathy develops or in cases of clinically significant COVID-19. Pure red cell aplasia. Monitor CBC wkly during 1st mth of treatment, twice mthly for 2nd & 3rd mth, then mthly through the 1st yr. Monitor for neutropenia. Do not donate blood during & for at least 6 wk following discontinuation of therapy. Increased incidence of digestive system adverse events. Patients w/ active digestive system disease. Avoid in patients w/ rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Avoid use of live attenuated vaccines during treatment. Not to be administered concomitantly w/ azathioprine. Switching combination therapy from regimens containing immunosuppressants interfering w/ MPA enterohepatic recirculation (eg, ciclosporin) to others devoid of this effect (eg, tacrolimus, sirolimus, belatacept) or vice versa. Concomitant use w/ drugs interfering w/ MPA's enterohepatic cycle eg, cholestyramine, sevelamer, antibiotics. May have moderate influence on ability to drive & use machines. Women of childbearing potential should use 2 reliable forms of contraception simultaneously before beginning, during, & for 6 wk following discontinuation of therapy. Men should not donate semen during & for 90 days following discontinuation of therapy. Sexually active males &/or their female partners should use effective contraception during & for at least 90 days after cessation of treatment. Elderly.

Bacterial, fungal, viral infections; benign neoplasm of skin, neoplasm, skin cancer; anemia, ecchymosis, leukocytosis, leukopenia, pancytopenia, pseudolymphoma, thrombocytopenia; acidosis, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipidemia, hypocalcemia, 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, constipation, decreased appetite, diarrhea, dyspepsia, esophagitis, flatulence, gastritis, GI hemorrhage & ulcer, ileus, nausea, stomatitis, vomiting; increased blood alkaline phosphatase, blood LDH & hepatic enzyme, hepatitis; alopecia, rash; arthralgia, muscular weakness; increased blood creatinine & blood urea, hematuria; asthenia, chills, edema, hernia, malaise, pain, pyrexia.

Higher MPAG (MPA phenolic glucuronide) & acyclovir plasma conc. Increased MPAG & ganciclovir conc. Decreased exposure w/ antacids eg, Mg & Al hydroxides & PPIs including lansoprazole & pantoprazole; rifampicin. Reduced AUC w/ cholestyramine; antibiotics eliminating β-glucuronidase-producing bacteria in the intestine eg, aminoglycoside, cephalosporin, fluoroquinolone & penicillin. Decreased C_max & AUC_0-12 w/ sevelamer. Reduced exposures in renal transplant patients w/ ciclosporin A. Increased tacrolimus AUC in hepatic transplant patients. Reduced pre-dose (trough) conc w/ oral ciprofloxacin or amoxicillin + clavulanic acid. Reduced AUC_0-48 w/ norfloxacin in combination w/ metronidazole. Increased exposure w/ isavuconazole. Decreased conc w/ telmisartan. Raised plasma AUC of MPAG w/ probenecid. Not to be given w/ live vaccines to patients w/ impaired immune response.

Immunosuppressants

L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.

Rx