Mycophenolate Mofetil (Page 4 of 10)

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval 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 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:
    • Facial malformations: cleft lip, cleft palate, micrognathia, hypertelorism of the orbits
    • Abnormalities of the ear and eye: abnormally formed or absent external/middle ear, coloboma, microphthalmos
    • Malformations of the fingers: polydactyly, syndactyly, brachydactyly
    • Cardiac abnormalities: atrial and ventricular septal defects
    • Esophageal malformations: esophageal atresia
    • 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

Table 5: Drug Interactions with Mycophenolate Mofetil that Affect Mycophenolic Acid (MPA) Exposure

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 for oral suspension 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 coadministered with mycophenolate mofetil for oral suspension.

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 coadministered with mycophenolate mofetil for oral suspension.

Examples

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 coadministered with mycophenolate mofetil for oral suspension.

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 for oral suspension.

Examples

Sevelamer

7.2 Effect of Mycophenolate Mofetil on Other Drugs

Table 6: Drug Interactions with Mycophenolate Mofetil that Affect 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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