Sleep-wake disorders:
Indications for XYWAV:
Cataplexy or excessive daytime sleepiness in patients ≥7yrs of age with narcolepsy.
Adult Dosage:
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. Some patients may respond better with unequal doses. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Transitioning from Xyrem: initiate at same dose (gram for gram) and regimen; titrate as needed. Hepatic impairment: initially 1⁄2 of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xywav dose by at least 20%; if already taking divalproex sodium, start Xywav at lower dose; monitor, adjust accordingly.
Children Dosage:
<7yrs: not established. Take on empty stomach. Dilute each dose with 60mL of water. ≥7yrs (<20kg): see full labeling. (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. Some patients may respond better with unequal doses. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Transitioning from Xyrem: initiate at same dose (gram for gram) and regimen; titrate as needed. Hepatic impairment: initially 1⁄2 of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xywav dose by at least 20%; if already taking divalproex sodium, start Xywav at lower dose; monitor, adjust accordingly.
XYWAV Contraindications:
Concomitant sedative hypnotics or alcohol. Succinic semialdehyde dehydrogenase deficiency.
Boxed Warning:
CNS depression. Abuse and misuse.
XYWAV Warnings/Precautions:
Risk of CNS depression. Abuse potential (monitor). Respiratory dysfunction. Sleep-related breathing disorders (esp. in men, postmenopausal women not on HRT, obese, or narcolepsy patients). History of depression or suicidal ideation (monitor). Parasomnias. Hepatic impairment. Drug abusers. Elderly. Labor & delivery. Pregnancy. Nursing mothers.
XYWAV Classification:
Antinarcoleptic (CNS depressant).
XYWAV 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:
Headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety, vomiting; children also: enuresis, weight decreased; CNS and respiratory depression, sleep-disordered breathing, sleepwalking, depressive symptoms, confusion, anxiety, other behaviorial/psychiatric reactions.
Note:
Only available through the Xywav REMS Program. For more information call (866) 997-3688.
REMS:
Generic Drug Availability:
NO
How Supplied:
Soln—180mL (w. oral measuring syringe)
