What is SPRAVATO® (esketamine) CIII nasal spray?
SPRAVATO is FDA approved intranasal ketamine, used along with an antidepressant taken by mouth to treat:
- Adults with treatment-resistant depression (TRD)
- Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or action
Spravato Treatment at Lake Mary Behavioral Infusion Center
- You will take SPRAVATO nasal spray yourself, under the supervision and directions of our staff.
- During and after each use of the SPRAVATO nasal spray device, your vital signs will be monitored by one of our medical assistants. After treatment is complete, we will instruct you on when to leave our office and schedule your next treatment.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO.
- Some people taking SPRAVATO get nausea and vomiting. You should not eat for at least 2 hours and should 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.
- Treatment will likely be scheduled twice a week for 4 weeks then once a week for 4 weeks during the induction phase of treatment then maintenance dose will depend on individual response
The most common side effects of SPRAVATO include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- feeling drunk
- feeling very happy or excited
SPRAVATO can also cause serious side effects, including:
- 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).
- The treatment with Spravato is an in-office treatment and the patient is monitored for at least 2 hours after treatment.
- Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO treatment.
- Our psychiatrist will look for signs of abuse and dependence before and during treatment with SPRAVATO. It is important to discuss any past history of substance abuse and drug addiction with the doctor prior to Spravato treatment.
- SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. Lake Mary Behavioral and Infusion Center is certified in the SPRAVATO® REMS Program. Patients treated in our office must be enrolled in the program.
- Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO is not for use in children
- 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.
- How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Keep all follow-up visits as scheduled. Call us between visits as needed, especially if you have concerns about suicidal symptoms.
- Contact us 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
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
SPRAVATO is CONTRAINDICATED if you:
- 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
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO
- are pregnant, looking to become pregnant or breastfeeding
- There is a pregnancy registry for women who are exposed to SPRAVATO during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
Other medical conditions that may affect your ability to take Spravato are:
- heart or brain problems, including:
- high blood pressure (uncontrolled hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- liver problems
- a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
Spravato is covered by most insurances as long as the patient meets the criteria for Treatment Resistant Depression as specified by their health insurance policy. Insurances will require a prior authorization for the medication before covering. In this form, specific information of the patient’s prior psychiatric treatments including medication trials, therapy, TMS and ECT will be detailed. Authorization for Spravato typically takes 2-4 weeks after the psychiatric evaluation occurs.