Mofecon-C 250/Mofecon 500

Mycophenolate mofetil

1st or refractory organ rejection in patients receiving allogeneic renal transplants. Prophylaxis of organ rejection concomitantly w/ cyclosporine & corticosteroids in patients receiving allogeneic renal, cardiac or hepatic transplants; acute organ rejection in patients receiving allogeneic cardiac & hepatic transplants. Induction & maintenance therapy of patients w/ Class III-IV lupus nephritis (diagnosed according to International Society of Nephrology/Renal Pathology Society classification).

Transplant patient 1st or refractory renal rejection 1.5 g bid (daily dose of 3 g). Prophylaxis of renal rejection 1 g bid (daily dose of 2 g), cardiac rejection 1.5 g bid (daily dose of 3 g), hepatic rejection 1 g bid (daily dose of 2 g) or 1.5 g bid (daily dose of 3 g). Lupus nephritis patient Induction therapy 750 mg to 1.5 g bid (daily dose of up to 3 g). Maintenance therapy 500 mg to 1 g bid.

250-mg hard cap: Should be taken on an empty stomach. 500-mg tab: May be taken with or without food. Take on empty stomach. May be taken w/ food in stable renal transplant patients if necessary.

Hypersensitivity to mycophenolate mofetil, mycophenolic acid or mycophenolate Na. Women of childbearing potential & not using highly effective contraceptive methods; not providing pregnancy test result. Pregnancy & lactation.

Interrupt treatment if neutropenia (ANC <1.3 x 10³/microL) develops. Pure red cell aplasia (PRCA). Polyomavirus associated nephropathy; JC virus-associated progressive multifocal leukoencephalopathy, cytomegalovirus infections, HBV or HCV reactivation. Patients w/ active digestive system disease. Increased risk for bacterial, viral, fungal, & protozoal infections including opportunistic infections; development of lymphoma & skin malignancy. Perform CBC wkly during 1st mth of treatment, twice mthly for 2nd & 3rd mth, then mthly through 1st yr. Avoid in patients w/ rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Avoid use of live attenuated vaccines; doses of >1 g bid in renal transplant patients. Switching combination therapy from regimens containing immunosuppressants, which interfere w/ MPA enterohepatic recirculation (eg, ciclosporin) to others devoid of this effect (eg, tacrolimus, sirolimus, belatacept) or vice versa. Concomitant use w/ cholestyramine, sevelamer & antibiotics. Not to be used concomitantly w/ azathioprine. Severe chronic renal impairment (GFR <25 mL/min/1.73 m²). Females of reproductive potential should use acceptable forms of contraception during treatment & for 6 wk after therapy. Increased risk of congenital malformations & 1st trimester pregnancy loss during pregnancy. Not recommended in breastfeeding during therapy or for 6 wk after completion of treatment. Ped patient receiving allogeneic cardiac or hepatic transplant; renal transplant patient <3 mth. Elderly.

CV disorder, HTN, hypotension, tachycardia; anxiety, asthenia, dizziness, headache, insomnia, paresthesia, tremor; abdominal pain, anorexia, constipation, diarrhea, dyspepsia, nausea, vomiting; abnormal kidney function, UTI; anemia, hypochromic anemia, leukocytosis, leukopenia, thrombocytopenia; ascites, abnormal LFTs; increased creatinine, edema, hypercholesterolemia, hyperglycemia, hyperkalemia, hypocalcemia, hypokalemia, hypomagnesemia, increased LDH & BUN, peripheral edema; increased cough, dyspnea, infection, lung disorder, pleural effusion, sinusitis; back & chest pain, fever, pain, rash, sepsis. Colitis, intestinal villous atrophy, pancreatitis; PRCA & hypogammaglobulinemia; interstitial lung disorders including fatal pulmonary fibrosis; meningitis & infectious endocarditis; congenital malformations including ear, facial, cardiac & nervous system malformations.

Increased effects/toxicity of acyclovir-valacyclovir, fingolimod, ganciclovir-valganciclovir, leflunomide, natalizumab, tofacitinib, live vaccines. Increased levels/effects by acyclovir-valacyclovir, denosumab, ganciclovir-valganciclovir, isavuconazonium sulfate, ocrelizumab, pimecrolimus, probenecid, roflumilast, topical tacrolimus, teriflunomide, trastuzumab. Decreased levels/effects of BCG (intravesical); Coccidioides immitis skin test; estrogen derivatives, nivolumab, pidotimod; progestins; sipuleucel-T; tertomotide; inactivated & live vaccines. Decreased levels/effects by antacids, bile acid sequestrants, cholestyramine resin, systemic cyclosporine & metronidazole, Echinacea, Mg salts, penicillins, PPIs, quinolones, rifamycin derivatives, sevelamer. Decreased C_max w/ food.

Immunosuppressants

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

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