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SPRAVATO® (Esketamine)

Aloha Medical Services is now offering a ketamine treatment called SPRAVATO® (esketamine) to treat the following:

  • Adults with treatment-resistant depression (TRD).
  • Depressive symptoms in adults with major depressive disorder (MDD) and suicidal ideation (MDSI).

The SPRAVATO® (esketamine) treatment plan is a minimum of eight, two hour sessions, twice a week, over the course of a month. Once a week the patient will also have a 30 minute therapy session with an Aloha provider to process their session. The patient must continue to see their regular therapist weekly. Antidepressants are also required in conjunction with SPRAVATO®. Weekly, bi-weekly, monthly, or quarterly maintenance sessions may also be needed depending on the diagnosis and provider discretion.

Aloha has dedicated private, comfortable rooms for patients to use during their 2 hour SPRAVATO® sessions.

Patient Treatment Process:

  • The patient will take SPRAVATO® nasal spray themself, under the supervision of a healthcare provider in our office. The healthcare provider will show the patient how to use the SPRAVATO® nasal spray device.
  • The healthcare provider will tell the patient how much SPRAVATO® the patient will take and when the patient will take it.
  • The patient must follow their SPRAVATO® treatment schedule exactly as the healthcare provider tells them to.
  • During and after each use of the SPRAVATO® nasal spray device, the patient will be checked by a healthcare provider who will decide when the patient is ready to leave the healthcare setting.
  • The patient will need to plan for a support person or family member to drive the patient home after taking SPRAVATO®.
  • If the patient misses  a SPRAVATO® treatment, the healthcare provider may change the patient’s dose and treatment schedule.

What makes Spravato® different than IV Ketamine?

Esketamine (Spravato) is more potent than ketamine, which allows medical professional to give lower doses and potentially see fewer side effects. Both ketamine and esketamine have to be administered by a medical professional. These drugs are DEA Schedule III controlled substances and can become highly addictive.

Ketamine must be administered intravenously up to 3 times a week. This can be inconvenient and painful as patients have to continue to return to the doctor’s office and receive a new IV injection each time.

SPRAVATO® (esketamine) is administered in an outpatient setting under medical professional supervision. You receive 3 doses of the medication spaced about 5 minutes apart and then you remain under a medical professional supervision for 2 hours until any potential side effects have passed.

Other SPRAVATO® Information

Aloha Medical Services is a Risk Evaluation and Mitigation Strategy (REMS)–certified to provide SPRAVATO® (esketamine) CIII, a nasal spray approved for use, in conjunction with an oral antidepressant, to treat treatment-resistant  depression (TRD) in adults and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. SPRAVATO® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO® as an anesthetic agent have not been established.

Because of the risks for sedation, dissociation, abuse and misuse, and suicidal thoughts and behaviors, SPRAVATO® carries a Boxed WARNING and is available only through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can be administered only at healthcare settings certified in the SPRAVATO® REMS Program and to patients enrolled in the program. SPRAVATO® is never dispensed directly to a patient for home use. The medical staff at our certified treatment center are trained to prescribe, dispense, and administer SPRAVATO®, and we have established processes and procedures in accordance with the REMS. A healthcare provider will provide direct medical 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 require transportation from Aloha Medical Services following the observation period, as they should not drive or operate machinery until the day after a treatment session, following a restful sleep. At Aloha Medical Services, we understand that finding an appropriate treatment option for these patients can be complex. We are committed to partnering with your practice to provide a well-coordinated treatment experience with SPRAVATO® for appropriate adult patients. Our healthcare providers are proactive about coordinating care and will ensure an open line of communication with referring providers about the patient’s progress through the patient treatment progress form. In addition, our care team will help provide patients with a clear understanding of what to expect with SPRAVATO® treatment sessions. Our treatment center will carry out benefits investigation to ensure that you and your patients are aware of coverage and costs prior to SPRAVATO® treatment.

© Janssen Pharmaceuticals, Inc. 2021 08/21 cp-88161v5 6

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