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Nulojix PTLD & PML Side Effects Lawsuit

Research shows the immunosuppressant belatacept—sold under the brand name Nulojix—causes post-transplant lymphoproliferative disorder and progressive multifocal leukoencephalopathy. The Rottenstein Law Group compassionately advocates for those who have suffered from the harmful side effects of potentially dangerous drugs. If you’ve taken Nulojix and believe it harmed you, contact RLG for a free, confidential legal consultation. We will evaluate your case and remain on the lookout for Nulojix recalls and Nulojix class action lawsuits. We might be the Nulojix law firm you are looking for.

What Is Nulojix and What Is Prescribed For?

Nulojix is the brand name for the drug belatacept. Made and sold by American pharmaceutical company Bristol-Myers Squibb, this prescription medication is used to prevent the immune system from rejecting transplanted kidneys. The U.S. Food and Drug Administration (FDA) has not established Nulojix’s efficacy for other organ transplants, so any Nulojix prescription for transplants of organs other than kidneys is strictly off-label.

Patients can use Nulojix in conjunction with the following immunosuppressants: basiliximab induction, mycophenolate mofetil (CellCept), and corticosteroids. The FDA approved Nulojix in June 2011, and it comes in an intravenous injection in doses proportional to the patient’s weight.

Nulojix is a genetically modified protein that blocks T-cells (lymphocytes), a type of white blood cell, from activating. When T-cells activate, they attack transplanted organs, which leads to organ rejection. By preventing T-cell activation, Nulojix hampers organ rejection and decreases the production of antibodies that attack the transplanted organ. It also limits the buildup of toxins created by standard immunosuppressants.

In July 2011, Bristol-Myers Squibb announced that the FDA required it to submit a Risk Evaluation and Mitigation Strategy (REMS) regarding Nulojix’s side effects when patients receive higher doses than recommended. A drug-maker creates a REMS to demonstrate that the drug’s benefits outweigh its potential risks.

Potential Side Effects Are Life-Threatening

Upon initial FDA approval, Nulojix’s label included a black box warning, the FDA’s most serious alert. The warning specifically cites as a potential Nulojix side effect post-transplant lymphoproliferative disorder (PTLD) affecting the central nervous system, and it advises against using the drug in liver transplants. The drug’s “Warnings and Precautions” section also notes progressive multifocal leukoencephalopathy (PML) as a potential side effect.

One problem with immunosuppressants is that, if they completely suppress the immune system, the patient risks further infection instead of organ rejection. This is true for Nulojix because, at doses above the recommended level, the patient can develop a number of diseases that a healthy immune system routinely blocks. In PTLD, a person’s B-cells proliferate due to the presence of the Epstein-Barr virus (EBV), known for causing mononucleosis, commonly called “mono.” In some cases, the B-cells can mutate and become malignant. Consequently, the FDA recommends that doctors determine whether transplant patients are already immune to EBV before administering Nulojix. Symptoms of mononucleosis include:

  • Sore throat;
  • Fever;
  • Swollen lymph nodes; and
  • Swollen spleen or liver.

Symptoms of PTLD can manifest as neurological, cognitive or behavioral changes.

PML is a fatal brain disease characterized by inflammation of the brain’s white matter at multiple locations. The disease destroys a number of its victims’ brain cells, thereby impairing transmission of electrical signals in the brain. Symptoms of this terrifying disease include:

  • Weakness;
  • Impaired speech;
  • Vision loss;
  • Paralysis; and
  • Cognitive deterioration.

An MRI can detect PML, but no known treatment exists. Patients usually die within four months of being diagnosed. The FDA described two cases of PML in Nulojix clinical trials—both due to the patients’ receipt of higher-than-recommended doses—but the FDA did not reveal whether the patients involved survived.

Nulojix’s label’s “Warnings and Precautions” section also warns that the drug can leave the body open to other serious bacterial, viral (cytomegalovirus and herpes), fungal, and protozoal infections. Two examples the FDA specifies are tuberculosis and polyoma virus nephropathy, a disease that causes kidney deterioration.

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Nulojix lawsuit on your behalf if necessary. RLG will also keep you up to date on any Nulojix class action lawsuits, FDA Nulojix warnings, and Nulojix FDA recall announcements.

If you have taken Nulojix and believe it harmed you, contact RLG today.

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