By Diane S. Aschenbrenner, MS, RN

CONCERNS ABOUT TNF BLOCKERS AND Watch program: (800) 332-1088 released on April 22. Symptoms OTHER IMMUNOSUPPRESSANTS or http://1.usa.gov/bW5WC. include “progressive weakness on one side of the body or clumsi- • Tumor necrosis factor blockers AND THE RISK OF ness of limbs, disturbance of vision, and the immunosuppressants PROGRESSIVE MULTIFOCAL and changes in thinking, mem ory, and mercaptopu- LEUKOENCEPHALOPATHY and orientation, leading to confu- rine have been associated with sion and personality changes.” an increased risk of a rare can- The revised label now lists the cer of white blood cells known • The label of the immune mod- prior use of immunosuppressants as hepatosplenic lym- ulator natalizumab (Tysabri) phoma (HSTCL) in adolescents has been revised to empha- (mitoxantrone [Novantrone], aza - and young adults. size the risk of progressive mul- thioprine [Azasan, Imuran], meth - • Concurrent use of more than tifocal leukoencephalopathy otrexate [Rheumatrex, Trexall], one of these drugs further (PML), a serious brain infec- cyclophosphamide [Cytoxan], my - increases the risk of HSTCL. tion. cophenolate [CellCept, Myfortic]) • The risk of PML increases if as a risk factor for developing he Food and Drug Adminis- the patient has previously re- PML; previously the label warned ceived immunosuppressive Ttration (FDA) stated in a com- drugs; long-term use of natali- only of the simultaneous use of munication dated April 14 that it zumab (24 infusions or more) any of these agents with natali- continues to receive reports of also increases the risk. zumab. Additionally, the new hepatosplenic T cell lymphoma • Patients with any symptoms of warn ings in dicate that the risk is (HSTCL), a rare cancer of white PML should be taken off na- dosage dependent: receiving 24 blood cells, in adolescents and talizumab immediately. or more infusions of natalizumab young adults receiving drugs clas- increases the risk of PML. sified as tumor necrosis factor or the second year in a row the Natalizumab was already a vail - (TNF) blockers and other drugs FFood and Drug Administra- able only through a restricted pre - that suppress the . tion (FDA) has revised the label of scribing program known as the TNF blockers prevent TNF natalizumab (Tysabri), an immune Tysabri Outreach: Unified Com- from causing inflammation that modulator used to treat relapsing mitment to Health (TOUCH) leads to immune system diseases forms of multiple sclerosis and pro gram, which was designed to such as Crohn’s ulcerative colitis, moderately-to-severely active mit igate risks to patients, includ- rheumatoid arthritis, ankylosing Crohn’s disease. The changes em- ing the risks related to PML. The spondylitis, psoriatic arthritis, and phasize the risk of the rare but se- drug will continue to be available plaque psoriasis. TNF blockers rious brain infection known as through the TOUCH program. include (Remicade), pro gressive multifocal leukoen- Nurses caring for patients pre- (Enbrel), cephalopathy (PML). scribed natalizumab should con- (Humira), Natalizumab works by prevent- firm, prior to administration of the (Cimzia), and (Sim- ing the migration of leukocytes first dose, that the patient hasn’t poni). Other immunosuppressants from the bloodstream into other previously taken a drug that sup- that have been associated with the parts of the body, thereby prevent- presses the immune system. Edu- development of HSTCL are aza- ing the immune cells from causing cation should include teaching thioprine (Azasan, Imuran) and damage. Leukocyte levels in the patients to recognize the symptoms mercaptopurine (Purinethol). bloodstream will rise as a result of PML. If any of the symptoms is Most of the related cases of of this inhibition. PML is a brain noted or reported by the patient, HSTCL have been in patients re- infection caused by the John Cun- nurses should immediately with- ceiving more than one drug to sup - ningham (JC) virus, a common vi- hold the drug and notify the pre- press the immune system. Nurses rus acquired by most people in their scriber. Nurses should also be should instruct patients and their childhood. The JC virus appears aware of the risk of a rare but families to be alert for signs and to be dormant until something, seri ous inflammatory response, symptoms that can indicate this such as a weakened immune sys- immune reconstitution inflamma- malignancy, which can include tem, reactivates it. The symptoms tory syndrome (IRIS), that can splenomegaly, hepatomegaly, ab- of PML are varied and can pro- occur when patients with PML dominal pain, persistent fever, night gress quickly (over days) or more stop taking natalizumab. ▼ sweats, and weight loss. Health slowly (over weeks). The progres- care providers should report any sion of deficits “can lead to death Diane S. Aschenbrenner is the course co or- adverse events involving TNF or severe disability over weeks or dinator for undergraduate pharmacology at Johns Hopkins University School of Nurs- blockers, azathioprine, or mer- months,” according to an FDA ing in Baltimore, MD. She also coordinates captopurine to the FDA’s Med- Drug Safety Com munication Drug Watch: [email protected]. [email protected] AJN ▼ August 2011 ▼ Vol. 111, No. 8 23