Risk Evaluation and Mitigation Strategy (REMS)
FDA REQUIRED REMS SAFETY INFORMATION

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Addyi REMS Support Center 1-844-233-9415

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 inform prescribers, outpatient pharmacies, inpatient pharmacies, and patients about the increased risk of:

  • Hypotension and Syncope due to an interaction with alcohol
Addyi REMS Program Requirements
Prescribers
  • To be able to prescribe Addyi, prescribers must be trained, successfully complete a knowledge assessment, and enroll to be certified in the Addyi REMS program.
  • Before prescribing Addyi, prescribers must review and complete the Addyi REMS Patient-Provider Agreement Form with every patient.
Outpatient Pharmacies
  • To be able to dispense Addyi, the Authorized Representative of the outpatient pharmacy must be trained, successfully complete a knowledge assessment, and enroll their pharmacy to be certified in the Addyi REMS program.
  • To be able to dispense Addyi, outpatient pharmacies must train all relevant pharmacy staff involved in dispensing.
  • Before dispensing every prescription, pharmacies must counsel all patients on the need to avoid alcohol.
Inpatient Pharmacies
  • To be able to dispense Addyi, the Authorized Representative of the inpatient pharmacy must be trained, successfully complete a knowledge assessment, and enroll their pharmacy to be certified in the Addyi REMS program.
  • To be able to dispense Addyi, inpatient pharmacies must train all relevant pharmacy staff involved in dispensing.
  • Inpatient Pharmacies must not dispense Addyi for outpatient use.
Click on the appropriate button below to complete the certification process in 3 easy steps.
PRESCRIBERS

Click Here to Start the Addyi REMS Program Prescriber and Pharmacy Training

PHARMACIES

Click Here to Start the Addyi REMS Program Prescriber and Pharmacy Training

Indication:

Addyi is indicated for the treatment of premenopausal women with 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 postmenopausal women or in men.
  • Addyi is not indicated to enhance sexual performance.
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