Do not take SPRAVATO™ 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™.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO™.
Before you take SPRAVATO™, tell your healthcare provider about all your medical conditions, including if you:
- have heart or brain problems, including:
- high blood pressure (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
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
- are pregnant or plan to become pregnant. SPRAVATO™ may harm your baby. You should not take SPRAVATO™ if you are pregnant.
Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO™.
If you can become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO™. If you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO™.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO™ with certain medicine may cause side effects. Especially tell your healthcare provider if you take Central Nervous System (CNS) depressants, psychostimulants, or Monoamine oxidase inhibitors (MAOIs) medicines.
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 dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.
If these common side effects occur, they usually happen right after taking SPRAVATO™ and go away the same day. These are not all the possible side effects of SPRAVATO™.