FDA Approves Spravato!

FDA Approves Spravato!

The FDA has finally approved the esketamine nasal spray Spravato for treatment of Treatment Resistant Depression. With this announcement came the initiation of patient protocols, and REMS program.

What is the SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy)?

Because of the risks associated with SPRAVATO™, the Food and Drug Administration (FDA) has required a special program called a Risk Evaluation and Mitigation Strategy (REMS). As part of the REMS, your doctor will discuss the risks of misuse, abuse, sedation (feeling sleepy), dissociation (feeling disconnected from yourself, including thoughts, feelings, and things around you) while on SPRAVATO™ with you. Both you and your doctor must sign the Patient Enrollment Form for you to receive SPRAVATO™. Your doctor will provide a copy of the signed form to the SPRAVATO™ REMS.

Spravato is not yet available to the public. Once our providers are made aware that it is available, along with our pharmacy having the ability to order the prescription we will let you know. Until then, here are the steps from the Spravato website on how patients can proceed…

If your healthcare provider and you have both agreed that SPRAVATO™ is the appropriate treatment for you, you will need to enroll in the SPRAVATO™ REMS in order to receive treatment with SPRAVATO™.

These are the steps to take in partnership with your healthcare provider:

Step 1: Read the SPRAVATO™ Medication Guide and Instructions for Use. Your healthcare provider will review specific risk and safety information of SPRAVATO™ with you and describe how to use the product

Step 2: Ask your healthcare provider any questions you have about taking SPRAVATO™ and about the SPRAVATO™ REMS

Step 3: Make sure you understand:

A. How to enroll and take part in the SPRAVATO™ REMSB. The benefits and risks of SPRAVATO™C. That each time you receive SPRAVATO™:You will need to use SPRAVATOTM Nasal Spray yourself under direct observation of a healthcare provider in a healthcare setting, such as a doctor’s office, clinic, or hospital;You will be monitored by a healthcare provider for at least 2 hours; the healthcare provider will then decide when you are ready to leave the healthcare setting.After treatment with SPRAVATO™, do not drive, operate heavy machinery, or do anything where you need to be completely alert until the next day following a restful sleep.

Step 4: Together with your healthcare provider complete and sign the SPRAVATO™ REMS Patient Enrollment Form.

Your healthcare provider will fill out most of the enrollment form for you and will send the form to SPRAVATO™ REMS

There are many stipulations for patients to be able to qualify for Spravato:

SPRAVATO is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults. Do not take SPRAVATO if you:

  • have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
  • have an abnormal connection between your veins and arteries (arteriovenous malformation)
  • have a history of bleeding in the brain
  • are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO. See the end of this Medication Guide for a complete list of ingredients in SPRAVATO. If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO.

Stay tuned for more updates! Once we hear the announcement it has been officially released to the public, we will let you know!

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