Boxed warning will list life-threatening, opportunistic infections that are associated with the medication..
FDA has made some labeling changes to Genentech’s psoriasis treatment, Raptiva, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML). The new boxed warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy, and other opportunistic infections.
The agency also requested 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.
Additionally, Raptiva’s label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). This data indicated a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.
The drug is sanctioned as a once-weekly injection approved for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy to control their psoriasis.
