What Is Nasal Ketamine?
AMG Ketamine & Wellness Center is REMS*-certified to provide SPRAVATO™ (esketamine) CIII, a nasal spray approved for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). People who are currently struggling with major depressive disorder (MDD) may have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.
SPRAVATO™ was approved by the U.S. Food & Drug Administration on March 5, 2019, and carries a Boxed WARNING because of the risks for sedation, dissociation, and abuse and misuse. SPRAVATO™ is only available through a restricted program called the SPRAVATO™ REMS Program and can only be administered at healthcare settings certified in the SPRAVATO™ REMS Program and to patients enrolled in the REMS Program.
*Risk Evaluation and Mitigation Strategy
Certified Treatment Center
As a certified treatment center, AMG Ketamine & Wellness Center medical staff have been trained to prescribe, dispense, and administer SPRAVATO™ and have established processes and procedures in accordance with the REMS Program requirements. A board-certified anesthesiologist will provide direct supervision as the patient self-administers SPRAVATO™ and will monitor every patient after every dose for at least 2 hours for resolution of sedation and dissociation time and changes in vital signs.
All patients will require transportation from AMG Ketamine & Wellness Center following the observation period, as they should not drive or operate machinery until the day after a treatment session, following a restful sleep.
Nasal ketamine can be administered either through the Spravato program or through generic nasal ketamine; your AMG physician will discuss the pros and cons of each alternative.
What Is SPRAVATO™?
SPRAVATO™ is a prescription medicine, used along with an oral antidepressant, for TRD in adults. SPRAVATO™ is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO™ is safe or effective as an anesthetic medicine. SPRAVATO™ is not for use in children.
What are the initial steps?
- Discuss the SPRAVATO™ REMS Program with your doctor.
- Have your doctor submit a referral from the Center’s website page for “Health Professionals”.
- Call the AMG Ketamine & Wellness Center at (615) 813-5006 and schedule a consultation.
- If, after evaluation, it is determined that you are a candidate for the SPRAVATO™ REMS Program, our board-certified anesthesiologist will write a prescription for SPRAVATO™ to be filled from a REMS-certified pharmacy and delivered to the Center.
- Once SPRAVATO™ is delivered for a named patient, AMG Ketamine & Wellness Center will schedule your appointment within 14 days after receipt.
- You will take SPRAVATO™ nasal spray yourself, under the direct observation of a healthcare provider. 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.
- During and after each use of the SPRAVATO™ nasal spray device, you will be monitored for unwanted side effects by a healthcare provider for at least 2 hours after SPRAVATO™ administration.
- During the monitoring period, you will relax in a reclining chair and may choose to read, watch television, use a portable electronic device, or visit with your designated driver.
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.
- Sedation and dissociation. SPRAVATO™ may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space, and time (dissociation).
- Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO™ treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO™.
- Increased risk of suicidal thoughts or actions. SPRAVATO™ may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
- 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.
- Are pregnant or are considering possible pregnancy while undergoing treatment;
- 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; or
- Are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO™.
