What is Xyrem REMS program?
The XYWAV and XYREM REMS is designed to ensure that prescribers and patients are educated on and understand the risks and safe use conditions of XYREM and agree to follow the requirements of the XYWAV and XYREM REMS. The program also ensures that XYREM is dispensed from the Certified Pharmacy.
Is Xyrem a REMS drug?
Prescriptions for XYWAV and XYREM are only dispensed and shipped to patients who are enrolled in the REMS with documentation of safe use conditions. Each pediatric patient must have a caregiver who is counseled by the healthcare provider. XYWAV and XYREM will be dispensed only by the REMS Certified Pharmacy.
Is Xyrem covered by insurance?
The XYREM Coupon Program is not prescription drug coverage or insurance. Patients cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through the XYREM Coupon Program.
What is Xyrem FDA approved for?
Xyrem oral solution, CIII, is the only product approved by the U.S. Food and Drug Administration ( FDA ) for both cataplexy and excessive daytime sleepiness in narcolepsy in adult and pediatric patients ages 7 and older.
What class is Xyrem?
Xyrem is a Schedule III controlled substance. The active ingredient of Xyrem, sodium oxybate or gamma-hydroxybutyrate (GHB), is a Schedule I controlled substance.
What class of drug is Xyrem?
How do you titrate Xyrem?
XYREM is taken in 2 doses at night. Start dosing at 4.5 g per night administered orally in 2 divided doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later. Titrate to effect in increments of 1.5 g per night at weekly intervals (an additional 0.75 g at bedtime and another 0.75 g taken 2.5 to 4 hours later).
What class drug is Xyrem?
Why is Xyrem taken at night?
XYREM is taken at night to reduce both excessive daytime sleepiness (EDS) in narcolepsy and cataplexy in narcolepsy during the day. XYREM can cause sleep very quickly. Some people fall asleep within 5 minutes, and most people fall asleep within about 15 minutes.
Does Xyrem have a generic?
A generic version of Xyrem was approved January 17, 2017 but it has since been discontinued. There is currently no therapeutically equivalent version of Xyrem available in the United States.
