A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Xyrem Patient, Information, Instructions - Sodium oxybate
Xyrem Patient, Information, Instructions - Sodium oxybate
PATIENT INFORMATION
The Xyrem Patient Success ProgramSM includes detailed
information about the safe and proper use of sodium oxy-bate, as well as information
to help the patient prevent accidental use or abuse of sodium oxybate by others.
Patients must confirm that they have read the materials before the first prescription
will be filled. Prescribers will discuss the details of the program and the
treatment (including the procedure for preparing the dose to be administered)
prior to the initiation of treatment. Patients should also be informed that
they must be seen by the prescriber frequently during the course of their treatment,
and that a detailed account of the adverse reactions they may have experienced
will be taken. Food significantly decreases the bioavailability of sodium oxybate
(see Pharmacokinetics). Whether sodium
oxybate is taken in the fed or fasted state may affect both the efficacy and
safety of sodium oxybate for a given patient. Patients should be made aware
of this and try to take the first dose several hours after a meal. Patients
should be informed that sodium oxybate is associated with urinary and, less
frequently, fecal incontinence. Patients should be instructed to lie down and
sleep after each dose of sodium oxy-bate, and not to take sodium oxybate at
any time other than at night, immediately before bedtime and again 2.5 to 4
hours later. Patients should be instructed that they should not take alcohol
or other sedative hypnotics with sodium oxybate.
Please also refer to the WARNINGS
and PRECAUTIONS sections.
For additional information, patients should see the Medication
Guide for Xyrem®.
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