Xyrem

Xyrem Manufacturers

• Jazz Pharmaceuticals, Inc.
  

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  Xyrem | Jazz Pharmaceuticals, Inc.

  

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  Healthcare professionals who prescribe Xyrem must enroll in the Xyrem REMS Program and must comply with the requirements to ensure safe use of Xyrem [see Warnings and Precautions (5.3)].

  2.1 Dosing Information

  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

  2.2 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.

  2.3 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 (8.6); Clinical Pharmacology (12.3)].

  2.4 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 with introducing Xyrem. Prescribers should monitor patient response and adjust dose accordingly [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

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