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belatacept (cont.)

What should I discuss with my healthcare provider before taking belatacept (Nulojix)?

You should not use belatacept if you have received a liver transplant.

Before you start treatment with belatacept, your doctor will perform tests to make sure you are immune to Epstein-Barr virus (EBV-positive). Your risk of serious infection is higher if you have never been exposed to EBV.

Talk with your doctor about the risks and benefits of using this medication. Also tell your doctor about all of your medical conditions.

Belatacept can lower blood cells that help your body fight infections. This can make it easier for you to develop serious bacterial, fungal, or viral infections. Serious infections that have occurred in people using belatacept include tuberculosis, a severe brain infection, or a virus that can cause failure of a transplanted kidney.

Belatacept may cause your body to produce too much of a certain type of white blood cells. This can lead to serious and sometimes fatal conditions, including cancer. Your risk is further increased if you have cytomegalovirus (CMV), or if you have never been exposed to the Epstein-Barr virus.

Belatacept may also cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

FDA pregnancy category C. It is not known whether belatacept will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

If you are pregnant, or if you are a man and your sexual partner is pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of belatacept on the baby.

It is not known whether belatacept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using belatacept.

How should I take belatacept (Nulojix)?

Belatacept is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Belatacept must be given slowly, and the IV infusion can take up at least 30 minutes to complete.

Belatacept is usually given just before your kidney transplant, and again 5 days later, followed by once every 2 to 4 weeks. Follow your doctor's dosing instructions very carefully.

You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly. Do not miss any follow up visits to your doctor for blood or urine tests.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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