Cognitive performance and mental effort were comparable between SPRAVATO® and placebo at 2 hours post-dose. This website also includes helpful information about the treatment center, such as contact information and business hours. Your Experts in Ketamine and IV Therapy Infusions and Clinics. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Infusion and IV Therapy. Scott Integrated Pain Management scottpain.com offers individualized pain management treatments including ketamine and spravato to patients in need of the most up to date treatments for pain and depression. Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure. Esketamine must be administered and monitored in an approved clinic. Closely monitor blood pressure with concomitant use of psychostimulants. Pregnancy: SPRAVATO® is not recommended during pregnancy. Controlled Substances Act. Single Line Text. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. KWC was one of the first ketamine clinics to open its doors to the public in 2011. You are being directed to a third-party website: This link is provided for your convenience. If you are an Inpatient Pharmacy (support inpatient units, emergency department, etc.) What is in the Nasal spray ketamine? At the end of four weeks, there was no statistically significant difference between … Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. Healthcare settings must be certified in the program and ensure that SPRAVATO. Treatment-resistant depression (TRD) in adults. All rights reserved. Call now for more information. Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included adult and pediatric patients, the incidence of suicidal thoughts and behaviors in patients age 24 years and younger was greater than in placebo-treated patients. Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. For a list of full-line wholesalers or specialty distributors and other downloadable resources, visit www.spravatotreatmentcenter.com/education. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. SPRAVATO® (esketamine) CIII nasal spray is the S-enantiomer of racemic ketamine. SPRAVATO® is not to be delivered directly to patients. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. This database is compiled for informational purposes only. Pediatric Use: The safety and effectiveness of SPRAVATO® in pediatric patients have not been established. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. Patients treated in outpatient settings (e.g., medical offices and clinics) must be enrolled in the program. Depending on how your insurance covers SPRAVATO®, there is a program benefit limit of list price of the medication and a quantity limit of … At the end of four weeks, there was no statistically significant difference between groups on the primary efficacy endpoint of change from baseline to Week 4 on the Montgomery-Åsberg Depression Rating Scale (MADRS). Multilingual phone support available. Treatment may include up to three devices administered on the same day. Only dispensed and administered in healthcare settings. Start your Ketamine Infusion journey today . Affordability supportto help your patients start and stay on the treatment you prescribe. To find a certified SPRAVATO® treatment center, you or your patients may visit www.spravatohcp.com/findacenter. When looking for a SPRAVATO™ clinic near you in NYC, consider Principium Psychiatry. Multilingual phone support is available. Information about coverage, coding, and the overall reimbursement process for SPRAVATO®. If a patient misses treatment sessions, provided there is no worsening of their depressive symptoms, the patient should continue the current dosing schedule. Increases in BP peak approximately 40 minutes after SPRAVATO® administration and last approximately 4 hours. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO®, during pregnancy. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO®. Please call us at 716-961-9204 to see if a referral is necessary. Multiple Treatments. Patient insurance benefits investigation and other Janssen CarePath program offerings are provided by third-party service providers for Janssen CarePath, under contract with Johnson & Johnson Health Care Systems Inc. on behalf of Actelion Pharmaceuticals US, Inc., Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc., and Janssen Products, LP (Janssen). In patients with history of hypertensive encephalopathy, more intensive monitoring, including more frequent blood pressure and symptom assessment, is warranted because these patients are at increased risk for developing encephalopathy with even small increases in blood pressure. A derivative of the drug ketamine, Spravato has been in development for 10 years with clinical studies revealing effectiveness when . There are no samples of SPRAVATO® available—in accordance with federal guidelines, which prohibit the distribution of samples of class III medications. Spravato is designed to treat depression that has resisted other treatments and differs from most commonly used antidepressants by targeting a different neuroreceptor in the brain. Closely monitor for sedation with concomitant use of CNS depressants. Safe, Effective Relief, Fast. Our location has 6 full time custom designed rooms for the optimal and most comfortable Spravato Treatment experience. 215.825.5979. Click here for the Resource Guide. | 877-524-3579877-CarePath (877-227-3728), Monday-Friday, 8:00 AM to 8:00 PM ET. Searchable by ZIP Code, this helpful site provides detailed search results organized by driving distance. Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label use or misuse/abuse of ketamine. Both SPRAVATO® and ketamine are Schedule III controlled substances under the US Controlled Substances Act. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Impaired Ability to Drive and Operate Machinery: 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. Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included adult and pediatric patients, the incidence of suicidal thoughts and behaviors in patients age 24 years and younger was greater than in placebo-treated patients. CNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increase sedation. We have treated the largest number of Spravato patients in the country. In patients with history of hypertensive encephalopathy, more intensive monitoring, including more frequent blood pressure and symptom assessment, is warranted because these patients are at increased risk for developing encephalopathy with even small increases in blood pressure. Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO® and refer to an appropriate healthcare provider as clinically warranted. Hypersensitivity to esketamine, ketamine, or any of the excipients. Closely monitor blood pressure with concomitant use of SPRAVATO® with psychostimulants or monoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)]. I haven’t felt normal in six years. Thrive Wellness Group. You administer SPRAVATO® nasal spray yourself under the supervision of a healthcare provider at a certified SPRAVATO® treatment center. Our clinical program is led by board certified Anesthesiologist, Dr. Mark Murphy and Psychologist, Dr. Ellen Diamond. Call a Janssen CarePath Care Coordinator at 844-777-2828, Monday–Friday, 8:00 AM to 8:00 PM ET for more information, including help in finding a certified SPRAVATO® treatment center. In MDSI trials for adults with MDSI, all patients received comprehensive standard-of-care treatment, including an initial inpatient hospitalization and a newly initiated or optimized oral AD therapy as determined by the investigator. Program does not cover the cost to give patients their treatment. Call a Janssen CarePath Care Coordinator at 844-777-2828, Monday - Friday, 8:00 AM to 8:00 PM ET. Due to the possibility of delayed or prolonged sedation or dissociation in some cases, patients should be monitored by a healthcare provider for at least 2 hours following each treatment session, or until the clinician determines the patient is safe to leave. Approximately 8% to 19% of SPRAVATO®-treated patients experienced an increase of more than 40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the first 1.5 hours after administration at least once during the first 4 weeks of treatment. SPRAVATO® has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Access supportto help navigate payer processes. The efficacy of SPRAVATO ® for the treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO ® plus a newly initiated oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 years of age. No adverse effects of SPRAVATO® nasal spray on cognitive functioning were observed in a one-year open-label safety study; however, the long-term cognitive effects of SPRAVATO® have not been evaluated beyond one year. There are risks to the mother associated with untreated depression in pregnancy. “I have been doing Spravato treatments for approximately 10 weeks (for bipolar) and I, and everyone who knows me, have seen a wonderful improvement in mood and energy. The efficacy of SPRAVATO® for the treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO® plus a newly initiated oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 years of age. Before prescribing SPRAVATO®, patients with other cardiovascular and cerebrovascular conditions should be carefully assessed to determine whether the potential benefits of SPRAVATO® outweigh its risk. If a woman becomes pregnant while being treated with SPRAVATO®, treatment with SPRAVATO® should be discontinued and the patient should be counseled about the potential risk to the fetus. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label use or misuse/abuse of ketamine. Terms expire at the end of each calendar year and may change. There is no income requirement. Read the press release Download the full PI, © Janssen Pharmaceuticals, Inc. 2020. Ketamine has not been approved by the FDA to treat depression. Controlled Substance: SPRAVATO® contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act. There are risks to the mother associated with untreated depression in pregnancy. This website also includes helpful information about the treatment center, such as contact information and business hours. Hepatic Impairment: SPRAVATO®-treated patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time. 3300 Henry Ave. Suite 112 . Scott Integrated Pain Management. Amelia D. has taken esketamine through a … Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO® caused cognitive performance decline 40 minutes post-dose. If a woman becomes pregnant while being treated with SPRAVATO®, treatment with SPRAVATO® should be discontinued and the patient should be counseled about the potential risk to the fetus. SPRAVATO® is only administered in a medically supervised healthcare setting that is certified under the SPRAVATO® REMS. Information for your certified SPRAVATO® treatment center, to help understand patients’ individual reimbursement scenarios. What to expect with IV Infusion therapy. Hypersensitivity to esketamine, ketamine, or any of the excipients. Consider the risks and benefits of prescribing SPRAVATO® prior to using in patients at higher risk of abuse. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. This is an initial option for treatment therapies for depression, pain, PTSD, nxiety, and cluster headaches. To find a certified SPRAVATO® treatment center, you or your patients may visit www.spravatohcp.com/findacenter. Pediatric Use: The safety and effectiveness of SPRAVATO® in pediatric patients have not been established. If BP remains high, promptly seek assistance from practitioners experienced in BP management. SPRAVATO (esketamine) Nasal Spray. This means: You must come to the clinic to get the medications administered a. BP should be monitored for at least 2 hours after SPRAVATO® administration. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Our clinics, located nationwide, provide a healing and comfortable environment for patients as they embark on their road to wellness. BP should be monitored for at least 2 hours after SPRAVATO® administration. Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. Specialty Ketamine Treatment Provider Located in Brentwood, TN. Ingredients. Searchable by ZIP Code, this helpful site provides detailed search results organized by driving distance. Coverage & Cost Support. Dissociation: The most common psychological effects of SPRAVATO® were dissociative or perceptual changes (including distortion of time, space and illusions), derealization and depersonalization (61% to 84% of SPRAVATO®-treated patients developed dissociative or perceptual changes). Book Now - 972-221-1741. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. SPRAVATO® is contraindicated in patients for whom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage). Because of the possibility of delayed or prolonged sedation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.