Opsumit REMS (Risk Evaluation and Mitigation Strategy) Program
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 Program is for females only. Male patients are not required to enroll in the Opsumit REMS Program.
The goals of the Opsumit REMS are:
- To inform prescribers, patients, and pharmacists about the risk of serious birth defects and safe-use conditions for Opsumit
- To minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential prescribed Opsumit:
- Females who are pregnant must not be prescribed Opsumit
- Females taking Opsumit must not become pregnant
Opsumit REMS Program Overview:
- All healthcare providers must enroll in the Opsumit REMS Program and comply with requirements to prescribe Opsumit
- All female patients must be enrolled in the Opsumit REMS Program 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 Program and agree to the REMS requirements
- Pharmacies that supply inpatient use of Opsumit must also be certified by enrolling in the Opsumit REMS Program and agreeing to the REMS requirements
Changes to the Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program
- New definition of Female of Non-Reproductive Potential
- Revised Form: Opsumit REMS Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form
- Audits will be performed for a select number of inpatient pharmacies
Opsumit® is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced 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 were treated with Opsumit monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. 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%).