SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS. A REMS program is in place to ensure the safety of all patients who are treated with SPRAVATO®. The goals of the REMS are to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO® administration, and abuse and misuse of SPRAVATO®, by
- Ensuring SPRAVATO® is only dispensed and administered to patients in medically supervised healthcare settings that monitor these patients
- Ensuring pharmacies and healthcare settings that dispense SPRAVATO® are REMS certified
- Ensuring patients are informed about serious adverse outcomes from dissociation and sedation and the need for monitoring
- Enrolling all patients who receive treatment in an outpatient healthcare setting in a REMS registry to further characterize the risks and support safe use
- Patients’ first visit may be a consultation to discuss the details with a healthcare provider at the certified SPRAVATO® treatment center to determine if SPRAVATO® is considered an appropriate treatment option. If SPRAVATO® is recommended, the healthcare provider will discuss important safety risks and enroll patients in the SPRAVATO® REMS Program prior to treatment initiation.
We will work with your insurance provider to confirm your coverage and your costs prior to SPRAVATO® treatment.
Dissociation, dizziness, nausea, sedation, vertigo, feeling numb, anxiety, lethargy, transient increase in blood pressure, vomiting, and feeling intoxicated.
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 or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- worsening depression
- thoughts about suicide or dying
- other unusual changes in behavior or mood
You may notice your mood improving as well as improvements in motivation, enjoyment, appetite, sleep, concentration, and energy levels. Sometimes, however, subtle changes will be noticed by your doctor or your friends and loved ones. The benefits of Spravato can occur quickly or over the course of 2-3 months.
Do not use SPRAVATO® if any of the following conditions apply to you:
- You are allergic to esketamine, a related medication such as ketamine used for anesthesia, or any of the other components in SPRAVATO®.
- You have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation), or a history of brain bleeding.
- Inform your healthcare provider if you have heart, brain, or liver issues, a history of psychosis, or if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. SPRAVATO® is not recommended during pregnancy, and breastfeeding is contraindicated while using SPRAVATO®.
- Disclose all medications you are taking, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements to your healthcare provider.
Individual responses to SPRAVATO® may vary. Your healthcare provider will assess your major depressive disorder symptoms throughout the eight-week treatment period to determine if satisfactory improvement has occurred. After this duration, engage in discussions with all healthcare providers involved in your treatment management to determine the appropriate next steps. It is essential not to discontinue SPRAVATO® treatments without first consulting your healthcare provider, discussing your reasons, expressing concerns, and collaboratively formulating a treatment plan. If you are using another nasal spray medication or prescription, such as a nasal steroid or decongestant spray, refrain from administering these within the hour before taking SPRAVATO®.
SPRAVATO® (esketamine) CIII nasal spray is a ketamine derivative. Approved by the FDA, SPRAVATO® is a nasal spray designed for the treatment of treatment-resistant depression. It is also sanctioned for alleviating depressive symptoms in adults with major depressive disorder, particularly those with suicidal thoughts or actions. It’s important to note that ketamine itself has not received FDA approval for the treatment of depression. Both SPRAVATO® and ketamine are classified as Schedule III controlled substances under the US Controlled Substances Act.
Spravato is FDA approved for treatment resistant depression in adults, depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. If you suffer from one of these conditions, you should request a consultation to discuss your treatment options, including Spravato.
Spravato can only be taken in certified treatment center. Ketamine products that can be taken at home have not been evaluated by the FDA for safety and efficacy and are potentially dangerous, in part due to a lack of safety guardrails.
The first appointment will be a consultation with the doctor to determine if you are a good candidate for Spravato treatment and what alternative treatment options you may have. The doctor will gather all the information necessary to request insurance authorization for your treatment.
Some patients may see results as early as the first week of treatment and for others it may take longer. It’s important to give it up to 8-12 weeks in case you are a slow responder.