Mycophenolate Mofetil (Page 4 of 11)
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of mycophenolate mofetil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- Embryo-Fetal Toxicity: Congenital malformations and spontaneous abortions, mainly in the first trimester, have been reported following exposure to mycophenolate mofetil (MMF) in combination with other immunosuppressants during pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1), (8.3)]. Congenital malformations include:
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- Facial malformations: cleft lip, cleft palate, micrognathia, hypertelorism of the orbits
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- Abnormalities of the ear and eye: abnormally formed or absent external/middle ear, coloboma, microphthalmos
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- Malformations of the fingers: polydactyly, syndactyly, brachydactyly
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- Cardiac abnormalities: atrial and ventricular septal defects
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- Esophageal malformations: esophageal atresia
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- Nervous system malformations: such as spina bifida
- Cardiovascular: Venous thrombosis has been reported in patients treated with mycophenolate mofetil administered intravenously.
- Digestive: Colitis, pancreatitis
- Hematologic and Lymphatic: Bone marrow failure, cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents [see Warnings and Precautions (5.4)].
- Immune: Hypersensitivity, hypogammaglobinemia
- Infections: Meningitis, infectious endocarditis, tuberculosis, atypical mycobacterial infection, progressive multifocal leukoencephalopathy, BK virus infection, viral reactivation of hepatitis B and hepatitis C, protozoal infections [see Warnings and Precautions (5.3)].
- Respiratory: Bronchiectasis, interstitial lung disease, fatal pulmonary fibrosis, have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in post-transplant patients receiving mycophenolate mofetil.
- Vascular: Lymphocele
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on Mycophenolate Mofetil
Antacids with Magnesium or Aluminum Hydroxide | |
Clinical Impact | Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology (12.3)] , which may reduce mycophenolate mofetil efficacy. |
Prevention or Management | Administer magnesium or aluminum hydroxide containing antacids at least 2h after mycophenolate mofetil administration. |
Proton Pump Inhibitors (PPIs) | |
Clinical Impact | Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology (12.3)] , which may reduce mycophenolate mofetil efficacy. |
Prevention or Management | Monitor patients for alterations in efficacy when PPIs are co- administered with mycophenolate mofetil. |
Examples | Lansoprazole, pantoprazole |
Drugs that Interfere with Enterohepatic Recirculation | |
Clinical Impact | Concomitant use with drugs that directly interfere with enterohepatic recirculation, or indirectly interfere with enterohepatic recirculation by altering the gastrointestinal flora, can decrease MPA systemic exposure [see Clinical Pharmacology (12.3)] , which may reduce mycophenolate mofetil efficacy. |
Prevention or Management | Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil. |
Examples | Cyclosporine A, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials |
Drugs Modulating Glucuronidation | |
Clinical Impact | Concomitant use with drugs inducing glucuronidation decreases MPA systemic exposure, potentially reducing mycophenolate mofetil efficacy, while use with drugs inhibiting glucuronidation increases MPA systemic exposure [see Clinical Pharmacology (12.3)] , which may increase the risk of mycophenolate mofetil related adverse reactions. |
Prevention or Management | Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil. |
Examples | Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation). |
Calcium Free Phosphate Binders | |
Clinical Impact | Concomitant use with calcium free phosphate binders decrease MPA systemic exposure [see Clinical Pharmacology (12.3)] , which may reduce mycophenolate mofetil efficacy. |
Prevention or Management | Administer calcium free phosphate binders at least 2 hours after mycophenolate mofetil. |
Examples | Sevelamer |
7.2 Effect of Mycophenolate Mofetil on Other Drugs
Drugs that Undergo Renal Tubular Secretion | |
Clinical Impact | When concomitantly used with mycophenolate mofetil, its metabolite MPAG, may compete with drugs eliminated by renal tubular secretion which may increase plasma concentrations and/or adverse reactions associated with these drugs. |
Prevention or Management | Monitor for drug-related adverse reactions in patients with renal impairment. |
Examples | Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir |
Combination Oral Contraceptives | |
Clinical Impact | Concomitant use with mycophenolate mofetil decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure to ethinylestradiol [see Clinical Pharmacology (12.3)] , which may result in reduced combination oral contraceptive effectiveness. |
Prevention or Management | Use additional barrier contraceptive methods. |
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