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Limitations of Use
Xyrem may only be dispensed to patients enrolled in the Xyrem Success Program [see WARNINGS AND PRECAUTIONS].
Cataplexy In Narcolepsy
Excessive Daytime Sleepiness In Narcolepsy
Xyrem (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness (EDS) in narcolepsy.
DOSAGE AND ADMINISTRATION
Healthcare professionals who prescribe Xyrem must enroll in the Xyrem Success Program and must comply with the requirements to ensure safe use of Xyrem [see WARNINGS AND PRECAUTIONS].
The recommended starting dose is 4.5 grams (g) per night administered orally in two equal, divided doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). Increase the dose by 1.5 g per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later) to the effective dose range of 6 g to 9 g per night orally. Doses higher than 9 g per night have not been studied and should not ordinarily be administered.
Table 1: Xyrem Dose Regimen (g = grams)
|If A Patient’s Total Nightly Dose is:||Take at Bedtime:||Take 2.5 to 4 Hours Later:|
|4.5 g per night||2.25 g||2.25 g|
|6 g per night||3 g||3 g|
|7.5 g per night||3.75 g||3.75 g|
|9 g per night||4.5 g||4.5 g|
Important Administration Instructions
Take the first dose of Xyrem at least 2 hours after eating because food significantly reduces the bioavailability of sodium oxybate.
Prepare both doses of Xyrem prior to bedtime. Prior to ingestion, each dose of Xyrem should be diluted with approximately ¼ cup (approximately 60 mL) of water in the empty pharmacy vials provided. Patients should take both doses of Xyrem while in bed and lie down immediately after dosing as Xyrem may cause them to fall asleep abruptly without first feeling drowsy. Patients will often fall asleep within 5 minutes of taking Xyrem, and will usually fall asleep within 15 minutes, though the time it takes any individual patient to fall asleep may vary from night to night. Patients should remain in bed following ingestion of the first and second doses, and should not take the second dose until 2.5 to 4 hours after the first dose. Patients may need to set an alarm to awaken for the second dose. Rarely, patients may take up to 2 hours to fall asleep.
Dose Modification In Patients With Hepatic Impairment
The recommended starting dose in patients with hepatic impairment is 2.25 g per night administered orally in two equal, divided doses: approximately 1.13 g at bedtime and approximately 1.13 g taken 2.5 to 4 hours later [see Use In Specific Populations; CLINICAL PHARMACOLOGY].
Dose Adjustment With Co-administration Of Divalproex Sodium
Pharmacokinetic and pharmacodynamic interactions have been observed when Xyrem is co-administered with divalproex sodium. For patients already stabilized on Xyrem, it is recommended that addition of divalproex sodium should be accompanied by an initial reduction in the nightly dose of Xyrem by at least 20%. For patients already taking divalproex sodium, it is recommended that prescribers use a lower starting Xyrem dose when introducing Xyrem. Prescribers should monitor patient response and adjust dose accordingly. [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
Xyrem is a clear to slightly opalescent oral solution, in a concentration of 0.5 g per mL.
Storage And Handling
Xyrem is a clear to slightly opalescent oral solution. Each prescription includes a carton containing one bottle of Xyrem, a press-in-bottle-adaptor, an oral measuring device (plastic syringe), and a Medication Guide. The pharmacy provides two empty vials with child-resistant caps with each Xyrem shipment.
Each amber bottle contains Xyrem oral solution at a concentration of 0.5 g per mL and has a child-resistant cap.
Carton containing one 180 mL bottle NDC 68727-100-01
Keep out of reach of children.
Xyrem should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
Dispense in tight containers.
Solutions prepared following dilution should be consumed within 24 hours.
Handling And Disposal
Xyrem is a Schedule III drug under the Controlled Substances Act. Xyrem should be handled according to state and federal regulations. It is safe to dispose of Xyrem down the sanitary sewer.
Distributed By: Jazz Pharmaceuticals, Inc. Palo Alto, CA 94304. Revised: April 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/28/2014
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