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 Actelion Pathways® 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 Program. 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 Program
  • Dispense to a female patient only after she has been enrolled in the Opsumit REMS Program 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 Actelion Pathways

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

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



Opsumit REMS Inpatient Pharmacy
Enrollment Form


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, 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


Opsumit Medication Guide


Prescriber and Pharmacy Guide for the Opsumit REMS Program


Opsumit REMS Guide for Females
Who Can Get Pregnant