Approved Risk Evaluation and Mitigation Strategies (REMS)

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Adempas (riociguat)
NDA #204819
REMS last update: 01/17/2017



What is the purpose of the REMS?

The goals of the Adempas REMS are:

  1. To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Adempas.
  2. To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Adempas.
    1. Females who are pregnant must not be prescribed Adempas.
    2. Females taking Adempas must not become pregnant.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Adempas must

To become certified to prescribe
  • Be able to determine whether a female is of reproductive potential as defined in the Prescriber and Pharmacy Guide for the Adempas REMS program.
    | Prescriber and Pharmacy Guide |
  • Review the drug’s prescribing information.
  • Review the following educational materials: Prescriber and Pharmacy Guide for the Adempas REMS program and Medication Guide.
    | Prescriber and Pharmacy Guide |
  • Enroll in the REMS by completing the Prescriber Enrollment and Agreement and submitting it to the REMS program.
    | Prescriber Enrollment and Agreement Form |
Before the first prescription
  • For a female: counsel the patient that drug is only available through a restricted distribution program.
  • For a Female of Reproductive Potential (FRP): counsel the patient on the risk of teratogenicity, the need to use reliable contraception during treatment and for one month following treatment discontinuation, and her medical options in the event of unprotected sexual intercourse or known or suspected contraception failure using the Guide for Females Who Can Get Pregnant and Medication Guide.
    | Guide for Females Who Can Get Pregnant |
  • For a FRP: counsel the patient to immediately contact her prescriber if the patient misses her period or suspects a pregnancy.
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
  • For a Pre-Pubertal Female of Non-Reproductive Potential (FNRP): counsel the patient and/or patient guardian on the risk of teratogenicity using the Medication Guide.
  • For a FNRP: counsel the patient and/or patient guardian to immediately contact their prescriber if the patient begins to menstruate.
  • For all females: enroll the patient by completing and submitting the Patient Enrollment and Consent Form to the REMS program.
    | Patient Enrollment and Consent Form |
Before each prescription after the first prescription
  • For a FRP not complying with required testing: counsel the patient on testing requirements and appropriate contraception.
Monthly during treatment
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
At least annually during treatment
One month after treatment discontinuation
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
At all times

Females of Reproductive Potential (FRP) Patients who are prescribed Adempas

Before the first prescription
  • Review the education materials for patients: Guide for Females Who Can Get Pregnant and Medication Guide.
    | Guide for Females Who Can Get Pregnant |
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with the prescriber.
    | Patient Enrollment and Consent Form |
  • Get a pregnancy test.
  • Receive counseling from the prescriber on the requirements of the REMS program and risk of serious birth defects.
During treatment
  • For females who can get pregnant: Use contraception as described in the Guide for Females Who Can Get Pregnant.
Monthly during treatment
  • Get a pregnancy test.
  • Receive counseling from the pharmacy on the need to use reliable contraception during treatment and for one month after stopping treatment.
One month after discontinuing
  • Get a pregnancy test.
At all times
  • Immediately, inform the prescriber if the patient misses her period or suspects a pregnancy.

Pre-pubertal Females of Non-Reproductive Potential (FRNP) Patients and/or Patient Guardian who are prescribed Adempas

Before the first prescription
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with the prescriber.
    | Patient Enrollment and Consent Form |
  • Receive counseling from the prescriber on the risk of teratogenicity using the Medication Guide.
At least annually during treatment
  • If 8 years or older, get evaluated for a change in reproductive status.
At all times
  • Inform the prescriber if the patient begins to menstruate.

Post-Menopausal Pre-pubertal Females of Non-Reproductive Potential (FNRP) Patients and Female Patients with other medical reason for permanent, irreversible infertility who are prescribed Adempas

Before the first prescription

Outpatient pharmacies that dispense Adempas must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the outpatient pharmacy.
  • Train all relevant staff involved in dispensing on the REMS program procedures and REMS materials.
  • Establish processes and procedures to verify that patient and prescriber enrollment forms are only received from the REMS program, prescriber is enrolled, and patient is enrolled.
Before dispensing
  • For a female of reproductive potential (FRP): counsel the patient on the risk of serious birth defects and the need to use reliable contraception during treatment and for one month after stopping treatment.
  • For a FRP: counsel the patient on the need to complete a monthly pregnancy test and to inform her prescriber immediately if she suspects a pregnancy.
  • For a FRP: verify that the pregnancy test was completed by asking the patient. If the patient is unable to confirm, then ask the prescriber. If both the patient and prescriber are unable to confirm, then ask the prescriber to authorize a refill and remind the prescriber of obligation to order and review a monthly pregnancy test.
  • Obtain authorization to dispense by contacting the REMS coordinating center.
  • Dispense no more than a thirty days’ supply.
At all times
  • Report any reports of pregnancy to the Manufacturer.
  • Do not distribute, transfer, loan, or sell product, except to certified dispensers.
  • Maintain records of dispensing data for all enrolled patients.
  • Cooperate with audits carried out by the REMS program to ensure that all processes and procedures are in place and are being followed.

Inpatient pharmacies that dispense Adempas must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the inpatient pharmacy.
  • Have the authorized representative review the drug’s prescribing information.
  • Have the authorized representative review the educational materials for dispensers, including: Prescriber and Pharmacy Guide for the Adempas REMS program and Medication Guide.
    | Prescriber and Pharmacy Guide |
  • Train all relevant staff involved in dispensing on REMS program requirements and REMS materials.
  • Establish processes and procedures to verify the patient is under the supervision and care of a healthcare provider who is enrolled and a female patient is enrolled or will be enrolled prior to discharge.
  • Have the authorized representative enroll in the REMS by completing the Inpatient Pharmacy Enrollment Form.
    | Inpatient Pharmacy Enrollment Form |
Before dispensing
  • Obtain authorization to dispense by contacting the REMS Program Coordinating Center.
Upon discharge
  • Dispense no more than a fifteen days’ supply.
At all times
  • Report any reports of pregnancy to the Manufacturer.
  • Do not distribute, transfer, loan, or sell product, except to certified dispensers.
  • Maintain records of compliance with REMS requirements.
  • Cooperate with audits carried out by the REMS program to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Adempas REMS, see the DailyMed link(s).
Material Name Material Name Link
Change in Reproductive Potential Status and Prepubertal Annual Verification Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Change_in_Reproductive_Potential_Status_and_Pre_pubertal_Annual_Verification_Form.pdf
Guide for Females Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Guide_for_Females_Who_Can_Get_Pregnant.pdf
Inpatient Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Inpatient_Pharmacy_Enrollment_Form.pdf
Patient Enrollment and Consent Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Patient_Enrollment_and_Consent_Form.pdf
Prescriber and Pharmacy Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Prescriber_and_Pharmacy_Guide.pdf
Prescriber Enrollment and Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Prescriber_Enrollment_and_Agreement_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2017-01-17_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
01/17/2017 Modified to include information regarding idiopathic hypertension and switching from a PDE5 inhibitor to Adempas and vice versa in the Medication Guide.
10/04/2016 Modified to:

  1. Remove non-REMS related information from the Adempas REMS Patient Enrollment and Consent Form eliminate the VA REMS Patient Enrollment and Consent Form
  2. Add the word “REMS” to the title of the following forms: Adempas REMS Patient Enrollment and Consent Form and Adempas REMS Patient Enrollment and Consent Form
12/04/2015 Modified to:

  1. Modify a statement to ensure all certified outpatient pharmacies are audited within 180 days after they are certified in the Adempas REMS program in the REMS document.
  2. Make changes to clarify the roles and responsibilities of the inpatient and outpatient pharmacy authorized representatives in the REMS document.
  3. Change the title to “Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form from the Reproductive Potential Status Form.
  4. Add a field (Reason for change in classification) to capture reasons for previous misclassification of reproductive status in the Reproductive Potential Status Form.
  5. Add a new female of non-reproductive potential subcategory (“Other medical reasons for permanent, irreversible infertility”) and update all relevant sections of the REMS document and related forms to reflect this change.
06/11/2014 Modified to:

  1. Update the REMS website to include links to Spanish versions of the Medication Guide and the REMS Guide for Females Who Can Get Pregnant.
  2. Make a logo change to add tablet dose availability just below the words “Adempas” and “riociguat tablets”.
  3. Update the REMS website so that when one clicks on the Patient Information Tab, the important safety information (ISI) for the patient appears.
  4. Make administrative changes to the Veteran’s Administration (VA) Adempas Patient Enrollment and Consent Form.
10/08/2013 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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