Efalizumab (withdrawn from market 2009)
Risk of Serious Infections
- Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with efalizumab (see WARNINGS and ADVERSE REACTIONS).
- These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections.
- Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with efalizumab.
- If a patient develops a serious infection, efalizumab should be discontinued and appropriate therapy instituted.
Risk of Progressive Multifocal Leukoencephalopathy
- This agent increases the risk for PML, a rapidly progressive viral infection of the central nervous system that has no known treatment and that leads to death or severe disability.
- The risk of PML may markedly increase with longer duration of efalizumab exposure.The time dependent threshold when the risk for PML increases is unknown [see Warnings].
- Patients on efalizumab should be monitored frequently to ensure that they are receiving significant clinical benefit, to ensure that they understand the significance of the risk of PML, and for any sign or symptom that may be suggestive of PML. [see WARNINGS]
- Efalizumab dosing should be withheld immediately at the first sign of symptom suggestive of PML. For diagnosis, brain magnetic resonance imaging (MRI) and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended (See WARNINGS). Resulting JC virus infection has occurred during therapy with efalizumab (See WARNINGS).
FDA and Industry Communications
Updated November 2016