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XYREM
Sleep-wake disorders
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Drug Name:

XYREM CIII

Generic Name and Formulations:
Sodium oxybate 500mg/mL; soln.

Company:
Jazz Pharmaceuticals plc

Therapeutic Use:

Indications for XYREM:

Cataplexy or excessive daytime sleepiness in patients ≥7yrs of age with narcolepsy.

Adult:

Take on empty stomach. Dilute each dose with 60mL of water. Initially 4.5g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1.5g/night (0.75g/dose) at weekly intervals; usual range: 6–9g/night; max 9g/night. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Hepatic impairment: initially ½ of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xyrem dose by at least 20%; if already taking divalproex sodium, start Xyrem at lower dose; monitor, adjust accordingly.

Children:

<7yrs: not established. Take on empty stomach. Dilute each dose with 60mL of water. ≥7yrs (20–<30kg): initially ≤2g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1g/night (0.5g/dose) at weekly intervals. Max total dose: 6g/night. (30–<45kg): initially ≤3g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1g/night (0.5g/dose) at weekly intervals. Max total dose: 7.5g/night. (≥45kg): initially ≤4.5g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1.5g/night (0.75g/dose) at weekly intervals. Max total dose: 9g/night. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Hepatic impairment: initially ½ of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xyrem dose by at least 20%; if already taking divalproex sodium, start Xyrem at lower dose; monitor, adjust accordingly.

Contraindications:

Concomitant sedative hypnotics or alcohol. Succinic semialdehyde dehydrogenase deficiency.

Boxed Warning:

CNS depression. Abuse and misuse.

Warnings/Precautions:

Risk of CNS depression. Abuse potential (monitor). Respiratory dysfunction. History of depression or suicidal ideation (monitor). Consider sodium intake with heart failure, hypertension, renal insufficiency (see full labeling). Hepatic impairment. Drug abusers. Reevaluate every 3 months. Elderly. Labor & delivery. Pregnancy. Nursing mothers.

Pharmacological Class:

Antinarcoleptic (CNS depressant).

Interactions:

See Contraindications. CNS depression potentiated by concomitant other CNS depressants (eg, opioids, benzodiazepines, antidepressants, antipsychotics, general anesthetics, muscle relaxants, sedating antiepileptic drugs). Potentiated by divalproex sodium.

Adverse Reactions:

Nausea, dizziness, vomiting, somnolence, enuresis, tremor; children also: headache, weight decreased, decreased appetite; CNS and respiratory depression, sleep-disordered breathing, sleepwalking, depressive symptoms, confusion, anxiety, other neuropsychiatric reactions.

Note:

Only available through the Xyrem REMS Program. For more information call (866) 997-3688.

REMS:

YES

Generic Availability:

NO

How Supplied:

Soln—180mL (w. oral measuring syringe)

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