Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. Spravato® is indicated, in conjunction with an oral antidepressant, for the treatment of: Spravato must be administered under the direct supervision of a healthcare provider. Esketamine was not mutagenic with or without metabolic activation in the Ames test. TRD is depression that hasn’t improved after treatment with two or more antidepressants. In a single-dose neuronal toxicity study in adult rats, subcutaneously administered racemic ketamine caused neuronal vacuolation in layer I of the retrosplenial cortex of the brain without neuronal necrosis at a dose of 60 mg/kg. Follow these administration instructions and read the Instructions for Use before administration: During and after Spravato administration at each treatment session, observe the patient for at least 2 hours until the patient is safe to leave [see Warnings and Precautions (5.1, 5.2, 5.6, 5.8)]. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. Advise the patient to read the FDA-approved patient labeling (Medication Guide). You will give yourself the nasal spray while being supervised by a healthcare professional. The mean esketamine AUC and t1/2 values were higher in patients with moderate hepatic impairment compared to those with normal hepatic function [see Clinical Pharmacology (12.3)]. This sensor can track when you take your medication. Approximately 19% of patients had reduction in Spravato dosage from 84 mg to 56 mg twice weekly. You should also avoid taking part in activities that require coordination and mental alertness. They’ll ultimately prescribe the smallest dosage that provides the desired effect. Because Spravato has these serious side effects, the FDA has placed restrictions on its use. People who were younger. The safety and effectiveness of Spravato as an anesthetic agent have not been established. Dissociation was more common in people ages 65 years and older. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or significant dosage reduction of a drug. It’s not known for sure how Spravato would affect humans who consume it in breast milk. Advise women not to breastfeed during treatment with Spravato [see Use in Specific Populations (8.2)]. You will need to plan for a caregiver or family member to drive you home after taking Spravato. They will advise when you can safely go home. Spravato is classified by the DEA as a Schedule III controlled substance, indicating a potential for misuse and dependence. All patients received comprehensive standard of care treatment, including an initial inpatient psychiatric hospitalization and a newly initiated or optimized oral antidepressant (AD) (AD monotherapy or AD plus augmentation therapy) as determined by the investigator. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Inform patients that Spravato has potential to cause sedation, dissociative symptoms, perception disturbances, dizziness, vertigo, and anxiety. Use 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device. Spravato and Symbyax have different FDA-approved uses, but they’re both used to treat treatment-resistant depression (TRD). Taking Spravato with caffeine could increase your blood pressure to levels that are not safe. These lists do not contain all the drugs that may interact with Spravato. Nasal Spray Device. You’ll stay at the facility for at least two hours after you receive your dose. Symptoms of sedation include extreme sleepiness, having trouble thinking, and a decreased ability to respond. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 10-05-2019. They’ll also make sure it’s safe for you to leave the facility. Spravato is contraindicated in patients with: In clinical trials, 48% to 61% of Spravato-treated patients developed sedation based on the Modified Observer's Assessment of Alertness/Sedation scale (MOAA/S) [see Adverse Reactions (6.1)], and 0.3% to 0.4% of Spravato-treated patients experienced loss of consciousness (MOAA/S score of 0). Before Spravato administration, instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep. This device is intended for administration by the patient, under supervision of a healthcare professional. Your healthcare provider will monitor you for side effects or allergic reactions. Examples of neurotransmitters include serotonin and dopamine. If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with Spravato. Those who took Spravato were 51% to 70% less likely to relapse back to severe depression than those taking the placebo. Cognitive performance and mental effort were comparable between Spravato and placebo at 2 hours post-dose. Some people taking SPRAVATO ® get nausea and vomiting. After discontinuing prior antidepressant treatments, patients in Study 1 were randomized to receive twice weekly doses of intranasal Spravato (flexible dose; 56 mg or 84 mg) or intranasal placebo. In the year-long study, Spravato also improved depression symptoms. You shouldn’t drive or operate heavy machinery until after you’ve had a full night’s sleep. Depression is a very complicated disease that we’re still learning about. Other antidepressant medications also affect glutamate, but they follow an indirect pathway that takes weeks to produce results if they lead to symptom improvement. If BP remains high, promptly seek assistance from practitioners experienced in BP management. Unit-Dose Container: This drug has boxed warnings. The recommended dosage of Spravato for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior is 84 mg twice per week for 4 weeks. Each spray contains 14 mg of Spravato. Ketamine is approved by the Food and Drug Administration (FDA) for use as an anesthetic. However, more studies are needed to know if ketamine is safe and effective for long-term treatment of depression. Spravato (esketamine) is a prescription medication used in conjunction with an oral antidepressant to treat treatment-resistant depression (TRD) in adults. more than 40 mmHg increase in systolic blood pressure (the top number of your blood pressure), more than 25 mmHg increase in diastolic blood pressure (the bottom number of your blood pressure), don’t eat food for at least two hours before your treatment, don’t drink any liquids for at least 30 minutes before your treatment. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which included treatment for up to a year. Esketamine and its major circulating metabolites do not inhibit these transporters or multi-drug and toxin extrusion 1 (MATE1) and MATE2-K, or organic cation transporter 2 (OCT2), OAT1, or OAT3. If you’re taking an opioid, they may recommend a different medication for you. Examples of stimulant medications include: If you are taking a stimulant medication, talk to your doctor about your risk of elevated blood pressure. Withdrawal symptoms have been reported after the discontinuation of frequently used (more than weekly) large doses of ketamine for long periods of time. Pharmacies must be certified in the REMS and must only dispense Spravato to healthcare settings that are certified in the program. 3. They may monitor you more closely for dangerously high blood pressure after your Spravato treatments. Spravato is taken once or twice per week. Esketamine and its major metabolites do not induce CYP1A2. You’ll need to have someone who can drive you home after your treatment. Spravato is a nasal spray that is used in a healthcare setting. Sleepiness was comparable after 4 hours post-dose. At the highest dose, the AUC exposure to esketamine was lower than the human exposure (AUC) at the maximum recommended human dose (MRHD) of 84 mg. Once-daily subcutaneous administration of esketamine up to 75 mg/kg/day (reduced to 40 mg/kg/day during week 17) did not increase the incidence of tumors in a 6-month study in transgenic (Tg.rasH2) mice. Taking a nasal corticosteroid or nasal decongestant around the time of your Spravato dose may reduce how much Spravato your body absorbs. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Spravato isn’t available for you to purchase at a pharmacy. These medications belong to different drug classes, but they’re both used to treat depression. Based on published findings from pregnant animals treated with ketamine, the racemic mixture of arketamine and esketamine, Spravato may cause fetal harm when administered to pregnant women (see Data). Do not take Spravato if pregnant or breastfeeding. This typically includes drugs that have serious side effects. This drug can be taken at home. Published juvenile animal studies demonstrate that the administration of drugs that block NMDA receptors, such as ketamine, during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Symptoms of high blood pressure can include: vision problems (such as blurry vision, or seeing double). Esketamine (the active drug in Spravato) and ketamine are not the same drug, but they are similar chemicals. What is the most important information I should know about Spravato? Ketamine, the racemic mixture of arketamine and esketamine, is a Schedule III controlled substance and has known abuse potential. Monitor for urinary tract and bladder symptoms during the course of treatment with Spravato, and refer to an appropriate healthcare provider as clinically warranted. Spravato can cause nausea and vomiting. norepinephrine-serotonin modulators, including: aripiprazole (Abilify, Abilify Maintena, Aristada), manic or mixed episodes of bipolar I disorder, agitation related to schizophrenia or bipolar mania, orally disintegrating tablets (dissolve inside your mouth), numbness or strange sensations in your skin, high blood pressure, leading to serious events, including heart attack or stroke, neuroleptic malignant syndrome (an adverse reaction to antipsychotics, similar to serotonin syndrome), tardive dyskinesia (uncontrolled movement of body parts), changes in metabolism that can cause high blood sugar, diabetes, and weight gain, unusual urges (such as gambling or binge eating), orthostatic hypotension (low blood pressure when you stand up), trouble swallowing, which may lead to food or liquid entering your lungs, suicidal thoughts or behavior, especially in young adults, edema (swelling) in your feet, ankles, and legs, tremor (shaking, usually in your hands and arms), increased blood pressure, leading to serious events, including heart attack or stroke, neuroleptic malignant syndrome (adverse reaction to antipsychotics, similar to serotonin syndrome), changes in metabolism that cause high blood sugar, diabetes, and weight gain, life-threatening rash, called drug reaction with eosinophilia and systemic symptoms (DRESS), bleeding easily or bleeding more often than usual, high levels of prolactin (a certain hormone in your body), increased risk of death in people ages 65 years and older with psychosis, oxycodone (Oxycontin, Roxicodone, Xtampza ER), fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Subsys), zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist), amphetamines/amphetamine salts (Adderall XR, Dexedrine, Dyanavel XR, Evekeo, Mydayis, Vyvanse), methylphenidate (Adhansia XR, Aptensio XR, Concerta, Daytrana, Focalin, many others), don’t eat food for at least two hours before taking Spravato, and, don’t drink liquids for at least 30 minutes before taking Spravato.