A Risk Evaluation and Mitigation Strategy (REMS) is a program required by the Food and Drug Administration (FDA) to manage serious risks associated with a drug product.

The Opsumit REMS is for females only. Male patients are not required to enroll in the Opsumit REMS.

The goal of the Opsumit REMS is to mitigate the risk of embryo-fetal toxicity associated with Opsumit by:

1. Ensuring prescribers are educated on the following:
   • the risks of embryo-fetal toxicity
2. Ensuring prescribers are educated on and adhere to the following:
   • counseling patients about these risks and the need for monthly monitoring
   • enrolling patients in the Opsumit REMS
   • monitoring patients at baseline and monthly
3. Ensuring that pharmacies are educated on the following:
   • the risks of embryo-fetal toxicity
4. Ensuring that pharmacies are educated on and adhere to the following:
   • confirming that the appropriate patient monitoring and counseling has occurred before dispensing Opsumit
5. Ensuring that patients are informed about:
   • the risks of embryo-fetal toxicity
   • appropriate baseline and monthly patient monitoring
   • appropriate contraception

Opsumit REMS Overview:

• All healthcare providers must enroll in the Opsumit REMS and comply with requirements to prescribe Opsumit
• All female patients must be enrolled in the Opsumit REMS to receive Opsumit
• Females of Reproductive Potential and Pre-pubertal Females of Non-Reproductive Potential are required to be counseled on the risks of Opsumit
• Females of Reproductive Potential are required to get monthly pregnancy testing
• A limited number of certified pharmacies will dispense Opsumit for outpatients. They must enroll in the Opsumit REMS and agree to the REMS requirements
• Pharmacies that supply inpatient use of Opsumit must also be certified by enrolling in the Opsumit REMS and agreeing to the REMS requirements

Opsumit^® is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).