PONVORY®: fastest lymphocyte recovery among the S1P class1-4

7_days_reversibility_icon

~7-day recovery in lymphocyte counts provides the agility to pause therapy if needed for infections or vaccines, and then restart1*

In PK-PD assessments

  • After pausing PONVORY®, lymphocyte counts recovered in ~7 days1
  • 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

Clinical implications

  • 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

Vaccine considerations

  • 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.

MS = multiple sclerosis; PD = pharmacodynamic; PK = pharmacokinetic; S1P = sphingosine-1-phosphate.

*If 4 or more consecutive doses of PONVORY® are missed, treatment should be re-initiated with Day 1 of the titration regimen using a new 14-Day Starter Pack. First dose monitoring should also be completed in patients for whom it is recommended.1

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

For more detailed information about infections and vaccinations, please see Section 5 in the PONVORY® full Prescribing Information.