The FDA, has approved a new medication for the treatment of Depression, Spravato (Esketamine) which is an isomer of the drug Ketamine. Spravato was approved by the FDA to be covered by insurance for patients suffering from Treatment Resistant Depression (TRD), and recently added condition of Major Depression Disorder (MDD). Commonly new medications remain in a very controlled state and may be difficult to obtain for patients due to the regulations placed by the FDA.
The Spravato program is currently being guided by the Risk Evaluation and Mitigation Strategy (REMS). What this means is that you must meet specific criteria to become a candidate for this type of treatment including failing two previous antidepressants. In addition, the REMS program also stipulates how the medication may be given to patients and how your medical providers should be monitoring your progress.
Some of the regulations surrounding the medication require a lengthy process to be approved as well as a specific medication dosing regimen to be followed by the patient.
- Patients be monitored by appropriate medical providers within the facility.
- This means that patients may not get the nasal form of Ketamine or have it delivered outside of any REMS registered medical facility.
- Medications may not be taken home or removed from the facility.
- Patients must follow medication protocol.
- Monitoring within the facility for a minimum of 2 hours of observation. (This is mandated by FDA and no exceptions may be made)
- Blood pressure must be recorded and monitored during the 2-hour observation
- Providers must complete a detailed monitoring record and submit all details of treatment to Janssen (Spravato Manufacturer).
How often do I need Spravato?
The Spravato nasal medication is delivered in 3 phases to understand the outcomes of the medication for patients utilizing this drug.
Phase 1 (Induction): Weeks 1-4 patients are required to administer the medication within the approved medical facility and be monitored for a minimum of 2 hours twice a week.
Phase 2 (Maintenance): Weeks 5-8 patients come 1 time weekly and continued medical observation requirements remain.
Phase 3 (Ongoing Treatment): Patients follow up every 2 weeks for administration and required observation during the single treatment.
What are the side effects of Spravato?
During the Spravato treatment, we will maintain a relaxing environment while we monitor based on the requirements set before us. Commonly patients may experience mild disassociation and elevated blood pressure. As a controlled substance this medication does carry a risk of dependence. We encourage all patients who consider using Spravato to ensure they are under the observation of a Ketamine specialist.
Additional side effects may include:
- Dissociation (Feeling of disconnect from your body)
- Increased blood pressure
- Difficulty concentrating and dizziness
- Inability to drive or operate machinery
- Suicidal thoughts for young adults
Is Spravato right for me?
Because of the side effects that may occur elevate medical requires a comprehensive evaluation and screening prior to being cleared for Spravato treatment. Referral from your current medical provider and medical records are required to ensure the REMS patient criteria is met prior to starting the Spravato medication.
We here at elevate medical believe strongly in IV Ketamine and the benefits our patients receive. However, in our goal to assist in better quality of life for our patients we understand that IV Ketamine might not always be a good fit for every patient. If you have not seen improvements in your current and past medication, please reach out and speak with one of our knowledgeable team members to see if IV Ketamine or Spravato is right for you.