SPRAVATO

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What is SPRAVATO® (Esketamine) CIII nasal spray?

SPRAVATO® (Esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of:

  • Treatment-resistant depression (TRD) in adults.
  • Depressive symptoms

SPRAVATO Treatment at Orange Psychiatric Associates Associates

  • You will administer SPRAVATO nasal spray yourself, under the supervision and directions of our provider and staff.
  • During and after each use of the SPRAVATO nasal spray device, your vital signs will be monitored by our team. After the 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 and provider recommendation.

The most common side effects of SPRAVATO include:

  • feeling disconnected from yourself, your thoughts, feelings and things around you
  • dizziness
  • nausea
  • feeling sleepy
  • spinning sensation
  • decreased feeling of sensitivity (numbness)
  • feeling anxious
  • lack of energy
  • increased blood pressure
  • vomiting
  • 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.
  • Your healthcare provider will decide when you are ready to leave the healthcare setting.

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. Orange Psychiatric Associates Associates 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 womensmentalhealth.org

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 cost:

SPRAVATO medication is covered by most insurances as long as the patient meets the criteria for Treatment Resistant Depression as specified by the health insurance policy. Insurances will require a prior authorization for the medication before covering. We can provide a superbill you can submit to your insurance company to get coverage for the treatments (we do not bill insurance directly). In this prior authorization process, specific information of the patient’s prior psychiatric treatments including medication trials, therapy, TMS and ECT will be detailed. The patient monitoring cost is not included in the medication cost and is paid at the time of the treatment; a superbill will be provided should you wish to request reimbursement by the insurance company. Authorization for SPRAVATO typically takes 2-4 weeks after the SPRAVATO psychiatric evaluation occurs. For more detailed cost information please contact our office.