Nulojix

Generic Name: belatacept (bel AT a sept)
Brand Name: Nulojix

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 other medications to prevent organ rejection after a kidney transplant.

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

What is the most important information I should know about belatacept?

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.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

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.

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

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?

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.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should 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 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.

Belatacept side effects

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:

  • fever, night sweats, tired 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 less than usual 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 rate, trouble concentrating;

  • wheezing, chest tightness, trouble breathing;

  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or

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

Less serious side effects may include:

  • nausea, constipation;

  • headache, back pain, joint pain;

  • cold 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 report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect belatacept?

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.

Where can I get more information?

  • Your pharmacist can provide more information about belatacept.
  • 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.
  • Disclaimer: Every 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 outside 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 should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision Date: 2013-12-03, 2:26:53 PM.

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