Spravato

What is SPRAVATO® (esketamine) CIII nasal spray?

SPRAVATO® is a prescription nasal ketamine 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

How will I take SPRAVATO®?

  •  You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
  •  Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
  •  Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
  •  During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
  •  You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
  •  If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
  •  Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and 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®.

What should I avoid while taking SPRAVATO®?

Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep

What are the possible side effects of SPRAVATO®?

SPRAVATO® may cause serious side effects including:

  • 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® when used along with an antidepressant taken by mouth 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

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

Limitations of Use:

SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.

It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.

It is not known if SPRAVATO® is safe and effective in children.