Belatacept (bel-AT-a-sept)

Used with other medicines to keep your body from rejecting a transplanted kidney. This medicine suppresses your immune system.

Brand Name(s):

Nulojix

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• This medicine must be injected slowly, so the needle will need to stay in place for at least 30 minutes.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using medicines that weaken the immune system, such as steroids. Tell your doctor if you are also using mycophenolate mofetil (Cellcept®).
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or planning to become pregnant. Your doctor may want you to join a pregnancy registry for patients using this medicine.
• Tell your doctor if you are breastfeeding or have any type of infection.
• Using this medicine may increase your risk of having serious conditions called progressive multifocal leukoencephalopathy or post-transplant lymphoproliferative disorder (PTLD). The risk of PTLD is higher in patients who are EBV negative, have cytomegalovirus (CMV) infection, or have received other treatments for transplant rejections. Check with your doctor right away if you have changes in mood or usual behavior, confusion, problems with thinking, loss of memory, decreased strength on one side of the body, or changes in vision, walking, or talking.
• This medicine may increase your risk of getting certain types of cancer, especially of the skin. Talk to your doctor if you have concerns about this risk.
• Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats, and stay out of direct sunlight between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.
• This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
• You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
• This medicine may increase your risk for developing a rare and serious virus infection called polyoma virus-associated nephropathy (PVAN). PVAN is caused by a BK virus. The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, changes in mood or usual behavior.
• Confusion, body weakness, shortness of breath, or numbness or tingling in your hands, feet, or lips.
• Decrease in how much or how often you urinate, painful urination, or cloudy or bloody urine.
• Dry mouth, muscle cramps, nausea, or vomiting.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches.
• Increased thirst or hunger.
• Lightheadedness, dizziness, or fainting.
• Problems with thinking or memory.
• Problems with vision, speech, or walking.
• Skin lesions, or change in the size or color of a mole.
• Swelling in your hands, ankles, or feet.
• Tenderness over the transplanted kidney.
• Tremors or seizures.
• Unusual bleeding, bruising, or weakness.
• Weight loss.

If you notice these less serious side effects, talk with your doctor:

• Acne or pimples.
• Back, muscle, or joint pain.
• Diarrhea, constipation, loss of appetite, or stomach pain.
• Headache.
• Sores or ulcers in your mouth.
• Trouble with sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088