(Spravato) Esketamine Nasal Spray

 SPRAVATO is a derivative of ketamine. It boosts neurotransmitters in the brain and helps them better communicate to regulate mood and diminish harmful depression symptoms. 

SPRAVATO is a prescription medicine, 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 actions

Compounded ketamine nasal spray and esketamine (Spravato) are both used in the treatment of depression, but they differ significantly in several ways:

1. Formulation and Composition:
   
   • Compounded Ketamine Nasal Spray: This is a custom-made medication prepared by a compounding pharmacy. It typically contains racemic ketamine, which is a mixture of two enantiomers: R-ketamine and S-ketamine. The exact formulation can vary based on the compounding pharmacy and the prescriber's specifications.
   • Esketamine (Spravato): This is a commercial medication approved by the FDA specifically for treatment-resistant depression. It contains esketamine, which is the S-enantiomer of ketamine. Esketamine is a single, purified enantiomer of ketamine, distinct from the racemic mixture found in compounded formulations.

1. Approval and Regulation:
   
   • Compounded Ketamine Nasal Spray: Since this is a compounded medication, it is not approved by the FDA as a specific product for depression. The FDA does not regulate compounded drugs as rigorously as commercially manufactured drugs. The safety, efficacy, and quality of compounded ketamine nasal spray can vary.
   • Esketamine (Spravato): This medication is FDA-approved for use in treatment-resistant depression. It has undergone extensive clinical trials to demonstrate its safety and efficacy. It is subject to strict regulations and quality control measures.

1. Administration:
   
   • Compounded Ketamine Nasal Spray: This is typically used off-label for depression and can be administered in varying doses, depending on the compounding pharmacy's formulation and the prescribing physician's recommendations.
   • Esketamine (Spravato): This is administered under the supervision of a healthcare provider in a clinical setting. Patients receive the medication in a controlled environment, often in a specialized clinic, where their response and side effects can be monitored.

1. Usage and Protocols:
   
   • Compounded Ketamine Nasal Spray: The use and dosing protocols for compounded ketamine can vary widely, and there is less standardized guidance for its use compared to Spravato. Treatment plans might be less structured and individualized.
   • Esketamine (Spravato): The treatment regimen for Spravato is well-defined, with specific dosing schedules and protocols established through clinical trials. The treatment typically involves an initial phase with more frequent dosing, followed by a maintenance phase.

1. Insurance and Cost:
   
   • Compounded Ketamine Nasal Spray: Insurance coverage can be unpredictable, as compounded drugs may not always be covered or may have varying levels of coverage depending on the plan.
   • Esketamine (Spravato): As an FDA-approved medication, Spravato is more likely to be covered by insurance, though coverage can still vary. The cost may be higher due to its status as a specialized, regulated drug.

• 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).
  • Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
  • Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO. Your healthcare provider will decide when you are ready to leave the healthcare setting.
• Respiratory depression was observed with the use of SPRAVATO; additionally, there were rare reports of respiratory arrest.
  • Your healthcare provider must monitor you for serious side effects for at least 2 hours (including pulse oximetry) after taking SPRAVATO. 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. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
  • Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression, and abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO can only be administered at healthcare settings certified in the SPRAVATO REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) 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.

• 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.