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

What is Nulojix?

Nulojix (belatacept) 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.

Nulojix is used in combination with other medicines to prevent organ rejection after a kidney transplant.

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

Important information

You should not use Nulojix if you have received a liver transplant. Before you start treatment with Nulojix, 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 Nulojix 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 medicine. 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 symptoms such as: fever, swollen glands, flu symptoms, night sweats, weight loss, vomiting or diarrhea, painful or difficult urination, blood in your urine, a new skin lesion, any change in your mental state, decreased vision, weakness on one side of your body, problems with speech or walking, or pain on the side of your transplant.

Before taking this medicine

You should not receive Nulojix if you are allergic to belatacept, or:

  • if you have never been exposed to Epstein-Barr virus (your doctor will perform a test to confirm this); or

  • if you have ever received a liver transplant.

Talk with your doctor about the risks and benefits of using this medicine. Nulojix can lower blood cells that help fight infection, and may cause you to produce too much of a certain type of white blood cell. This can lead to serious conditions including cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

To make sure Nulojix is safe for you, tell your doctor if you have:

  • cytomegalovirus (CMV); or

  • if you are scheduled to receive any vaccine.

It is not known whether Nulojix will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, or 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 Nulojix 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 Nulojix.

How is Nulojix given?

Nulojix is injected into a vein through an IV. A healthcare provider will give you this injection.

The injection must be given slowly, and the IV infusion can take up at least 30 minutes to complete.

Nulojix 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.

This medicine can increase your risk of infection by changing the way your immune system works. You will need frequent medical tests.

Nulojix dosing information

Usual Adult Dose for Rejection Prophylaxis:

Initial dose: 10 mg/kg, intravenously, once daily, on day 1 (day of transplant, prior to implantation) and day 5, and at the end of weeks 2, 4, 8, and 12.

Maintenance dose: 5 mg/kg, intravenously, at the end of week 16 and every 4 weeks (plus or minus 3 days) thereafter.

Nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. In clinical trials the median corticosteroid doses were tapered to approximately 15 mg per day by the first 6 weeks and remained at approximately 10 mg per day for the first 6 months post-transplant. Corticosteroid utilization should be consistent with the clinical trial experience.

Dosage Information (comprehensive)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Nulojix 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 receiving Nulojix?

Avoid exposure to sunlight or tanning beds. Nulojix can increase your risk of skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a "live" vaccine while using Nulojix. 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), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Nulojix side effects

Get emergency medical help if you have any signs of an allergic reaction to Nulojix: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as:

  • fever, swollen glands, flu symptoms, night sweats, stomach pain, vomiting, diarrhea, weight loss;

  • any change in your mental state, weakness on one side of your body, decreased vision, problems with speech or walking;

  • blood in your urine, painful or difficult urination, little or no urinating;

  • pain on the side where you received the transplanted kidney; or

  • a new skin lesion, or a mole that has changed in size or color.

Also call your doctor at once if you have:

  • low potassium - constipation, numbness or tingling, tiredness, muscle weakness, slow heart rate, fainting;

  • high potassium - nausea, slow or unusual heart rate, weakness, loss of movement; or

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common Nulojix side effects may include:

  • nausea, diarrhea, constipation;

  • headache;

  • cough;

  • fever; 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.

Side Effects (complete list)

What other drugs will affect Nulojix?

Other drugs may interact with belatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Nulojix.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Nulojix 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 1996-2017 Cerner Multum, Inc. Version: 3.02. Revision Date: 2017-02-14, 12:53:24 PM.