I hereby consent to treatment with Spravato at our Focusdfw Office.
SPRAVATO is a prescription 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
SPRAVATO can cause serious side effects, including:
• Sedation and dissociation. SPRAVATO may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
° 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.
YOU MUST HAVE SOMEONE TO DRIVE YOU HOME AFTER YOUR TREATMENT
• Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO treatment.
• SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO can only be administered at healthcare settings certified in the SPRAVATO REMS Program. Patients treated in outpatient healthcare settings (e.g. medical offices and clinics) must be enrolled in the program.
• 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. SPRAVATO is not for use in children.
It is not known if SPRAVATO is safe and effective in children.
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.
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
° 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 are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment
with SPRAVATO.
° There is a pregnancy registry for women who are exposed to SPRAVATO during pregnancy.
• 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 medicines 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 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.
• 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.