SPRAVATO™ is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.
In SPRAVATO clinical trials, treatment-resistant depression was defined as a condition in which adults who are currently struggling with major depressive disorders have not responded adequately to at least two different antidepressants of adequate dose and duration.
SPRAVATO is only available at certified SPRAVATO treatment centers under the supervision of a properly trained healthcare professional. Due to the risks for sedation, dissociation, abuse, and misuse, your doctor will enroll you in the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) program.
In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO and an oral antidepressant experienced greater reduction in depression symptoms after four weeks, compared to those who received a placebo plus an oral antidepressant.
If you’ve struggled with depression and you’ve tried two or more antidepressants during your current episode without adequate relief, talk to your doctor to find out if you have treatment-resistant depression. Talk to your doctor to learn if SPRAVATO may be right for you. Be sure to tell your doctor if you have a history of abusing prescription meds or street drugs or a problem with alcohol. You should also tell your doctor if you are pregnant, planning to become pregnant, are breastfeeding or planning to breastfeed.
You will take SPRAVATO nasal spray yourself with the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO device, how much SPRAVATO to take and when to take it. Follow your treatment schedule exactly as your healthcare provider recommends. Your health provider will check on you during and after each use of the SPRAVATO nasal spray device and decide when you are ready to leave the healthcare setting. You will need to have a caregiver or family member drive you home after taking SPRAVATO. Do not eat for at least two hours before taking SPRAVATO and do not drink liquids for at least 30 minutes before taking SPRAVATO. If you take a nasal corticosteroid or nasal decongestant, use these medicines at least one hour before taking SPRAVATO.
SPRAVATO can cause serious side effects, including anxiety, dissociation, dizziness, nausea, sedation, spinning sensations, increased blood pressure, reduced sense of touch and sensation, lack of energy, vomiting, and feeling drunk. These common side effects usually occur right after taking SPRAVATO and then disappear the same day. Dissociation means feeling disconnected from yourself, your thoughts, feelings, space, and time. SPRAVATO may cause a temporary increase in blood pressure that can last about four hours after a dose. Your healthcare provider will check your blood pressure before you take SPRAVATO and for at least two hours after. Tell your provider immediately if you experience chest pain, shortness of breath, sudden severe headache, a change in vision, or seizures after taking SPRAVATO. Tell your provider if you have difficulty thinking or remembering, develop trouble urinating, have a frequent or urgent need to urinate, urinate frequently at night, or have pain when urinating.
Do NOT take SPRAVATO if any of the following apply to you:
You are allergic to esketamine, a similar medicine called ketamine used for anesthesia, or any of the other ingredients in SPRAVATO.
You have had medical conditions such as blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation), or a history of bleeding in the brain.
Be sure to tell your doctor if you have any heart (e.g., high blood pressure) or brain problems (e.g., stroke or history of brain injury), liver problems, psychosis, are pregnant or plan to become pregnant, or are breastfeeding or planning to breastfeed. You should not take SPRAVATO if you are pregnant. You should not breastfeed if you are taking SPRAVATO.
No, treatment with SPRAVATO is not recommended during pregnancy or while breastfeeding. You should let your doctor know if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. If you are a woman planning to start SPRAVATO and are of childbearing age, you should use highly effective contraception while taking SPRAVATO. Talk with your doctor about methods of birth control that should be used.
If you become pregnant while being treated with SPRAVATO, you should talk to your doctor as soon as possible about discontinuing treatment and about other options for treating your depression.
If you miss a SPRAVATO treatment, your healthcare provider may change your dose and treatment schedule. Be sure to let him or her know that you missed a treatment.
Do not drive, operate machinery, or perform any activity where you need to be completely alert. Avoid these activities until the next day following a restful sleep, even if you think you feel well enough to do so. Once your healthcare professional gives you permission to leave after treatment, discuss your plans for the remainder of that day. The driving restriction means you will need to plan for your rides on treatment days.
Some patients may experience nausea or vomiting. Because of this, you should avoid eating two hours before, and drinking liquids 30 minutes before, taking SPRAVATO.
SPRAVATO (esketamine) CIII nasal spray is a derivative of ketamine. SPRAVATO is an FDA-approved nasal spray for treatment-resistant depression. Intravenous (IV) ketamine has not been approved by the FDA to treat depression. Both SPRAVATO and ketamine are Schedule III controlled substances under the U.S. Controlled Substances Act.
You’ll take SPRAVATO with a daily oral antidepressant twice a week for the first four weeks.
After the first four weeks, you’ll take SPRAVATO once a week for a month. After this, you’ll typically take SPRAVATO either once a week or once every two weeks, according to your health provider.
You and your doctor will decide how long you stay on SPRAVATO, based on how you respond to it and how stable your response is. Your doctor will determine the dosing frequency based on how you feel.
In clinical studies, improvement of depression symptoms was demonstrated at four weeks of treatment with SPRAVATO plus an oral antidepressant, as compared with placebo nasal spray plus an oral antidepressant.
Not all patients respond to SPRAVATO. Your doctor may decide to have you complete the first four weeks of SPRAVATO treatment to see whether you have had satisfactory depression-symptom improvement. If so, talk to all of the healthcare professionals involved in the management of your treatment-resistant depression about appropriate next steps. Do not stop SPRAVATO treatments without first discussing your reasons/concerns with your doctor and formulating an alternate treatment plan.
Your certified SPRAVATO treatment center team may be able to assist you in determining your specific insurance coverage for SPRAVATO and your potential out-of-pocket costs. Janssen CarePath can also help in reviewing with you and your healthcare professional your health plan benefits, insurance coverage and out-of-pocket costs.
Treatment-resistant depression is when adults who are currently struggling with major depressive disorder and have not responded adequately to at least two different antidepressants of adequate dose and duration in the current episode.