MYCOPHENOLATE MOFETIL HYDROCHLORIDE

AbsorptionFollowing oral and intravenous administration, MMF undergoes complete conversion to MPA, the active metabolite. In 12 healthy volunteers, the mean absolute bioavailability of oral MMF relative to intravenous MMF was 94%. Two 500 mg CELLCEPT tablets have been shown to be bioequivalent to four 250 mg CELLCEPT capsules. Five mL of the 200 mg/mL constituted CELLCEPT oral suspension have been shown to be bioequivalent to four 250 mg capsules. The mean (±SD) pharmacokinetic parameters estim...

14.1 Kidney Transplantation Adults The three de novo kidney transplantation studies compared two dose levels of oral Mycophenolate Mofetil (1 g twice daily and 1.5 g twice daily) with azathioprine (2 studies) or placebo (1 study) to prevent acute rejection episodes. One of the two studies with azathioprine (AZA) control arm also included anti-thymocyte globulin (ATGAM ® ) induction therapy. The geographic location of the investigational sites of these studies are included in Table 13 . In all three de novo kidney transplantation studies, the primary efficacy endpoint was the proportion of pati...

The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] Gastrointestinal Complications [see Warnings and Precautions (5.5) ] Acute Inflammatory Syndrome Associated with Mycophenolate ...

Allergic reactions to Mycophenolate Mofetil have been observed; therefore, Mycophenolate Mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Mycophenolate Mofetil for Injection is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).

• Hypersensitivity to mycophenolate mofetil,...

Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. ( 5.4 ) Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. ( 5.5 ) Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of Mycophenolate Mofetil. ( 5.6 ) Acute Inflammatory Syndrome Associated with Mycophenolate Products: Monit...

7 DRUG INTERACTIONS See FPI for drugs that may interfere with systemic exposure and reduce Mycophenolate Mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. ( 7.1 ) Mycophenolate Mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier c...