Letairis medication guide

Non-Formulary.  Automatic interchange.

For Formulary Substitution from ambrisentan to macitentan:

1. If a FEMALE patient was on ambrisentan as an outpatient and auto-subbed to macitentan as an inpatient, verify patient enrolled in the ambrisentan REMS prior to dispensing (see below for details). 
2. For short-term substitution while an inpatient, the patient does NOT need to be enrolled in the macitentan REMS.  The respective REMS programs are very similar, therefore enrollment into the macitentan program is not necessary for short-term substitution.  If the physician decides to make a permanent change over to macitentan, the enrollment process into the Macitentan REMS program should be initiated prior to discharge.
3. The prescriber continuing the outpatient medication does NOT need to be an authorized prescriber with the REMS program.

Pharmacy requirements for the Ambrisentan REMS program vary depending on the gender of the patient and whether the drug is a New Start or a Continuation of Home Med.  See below for details.

The Ambrisentan REMS program can be contacted at 1-888-417-3172, and is open Mon-Fri 7a - 7p Central Standard Time.  No username or password is required for the phone call.  The HH Pharmacy NPI # is 1447221056 and the HH Pharmacy REMS ID # is 20457.  They will ask for one of these numbers.  If it is after 7p and the REMS will reopen the next morning, reject the order and create an open intervention with instructions to call the next morning.  If it is the weekend, contact a member of the NSS/PKS weekend team or create an open intervention to have a member of the NSS/PKS weekend team use the on-line portal asap.  The on-line portal requires a username/password which someone on the NSS/PKS weekend team should have. 

Before dispensing/verifying first dose:

• For Female, New Start: Contact the REMS program and verify the prescriber is authorized to prescribe ambrisentan.  Do not dispense without first verifying the prescriber is authorized.  Determine pregnancy status.  Pharmacist may order a pregnancy test (blood or urine) if necessary.  Patient must be negative.   Female patients, regardless of age/reproductive potential, must be enrolled into the REMS program, but dispensing can occur as long as the enrollment process is started prior to discharge.   Patient Enrollment and Consent Form can be found at www.ambrisentanrems.us.com.  It is NOT the responsibility of pharmacy to complete/submit the form.
• For Female, Continuation of Home Med:  Pharmacy does NOT need to confirm the original prescriber is authorized to prescribe ambrisentan.  Pharmacy does need to contact the REMS program and confirm the patient is enrolled in the REMS program.  Do not dispense until this verification is complete.  Determine pregnancy status.  Pharmacist may order a pregnancy test (blood or urine) if necessary.  Patient must be negative.  Note that any prescriber may continue a home med ambrisentan i.e. continuing a home ambrisentan does not need to be done by an authorized prescriber.
• For Female, Progress Note:  Use the Pharmacy -- REMS Documentation template to generate a progress note denoting completion of the applicable steps above.  Inpatient pharmacies do not need to obtain a Dispense Authorization #.   The progress note is our proof of meeting the requirements should an audit of our site occur.

• For Male, New Start or Continuation of Home Med:  Pharmacy does NOT  need to confirm the prescriber is authorized to prescribe ambrisentan.   Male patients do NOT need to be enrolled into the REMS program.   Basically treat it like any other med.  Note that any prescriber may continue a home med ambrisentan i.e. continuing a home ambrisentan does not need to done by an authorized prescriber.  No progress note necessary for a male patient.

Discharge Prescription Considerations

• Ambrisentan is only available through specialty pharmacies.  For a New Start (male or female), HH Pharmacy may send the patient home with a max 15 day supply of drug.  Work closely with the prescribing physician and patient to determine when the specialty pharmacy will deliver first maintenance supply of drug.
  

Reviewed: September 23, 2008

Updated: May 2019 (REMS confirmation instructions), June 2020 (Interchange with Opsumit)

REMS: View FDA REMS Info

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