NULOJIX Warnings and Precautions

People who have an infection of any kind or who have not been exposed to the Epstein-Barr virus may not be able to safely receive NULOJIX. Other warnings and precautions involve an increased risk for certain cancers and possibly even death. In addition, you may not be able to safely take this medicine if you are using certain other medications or if you have certain allergies.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to receiving NULOJIX® (belatacept) if you have:
  • Plans to receive a vaccination
  • Received a liver transplant
  • Skin cancer or any other type of cancer
  • A history of tuberculosis
  • Ever had a positive tuberculosis test (purified protein derivative, or PPD skin test)
  • An infection of any kind, including a viral, fungal, or bacterial infection
  • A weakened immune system due to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or any other cause
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With NULOJIX

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • People who use this medicine are at risk for a condition known as post-transplant lymphoproliferative disorder (PTLD), which occurs when certain white blood cells grow out of control because the immune system is weak. PTLD from NUOJIX may involve the brain and could lead to cancer and death.
You are at a higher risk for this condition if you have cytomegalovirus (CMV) or if you have never been exposed to Epstein-Barr virus (EBV), the virus that causes mononucleosis ("mono"). Therefore, your healthcare provider will test you for EBV before treatment. Talk to your healthcare provider right away if you experience confusion or changes in your behavior, which could be signs of PTLD.
  • You must take this medicine under the direction of a healthcare provider who has experience prescribing medications that suppress the immune system, and in treating people who have had an organ transplant.
  • Like other immunosuppressants, NULOJIX increases the risk for developing certain cancers, including skin cancer. Protect your skin by limiting your time in the sun, and wearing protective clothing and sunscreen when you are outside. Also, contact your healthcare provider if you notice any skin changes, discoloration, or changes in the shape or size of moles.
  • People who have received a liver transplant may have an increased risk of liver transplant failure and death if they take this medicine. Therefore, NULOJIX should not be used to prevent transplant rejection after a liver transplant.
  • Because NULOJIX suppresses the immune system, it can make it harder for your body to recover from an infection. You could develop potentially serious bacterial, viral, or fungal infections, including tuberculosis, a life-threatening brain infection known as progressive multifocal leukoencephalopathy (PML), or an infection with the BK virus, a virus that can damage your kidneys. Contact your healthcare provider immediately if you experience any signs of infection, such as:
    • Weakness on one side of the body
    • Confusion or difficulty thinking
    • Fever or chills
    • A sore throat
    • Body aches
    • Sores or wounds that do not heal, are red, or ooze pus
    • Painful urination.
  • People receiving NULOJIX should not receive live vaccines (see NULOJIX Drug Interactions). Check with your healthcare provider before getting a vaccination while you are on this medication.
  • NULOJIX is a pregnancy Category C medication, which means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using this medicine while pregnant (see NULOJIX and Pregnancy).
  • It is unknown if this medicine passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see NULOJIX and Breastfeeding).

NULOJIX Medication Information

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