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XYWAV and XYREM REMS The XYWAV and XYREM REMS (Risk Evaluation and Mitigation Strategy) is a safety program that manages the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM
XYREM - Sodium Oxybate Treatment for Cataplexy and EDS in Narcolepsy Because of the risks of CNS depression and abuse and misuse, XYWAV and XYREM are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS
How to Enroll Your Patient in XYWAV® REMS Programs | XYWAV HCP Because of the risks of CNS depression and abuse and misuse, XYWAV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS
PRESCRIBER BROCHURE - device. report Welcome to the XYWAV and XYREM REMS, which was developed in collaboration with the Food and Drug Administration (FDA) as a Risk Evaluation and Mitigation Strategy (REMS)
What is the Xyrem REMS program and how does it work? - Drugs. com Xyrem REMS refers to the program through which Xyrem can be prescribed by a doctor and through which Xyrem can be dispensed to a patient REMS stands for Risk Evaluation and Mitigation Strategy and the purpose of the program is to manage known or potential serious risks associated with a drug
JazzCares | Patient Advocate University - FAQs The XYWAV and XYREM Risk Evaluation and Mitigation Strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure that the benefits of the drug outweigh its risk
Oxybate Treatment for Cataplexy and EDS in Narcolepsy |XYREM® XYREM is approved to treat cataplexy and or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy It is taken at night to help relieve these symptoms that occur during the day
PRESCRIBER BROCHURE - xywavxyremrems. com Welcome to the XYWAV and XYREM REMS, which was developed in collaboration with the Food and Drug Administration (FDA) as a Risk Evaluation and Mitigation Strategy (REMS)
Review - Food and Drug Administration Assess the patient’s health status to determine if XYWAV or XYREM is medically appropriate by screening for concomitant use of sedative hypnotics, other CNS depressants, or other potentially