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REMS Overview

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 AcelRx Pharmaceuticals, Inc. or a third party acting on behalf of AcelRx Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.
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ENROLLMENT FORM

DSUVIA Healthcare Setting Enrollment Form


Download and complete the enrollment form
to submit it 1 of 3 ways:

By email: DSUVIAREMS@acelrx.com
By fax: 1-650-649-1855
By mail: AcelRx Pharmaceuticals, Inc.
Attn: REMS Administrator
351 Galveston Drive
Redwood City, CA 94063

Complete and submit the enrollment form online.

How does my healthcare setting become certified in the DSUVIA REMS?

Your healthcare setting must designate an Authorized Representative to coordinate the certification process and oversee implementation of and compliance with the DSUVIA REMS. To enroll your healthcare setting, the Authorized Representative must complete, sign, and submit the Healthcare Setting Enrollment Form to the DSUVIA REMS.

By signing the Healthcare Setting Enrollment Form, the Authorized Representative agrees to comply, on behalf of your healthcare setting, with the following REMS requirements:

  • He/she is authorized to complete the Healthcare Setting Enrollment Form and submit it to the REMS Program on behalf of your healthcare setting
  • Your healthcare setting is able to manage acute opioid overdose, including respiratory depression
  • Your healthcare setting must not dispense DSUVIA for outpatient use
    1. Train all relevant staff that DSUVIA must not be dispensed for use outside of the healthcare setting
    2. Establish processes and procedures to verify that DSUVIA is not dispensed for use outside of your healthcare setting
  • Your healthcare setting must train all relevant staff involved in administration of DSUVIA to read the Directions for Use prior to administering DSUVIA
  • Your healthcare setting must not distribute, transfer, loan, or sell DSUVIA
  • Your healthcare setting must maintain records of staff training and of all processes and procedures including compliance with those processes and procedures
  • Your healthcare setting must comply with audits by AcelRx Pharmaceuticals, Inc. or a third party acting on behalf of AcelRx Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed for the DSUVIA REMS. Failure to comply may result in decertification of the healthcare setting
  • If the Authorized Representative changes, your healthcare setting will have a new Authorized Representative enroll in the REMS by completing the Healthcare Setting Enrollment Form
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On-site Support

Receive On-Site Medical Information

AcelRx Pharmaceuticals, Inc. will provide information on DSUVIA at certified healthcare settings upon request.

To make an appointment, call

This phone number is also available for reporting product complaints.

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Resources

Healthcare Setting Resources

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

Product Information:

DSUVIA
Directions for Use

Download

Prescribing Information

Download

Healthcare Setting Enrollment Form

Download

Indication

DSUVIA contains sufentanil, an opioid agonist, and 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.
  • 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:

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

AcelRx Pharmaceuticals, Inc.
1-855-925-8476

Food and Drug Administration (FDA)
1-800-FDA-1088