NULOJIX® (Belatacept)

NULOJIX®

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Important Safety Information

NULOJIX® (belatacept) is an effective prescription medication to treat adults who are kidney transplant recipients. It’s an infusion treatment used in conjunction with corticosteroids and other medications. Tell your doctor about all medications you’re taking — regardless of whether they’re prescription, over-the-counter, herbal, or vitamins. Avoid live vaccines while undergoing treatment with NULOJIX®. In addition, other types of vaccines may not be as effective while you are receiving NULOJIX®.

Talk with your doctor if you’re planning on becoming pregnant or become pregnant while undergoing NULOJIX® infusion therapy to determine whether treatment should be paused during pregnancy. It is unknown if NULOJIX® passes to your baby through breast milk. Therefore, if you’re breastfeeding or planning to breast-feed, and it is not recommended you do either while on NULOJIX®. Talk with your doctor to discuss your options.

What is the most important information I should know about NULOJIX®?

NULOJIX® increases the risk of post-transplant lymphoproliferative disorder (PTLD), certain cancers, progressive multifocal leukoencephalopathy (PML), and serious infections —  including tuberculosis, viruses, and fungus. The risk of PTLD is increased in patients who have never been exposed to the Epstein-Barr virus or have received treatment for transplant rejection that has lowered their white blood cell count.

NULOJIX® Side Effects

As with any prescription medication, NULOJIX® carries a risk of side effects. The most common ones include:

  • Fever
  • Diarrhea or constipation
  • Coughing
  • Nausea
  • Vomiting
  • Headaches
  • Swollen legs, feet, or ankles
  • Anemia
  • Low levels of potassium in the blood
  • Low white blood cell count

In addition, NULOJIX® could cause more serious side effects, including:

Skin Cancer

Limit exposure to sunlight while receiving NULOJIX® infusions — including tanning beds. When outside, wear sunscreen with a high SPF, as well as protective clothing.

Progressive Multifocal Leukoencephalopathy (PML)

PML is a rare infection of the brain caused by the JC virus. Tell your doctor right away if you experience vision loss, a decline of cognitive function, or speaking difficulties.

Other Serious Infections

NULOJIX® weakens the immune system, raising the risk of serious infections, including tuberculosis. Tell your doctor immediately if you experience fever, chills, shortness of breath, cough, weight loss, tiredness, and/or diarrhea.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

NULOJIX® is designed to treat adults who’ve undergone a kidney transplant to prevent rejection. It is unknown whether the medication is safe for patients under 18 years of age or in individuals who have received any other organ transplant. The medication should only be administered in people who have been exposed to the Epstein-Barr virus.

Please refer to the full prescribing information.