PONVORY® reversibility: fastest among the S1P class1-4
Rapid reversibility provides the flexibility to pause therapy if needed1
In PK-PD assessments
- The effects of PONVORY® on lymphocyte counts were reversible in ~7 days, allowing you to pause therapy if needed (eg, infection, surgery)1
- Lymphocyte counts returned to the normal range in 90% of patients within 1 week of stopping therapy1
In the OPTIMUM study
- Peripheral lymphocyte counts returned to the normal range within 2 weeks after discontinuation of PONVORY®, which was the first time point evaluated1
- Residual PD effects, such as lowering of peripheral lymphocyte counts, may persist for 1 to 2 weeks after discontinuation of PONVORY®1
- Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of an S1P receptor modulator1
PONVORY® may increase the risk of infections
- In the OPTIMUM study, the overall rate of infections was comparable between patients taking PONVORY® and patients taking Aubagio®1
- Initiation of treatment with PONVORY® should be delayed in patients with active infections until resolution1
- Monitor for infection during treatment and for 1 to 2 weeks after discontinuation of PONVORY®1
- Consider interruption of treatment with PONVORY® if a patient develops a serious infection1
- No clinical data are available on the efficacy and safety of vaccinations in patients taking PONVORY®. Vaccinations may be less effective if administered during PONVORY® treatment1
For live vaccines
- The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during PONVORY® treatment and for 1 to 2 weeks after discontinuation of treatment with PONVORY®1
- PONVORY® should be paused 1 to 2 weeks prior to and until 4 weeks after a planned vaccination1
For non-live vaccines
- No dose adjustment or discontinuation of PONVORY® treatment was required for non-live vaccinations in the OPTIMUM study5
Your patients with MS should always consult with you before receiving any vaccine.
The possibility of severe exacerbation of disease should be considered after stopping treatment with PONVORY®. Patients should be observed for a severe increase in disability upon PONVORY® discontinuation and appropriate treatment should be instituted, as required.1
MS = multiple sclerosis; PD = pharmacodynamic; PK = pharmacokinetic; S1P = sphingosine-1-phosphate.
For more detailed information about infections and vaccinations, please see Section 5 in the PONVORY® full Prescribing Information.