XYREM was not involved in the second suicide. Of the two suicides, one patient used XYREM in conjunction with other drugs. In adult clinical trials in patients with narcolepsy (n=781), there were two suicides and two attempted suicides in XYREM-treated patients, including three patients with a previous history of depressive psychiatric disorder. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy and among patients with narcolepsy. Prescribers should be aware that increased central apneas and clinically relevant desaturation events have been observed with XYREM administration in adult and pediatric patients. In overdoses, life-threatening respiratory depression has been reported. XYREM may impair respiratory drive, especially in patients with compromised respiratory function. Respiratory Depression and Sleep-Disordered Breathing XYREM will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe useįurther information is available at or 1-86.
XYREM will be dispensed only by the central pharmacy that is specially certified.Healthcare Providers who prescribe XYREM are specially certified.Notable requirements of the XYWAV and XYREM REMS include the following: XYWAV and XYREM REMSīecause of the risks of central nervous system depression and abuse/misuse, XYREM is available only through a restricted distribution program called the XYWAV and XYREM REMS. Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely. The rapid onset of sedation, coupled with the amnestic features of XYREM, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The active ingredient of XYREM, sodium oxybate or gamma hydroxybutyrate (GHB), is a Schedule I controlled substance. XYREM is a Schedule III controlled substance. Patients should be queried about CNS depression-related events upon initiation of XYREM therapy and periodically thereafter. Also caution patients against these hazardous activities for at least 6 hours after taking XYREM. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYREM should be considered.Īfter first initiating treatment and until certain that XYREM does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. If use of these CNS depressants in combination with XYREM is required, dose reduction or discontinuation of one or more CNS depressants (including XYREM) should be considered. The concurrent use of XYREM with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. WARNINGS AND PRECAUTIONS Central Nervous System Depression patients with succinic semialdehyde dehydrogenase deficiency.combination with sedative hypnotics or alcohol.CONTRAINDICATIONS XYREM is contraindicated for use in:
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