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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