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What is the Siliq REMS Program?

Answers (1)

Official Answer by 5 Jul 2017
Siliq (brodalumab) injection is FDA-approved to treat adults with moderate-to-severe plaque psoriasis. Suicidal ideation and behavior, including completed suicides, occurred in patients treated with Siliq during clinical trials, but a definite link with the drug has not been determined. Due to this possible risk, the drug can only be accessed through a restricted program called the Siliq Risk Evaluation and Mitigation Strategy (REMS) program. Components of the Siliq REMS program include:
  • Prescriber Certification and Patient Counseling
  • A Patient-Prescriber Agreement Form to seek medical care if suicidal thoughts, depression, or mood changes occur
  • A Medication Guide to inform patients of the risk of using Siliq
  • Pharmacies must be certified only dispense to patients who are authorized to receive Siliq.
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