BELATACEPT

(bel AT a sept) Brand: Nulojix

What is the most significant information I must know about belatacept?

• You must not use belatacept if you have received a liver transplant. Till you start treatment with belatacept, your doctor will perform trials to create certain 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 magnify your risk of developing determined life-threatening conditions, including serious infections, cancer, or transplant failure. Conversation with your doctor about the risks and benefits of using this medicine.

• Serious infections that have occurred in people using belatacept include tuberculosis, a severe brain infection, or a virus that can reason 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 smaller than normal or not at all.

• You will need regular medical trials to be certain this medicine is not causing deleterious effects. Visit your doctor regularly.

What is belatacept?

• 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 another medications to prevent organ rejection after a kidney transplant.

Belatacept may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking belatacept?

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

• Till you start treatment with belatacept, your doctor will perform trials to create certain 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 speak your doctor about all of your medical conditions.

Belatacept can lower blood cells that help your body fight infections. This can create 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 reason failure of a transplanted kidney.

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

Belatacept may also reason 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 determined 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 child. Speak 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 estimate any effects of belatacept on the baby.

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

How must I take belatacept?

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

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

• You will need regular medical trials to be certain this medicine is not causing deleterious effects. Visit your doctor regularly. Do not miss any follow up visits to your doctor for blood or urine tests.

What happens if I miss a dose?

• Call your doctor for instructions if you miss an appointment for your belatacept injection.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking belatacept?

• 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 malady. 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 create you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of belatacept?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, 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:

· fever, night sweats, weary feeling;

· cough, sore throat, swollen glands;

· flu symptoms, weight loss;

· confusion, change in your mental state;

· problems with thinking or memory;

· problems with speech or walking,

· decreased vision;

· stomach pain, vomiting, diarrhea;

· tenderness on the side where you received the transplanted kidney;

· a new bump or lesion on your skin, or a mole that has changed in size or color; or

· blood in your urine, pain or burning when you urinate, urinating smaller than normal or not at all.

• Call your doctor at once if you have a serious side effect such as:

· pale skin, feeling light-headed or short of breath, rapid heart course, trouble concentrating;

· wheezing, chest tightness, trouble breathing;

· tall potassium (slow heart course, weak pulse, muscle weakness, tingly feeling);

· low potassium (confusion, uneven heart course, extreme thirst, heighten urination, leg discomfort, muscle weakness or limp feeling);

· tall blood sugar (increased thirst, heighten urination, famine, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or

· dangerously tall blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

• Smaller serious side effects may include:

· nausea, constipation;

· headache, back pain, joint pain;

· cool symptoms such as runny or stuffy nose, sneezing

· sleep problems (insomnia); or

· swelling in your hands or feet.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect belatacept?

• There may be another drugs that can interact with belatacept. Speak your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start using a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about belatacept.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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