Prescriber Requirements

 

How do I become certified to prescribe FINTEPLA?

1. Review the following educational materials on FINTEPLA to understand the risk of valvular heart disease and pulmonary arterial hypertension associated with FINTEPLA:
   • Review the Prescribing Information
   • Review the Prescriber Training and REMS Program Overview
2. Successfully complete the Prescriber Knowledge Assessment and submit it to the REMS:
   • Online
   • By Fax
   • By Mail
3. Enroll in the REMS by completing the Prescriber Enrollment form and submitting it to the REMS:
   • Online
   • By Fax
   • By Mail

How do I enroll a patient in the FINTEPLA REMS?

1. Counsel the patient on the risks of valvular heart disease and pulmonary arterial hypertension, including how to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension, and the need for cardiac monitoring via echocardiogram at baseline (treatment initiation), every 6 months during treatment, and once 3 to 6 months after treatment discontinuation using the Patient Guide.
2. Provide the patient with the Patient Guide.
3. Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS:
   • Online
   • By Fax
   • By Mail
4. Assess the patient's cardiovascular status and the appropriateness of initiating treatment by obtaining echocardiogram. Document and submit the results and authorization for treatment to the REMS, using the Patient Status Form:
   • Online
   • By Fax
   • By Mail

To ensure compliance with FINTEPLA REMS requirements, healthcare providers must:

During treatment: Every 6 months

1. Counsel the patient on the need for cardiac monitoring via echocardiogram every 6 months during treatment using the Patient Guide.
2. Assess the patient's cardiovascular status and the appropriateness of continuing treatment by obtaining an echocardiogram. Document and submit the results and appropriateness of continued treatment to the REMS using the Patient Status Form.

After treatment discontinuation: 3 to 6 months

1. Assess the patient’s cardiovascular status by obtaining an echocardiogram. Document and submit the results to the REMS using the Patient Status Form.

At all times

1. Report adverse events suggestive of valvular heart disease and/or pulmonary arterial hypertension on the Cardiovascular Adverse Event Reporting Form to the REMS.
2. Report treatment discontinuation or transfer of care to the REMS.