Pharmacy Certification

Due to the risk of serious birth defects, Opsumit is only available through a network of certified pharmacies. For information on Opsumit certified pharmacies or wholesale distributors, please call Opsumit REMS at 1-866-228-3546.

Outpatient Pharmacy Certification

Opsumit will be dispensed to outpatients by a limited number of certified pharmacies. Prior to dispensing Opsumit the pharmacy will confirm that the prescriber who wrote the prescription is enrolled, and if the patient is a female that she is enrolled in the Opsumit REMS. If either the female or prescriber is not enrolled, Opsumit will not be dispensed.

For Females of Reproductive Potential, pharmacies will:

  • Ask the patient if she has had a pregnancy test within the last month
  • Counsel her on the need to use reliable contraception during Opsumit treatment and for one month after stopping treatment
  • Counsel her to inform her prescriber immediately if she misses a menstrual period or suspects that she may be pregnant or if her reproductive status changes

For Pre-pubertal Females, pharmacies will:

  • Counsel her to inform her healthcare provider immediately if her reproductive status changes

Females of Reproductive Potential and Pre-pubertal Females will only be able to get a 30-day supply of Opsumit at one time. The Opsumit Medication Guide  will be provided to all patients each time Opsumit is dispensed.

Inpatient Pharmacy Certification

This inpatient pharmacy will:

  • Dispense only to those patients under the supervision and care of a healthcare provider who is enrolled in the Opsumit REMS
  • Dispense to a female patient only after she has been enrolled in the Opsumit REMS or if she will be enrolled prior to discharge from this healthcare facility. A female who has not been enrolled by the certified prescriber will not have access to Opsumit in the outpatient setting until such time that registration has been completed
  • Dispense no more than a fifteen (15) day temporary supply of Opsumit upon discharge of any patient
  • Not transfer Opsumit to any pharmacy, practitioner, or healthcare setting not certified by Opsumit REMS

To be certified in the Opsumit REMS, an authorized representative of the inpatient pharmacy must:

  • Read the Opsumit Prescribing Information and Prescriber and Pharmacy Guide.
  • Put processes and procedures in place to ensure the Opsumit REMS requirements are met
  • Ensure training of dispensing staff on the Opsumit REMS procedures and materials, including the Prescriber and Pharmacy Guide prior to dispensing Opsumit
  • Enroll in the Opsumit REMS if the inpatient pharmacy designates a new authorized representative by completing, signing, and submitting a new Inpatient Pharmacy Enrollment Form as soon as the designated authorized representative changes.
  • Notify Opsumit REMS or FDA if any patient becomes pregnant during Opsumit treatment
  • Develop a process to track compliance with the conditions above and provide information about its compliance to Opsumit REMS
  • Agree that this pharmacy may be subject to an audit by the FDA, Actelion, or a designated third party
  • Agree to follow the REMS requirements by completing and submitting an Inpatient Pharmacy Enrollment Form to the Opsumit REMS

If an inpatient pharmacy needs Opsumit and is not enrolled in the Opsumit REMS, the inpatient pharmacy can contact Opsumit REMS at 1-866-228-3546 for assistance in obtaining a 15-day supply of Opsumit for a specific inpatient while initiating enrollment.

Inpatient Pharmacy Enrollment Form

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1-800-FDA-1088.

To learn more about the serious risks associated with Opsumit, please refer to the resources below.

Opsumit Prescribing Information

Prescriber and Pharmacy Guide

Guide for Female Patients