Prescriber Roles & Responsibilities

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

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

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

2. Complete a Prescriber Enrollment and Agreement Form

  • You can download the Prescriber Enrollment and Agreement Form here and fax it to Actelion Pathways® at 1-866-279-0669 or you may enroll by calling Actelion Pathways at 1-866-228-3546. Actelion Pathways administers the Opsumit REMS. After providing your enrollment by phone, you will receive a pre-populated form by fax to sign and fax to 1-866-279-0669
  • By signing the form, you will attest to understanding the risks of Opsumit and agree to comply with the Opsumit REMS.

3. Determine the reproductive potential for female patients

  • Prescribers should identify female patients (captured on the Patient Enrollment and Consent Form) as one of the following categories:
    1. Female of Reproductive Potential
      • Females of reproductive potential include girls who have entered puberty and all females who have a uterus and have not passed through menopause (as defined in the Prescriber and Pharmacy Guide)
      • For the purposes of this REMS, puberty includes those girls who are at least Tanner Stage 3 and have not yet had a menses (premenarchal)
      • For the purposes of this REMS, females who have undergone tubal sterilization are classified as females 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 Overview” section of the Prescriber and Pharmacy Guide.

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
    • Educate and counsel patients about the risks of Opsumit
  • For Females of Reproductive Potential, prescribers must:
    • Review with her the Guide for Female Patients
    • Educate her about
      • the risk of embryo-fetal toxicity;
      • 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 provide the Guide for Female Patients and instruct her to read it.
    • For Pre-pubertal Females, prescribers must:
      • Review with her and her parent/guardian the Guide for Female Patients
      • 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 by completing the Patient Enrollment and Consent Form via one of three options below:

  • Enroll a patient online (see below)
    • Confirm patient has agreed to comply with program requirements and has signed the form where indicated
    • Patients can sign electronically at the time of enrollment by typing their name into the signature box, or signing with their finger or stylus on touchscreen devices. Patients can also provide their email address to provide an electronic signature later.
    • Click the button below and complete the enrollment form
    • Print the form and keep it with the patient's records
  • Enroll a patient by fax using the printed form
    • Download the Patient Enrollment and Consent Form from this website
    • 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
    • Keep the original form with the patient's records
  • Enroll a patient by calling Actelion Pathways at 1-866-228-3546
    • Confirm patient has agreed to comply with program requirements and provided their verbal consent by calling Actelion Pathways at 1-866-228-3546
    • Sign the pre-populated form faxed by Actelion Pathways and fax the signed and completed form to Actelion Pathways at 1-866-279-0669
    • Keep the signed form with the patient's records

Enrollment for VA patients can only be done by faxing a completed and signed Patient Enrollment and Consent Form - for VA use only. Enrollment by phone and online enrollment are not available for VA patients.

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

  • For Females of Reproductive Potential, prescribers must:
    1. Order and review pregnancy tests monthly during treatment with Opsumit and for one month after stopping treatment
    2. Notify the patient and Actelion if a patient's pregnancy test is positive
    3. Monitor patients' reproductive status during treatment with Opsumit and report any changes or misclassifications to the Opsumit REMS by completing and submitting a Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form or contacting Actelion Pathways at 1-866-228-3546 within 10 business days of becoming aware of the change.
  • For Females of Non-Reproductive Potential, prescribers must:
    1. Monitor patients' reproductive status during treatment with Opsumit and report any changes or misclassifications to the Opsumit REMS by completing and submitting the Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form or by contacting Actelion Pathways at 1-866-228-3546 within 10 business days of becoming aware of the change
    2. For each Pre-pubertal Female who is at least 8 years of age and older, annually verify and report the reproductive status by completing and submitting the Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form or by contacting Actelion Pathways at 1-866-228-3546

Click here to electronically enroll
a patient in the Opsumit REMS

Prescriber and Pharmacy Guide

Prescriber Enrollment and Agreement Form

Patient Enrollment and Consent Form

Patient Enrollment and Consent
Form - for VA use only

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.