Prescriber Roles & Responsibilities

Healthcare providers must complete the following steps in the Opsumit REMS Program:

1. Read the Opsumit Prescribing Information and the Prescriber and Pharmacy Guide for the Opsumit REMS Program to understand the risks of Opsumit, and to learn about the Opsumit REMS Program

  • Prescribers must understand the risks of Opsumit, and become familiar with the Opsumit REMS Program

2. Complete an Opsumit REMS Prescriber Enrollment and Agreement Form

  • By signing the form, you will attest to understanding the risks of Opsumit and agree to comply with the Opsumit REMS Program. You can download the Opsumit REMS Prescriber Enrollment and Agreement Form here and fax it to Actelion Pathways® at 1-866-279-0669. Actelion Pathways administers the Opsumit REMS Program

3. Determine the reproductive potential for female patients

  • Prescribers should identify female patients (captured on the Opsumit Patient Enrollment and Consent Form) as one of the following categories:
    1. Female of Reproductive Potential
      Or
    2. Female of Non-Reproductive Potential (choose one of the options below)
      • Pre-pubertal Female of Non-Reproductive Potential
      • Post-menopausal Female of Non-Reproductive Potential
      • Female with other medical reasons for permanent, irreversible infertility

Definitions are provided in the "Opsumit REMS Program Overview" section of the Prescriber and Pharmacy Guide for the Opsumit REMS Program.

4. Educate and counsel female patients about the risks of Opsumit

  • For all females, prescribers must:
    • Advise the patient that Opsumit is only available through a restricted distribution program called the Opsumit REMS Program
    • Educate and counsel patients about the risks of Opsumit
  • For Females of Reproductive Potential, prescribers must:
    • Review with her the Opsumit Medication Guide and the Opsumit REMS Guide for Females Who Can Get Pregnant
    • Educate her about
      • the risk of teratogenicity;
      • the need to use reliable contraception during Opsumit treatment and for one month following treatment discontinuation; and
      • her need to consider medical options in the event of unprotected sexual intercourse or known or suspected contraception failure.
    • Advise the patient of the requirement for initial and monthly pregnancy tests to confirm they are not pregnant, so they can begin and continue to receive Opsumit
    • Counsel her to immediately contact her healthcare provider if she misses a menstrual period or suspects she is pregnant
    • Counsel her that she must agree to be contacted prior to each shipment to confirm that the pregnancy tests have been completed

  • For Females of Non-Reproductive Potential
    • For a Post-menopausal Female or a female with other medical reasons for permanent, irreversible infertility, prescribers must:
    • For Pre-pubertal Females, prescribers must:
      • Review with her and her parent/guardian the Opsumit Medication Guide
      • Educate her and her parent/guardian about the risk of serious birth defects
      • Counsel her and her parent/guardian to immediately contact her healthcare provider if she gets her menstrual period
  • Prescribers must counsel any patient who fails to comply with the program requirements.

5. Enroll female patients into the Opsumit REMS Program by completing the Opsumit Patient Enrollment and Consent Form

  • Confirm patient has agreed to comply with program requirements and has signed the form where indicated
  • Fax the completed form to Actelion Pathways at 1-866-279-0669. Actelion Pathways administers the Opsumit REMS Program
  • Keep the original form with patient’s records

6. Check patients' pregnancy status (for Females of Reproductive Potential)

  • Order and review pregnancy tests for the patient:
    1. prior to initiating treatment
    2. monthly during treatment
    3. one (1) month after stopping treatment

7. Monitor patients throughout treatment

Prescriber and Pharmacy Guide for the Opsumit REMS Program

Opsumit REMS Prescriber Enrollment
and Agreement Form

Opsumit Patient Enrollment
and Consent Form

Opsumit REMS Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form



Reporting to Actelion
To report any pregnancies and suspected adverse reactions, contact Actelion at 1-866-228-3546.

Reporting to FDA MedWatch
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.