Xyrem (Sodium Oxybate) - Indications and Dosage

INDICATIONS AND USAGE

Xyrem (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

In Xyrem clinical trials, approximately 80% of patients maintained concomitant stimulant use (see BLACK BOX WARNINGS).

DOSAGE AND ADMINISTRATION

Xyrem is required to be taken at bedtime while in bed and again 2.5 to 4 hours later. The dose of Xyrem should be titrated to effect. The recommended starting dose is 4.5 g/night divided into two equal doses of 2.25 g. The starting dosage can then be increased to a maximum of 9 g/night in increments of 1.5 g/night (0.75 g per dose). One to two weeks are recommended between dosage increases to evaluate clinical response and minimize adverse effects. The effective dose range of Xyrem is 6 to 9 g/night. The efficacy and safety of Xyrem at doses higher than 9 g/night have not been investigated, and doses greater than 9 g/night ordinarily should not be administered.

Prepare both doses of Xyrem prior to bedtime. Each dose of Xyrem must be diluted with two ounces (60 mL, ¼ cup, or 4 tablespoons) of water in the child-resistant dosing cups provided prior to ingestion. The first dose is to be taken at bedtime and the second taken 2.5 to 4 hours later; both doses should be taken while seated in bed. Patients will probably need to set an alarm to awaken for the second dose. The second dose must be prepared prior to ingesting the first dose, and should be placed in close proximity to the patient’s bed. After ingesting each dose patients should then lie down and remain in bed.

Because food significantly reduces the bioavailability of sodium oxybate, the patient should allow at least 2 hours after eating before taking the first dose of sodium oxybate. Patients should try to minimize variability in the timing of dosing in relation to meals.

Hepatic Insufficiency

Patients with compromised liver function will have increased elimination half-life and systemic exposure along with reduced clearance (see Pharmacokinetics). As a result, the starting dose should be decreased by one-half and dose increments should be titrated to effect while closely monitoring potential adverse events.

Preparation and Administration Precautions

Each bottle of Xyrem is provided with a child resistant cap. The pharmacy provides two dosing cups with child-resistant caps with each Xyrem shipment.

Care should be taken to prevent access to this medication by children and pets.

See the MEDICATION GUIDE for a complete description.

HOW SUPPLIED

Xyrem (sodium oxybate) is a clear to slightly opalescent oral solution. It is supplied in kits containing one bottle of Xyrem, a press-in-bottle-adaptor, a 10 mL oral measuring device (plastic syringe), a Medication Guide and a professional insert. The pharmacy provides two 90 mL dosing cups with child-resistant caps with each Xyrem shipment. Each amber oval PET bottle contains 180 mL of Xyrem oral solution at a concentration of 500 mg/mL and is sealed with a child resistant cap.

NDC 68727-100-01: Each tamper evident single unit carton contains one 180 mL bottle (500 mg/mL) of Xyrem, one press-in-bottle-adaptor and one oral dispensing syringe.

STORAGE

Store at 25°C (77°F); excursions permitted up to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Solutions prepared following dilution should be consumed within 24 hours to minimize bacterial growth and contamination.

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 oral solution down the sanitary sewer.