You are being asked for your consent to participate in our Spravato (esketamine) nasal spray treatment program. This form describes the basic program information and indicates you have been educated and informed on the use of esketamine nasal spray, potential side effects, and treatment expectations.
Spravato (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults.
Spravato is not approved as an anesthetic agent. The safety and effectiveness of Spravato as an anesthetic agent have not been established.
Spravato can only be administered at a REMS-certified treatment center such as Journey Healthcare.
Risk & Potential Side Effects
The most important risks that you may expect from taking part in this program include:
Risk for sedation and dissociation after administration. You will be monitored for at least two hours after administration.
Potential for abuse and misuse.
Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants.
Increased blood pressure.
Problems with thinking clearly.
Additional common side effects of SPRAVATO when used 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, feeling drunk.
Common side effects generally occur right after taking SPRAVATO and go away the same day.
These are not all the possible side effects of spravato.
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.
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.
Before you take spravato please alert your healthcare provider about all of your medical conditions, including if you:
Have heart of brain problems (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 other condition where there is increased pressure in the brain.
Have liver problems.
Have ever had a conditioned called "psychosis".
Are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO.
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 over-the-counter medicines, vitamins and herbal supplements.
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.
By partaking in the SPRAVATO treatment program you are subjected to random uranalysis and will provide uranalysis for the purposes of drug testing upon request of your treatment provider.
Follow you 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 a family member to drive you home after taking SPRAVATO. NOTE: by signing this form you agree to coordinate a ride to and from each SPRAVATO treatment session.
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.
Statements & Consent:
Your signature documents your consent to take part in the SPRAVATO treatment program..