Addyi Risk Evaluation and Mitigation Strategy (REMS)

What is the Addyi REMS Program?

A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure the benefits of a drug outweigh its risks. The purpose of the Addyi REMS Program is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol when taken together close in time.

BOXED WARNING: Hypotension and Syncope Due to an Interaction with Alcohol

  • Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope.
  • Counsel patients to wait at least two hours after consuming alcohol before taking ADDYI at bedtime.
  • Alternatively, counsel patients to skip the ADDYI dose at bedtime if the patient consumes alcohol in the evening.
  • After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.

More Information

For detailed information regarding Addyi, it is essential that you read the full Prescribing Information for Addyi.

Indication

Addyi is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

  • A co-existing medical or psychiatric condition,
  • Problems within the relationship, or
  • The effects of a medication or other drug substance.

Limitations of Use

  • Addyi is not indicated for the treatment of HSDD in post-menopausal women or in men.
  • Addyi is not indicated to enhance sexual performance.

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