Page 78 - Heart Transplant Protocol

Heart Function Service: Heart Transplant Protocols

Protocol for Administration of Belatacept (Nulojix®)

Description: Belatacept, a second generation cytotoxic T lymphocyte-associated antigen 4
immunoglobulin (CTLA4-Ig) is a selective T-cell costimulation blocker produced via recombinant DNA
technology. Specifically, belatacept binds to CD 80 & CD 86 ligands on the antigen-presenting cells,
prevents them from binding to CD28 on the T lymphocytes and blocks the resultant costimulation signal.
As a result, belatacept inhibits proliferation of T lymphocyte and production of cytokines.

Indication: Approved for prophylaxis of organ rejection in adult kidney transplant patients. Belatacept
is only approved for patients who are EBV seropositive.

Dose:
 Maintenance phase: 5mg/kg every 4 weeks (± 3 days)
 Use actual body weight unless there is a change of greater than 10%.
 The dose must be divisible by 12.5mg in order to be prepared accurately using reconstituted
solution & the silicon-free disposable syringe provided (Available as a 250mg vial)

Administration:
 Preparation: Dilute in NS or D5W to a final concentration of 2mg/ml to 10 mg/ml
 100 ml is the most common infusion volume
 Premedication: None required
 Administration: Administer intravenously over 30 minutes through a dedicated line and must be
administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter with
pore size of 0.2 – 1.2 micron

Converting from CNIs to Belatacept:
Betalacept dose: 5mg/kg on days 1, 15, 30, 45, 60 then every 4 wks.
CNI dose:
1. 100% current dose on day 1,
2. 50% current dose on day 15,
3. 25% current dose on day 23,
4. Stop on day 30.
Monitoring:
Follow routine heart transplant monitoring protocol
Stability
Use within 24hours of reconstitution. Store under refrigeration (2-8°C) and protect from light
Side Effects:
Most common adverse reactions (≥ 20%): anemia, diarrhea, urinary tract infection, peripheral edema,
constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia,
hyperkalemia and leukopenia.
Reference:
1. Product Information. NULOJIX (Belatacept). Bristol-Myers Squibb Company, Princeton, NJ, 2011.
2. Archdeacon P et al. Summary of the US FDA approval of Belatacept. Am J of Transplant 2012; 12: 554-62.
3. Vincenti F et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in
renal transplant recipients (BENEFIT study). Am J Transplant 2010; 10: 535-46.
4. Rostaing L et al. Switching from Calcineurin Inhibitor-based Regimens to a Belatacept-based Regimen in
Renal Transplant Recipients: a Randomized Phase II Study. Clin J Am Soc Nephrol 6;430-439.

Updated November 9, 2017 78