Introducing NULOJIX™ Experience (belatacept) THE
NEXT FRONTIER A fi rst-in-class therapy that offers selective immunosuppression in transplantation via co-stimulation blockade*1,2 *NULOJIX-treated patients had similar rates of patient and graft survival at 3 years compared with ciclosporin-treated patients.1 post-transplant, NULOJIX was associated with 6–9 mmHg lower mean systolic blood pressure, and approximately 2–4 mmHg lower mean diastolic blood pressure than ciclosporin.1 In addition to lowering blood pressure levels, NULOJIX decreased the non-HDL and triglyceride levels compared with ciclosporin.1,6 There were no reports of anaphylaxis or drug hypersensitivity in the Phase III studies at 3 years.1 infusion-related reactions (reactions occurring within 1 hour of infusion) occurred in 4.4% of patients in NULOJIX-treated patients up to Year 3.1 When belatacept was compared with placebo infusions, there were no differences in rates of infusion-related events.1 higher in NULOJIX than in ciclosporin-treated patients receiving living or standard criteria deceased donor kidneys, and 11 mL/min/1.73 m² higher with NULOJIX in patients receiving extended criteria deceased donor kidneys.1 The incidence of new-onset diabetes after transplantation was numerically lower in NULOJIX-treated patients compared with those receiving ciclosporin at 1 and 3 years.1,6 At 3 years, mean calculated glomerular fi ltration rate was 21 mL/min/1.73 m² At 1 and 3 years Acute In the NULOJIX development programme, safety has been studied in over 900 patients, many of which have been followed for 3 years and beyond. Patients treated with NULOJIX are at risk of PTLD§ EBV§-seronegative patients and in patients whose serostatus is unknown.1 and serious infections.1,3,4,7 NULOJIX is contra-indicated in NULOJIX, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 of the SmPC for data on renal function). It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this NULOJIX-based regimen.1 A Patient Alert Card contains important information about NULOJIX and is provided with each pack of NULOJIX. The patient should keep this card with him at all times. References 1. NULOJIX (belatacept) Summary of Product Characteristics, June 2011. 2. Latek R, et al. Transplantation. 2009;87:926–933. 3. Vincenti F, et al. Am J Transplant. 2010;10:535–546. 4. Durrbach A, et al. PTLD=post-transplant lymphoproliferative disorder; EBV=Epstein-Barr virus. For Prescribing Information please see overleaf. www.bms.se Am J Transplant. 2010;10:547–557. 5. Larsen CP, et al. Transplantation. 2010:90:1528–1535. 6. Vanrenterghem Y, et al. Transplantation. 2011;91:976−983. 7. Vincenti F, et al. J Am Soc Nephrol. 2010;21:1587–1596. § ◆ Provides high rates of patient and graft survival and prophylaxis of graft rejection*1,3–5 ◆ Preserves renal function*1,3–5 ◆ Reduces the key factors associated with cardiovascular co-morbidity*1,6