WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SPRAVATO?

• SPRAVATO can cause serious effects, including ¹:
• Sedation, dissociation, and respiratory depression: SPRAVATO may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), and breathing problems (respiratory depression and respiratory arrest).¹
  • 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.
• Abuse and misuse: There is a risk for abuse and misuse with SPRAVATO, which may lead to physical and psychological dependence. Your healthcare provider should check you for signs of abuse, misuse, and dependence before and during treatment.¹
  • 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 in drug addiction.
• SPRAVATO Risk Evaluation and Mitigation Strategy (REMS): Because of the risks for sedation, dissociation, respiratory depression, abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO REMS Program. SPRAVATO can only be administered at healthcare settings certified in the SPRAVATO REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program. ¹
• 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.¹
  • 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 and actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts and 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.
    • Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
    • 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 or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse or worry you:
    • thoughts about suicide or dying
    • new or worse depression
    • suicide attempts
    • new or worse anxiety
    • panic attacks
    • feeling very agitated or restless
    • trouble sleeping (insomnia)
    • acting aggressive, being angry, or violent
    • an extreme increase in activity and talking (mania)
    • new or worse irritability
    • acting on dangerous impulses
    • other unusual changes in behavior or mood

See SUMMARY below for more information about side effects.

summary

• Here is a passage from the SPRAVATO MEDICATION GUIDE which may be helpful to address your question.

SPRAVATO may cause serious side effects, including¹:

• See above “What is the most important information I should know about SPRAVATO?”
• Increased blood pressure. SPRAVATO can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose.
  • Your healthcare provider will check your blood pressure before taking SPRAVATO and for at least 2 hours after you take SPRAVATO.
  • Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO.
• Problems with thinking clearly.
  • Tell your healthcare provider if you have problems thinking or remembering.
• Bladder problems.
  • Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.

The most common side effects of SPRAVATO include¹:

• 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
• Headache
• Feeling very happy or excited

If these common side effects occur, they usually happen right after taking SPRAVATO and go away the same day.¹

These are not all possible side effects of SPRAVATO ¹.

• Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.¹

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest use in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the MEDICATION GUIDE for SPRAVATO.¹