REMS Patient Monitoring Form Overview

 

[Introduction]

SPRAVATO® (esketamine) nasal spray CIII is available only through a restricted distribution program called the SPRAVATO® REMS because of the risks of serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse and misuse. SPRAVATO® is intended for use only in a certified Healthcare Setting.

SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO® must never be dispensed directly to a patient for home use.

The Patient Monitoring Form is an important component of the SPRAVATO® REMS to ensure compliance and patient safety. The form must be completed after every SPRAVATO® treatment session for all patients enrolled in the SPRAVATO® REMS and submitted within 7 days. The Patient Enrollment Form must also be submitted if this is the patient’s first treatment session. Completed forms can be submitted online at www.SpravatoREMS.com.

Patients MUST be monitored for any signs of sedation, dissociation, or respiratory depression during the required 2-hour monitoring period.

Sections marked by an asterisk are required fields.

 

[Patient Section]

The first section (Patient) of the form asks for the patient’s first and last name, date of birth, and sex. If this is the patient’s first treatment, please check “yes” or “no.” If yes is selected, please mark “yes” or “no” if the patient is enrolled in the SPRAVATO® REMS program. If the patient is not enrolled, please submit the Patient Enrollment Form at www.SpravatoREMS.com or by fax prior to treatment with SPRAVATO®.

The following section (Concomitant Medication) asks you to identify medications the patient is currently taking that may cause sedation, dissociation, respiratory depression, or blood pressure changes (including but not limited to benzodiazepines, sedative hypnotics, opioids, psychostimulants).

 

[HCP Section]

In the third section (Monitoring Healthcare Provider) of the form, please provide the first and last name, telephone number, and email of the monitoring healthcare provider.

Healthcare setting information including name, address, and DEA number are also required on the form. It is very important that the DEA number used during your facility’s REMS certification is listed.

 

[Patient Treatment Session]

In this section (treatment date/dose administered/treatment duration), please record the treatment date, check the corresponding box for the dose administered, write in the package lot number, and record the total treatment duration in minutes. The treatment duration starts with the first spray in the first nostril and ends when monitoring is completed. If the patient is not monitored for at least 2 hours, please provide the reason.

In the monitoring portion (Monitoring of Vital Signs/Pulse Oximetry) of the form, please check “yes” or “no” if vital signs were in acceptable range prior to administration AND prior to treatment session completion. Please check “yes” or “no” if pulse oximetry was at an acceptable level prior to administration, during treatment, AND at treatment session completion.

 

[Serious Adverse Events of Interest]

A serious adverse event (SAE) of interest for the SPRAVATO® REMS is defined as any event involving sedation, dissociation, respiratory depression, or hypertension that results in death, hospitalization, disability/permanent damage, an important medical event, or is life-threatening.

Please check “yes” or “no” if the patient experienced an SAE of interest based on the definition provided above. If the patient did not experience a serious adverse event of interest, the monitoring HCP must check the “No” box. In this case, the second page of the monitoring form need not be filled out.

If “yes” is checked, please provide information on the patient as well as the monitoring healthcare provider at the top of the form on the second page (Patient/Monitoring Healthcare Provider).

If an SAE of interest occurs during the session, please provide additional details on the second page of the form:

• (Event Outcome/Event Timing/Description of SAE of Interest) Indicate the outcome(s) resulting from the SAE, the date of the event, if the SAE occurred during the treatment session, and a description of the SAE. Be sure to check the box(es) to indicate which adverse event of interest (sedation, dissociation, respiratory depression, hypertension) this SAE involved.
• (Event Resolution) Check “yes,” “no,” or “unknown” if the event was resolved. If resolved, please provide the time to resolution in minutes.
• If there are multiple SAEs, please provide details separately for each one on the form.
• If needed, add additional pages to document SAEs.

 

[Closing]

Report other product quality complaints or adverse events that are not defined above to:

Janssen at 1-800-526-7736 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information, please visit www.SpravatoREMS.com.

Please see the full US prescribing information for SPRAVATO® at www.SpravatoHCP.com.

 

cp-486850v1