New Anti-Rejection Medications: The Low Down

By Dan Paley, Pharm.D. Candidate 2015 and Tracy Anderson-Haag, Pharm.D., BCPS

Within the past year, you may have heard about two new medications that were approved by the FDA for use in kidney transplant recipients, Nulojix® (belatacept) injection and Astagraf XL® (extended-release tacrolimus) capsules. Both of these medications have been approved to be used along with steroids (such as prednisone) and mycophenolate to prevent transplant rejection.

You may be wondering whether these medications would be a good fit for you. As with most medications, every person has different health needs and these medications have unique advantages and disadvantages that must be evaluated on an individual case-by-case basis before considering a switch in therapy. More trials are currently underway to learn more about their long-term safety and effectiveness. You should always speak to your physician and pharmacist for more information and to determine whether these medications are a good fit for you. Get informed about these medications with some of the key pros/cons and potential side effects:

1. Nulojix®
   Nulojix® is an injectable medication that works in a different way than any other anti-rejection medicines available. It was designed as a potential replacement medication for Prograf® (tacrolimus) or Neoral® (Gengraf®, cyclosporine). The goal of this medication is still to prevent rejection, but to also avoid toxic effects on the kidney, heart and nervous system. Nulojix® is given monthly as a 30-minute intravenous (IV) injection that must be administered in a clinic by a health care professional.

   Pros:

   • Administered monthly
   • No longer need to take daily cyclosporine or tacrolimus pills
   • Long term kidney function may be better when taking Nulojix® compared to cyclosporine
   • May cause smaller increase in cholesterol compared to cyclosporine
   • May help to better control blood pressure in the short-term (less than 3 years)
   • May avoid toxic risks to kidney, heart and nervous systems

    

   Cons:
   

   • Must be administered in clinic by health care professional
   • Injection-only format, so may not be a good fit if you don’t like needles
   • Blood pressure control may worsen long-term (after 3 years)
   • More rejection episodes in the first year on the medication
   • Only approved for patients who have been exposed to Epstein-Barr virus (EBV), the cause of mononucleosis or “Mono”
   • Same warnings as other immunosuppressants, including increased risk for serious infections and cancers

   Possible Side Effects:
   Low red blood count (anemia), constipation, urinary tract infections, swelling in the legs, increased risk of developing post-transplant lymphoproliferative disorder (PTLD), a cancer that causes white blood cells to multiply out of control

2. Astagraf XL®
   Astagraf XL® is the first once-a-day version of oral tacrolimus that is now available in the U.S. A clinical trial has shown that Astagraf XL® had the same effectiveness and side effects as twice-daily Prograf® (also oral tacrolimus).

   Pros:

   • More convenient because only taken once a day
   • Same effectiveness as twice-daily tacrolimus (Prograf®)

   Cons:
   

   • May lead to increased blood pressure and cholesterol
   • Same risk of side effects as twice-daily tacrolimus

   Possible Side Effects:
   Diarrhea, constipation, anemia, tremor, nerve toxicity, renal toxicity, increased risk of new-onset diabetes