Prescriber Resources - PS-Pomalidomide REMS

Key Points for Prescribers

The prescriber enrolls and becomes certified with PS-Pomalidomide REMS
The prescriber counsels patient on benefits and risks of pomalidomide
The prescriber provides contraception and emergency contraception counseling
The prescriber verifies negative pregnancy test for all female patients of reproductive potential
The prescriber completes a PS-Pomalidomide REMS Patient-Physician Agreement Form with each patient and sends to PS-Pomalidomide REMS
The prescriber/patient completes applicable mandatory confidential survey
The prescriber obtains an authorization number from PS-Pomalidomide REMS and writes it on every prescription, along with the patient risk category
The prescriber writes no more than a 4-week (28-day) supply, with no automatic refills or telephone prescriptions
The prescriber sends pomalidomide prescription to certified pharmacy

Enrolling in PS-Pomalidomide REMS

In order to prescribe pomalidomide, you must enroll in PS-Pomalidomide REMS. You can enroll by visiting BMS REMS Patient Safety, a website that allows prescribers to handle the REMS process for all of the REMS programs. You can also download the Prescriber Enrollment Form below and fax it to PS-Pomalidomide REMS at 1-888-432-9325.

Prescriber Enrollment Form

Prescribing pomalidomide for your patients

In order to receive pomalidomide, your patients must also be enrolled in PS-Pomalidomide REMS. You can enroll your patients and fill out a prescription form using BMS REMS Patient Safety. You and your patients can also complete your mandatory confidential surveys there.

Enroll Your Patients at
BMS REMS Patient Safety Patient Prescription Form

Remind your patients to download the REMS Companion App on their smartphones

The REMS Companion App lets your patients complete their mandatory surveys on their smartphone.

They can also get reminders when it’s time to complete the surveys by allowing notifications in the app.

Learning more about PS-Pomalidomide REMS

For additional information about PS-Pomalidomide REMS, please see the educational materials below.

Prescriber Guide to
PS-Pomalidomide REMS PS-Pomalidomide REMS
At-A-Glance Prescribing Information

REPORTING TO PS-Pomalidomide REMS

Please report any suspected pregnancy occurring during the treatment with pomalidomide to PS-Pomalidomide REMS using any of the following methods:

Email:

Worldwide.safety@bms.com

Toll-free:

1-888-423-5436 (REMS Call Center)

REPORTING TO THE FDA

Adverse drug experiences that are suspected to be associated with the use of pomalidomide and any suspected pregnancy occurring during the treatment with pomalidomide may also be reported to the FDA MedWatch Reporting System using any of the following methods:

Online:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Telephone:

1-800-FDA-1088

Mail to:

MedWatch
5600 Fishers Lane
Rockville, MD 20852-9787