Dear Healthcare Setting Authorized Representative,
Starting today, the SPRAVATO® REMS has undergone changes, as detailed in previous emails. As a reminder, the updates to the REMS are:
- All REMS-certified healthcare settings are required to have a pulse oximeter monitoring device in accordance with the United States Prescribing Information (USPI).
- The new PMF has been updated to include verification that the patient’s pulse oximetry reading was taken prior to, during, and toward the end of SPRAVATO® administration.
- Healthcare settings must continue to monitor vital signs, including blood pressure. There is no longer a requirement to report measurements of blood pressure, sedation, and dissociation within the PMF.
- On the new PMF, users are required to report Serious Adverse Events (SAEs) of Interest. SAEIs are defined as Adverse Events involving sedation, dissociation, respiratory depression, and hypertension that result in death, life-threatening, hospitalization, disability/permanent damage, or an important medical event. An important medical event is further defined as any event that may jeopardize the patient or may require intervention to prevent one of the above outcomes
- If you report a SAE of Interest via the PMF, please ensure that all fields are filled out.
Please discontinue use of previous version(s) of the Patient Monitoring Form (PMF) and ensure you begin using the new PMF.
REMS PORTAL USERS: If you submit your PMFs through the REMS Portal, the form has been automatically updated in the system. No additional action is required!
PAPER/FAX USERS: If you fax your PMFs to REMS or have the PMF embedded in your EHR, please be sure to replace the old PMF with the new version. The new PMF is attached for your reference.
If you have any questions about the upcoming changes or the SPRAVATO REMS® in general, please reach out to the Coordinating Center at 1-855-382-6022.
At all times, staff should report suspected adverse events or product quality complaints to Janssen at 1-800-Janssen (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch.