Spectrum Behavioral Health is now REMS Certified to Provide SPRAVATO™ (esketamine) CIII Nasal Spray Medication for Adults with Treatment-Resistant Depression
SPRAVATO™ (esketamine) CIII, is a nasal spray approved for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD).1 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.2
According to the National Institute of Mental Health, MDD is one of the most common mental health disorders in the United States.3 For many people, treatments such as therapy, medicine, and lifestyle changes may help relieve symptoms.4 However, up to one-third of adults may have treatment-resistant depression, and continue to experience symptoms such as persistent feelings of sadness, sleep disturbances, low energy and thoughts of death or suicide, despite trying multiple treatments.5
SPRAVATO™ was approved by the U.S. Food & Drug Administration on March 5, 2019, and is only available to patients at REMS–certified treatment centers in the United States.
As a certified treatment center, our medical staff have been trained to prescribe, dispense and administer SPRAVATO™ and have established processes and procedures in accordance with the REMS. A healthcare provider will provide direct supervision as the patient self-administers SPRAVATO™ and will monitor every patient after every dose for at least two hours for resolution of sedation and dissociation and changes in vital signs. SPRAVATO™ must never be dispensed directly to a patient for home use.
Additionally, all patients will require transportation from Spectrum Behavioral Health following the observation period, as they should not drive or operate machinery until the day after a treatment session, following a restful sleep.
Because of the risks for sedation, dissociation (feeling disconnected from yourself, your thoughts, feelings, space and time), and abuse and misuse, SPRAVATO™ carries a Boxed WARNING and is only available through a restricted program called the SPRAVATO™ Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO™ can only be administered at healthcare settings certified in the SPRAVATO™ REMS Program and to patients enrolled in the program.
For more information regarding administration, REMS requirements, or other related questions, please contact email@example.com to receive a more detailed information packet. For more information on SPRAVATO™, please refer to the manufacturer’s Prescribing Information and Medication Guide or visit www.SPRAVATO.com. If you are a patient, please speak to your healthcare provider for more information.
What is SPRAVATO™?
SPRAVATOTM is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression in adults. SPRAVATOTM is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATOTM is safe or effective as an anesthetic medicine. It is not known if SPRAVATOTM is safe and effective in children.
How is SPRAVATO™ administered?
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. 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.
What are some possible side effects with SPRAVATO™?
The most common side effects of SPRAVATO™ when used along with an antidepressant taken by mouth include but are not limited to:
- Spinning sensation
- Reduced sense of touch
- Reduced sense of sensation
- Feeling drunk
- Lack of energy
- Increased blood pressure
If these common side effects occur, they usually happen right after taking SPRAVATO™. Speak with your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
1. SPRAVATO™ [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. May 2019.
2. Agency for Healthcare Research and Quality. Treatment-Resistant Depression: A Narrative and Systematic Review of Definitions and Methods in Clinical Research Studies. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/trdepression-protocol-amendment.pdf. Accessed May 8, 2019.
3. National Institute of Mental Health. Major depression. https://www.nimh.nih.gov/health/statistics/major-depression.shtml. Accessed May 8, 2019.
4. Mental Health America. Dealing With Treatment-Resistant Depression: What to Do When Treatment Doesn’t Seem to Work. https://www.mentalhealthamerica.net/treatment-resistant-depression. Accessed May 8, 2019.
5. Ionescu DF et al. Dialogues Clin Neurosci. 2015;17(2):111–126.