FDA Approves Updated Labeling for Psoriasis Drug Raptiva…

The FDA announced on October 16, 2008 that they are changing the labeling on the psoriasis drug Raptiva (Efalizumab) to include a boxed warning that will highlight an increased risk of life- threatening infections while taking Raptiva.  The FDA has received reports of serious infections leading to hospitalizations, and deaths in some cases, in people who use Raptiva.

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups.  This suppression can lead to a heightened risk of certain opportunistic infections such as bacterial sepsis, viral meningitis, invasive fungal disease, and progressive multifocal leukoencephalophathy.  Patients on Raptiva should be educated on recognizing signs and symptoms of infection. 

Along with these changes, Raptiva’s label will also be updated to include a potential risk for the permanent suppression of the immune system in juvenile patients (ages 1-14 years of age), although Raptiva is not approved for children under 18 years of age.  The FDA is also requiring the submission of a risk evaluation and mitigation strategy (REMS), which will include a medication guide for patients and a timetable for assessment of the REMS.

Raptiva is a monoclonal antibody that was approved for psoriasis treatment in October 2003.  It is a once weekly injection used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy to control their psoriasis. Health care professionals should monitor patients treated with Raptiva for signs and symptoms of adverse events, instruct patients to report any changes to them, and make sure all patients beginning Raptiva therapy are up-to-date on their age appropriate vaccines.

References:

1).   http://www.fda.gov/bbs/topics/NEWS/2008/NEW01905.html
2.)  http://www.raptiva.com/raptiva/index.jsp?hl=en&q=raptiva&aq=f&oq=
3.)  http://www.fda.gov/consumer/updates/raptiva102008.html

Preared by Nereah Wakala, PharmD. Candidate