BLENREP is available only through a restricted program under a REMS called the BLENREP REMS because of the risks of ocular toxicity.
Notable requirements of the BLENREP REMS include the following:
- Prescribers must be certified with the program by enrolling and completing training in the BLENREP REMS.
- Prescribers must counsel patients receiving BLENREP about the risk of ocular toxicity and the need for ophthalmic examinations prior to each dose.
- Patients must be enrolled in the BLENREP REMS and comply with monitoring.
- Healthcare facilities must be certified with the program and verify that patients are authorized to receive BLENREP.
- Wholesalers and distributors must only distribute BLENREP to certified healthcare facilities.