4 bis) Enter Addyi only after receiving the authorization by calling the REMS Assistance Centre to verify that the Addyi REMS program is certified. b) Advise patients to avoid drinking with Addyi before issuing. ii. Stationary pharmacies must: 1) In the Addyi REMS program, recertify whether the pharmacy appoints a new agent. 2) Addyi to be distributed only for hospital use, unless the pharmacy is registered in a mobile pharmacy and can meet the requirements of 2 (b) (i). v. Sprout Pharmaceuticals must: i. Make sure that pharmacies that deliver Addyi are specifically certified in accordance with the requirements described above. ii. iii iv. Ensure that pharmacies can complete certification and registration processes in the Addyi REMS program online, by fax or by phone.
Make sure pharmacies are notified if they have been certified by the Addyi REMS program. Check every 2 years to see if the agent`s name and contact information match that of the agent currently designated for the certified pharmacy. In this case, the pharmacy must again certify with a new agent. The following materials are part of the REMS and are attached to: Addyi REMS Program Multiple Location Pharmacy Enrollment Form Addyi REMS Program Individual Location Pharmaceutical Enrollment Form Addyi REMS Program Inpatient Pharmacy Enrollment Form Addyi REMS Program Prescriber and Pharmacy Training Addyi REMS Pro Knowledge Assessment B. System Implementation 1. Sprout Pharmaceuticals must ensure that Addyi is only distributed to pharmacies certified by: a. Ensure that wholesalers/distributors who distribute Addyi meet program requirements for wholesalers/distributors. Licensed wholesalers/distributors must: 3 Addyi REMS Prescription Program and Pharmacy Training The information presented in this training program does not contain a complete list of all risks and safety information about Addyi.
Before prescribing or administering Addyi, please read Addyi`s prescription information and Addyi`s medication guide for more information See also 3 12 Patients-Providers: Patients who take Addyi should understand the following: I understand that I cannot drink alcohol while taking Addyi (Flibanérine).