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Nulojix (Belatacept) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Cytochrome P450 Substrates

No formal drug interaction studies have been conducted with NULOJIX. Other biologic therapies that are cytokines or cytokine modulators have been shown to affect the expression and/or functional activities of cytochrome P450 (CYP450) enzymes in vitro and/or in vivo. In vitro studies have shown that NULOJIX inhibits the production of certain cytokines during an alloimmune response. No studies in kidney transplant patients have been conducted to assess if NULOJIX inhibits cytokine production in vivo. The potential for NULOJIX to alter the systemic concentrations of drugs that are CYP450 substrates has not been studied; however, in the event that kidney transplant patients receiving NULOJIX exhibit signs and symptoms of altered efficacy or adverse events associated with coadministered drugs which are known to be metabolized by CYP450, the clinician should be aware of potentially altered CYP450 metabolism of these drugs.

Use with Mycophenolate Mofetil

In a pharmacokinetic substudy of Studies 1 and 2, the plasma concentrations of mycophenolic acid (MPA) were measured in 41 patients who received fixed mycophenolate mofetil (MMF) doses of 500 mg to 1500 mg twice daily with either 5 mg per kg of NULOJIX or cyclosporine. The mean dose-normalized MPA Cmax and AUC0-12 were approximately 20% and 40% higher, respectively, with NULOJIX coadministration than with cyclosporine coadministration.

Clinicians should be aware that there is also a potential change of MPA exposure after crossover from cyclosporine to NULOJIX or from NULOJIX to cyclosporine in patients concomitantly receiving MMF.

OVERDOSAGE

Single doses up to 20 mg per kg of NULOJIX have been administered to healthy subjects without apparent toxic effect. The administration of NULOJIX of higher cumulative dose and more frequent dosing than recommended in kidney transplant patients resulted in a higher frequency of CNS-related adverse reactions [see Adverse Reactions ]. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

CONTRAINDICATIONS

NULOJIX is contraindicated in transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus due to the risk of post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) [see Boxed Warning and Warnings and Precautions ].

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