Safety & Tolerability

Inject Solesta: For well-studied safety and tolerability through 36 months1


  1. 96% of adverse events were mild or moderate over 18 months1

    • 96% of the events required no intervention or required medical or simple noninvasive interventions1

  2. The most common types of adverse events were proctalgia, minor anal or rectal bleeding (hemorrhage), pyrexia, abdominal complaints (diarrhea and constipation), and injection-site pain1

    • All instances of bleeding were listed as hemorrhages, regardless of intensity, in accordance with international standards2

    • Most treatment-related adverse events were experienced soon after injection with Solesta; the highest incidence occurred during the 48-hour interval following first injection1

  3. Only 3 adverse events assessed as related to Solesta, or 1.3% of the treatment-related adverse events, were deemed serious1

 

Solesta has minimal post-procedure impact on patients1

  • Patients may resume limited physical activity immediately

  • Patients are able to resume a normal lifestyle and engage in all physical activities after 1 week (e.g. jogging, bicycling, horseback riding, sexual intercourse, etc.)

  • Solesta is unlikely to impede future procedures


 

References

  1. Solesta [Package Insert]. Santa Barbara, CA: Palette Life Sciences.

  2. Solesta Post-Market Approval P100014; 2011.