Selected Important Safety Information:

NULOJIX increases your risk of serious side effects, including post-transplant lymphoproliferative disorder (PTLD), cancers other than PTLD, progressive multifocal leukoencephalopathy (PML, a rare, serious brain infection), and other serious infections caused by bacteria (including tuberculosis [TB]), viruses, or fungi. Scroll down for detailed and additional Important Safety Information, including bolded text.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about NULOJIX® (belatacept)?

  • NULOJIX increases your risk of serious side effects, including:

Post-transplant lymphoproliferative disorder (PTLD), a condition that can happen if certain white blood cells grow out of control because of a weakened immune system.

  • PTLD can worsen, become a type of cancer, and can lead to death
  • NULOJIX increases the risk of getting PTLD; if you get PTLD with NULOJIX, you are at especially high risk of PTLD in your brain
  • Your risk for PTLD is also higher if you:
    • have never been exposed to the Epstein-Barr virus (EBV). Your doctor will test you for EBV exposure. Do not receive NULOJIX unless you are EBV positive (you have been exposed to EBV).
    • get an infection with cytomegalovirus (CMV)
    • receive treatment for transplant rejection that lowers certain white blood cells (T cells)

 

Other cancers, including skin cancer due to a weakened immune system.

  • Limit the amount of time you spend in sunlight, wear protective clothing, use sunscreen with a high SPF, and avoid using tanning beds or sunlamps

 

Progressive multifocal leukoencephalopathy (PML), a rare, serious brain infection caused by JC virus due to a weakened immune system.

  • PML can result in death or severe disability
  • There is no known prevention, treatment, or cure for PML

 

Other serious infections, including tuberculosis (TB) and infections caused by bacteria, viruses, or fungi

  • These serious infections may lead to death
  • The BK virus can affect how your kidney works and cause your transplanted kidney to fail

 

  • Tell your doctor right away if you get any of these symptoms during treatment with NULOJIX:
  • change in mood or your usual behavior
  • confusion or problems with thinking or memory
  • change in the way you walk or talk
  • decreased strength or weakness on one side of your body
  • change in vision
  • fever, night sweats, or tiredness that does not go away
  • weight loss
  • swollen glands
  • flu, cold symptoms, or cough
  • stomach-area pain
  • vomiting or diarrhea
  • tenderness over transplanted kidney
  • change in amount of urine that you make, blood in your urine, pain, or burning upon urination
  • new skin lesion or bump, or change in size or color of a mole

 

  • Liver transplant patients should not receive NULOJIX due to increased risk of loss of transplanted liver and death.

 

What should I tell my doctor before receiving NULOJIX® (belatacept)?

  • Before receiving NULOJIX, tell your doctor if you:
  • Plan to receive any vaccines
    • Avoid receiving live vaccines during treatment with NULOJIX
    • Some vaccines may not work as well while you are receiving NULOJIX
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant
    • It is not known if NULOJIX will harm your unborn baby
    • If you become pregnant while taking NULOJIX, tell your doctor right away. You and your doctor should decide if you will keep taking NULOJIX while pregnant
  • Are breast-feeding or plan to breast-feed
    • It is not known if NULOJIX passes into your breast milk
    • You and your doctor should decide if you will take NULOJIX or breast-feed. You should not do both.

 

  • Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Do not take any new medicine without talking with your transplant doctor first. Take all the medicines prescribed by your doctor to prevent infection or transplant rejection.

 

What are other possible side effects of NULOJIX® (belatacept)?

  • low red blood count (anemia)
  • diarrhea
  • kidney or bladder infection
  • swollen legs, feet, or ankles
  • constipation
  • high blood pressure
  • fever
  • new kidney not working well
  • cough
  • nausea or vomiting
  • headache
  • low or high potassium in your blood
  • low white blood cell count

 

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of NULOJIX. For more information, ask your doctor or pharmacist.

 

Please see Full Prescribing Information, including “What is the most important information I should know about NULOJIX?” in the Medication Guide.

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