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U.S. Department of Health and Human Services

Safety

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Nulojix (Belatacept) Intravenous Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2014

Summary View

7 DRUG INTERACTIONS

7.1 Cytochrome P450 Substrates Mycophenolate Mofetil (MMF)
  • Monitor for a need to adjust concomitant mycophenolate mofetil (MMF) dosage when patient’s therapy is switched between cyclosporine and NULOJIX, as cyclosporine decreases mycophenolic acid (MPA) exposure by preventing enterohepatic recirculation of MPA while NULOJIX does not [see Clinical Pharmacology (12.3)]:
  • A higher MMF dosage may be needed after switching from NULOJIX to cyclosporine, since this may result in lower MPA concentrations and increase the risk of graft rejection.
  • A lower MMF dosage may be needed after switching from cyclosporine to NULOJIX, since this may result in higher MPA concentrations and increase the risk for adverse reactions related to MPA (review the Full Prescribing Information for MMF).
7.2 Cytochrome P450 Substrates
  • No dosage adjustments are needed for drugs metabolized via CYP1A2, CYP2C9, CYP2D6, CYP3A, and CYP2C19 when coadministered with NULOJIX [see Clinical Pharmacology (12.3)].

Note: see related changes in 12 CLINICAL PHARMACOLOGY/12.3 Pharmacokinetics subsection

 

April 2013

Summary View

WARNINGS AND PRECAUTIONS

  • Acute Rejection and Graft Loss With Corticosteriod Minimization:  In postmarketing experience, use of Nulojix in conjunction with Basiliximab induction, MMF, and corticosteroid minimization to 5 mg per day between Day 3 and Week 6 post-transplant was associated with an increased rate and grade of acute rejection, particularly Grade III rejection…