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 of 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
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- 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 are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATOTM.
- There is a pregnancy registry for women who are exposed to SPRAVATOTM during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATOTM and their baby. If you become pregnant during treatment with SPRAVATOTM, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATOTM.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATOTM 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 SPRAVATOTM?
You will take SPRAVATOTM nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATOTM nasal spray device.
Your healthcare provider will tell you how much SPRAVATOTM you will take and when you will take it.
Follow your SPRAVATOTM treatment schedule exactly as your healthcare provider tells you to.
During and after each use of the SPRAVATOTM 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 SPRAVATOTM.
If you miss a SPRAVATOTM treatment, your healthcare provider may change your dose and treatment schedule.
Some people taking SPRAVATOTM get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATOTM and not drink liquids at least 30 minutes before taking SPRAVATOTM.
If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATOTM.
What should I avoid while taking SPRAVATO?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATOTM. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATOTM?”
What are the possible side effects of SPRAVATO?
SPRAVATO may cause serious side effects including:
“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 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO and discuss any questions you may have with your healthcare provider.