Adempas medication guide

ADEMPAS is restricted to cardiologists, pulmonologists, or critical care physicians enrolled in the REMS program for therapy initiation.

Inpatients on maintenance therapy will be continued on the drug. Patient may use own supply in the hospital. Defer initiation to after discharge: Initiation for Group 1 patients should be deferred to the outpatient setting. For Group 4 patients, initiation in the hospital is allowed to ensure expedited delivery of drug to patient's home and a smooth transition to the outpatient setting. This drug should not be used for PH Groups 2 and 3 patients.

An overview of the REMS program can be found at https://www.adempasrems.com/#MainContent  (HH Pharmacy is registered with the REMS program).

Before dispensing/verifying first dose of a new start:    Confirm the prescriber is authorized to order riociguat by calling Adempas REMS (1-855-423-3672).  Hours are 7a-7p M-F.  If not authorized, do not verify the order and inform the prescriber they must enroll in the REMS program as an authorized prescriber, or consult an authorized prescriber.  If after hours, the MD will have to provide documentation they are an authorized prescriber or verification will have to wait until the REMS program reopens.

Before dispensing/verifying first dose of a continuance of home med:

1. If female, confirm the patient is enrolled in the REMS program by calling Adempas REMS (1-855-423-3672).  Hours are 7a-7p M-F.  If after hours, the patient may take their home med supply if ok with MD.  Do not dispense HH supply until REMS reopens and confirmation of enrollment can be done.  If patient takes own supply, still confirm enrollment in REMS when REMS reopens.  Create an open intervention until enrollment confirmed.
2. For males, no confirmation necessary.
3. The prescriber continuing the outpatient medication does NOT need to be an authorized prescriber with the REMS program.
4. Complete a ‘Pharmacy Progress Note – REMS’ in Cerner.   This is a record of pharmacy meeting or working on meeting the requirements of the REMS program.  REMS programs do audit inpatient pharmacies for compliance with meeting REMS requirements.

For New Start:

1. For females of reproductive potential, contact the prescriber and confirm reproductive risk counseling has been completed.  This MUST be done prior to dispensing.
2. Confirm prescriber is authorized to order riociguat (see above)
3. Verify the patient’s pregnancy status as negative or not-applicable (N/A).
4. If female, confirm with the prescriber the patient has been enrolled in the REMS program OR will be enrolled prior to discharge.  If the patient is not yet enrolled but will be prior to discharge, create an ongoing Active Intervention and close it out once the patient is enrolled. Males do not need to be enrolled.
5. Complete a ‘Pharmacy Progress Note – REMS’ in Cerner.  The progress note is pre-populated.  This is a record of pharmacy meeting or working on meeting the requirements of the REMS program.  REMS programs do audit inpatient pharmacies for compliance with meeting REMS requirements.
6. Patient Consent Forms and Patient Support Forms can be found on the REMS website.  RPhs may assist the MD by retrieving these forms if desired but it is not the responsibility of pharmacy to complete this form. 

Reviewed: 24 February 2015 (Adempas)

Updated: July 2020 (Adempas)

REMS (Adempas): View FDA REMS Info

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