Dosage & Administration Drug label Prior authorization Pharmacy Financial assistance

Xywav

(calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate)

calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / potassium oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]

BLACK BOX WARNING

Dosage & administration

See Full Prescribing Information for complete dosing instructions .

Dosage for Adult Patients with Narcolepsy

* Initiate dosage at 4.5 g per night orally, divided into two doses .
* Titrate to effect in increments of up to 1.5 g per night per week .
* Recommended dosage range: 6 g to 9 g per night orally, divided into two doses .
* Doses may be divided equally or unequally and the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later .

Dosage for Pediatric Patients with Narcolepsy (7 Years of Age and Older)

* The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight (2.2).

Dosage for Adult Patients with Idiopathic Hypersomnia

* XYWAV can be administered as a twice or once nightly regimen in adults .
* Twice nightly: Initiate dosage at 4.5 g or less per night orally, divided into two doses. Titrate to effect in increments of up to 1.5 g per night per week, up to 9 g total nightly dose .
* Once nightly: Initiate dosage at 3 g or less per night orally, as one dose. Titrate to effect in increments of up to 1.5 g per night per week, up to 6 g total nightly dose .

Important Administration Information

* Administer XYWAV at least 2 hours after eating .
* Prepare XYWAV prior to bedtime; dilute with approximately ¼ cup of water in pharmacy-provided containers .
* Take XYWAV while in bed and lie down after dosing .

For Patients Transitioning from Xyrem to XYWAV: Initiate at the same dose and regimen as Xyrem (gram for gram). Titrate as needed based on efficacy and tolerability .

Patients with Hepatic Impairment

Recommended starting dosage is one-half of the original dosage per night administered orally, divided into two doses .

drug label

Xywav prescribing information

Contact Medical Science Liaison Report Adverse Event

prior authorization

Xywav prior authorization resources

PDFGuide to Completing Prior Authorization: Narcolepsy

PDFGuide to Completing Prior Authorization: Idiopathic Hypersomnia

PDFFormulary Exception Process Guide

PDFLetter of Medical Necessity: Narcolepsy

PDFLetter of Medical Necessity: Idiopathic Hypersomnia

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Reimbursement help (FRM)

OTHERReceive Assistance from an FRM Regarding Reimbursement Information

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pharmacy

Xywav preferred pharmacy

OTHERPharmacy List

financial assistance

Xywav financial assistance options

Co-pay savings program

commercial only

OTHEREnroll in Patient Savings Program

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

commercial only

OTHEREnroll in Bridge Program

OTHERQuick Start Voucher Program

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

under insured

no insurance

goverment insurance

65+

PDFJazzCares Patient Assistance Program Application

JazzCares Patient Assistance Program Application - Online

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Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

patient education

Xywav patient education

Getting started on Xywav

To share resource; ask patient to:

1.Pull out phone

2.Open camera

3.Scan QR code with camera

4.Tap link