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Conditions: HSDD

Addyi: Information for Healthcare Providers

 

What is the risk evaluation and mitigation strategy (REMS)?

Sprout Pharmaceuticals, the manufacturer of Addyi, will oversee a risk evaluation and mitigation strategy (REMS) as required by the FDA.

Under the terms of the REMS, healthcare providers must be trained and certified to prescribe Addyi. They must also explain the risks of syncope and hypotension with patients and warn patients about interactions with alcohol. Further, they must be confident that a patient will abstain from alcohol during treatment.

Sprout Pharmaceuticals has prepared a Patient-Provider Agreement to be signed by both parties. This agreement includes a tear-off section for patients to take home, explaining the risks of alcohol use during Addyi treatment and giving instructions for dosing and for handling lightheadedness, dizziness, and fainting.

In addition, pharmacies must be trained and certified to dispense Addyi. Pharmacists may only fill prescriptions written by certified clinicians. They must also counsel patients on the use of Addyi, stressing the importance of avoiding alcohol while taking the drug. (Pharmacists may also use the Patient-Provider Agreement for counseling purposes.)

What is the REMS training and certification process?

 

Providers may access an enrollment form, training materials, a knowledge assessment form, and the Patient-Provider Agreement at this FDA website.


Print this article or view it as a PDF file here: Addyi: Information for Healthcare Providers


Resources

FDA.gov

“Addyi - Risk Evaluation and Mitigation Strategy (REMS)”

(August 2015)

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526REMS.pdf

International Society for Sexual Medicine

“Flibanserin approved as the 1st pharmacologic treatment option for women suffering from HSDD”

(August 18, 2015)

http://www.issm.info/news/flibanserin-approved-as-the-1st-pharmacologic-treatment-option-for-women-su

“What is flibanserin and how does it work?”

http://www.issm.info/education-for-all/sexual-health-qa/what-is-flibanserin-and-how-does-it-work/

Medicine.net

“Definition of syncope”

(Last editorial review: August 28, 2013)

http://www.medicinenet.com/script/main/art.asp?articlekey=5612

NPR

Stein, Rob

“FDA Approves First Drug To Boost Women's Sexual Desire”

(August 18, 2015)

http://www.npr.org/sections/health-shots/2015/08/18/432704214/addyi-fda-approves-drug-to-boost-womens-desire

Sprout Pharmaceuticals

“Sprout Pharmaceuticals Receives FDA Approval of ADDYI™ (Flibanserin 100 MG)”

(Press release. August 18, 2015)

http://www.sproutpharma.com/sprout-pharmaceuticals-receives-fda-approval-addyi-flibanserin-100-mg/

U.S. Food and Drug Administration

“FDA approves first treatment for sexual desire disorder”

(News release. August 18, 2015)

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm

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