Approved Risk Evaluation and Mitigation Strategies (REMS)

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Adempas (riociguat)
NDA #204819
REMS last update: 12/04/2015

View the Adempas Prescribing Information and Medication Guide at DailyMed.
View Adempas's Regulatory Information at Drugs@FDA

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 each female is of reproductive potential using the Prescriber and Pharmacy Guide for the Adempas REMS program.
  • Review the drug’s prescribing information and Medication Guide.
  • Review the following: Prescriber and Pharmacy Guide for Adempas REMS Program.
  • Enroll in the REMS by completing the Adempas REMS Prescriber Enrollment and Agreement Form and submitting to the REMS Coordinating Center.
Before treatment initiation
  • For a female: counsel the patient that Adempas is only available through a restricted distribution program.
  • For a female: enroll the patient by completing the Patient Enrollment and Consent Form and submitting to the REMS Coordinating Center.
  • For a female of reproductive potential (FRP): counsel the patient about the risk of teratogenicity, the need to use reliable contraception during Adempas 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.
  • For a FRP: counsel patient to immediately contact her healthcare provider if she misses a menstrual period or suspects that she is pregnant.
  • For a FRP: provide the patient with the Medication Guide and the Adempas REMS Program Guide for Females Who Can Get Pregnant.
  • 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 a parent/guardian about the risk of teratogenicity and to immediately contact her healthcare provider if she begins to menstruate.
  • For a pre-pubertal FNRP: provide the patient and/or a parent/guardian with a Medication Guide.
During treatment; before each prescription
  • For a female: assess the patient’s reproductive status. Document any changes or misclassification in reproductive status by completing the Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form and submitting to the REMS Coordinating Center within ten (10) business days of becoming aware of the change.
  • For a FRP: counsel patient to immediately contact her healthcare provider if she misses a menstrual period or suspects that she is pregnant.
  • For a FRP not complying with required testing or not using appropriate contraception: counsel the patient about the risk of teratogenicity, the need to use reliable contraception during Adempas 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.
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
  • For a pre-pubertal FNRP: counsel the patient and/or a parent/guardian to immediately contact her healthcare provider if she begins to menstruate.
During treatment; annually
  • For a pre-pubertal FNRP age 8 or older: assess the patient’s reproductive status. Document the results using the Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form and submit to the REMS Coordinating Center.
At one month after treatment discontinuation
  • For a FRP: assess the patient’s pregnancy status byordering and reviewing a pregnancy test.
At all times
  • Report as soon as possible any pregnancies during Adempas treatment to Bayer.

Female of reproductive potential who are prescribed Ademas

Before the first prescription
  • Review the Adempas REMS Program Guide for Females Who Can Get Pregnant and Medication Guide.
  • Enroll in the REMS by completing the Adempas Patient Enrollment and Consent Form with the prescriber. Enrollment information will be provided to the REMS Program.
  • Get a pregnancy test.
  • Receive counseling from the prescriber on risks of Adempas, including the risk of serious birth defects.
During treatment; before each prescription
  • Get a pregnancy test.
During treatment
  • Adhere to the safe use conditions, including using contraception described in the Adempas REMS Program Guide for Females Who Can Get Pregnant.
Monthly during treatment
  • Get a pregnancy test
At one month after treatment discontinuation
  • Get a pregnancy test.
At all times
  • Inform the prescriber if she misses a menstrual period or suspects that she is pregnant.

Pre-pubertal female of non-reproductive potential who are prescribed Adempas, and/or their parent/guardian

Before the first prescription
  • Review the Medication Guide.
  • Enroll in the REMS by completing the Adempas Patient Enrollment and Consent Form with the prescriber. Enrollment information will be provided to the REMS Coordinating Center.
  • Receive counseling from the prescriber on risks of Adempas, including the risk of serious birth defects.
At all times
  • Inform the prescriber immediately if she begins to menstruate.

Post-menopausal female of non-reproductive potential or female with other medical reason for permanent, irreversible infertility who are prescribed Adempas

Before the first prescription
  • Enroll in the REMS by completing the Adempas Patient Enrollment and Consent Form with the prescriber. Enrollment information will be provided to the REMS Coordinating Center.
At all times
  • Inform the prescriber of a change or misclassification in reproductive status.

Inpatient pharmacies (including, but not limited to, inpatient pharmacies in hospitals, long-term care facilities, prisons) that dispense Adempas must

To become certified to dispense
  • Train all relevant staff involved in dispensing on the Adempas REMS Program requirements and REMS materials prior to dispensing Adempas.
  • Establish processes and procedures to verify the REMS requirements are met.
  • Designate an authorized representative to carry out the certification process on behalf of the inpatient pharmacy.
  • Have the authorized representative review the Full Prescribing Information, Medication Guide, and Prescriber and Pharmacy Guide for the Adempas REMS Program.
  • Have the authorized representative enroll in the REMS by completing by completing the Inpatient Pharmacy Enrollment Form.
Before dispensing
  • Obtain authorization to dispense by contacting the REMS Program Coordinating Center.
  • Do not dispense refills.
Upon discharge
  • Dispense no more than a 15 days’ supply.
At all times
  • Report as soon as possible any pregnancies associated with the use of Adempas to Bayer.
  • Return unused product to the manufacturer.
  • Do not distribute, transfer, loan, or sell Adempas, except to certified dispensers.
  • Maintain records to track compliance with the REMS program requirements.
  • Comply with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Outpatient pharmacies that dispense Adempas must

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 Adempas treatment and for one month after stopping Adempas treatment using the Prescriber and Pharmacy Guide to the Adempas Program.
  • For a FRP: counsel the patient of the requirement to complete a pregnancy test every month and to inform her prescriber immediately is she misses a menstrual period or suspects that she may be pregnant.
  • For a FRP: verify the completion of a monthly pregnancy test by asking the patient. If unable to obtain confirmation from the patient then remind the prescriber of his or her obligation and ask the prescriber to authorize a refill for Adempas.
  • Obtain authorization to dispense each prescription by processing the prescription through the pharmacy management system.
  • Dispense no more than a 30 days’ supply.
At all times
  • Report as soon as possible any pregnancies associated with the use of Adempas to Bayer.
  • Return unused product to the manufacturer.
  • Do not distribute, transfer, loan, or sell Adempas.
  • Maintain records of dispensing data for all enrolled patients to the Adempas REMS Program.
  • Comply with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.
To become certified to dispense
  • Train all relevant staff involved in dispensing on the REMS Program and materials.
  • Establish processes and procedures to verify the REMS requirements are met.
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.

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:


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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