|Pronunciation:||bel AT a sept|
|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.|
|Treatment with belatacept may increase your risk of developing certain life-threatening conditions, including serious infections, cancer, or transplant failure. Talk with your doctor about the risks and benefits of using this medication.|
|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.|
Call your doctor right away if you have signs of infection such as: fever, night sweats, swollen glands, flu symptoms, change in your mental state, problems with speech or walking, decreased vision, tenderness of your transplanted kidney, a new skin lesion, a mole that has changed in size or color, pain or burning when you urinate, blood in your urine, or urinating less than usual or not at all.
|You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.|
Belacept lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a kidney. This is because the immune system treats the new organ as an invader.
Belatacept is used in combination with other medications to prevent organ rejection after a kidney transplant.
Belatacept may also be used for purposes not listed in this medication guide.
|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.|
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.|
Call your doctor for instructions if you miss an appointment for your belatacept injection.
|Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.|
Do not receive a "live" vaccine while using belatacept. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.
|Avoid exposure to sunlight or tanning beds. Belatacept can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.|
|Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.|
Serious and sometimes fatal infections may occur during treatment with belatacept. Call your doctor right away if you have signs of infection such as:
|Call your doctor at once if you have a serious side effect such as:|
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
There may be other drugs that can interact with belatacept. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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