SPRAVATO® (esketamine) CIII nasal spray is a prescription medicine used as an adjunct treatment for adults with major depressive disorder or treatment-resistant depression. This drug helps to reduce symptoms of depression, including suicidal thoughts or actions, when taken alongside an oral antidepressant. It should be noted, however, that SPRAVATO® does not replace the need for hospitalization if your healthcare provider deems it necessary. Additionally, the safety and effectiveness of SPRAVATO® have not yet been established as a preventive measure against suicide or to decrease suicidal thoughts or actions. It is also important to note that this drug has not been approved as an aesthetic pain reliever or preventer.
IMPORTANT SAFETY INFORMATION
When taking SPRAVATO®, it is essential to stay aware of the potential for serious side effects, including sedation and dissociation. These can lead to feelings of sleepiness, dizziness, fainting, and spinning sensations. If these feelings are experienced, you must contact your healthcare provider immediately. After taking this medication, your healthcare provider must monitor you for any adverse side effects or reactions for at least two hours to ensure safe usage. Based on their assessment, they will decide when you are ready to leave the healthcare setting.
Understanding the risks associated with SPRAVATO®, a Risk Evaluation and Mitigation Strategy (REMS) Program has been launched to protect those taking the medication. This program allows those taking SPRAVATO® to receive administration only at certified healthcare settings such as medical offices and clinics. Additionally, patients treated in these settings must be enrolled in the REMS Program. Although not designed for children, it is essential for everyone taking SPRAVATO® to monitor their mental health, as there is an increased risk of suicidal thoughts and actions among people 24 years old and younger, especially during the first few months or when changing doses.
When it comes to suicide, it is essential to recognize that depression and other serious mental illnesses are the most significant predictors of suicidal thoughts and actions. Those at higher risk may be those who have suffered from depression or have a family history of depression or suicidal ideation. Therefore, it is essential to be aware of and watch out for any sudden changes in moods, behaviors, thoughts, or feelings, as this could indicate the possible onset of suicidal tendencies. If you notice any such changes in yourself or a family member, it is essential to seek help immediately from a medical professional.
When prescribed SPRAVATO®, it is essential to be aware that not all potential side effects have been listed. Any symptom that feels concerning or unusual should be reported to a doctor immediately and discussed with healthcare providers. It’s also necessary to follow the complete Prescribing Information and read the Boxed WARNINGS and Medication Guide carefully. Safety is the primary priority with any medication, and it’s essential to ask questions of your provider if anything seems confusing or uncertain. To report side effects to FDA, call 1-800-FDA-1088.