Spravato™ or Esketamine was FDA approved for use in treatment resistant depression on March 5, 2019. This is an intra-nasal form of ketamine which was shown to be effective in conjunction with an antidepressant in treating severe and debilitating depression labeled as treatment resistant depression or TRD. The medication can only be administered under the supervision of a psychiatrist in a setting that has been approved by the manufacturer to give this product. Patients will not have direct access to the medication as it will only be available through a restricted program.
There are some drawbacks to this product in contrast to intravenous ketamine that is offered at our clinic. The concentration of medication is less than what is seen with the intravenous ketamine which could potentially lead to less benefit. Also, the dose that is given is a fixed amount so there is no easy way to modify the dosing of it on a customized basis which can be done with intravenous administration. It is also mandated that the patient be monitored in an office setting for potential side effects for at least two hours after the administration of this product. Lastly, it is uncertain as to how challenging it will be to obtain pre-authorization from insurance carriers for approval of this product.
In summary, it is currently uncertain as to when the product will be available for patient use and how difficult it will be to obtain authorization from insurance carriers for its use.
Spravato® is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults
SPRAVATO®, or Esketamine, was FDA approved for use in treatment resistant depression on March 5, 2019. This is an intra-nasal form of ketamine which was shown to be effective in conjunction with an antidepressant in treating severe and debilitating depression labeled as treatment resistant depression or TRD. The medication can only be administered under the supervision of a psychiatrist in a setting that has been approved by the manufacturer to give this product. Patients will not have direct access to the medication as it will only be available through a restricted program.
SPRAVATO® can cause serious side effects
Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
SPRAVATO® is not for use in children.
Do not take SPRAVATO® if you:
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you have heart or brain problems, including:
You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device. Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to. During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting. You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule. Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®. If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
SPRAVATO® may cause serious side effects including:
Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering. Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.
For more information, please visit www.spravato.com
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