Formulary, restricted to cardiologist, pulmonologists, rheumatologists and critical care prescribers enrolled in the REMS program.

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Before dispensing/verifying:  

New Start (Female): 

•  Confirm the prescriber is authorized to order macitentan by calling Macitentan REMS (1-888-572-2934).  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.  Macitentan REMS hours are Mon-Fri 7a - 7p Central Standard time.  If Macitentan REMS is closed, you may call the prescribing physician and ask if they are an authorized prescriber and they should have a prescriber #.  If they do not have this number, no dispensing can occur until they come up with the number or Macitentan REMS reopens.  There is no on-line portal for general use.
• For females of reproductive potential (definition of 'reproductive potential' can be found on the Macitentan REMS website), if the patient is enrolled in the REMS program then you know reproductive counseling has been done.  If the patient is in the process of being enrolled, contact the prescriber and confirm reproductive risk counseling has been completed.  This MUST be done prior to dispensing.
• Verify the patient’s pregnancy status as negative or not-applicable (N/A).  RPhs are authorized to order a pregnancy test (blood or urine).
• Confirm with the REMS program the patient has been enrolled OR confirm with the prescriber the patient 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.
• If the MD needs assistance enrolling the patient, the Patient Enrollment Form can be found in the REMS website   It is not the responsibility of pharmacy to complete this form.  Pharmacy may print the form and deliver to the RN for the MD to complete.

Continuance of Home Med (Female):

• Confirm the patient is enrolled in the REMS program by calling Macitentan REMS (1-888-572-2934).  Hours are Mon-Fri 7a - 7p Central Standard time.  If Macitentan REMS is closed, do not dispense, create an Open Intervention and call back when they reopen.  There is no on-line portal for general use.
• Verify the patient’s pregnancy status as negative or not-applicable (N/A).  A definition of 'reproductive potential' can be found on the REMS website.  RPhs are authorized to order a pregnancy test (blood or urine).
• Any physician may continue a home med macitentan i.e. they do not need to be an authorized prescriber.

New Start (Male):

• Confirm the prescriber is authorized to order macitentan by calling Macitentan REMS (1-888-572-2934).  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.  Macitentan REMS hours are Mon-Fri 7a - 7p Central Standard time.  If REMS is closed, you may call the prescribing physician and ask if they are an authorized prescriber and they should have a prescriber #.  If they do not have this number, no dispensing can occur until they come up with the number or Macitentan REMS reopens.  There is no on-line portal for general use
• Males do not need to be enrolled in the REMS program

Continuance of Home Med (Male):

• Any prescriber may continue a home med macitentan i.e. the prescriber continuing the home med does not need to be an authorized prescriber
• Males do not need to be enrolled in the REMS program
• Basically treat a continuance like you would any other home med

For all patients (male or female)

1. Complete a ‘Pharmacy Progress Note – REMS’ in Cerner.  The progress note is pre-populated.  Once all conditions are met, simply sign off the note.  Note that a Dispense Authorization Number is NOT required for inpatient pharmacies for any of the endothelin receptor antagonists.  The progress note is a record of pharmacy meeting our requirements for the REMS program.  REMS programs do audit inpatient pharmacies for compliance with meeting REMS requirements.  Even if it is a continuance of a male patients home med, complete a progress note so we know the patient was screened.

For Formulary Substitution from Ambrisentan or Bosentan to Macitentan:

1. Patients may take their home ambrisentan or bosentan if home supply is available.  If female, contact the respective REMS program to verify enrollment.  Ambrisentan (1-888-417-3172), Bosentan (1-866-359-2612).  See FormWeb for each respective drug for a complete listing of all requirements prior to dispensing.
2. If the patient is formulary-subbed from outpatient ambrisentan or bosentan to inpatient macitentan, verify patient is enrolled in their respective REMS (ambrisentan or bosentan). 
3. For short-term substitution while an inpatient, the patient does NOT need to be enrolled in the macitentan REMS. 
4. The prescriber continuing the outpatient medication does NOT need to be an authorized prescriber with the REMS program.

Reviewed: November 18, 2014 (Opsumit)

Updated: June 2020

REMS (Opsumit): View FDA REMS Info

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