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REMS PROGRAM PRESCRIPTION FORM (sodium oxybate) oral solution 500 mg/mL Prescriber: Signature verification is required on the front page of this REMS Program Prescription Form as acknowledgment that.

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Filling out the Medication Form online is a crucial step in ensuring safe and effective treatment with . This guide will provide clear instructions to help users complete the form accurately and efficiently.

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  1. Press the ‘Get Form’ button to access the Medication Form and open it for editing.
  2. Begin by filling in the prescriber’s details, ensuring that all required fields are accurately completed. This includes the name, contact information, and any relevant identification numbers.
  3. Acknowledge the understanding of ’s approved uses by reading the prescribed information and checking the box that confirms your agreement.
  4. Next, assess and verify the patient’s medical history. Include information about any history of alcohol or substance abuse, sleep-related breathing disorders, and any concurrent use of CNS depressants.
  5. Provide counseling notes summarizing the conversation with the patient regarding the risks and precautions associated with . This should cover topics like contraindications, dosing instructions, and safe handling.
  6. Review all completed fields to ensure accuracy and completeness. Make any necessary changes prior to finalizing the form.
  7. Once all sections are thoroughly reviewed, save your changes, and proceed to download, print, or share the form as necessary.

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The firm noted that is the first and only product approved in Canada to treat cataplexy, which is a sudden loss of muscle tone associated with narcolepsy.

is a Schedule III controlled substance. The active ingredient of , sodium oxybate or gamma-hydroxybutyrate (GHB), is a Schedule I controlled substance.

The cost for oral liquid (500 mg/mL) is around $5,344 for a supply of 180 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans. is available as a brand name drug only, a generic version is not yet available.

® is distributed through Express Scripts Specialty Distribution Services, Inc.

GHB is a Schedule I controlled substance under the Controlled Substances Act. FDA-approved products containing sodium oxybate, including and now the generic version of , are controlled under Schedule III.

is not available at your local pharmacy. As part of the XYWAV and REMS, is available only through a Certified Pharmacy. It is the only pharmacy in the United States permitted to fill the prescription and send directly to patients.

In the US, GHB is a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties.

The Coupon Program is not prescription drug coverage or insurance. Patients cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through the Coupon Program.

Sodium oxybate is not available at retail pharmacies. Sodium oxybate is available only through a restricted distribution program called the REMS Program. It is a special program to distribute the medication and provide information about the medication.

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