Ketamine Therapeutics has been Certified as a Health Care Center and a Pharmacy by the SPRAVATO™ REMS program.
SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression in adults.
The FDA has determined that a REMS is necessary to ensure that the benefits of SPRAVATO™ outweigh the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO™ administration, and abuse and misuse of SPRAVATO™.
SPRAVATO™ is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours after SPRAVATOTM administration. SPRAVATOTM must never be dispensed directly to a patient for home use.
MEDICATION GUIDE SPRAVATO™ (sprah vah’ toe) CIII (esketamine) nasal spray
What is the most important information I should know about SPRAVATO?
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.
- Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO. ° Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. ° Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- 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 and to patients enrolled in the program.
- Increased risk of suicidal thoughts or actions. SPRAVATO may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? ° Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. ° Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings. ° Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: ° attempts to commit suicide ° worsening depression ° thoughts about suicide or dying ° other unusual changes in behavior or mood SPRAVATO is not for use in children.
What is SPRAVATO?
SPRAVATO is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults. SPRAVATO is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO is safe or effective as an anesthetic medicine. 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. See the end of this Medication Guide for a complete list of ingredients in SPRAVATO. If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO. 2 of 3 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. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO and their baby. If you become pregnant during treatment with SPRAVATO, 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 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. See “What is the most important information I should know about SPRAVATO?” SPRAVATO™ (esketamine) nasal spray, CIII 3 of 3
What are the possible side effects of SPRAVATO?
SPRAVATO may cause serious side effects including: • See “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 • anxiety • dizziness • lack of energy • nausea • increased blood pressure • sedation • vomiting • spinning sensation • feeling drunk • reduced sense of touch and sensation 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. General information about the safe and effective use of SPRAVATO. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about SPRAVATO that is written for health professionals. What are the ingredients in SPRAVATO? Active ingredient: esketamine hydrochloride Inactive ingredients: citric acid monohydrate, edetate disodium, sodium hydroxide, and water for injection Manufactured by: Renaissance Lakewood LLC, Lakewood, NJ 08701 Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560 © 2019 Janssen Pharmaceutical Companies For more information, go to www.SPRAVATO.com or call 1-800-526-7736. This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 03/2019