Risk Evaluation and Mitigation Strategy (REMS)

What is the DSUVIA REMS (Risk Evaluation and Mitigation Strategy)?

A REMS is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug outweigh its risks. DSUVIA is intended for sublingual delivery only by a healthcare provider. DSUVIA is available only through a restricted distribution strategy called the DSUVIA REMS in order to prevent respiratory depression resulting from accidental exposure.

What are the DSUVIA REMS requirements?

Healthcare settings that dispense DSUVIA must:

To become certified to dispense

1. Be able to manage acute opioid overdose, including respiratory depression.
2. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the healthcare setting.
3. Have the Authorized Representative enroll in the REMS Program by completing the Healthcare Setting Enrollment Form and submitting it to the REMS Program.
4. Train all relevant staff that DSUVIA must not be dispensed for use outside of the certified healthcare setting.
5. Train all relevant staff involved in administration of DSUVIA to refer to the Directions for Use prior to administration.
6. Establish processes and procedures to verify that DSUVIA is not dispensed for use outside of the certified healthcare setting.
   To maintain certification to dispense
7. Have a new Authorized Representative enroll in the REMS Program by completing the Healthcare Setting Enrollment Form if the Authorized Representative changes.
   At all times
8. Not dispense DSUVIA for use outside the certified healthcare setting.
9. Not distribute, transfer, loan, or sell DSUVIA.
10. Maintain records of staff training.
11. Maintain records of all processes and procedures including compliance with those processes and procedures.
12. Comply with audits by Vertical Pharmaceuticals, LLC or a third party acting on behalf of Vertical Pharmaceuticals, LLC to ensure that all processes and procedures are in place and are being followed.

Healthcare Setting Resources

DSUVIA is only available through the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) developed by Vertical Pharmaceuticals, LLC Healthcare settings must enroll in the DSUVIA REMS to become certified to dispense DSUVIA. This section includes important product information.

Product Information:

Indications and Usage

DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

• Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting.
• Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied.
• Only to be administered by a healthcare provider.
• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
1. Have not been tolerated, or are not expected to be tolerated,
2. Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Adverse Reaction Reporting:

Vertical Pharmaceuticals, LLC is committed to patient safety. To report suspected adverse reactions with DSUVIA, please contact: