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Psoriasis Drug Safety Concerns
Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN
Monday December 8, 2008

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The Food and Drug Administration announced a new black box warning and labeling change for efalizumab (Raptiva). Efalizumab is available as a once-weekly injection approved for moderate to severe plaque psoriasis treatment among adults who are also candidates for systemic (whole body) therapy or phototherapy. The new warnings were prompted by reports of serious, life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, and progressive multifocal leukoencephalopathy (PML). Several patients required hospitalization, and there have also been deaths reported in conjunction with use of efalizumab.

Patient monitoring: Observe for signs suggestive of opportunistic infections and possible malignancies. Signs found with PML include confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems, anemia, orthostatic hypotension, weakness, jaundice, thrombocytopenia, bruising, bleeding gums, pin-point-sized red or purple dots under the skin, or the worsening of psoriasis or arthritis. Signs of a nervous system disorder may also include sudden onset of numbness, tingling, or weakness in the arms, legs, or face.

Because efalizumab suppresses the immune system to reduce psoriasis flare-ups, it also increases the risk of serious infections. The risk for permanent immune suppression increases with repeated use, especially among younger individuals. Patients under age 18 who are prescribed efalizumab “off-label” are especially at risk, and they should be carefully monitored.

Patient teaching: Advise patients to seek immediate medical attention at the first sign of illness. Adhering to recommendations for vaccinations is also crucial. Vaccinations must be completed before therapy with efalizumab begins; they might not confer immunity if given after therapy initiation. Patients may be at increased risk for infection during influenza season.

Caution: Review current drug information before administering and monitoring medications.


Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.

References

FDA approves updated labeling for psoriasis drug Raptiva. FDA Web site. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01905.html. Accessed December 2, 2008.

Raptiva (efalizumab) product information. FDA Web site. http://www.fda.gov/medwatch/safety/2008/Raptiva_PI.pdf. Accessed December 2, 2008.



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