Xywav prescribing information

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Actual: new indication of Idiopathic Hypersomnia (IH) for XYWAV. NDA /S-006 and NDA /S-036 provide for modifications to the approved XYWAV and XYREM risk evaluation and mitigation strategy (REMS) to align with the revisions to the XYWAV prescribing information. APPROVAL LABELING . We have completed our review of these applications, as
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how to use XYWAV properly, and how to store it safely. It also gives you important information about XYWAV. WHAT IS THE XYWAV AND XYREM REMS? Because of the serious risks associated with XYWAV, the FDA has required a special program called the XYWAV and XYREM REMS. Enrollment in the REMS by prescribers and patients is required by the FDA to ensure

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For further information, please refer to the Prescribing Information and/or Drug Monograph for Xywav. REFERENCES. Xywav [Prescribing Information]. Palo Alto

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Xyrem and Xywav Instructions, F- A. 34. PA requests for Xywav must include detailed clinical justification for prescribing Xywav instead of Xyrem.

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LUMRYZ (sodium oxybate for extended-release oral suspension). Prescribing Information. Chesterfield, MO: Avadel Pharmaceuticals. 2. XYWAV. Prescribing

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Your healthcare provider may prescribe one or two doses of Xywav each night. For more information about Xywav, you can visit the

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XYWAV and XYREM REMS. XYWAV is available only through a restricted program called the XYWAV and XYREM REMS [see Warnings and Precautions ]. Inform the patient and/or caregiver of the following notable requirements: XYWAV is dispensed only by the central pharmacy XYWAV will be dispensed and shipped only to patients enrolled in the XYWAV

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Notable requirements of the XYWAV and XYREM REMS include the following: Healthcare Providers who prescribe XYWAV are specially certified. XYWAV will be

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Xywav Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; April 2024. Available at:

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What is the XYWAV and XYREM REMS? Because of the serious risks See Medication Guide and Full Prescribing Information for complete information.

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