Mycophenolate: uses, dosing, side effects & brands

The following adverse reactions are discussed in greater detail in other sections of the label. Embryo-Fetal Toxicity [see Boxed Warning, Warnings and Precautions (5.1)] Lymphomas and Other Malignancies [see Boxed Warning, Warnings and Precautions (5.3)] Serious Infections [see Boxed Warning, Warnings and Precautions (5.4)] New or Reactivated Viral Infections [see Warnings and Precautions (5.5)] Blood Dyscrasias, Including Pure Red Cell Aplasia [see Warnings and Precautions (5.6)] Serious GI Tract Complications [see Warnings and Precautions (5.7)] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.8)] Hypersensitivity Reactions [see Warnings and Precautions (5.9)] Rare Hereditary Deficiencies [see Warnings and Precautions (5.11)] Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect…

Myfortic is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients [see Warnings and Precautions (5.9), Adverse Reactions (6.2)] . History of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. ( 4 )

Antacids with Magnesium and Aluminum Hydroxides: Decreases concentrations of MPA; concomitant use is not recommended. ( 7.1 ) Azathioprine: Competition for purine metabolism; concomitant administration is not recommended. ( 7.2 ) Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal, and Other Drugs that Interfere with Enterohepatic Recirculation: May decrease MPA concentrations; concomitant use is not recommended. ( 7.3 ) Sevelamer: May decrease MPA concentrations; concomitant use is not recommended. ( 7.4 ) Cyclosporine: May decrease MPA concentrations; exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine. ( 7.5 ) Norfloxacin and Metronidazole: May decrease MPA concentrations; concomitant use with both drugs is not recommended. ( 7.6 ) Rifampin: May decrease MPA concentrations; concomitant use is not recommended unless the benefit outweighs the risk. ( 7.7 ) Hormonal Contraceptives: May reduce the effectiveness of oral contraceptives. Additional barrier contraceptive methods must be used. ( 5.2 , 7.8 ) Acyclovir, Valacyclovir, Ganciclovir, Valganciclovir, and Other Drugs that Undergo Renal Tubular Secretion: May increase concentrations of mycophenolic acid glucuronide (MPAG) and coadministered drug; monitor blood cell counts. ( 7.9 ) 7.1 Antacids With Magnesium and Aluminum Hydroxides Concomitant use of Myfortic and antacids decreased plasma concentrations of mycophenolic acid (MPA). It is recommended that Myfortic and antacids not be administered simultaneously [see Clinical Pharmacology (12.3)] . 7.2 Azathioprine Given that azathioprine and MMF inhibit purine metabolism, it is recommended that Myfortic not be administered concomitantly with azathioprine or MMF. 7.3 Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal and Other Drugs That Interfere With Enterohepatic Recirculation Drugs that interrupt enterohepatic recirculation may decrease MPA plasma concentrations when coadministered with MMF. Therefore, do not administer Myfortic with cholestyramine or other agents that may interfere with enterohepatic recirculation or drugs that may bind bile acids, e.g., bile acid sequestrates or oral activated charcoal, because of the potential to reduce the efficacy of Myfortic [see Clinical Pharmacology (12.3)] . 7.4 Sevelamer Concomitant administration of sevelamer and MMF may decrease MPA plasma concentrations. Sevelamer and other calcium-free phosphate binders should not be administered simultaneously with Myfortic [see Clinical Pharmacology (12.3)] . 7.5 Cyclosporine Cyclosporine inhibits the enterohepatic recirculation of MPA, and therefore, MPA plasma concentrations may be decreased when Myfortic is coadministered with cyclosporine. Clinicians should be aware that there is also a potential change of MPA plasma concentrations after switching from cyclosporine to other immunosuppressive drugs or from other immunosuppressive drugs to cyclosporine in patients concomitantly receiving Myfortic [see Clinical Pharmacology (12.3)] . 7.6 Norfloxacin and Metronidazole MPA plasma concentrations may be decreased when MMF is administrated with norfloxacin and metronidazole. Therefore, Myfortic is not recommended to be given with the combination of norfloxacin and metronidazole. Although there will be no effect on MPA plasma concentrations when Myfortic is concomitantly administered with norfloxacin or metronidazole when given separately [see Clinical Pharmacology (12.3)] . 7.7 Rifampin The concomitant administration of MMF and rifampin may decrease MPA plasma concentrations. Therefore, Myfortic is not recommended to be given with rifampin concomitantly unless the benefit outweighs the risk [see Clinical Pharmacology (12.3)] . 7.8 Hormonal Contraceptives In a drug interaction study, mean levonorgestrel AUC was decreased by 15% when coadministered with MMF. Although Myfortic may not have any influence on the ovulation-suppressing action of oral contraceptives, additional barrier contraceptive methods must be used when Myfortic is coadministered with hormonal contraceptives (e.g., birth control pill, transdermal patch, vaginal ring, injection, and implant) [see Warnings and Precautions (5.1), Use in Specific Populations (8.3), Clinical Pharmacology (12.3)] . 7.9 Acyclovir (Valacyclovir), Ganciclovir (Valganciclovir), and Other Drugs That Undergo Renal Tubular Secretion The coadministration of MMF and acyclovir or ganciclovir may increase plasma concentrations of mycophenolic acid glucuronide (MPAG) and acyclovir/valacyclovir/ganciclovir/valganciclovir as their coexistence competes for tubular secretion. Both acyclovir/valacyclovir/ganciclovir/valganciclovir and MPAG concentrations will be also increased in the presence of renal impairment. Acyclovir/valacyclovir/ganciclovir/valganciclovir may be taken with Myfortic; however, during the period of treatment, physicians should monitor blood cell counts [see Clinical Pharmacology (12.3)] . 7.10 Ciprofloxacin, Amoxicillin Plus Clavulanic Acid and Other Drugs That Alter the Gastrointestinal Flora Drugs that alter the gastrointestinal flora, such as ciprofloxacin or amoxicillin plus clavulanic acid may interact with MMF by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption when Myfortic is concomitantly administered with ciprofloxacin or amoxicillin plus clavulanic acid. The clinical relevance of this interaction is unclear; however, no dose adjustment of Myfortic is needed when coadministered with these drugs [see Clinical Pharmacology (12.3)] . 7.11 Pantoprazole Administration of pantoprazole at a dose of 40 mg twice daily for 4 days to healthy volunteers did not alter the pharmacokinetics of a single dose of Myfortic [see Clinical Pharmacology (12.3)] .