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What is the Dsuvia REMS program?

Medically reviewed by Drugs.com. Last updated on Nov 21, 2023.

What exactly is a REMS program?

Official answer

by Drugs.com

Dsuvia REMS is a restricted program where Dsuvia can only be administered by a health care provider in a supervised health care setting to reduce the risk of respiratory depression from accidental exposure to sufentanil.

Some medications have an inherent risk that require a restricted program known as a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use.

  • Dsuvia (sufentanil) from AcelRx Pharmaceuticals is a 30 microgram (mcg) sufentanil tablet in a single-dose, pre-filled applicator. It is a potent opioid pain medication reserved for patients who have no alternative pain treatment options. It is given under the tongue as a sublingual tablet.
  • Because of the potential for life-threatening respiratory depression (reduced or stopped breathing) due to accidental exposure, Dsuvia is available only through a restricted program called the Dsuvia REMS Program.
  • Dsuvia must only be administered by a health care provider in a certified medically supervised health care setting.
  • The goal of the Dsuvia REMS is to lessen the risk of respiratory depression resulting from accidental exposure by ensuring that Dsuvia is dispensed only to eligible adult patients in certified, medically supervised health care settings.
  • Dsuvia is not available in retail pharmacy settings or dispensed directly to patients for use at home and should not be used for more than 72 hours. It is not for use in children.

What is a REMS?

  • A REMS is a drug safety program that may be required by the U.S. Food and Drug Administration (FDA) for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
  • A REMS may also be used to manage side effects that may be linked with certain high risk drugs and is required to ensure the benefits of the drug outweigh its hazards.
  • There are usually several required steps for any REMS, which can involve health care providers, patients, pharmacies, and wholesalers. Certification may be required.

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