Sleep-wake disorders:

Indications for: XYWAV

Cataplexy or excessive daytime sleepiness in patients ≥7yrs of age with narcolepsy. Idiopathic hypersomnia (IH) in adults.

Adult Dosage:

Take on empty stomach. Dilute each dose with 60mL of water. Narcolepsy: 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). IH (twice nightly regimen): 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 9g/night; (once nightly regimen): Initially ≤3g/night. May increase by ≤1.5g/night at weekly intervals; max 6g/night. May change between twice and once nightly regimens during titration based on efficacy and tolerability. 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:

IH: not established. Narcolepsy: <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, suicidal ideation, other behaviorial/psychiatric events; 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, sedating antidepressants or antipsychotics, sedating antiepileptics, general anesthetics, muscle relaxants, illicit CNS 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.

Note:

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

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Soln—180mL (w. oral measuring syringe)

Pricing for XYWAV

180ml of 0.5g/ml bottle of oral solution (Qty: 2)
Appx. price $10434
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