A well-established safety profile
TYSABRI® (natalizumab) increases the risk of progressive multifocal leukoencephalopathy (PML)1
PML is an opportunistic viral infection of the brain caused by the John Cunningham virus (JCV) that usually leads to death or severe disability.2 There is no known treatment, prevention or cure for PML. Infection by the JC virus is required for the development of PML. The decision to start or continue TYSABRI® (natalizumab) requires an individualized assessment based on 3 known risk factors and the estimated incidence of PML.1
Three known risk factors include:
- The presence of anti-JCV antibodies
- Prior treatment with an immunosuppressant
- Longer duration of TYSABRI treatment (especially beyond 2 years)
Evaluate and assess
- Continually evaluate treatment response and disease activity as measured by MRI activity, relapse rate, and EDSS progression
In the context of expected benefit when initiating and continuing treatment with TYSABRI consider:
LABEL INCLUDES PML RISK STRATIFICATION DATA OUT TO 6 YEARS1
Estimated United States incidence of PML stratified by risk factor1,a
bData beyond 6 years of treatment are limited.
Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI® (natalizumab).
IDENTIFY PML SIGNS AND SYMPTOMS
Look for signs and symptoms that may be suggestive of PML
Healthcare professionals should monitor patients on TYSABRI® (natalizumab) for any new sign or symptom suggestive of PML. Typical symptoms associated with PML are diverse, progress over days to weeks, and include1:
MRI findings may be apparent before clinical signs or symptoms of PML. Monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Consider monitoring patients at high risk for PML more frequently. Lower PML-related mortality and morbidity have been reported following TYSABRI discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis.
To make the diagnosis of PML, various MRI evaluations, including gadolinium-enhanced and T2-weighted scans, and PCR analysis of cerebrospinal fluid for JC viral DNA, are recommended.1
There are no known interventions that can reliably prevent or that can adequately treat PML if it occurs.
- If PML is detected, action should be taken to allow immune reconstitution, which would include stopping TYSABRI, and consideration of plasma exchange (PLEX)
- PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation
- Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI1
This information is provided as an educational resource for healthcare providers. It is not intended to be a substitute for consultation with your patients and review of reference material and medical literature. Healthcare providers should make all treatment decisions based on the context of the situation and their own clinical judgment.