Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

Providing resources to help your patients start and stay on the Janssen medications you prescribe

Your one source for patient support

Resource Guide

Visit us online JanssenCarePath.com/HCP/Spravato

Need help?

Call 844-777-2828Monday–Friday, 8:00 am–8:00 pm ETMultilingual phone support available

Janssen CarePath helps verify insurance coverage for your patients prescribed Janssen medications and provides reimbursement information.

Our offerings include:

• Benefits investigation support

• Prior authorization support and status monitoring

• Information on the exceptions and appeals process

• Coding and billing information for the product, if needed

Access support to help navigate payer processes

Janssen CarePath is your one source for

resources focused on access, affordability,

and treatment support for your patients.

Our dedicated Care Coordinator team

supports the Janssen medications you

prescribe. We can help make it easier for

you and your patients to get the resources

you both may need.

We can help make it simple for you to help your patients

Convenient online support at your fingertips.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

JanssenCarePath.com/HCP/Spravato

Janssen Products General Resources Contact Us For Patients and Caregivers

Indication & Important Safety Information Prescribing Information

Insurance Coverage A�ordability Support Forms & Documents

Welcome to Janssen CarePath

We’re here to help with Janssen Medications

At Janssen CarePath, we’re committed to helping you get your patients started on the Janssen medications you prescribed, �nding �nancial

assistance options, and providing ongoing support to help them stay on prescribed Janssen therapy.

What Janssen CarePath can do for you on behalf of your patients:

Provide support with dedicated Care Coordinators for you and your patients

Conduct bene�ts investigations and provide health plan coverage information

Review and explain patients' coverage and out-of-pocket cost for SPRAVATO

Help identify �nancial assistance options for eligible patients

Provide patient support resources, including educational materials

SPRAVATO is marketed by Janssen Pharmaceuticals, Inc.

®

®

IndicationSPRAVATO (esketamine) CIII Nasal Sprayis indicated, in conjunction with an oralantidepressant (AD), for the treatment oftreatment-resistant depression (TRD) inadults.

SPRAVATO is not approved as ananesthetic agent. The safety ande�ectiveness of SPRAVATO as ananesthetic agent have not beenestablished.

Important Safety Information For SPRAVATO

WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTSAND BEHAVIORS

See full prescribing information for complete boxed warning  

Risk for sedation and dissociation after administration. Monitor patients forat least two hours after administration (5.1, 5.2).Potential for abuse and misuse. Consider the risks and benets of usingSPRAVATO prior to use in patients at higher risk of abuse. Monitor for signsand symptoms of abuse and misuse (5.3).SPRAVATO is only available through a restricted program called theSPRAVATO REMS (5.4).Increased risk of suicidal thoughts and behaviors in pediatric and young adultpatients taking antidepressants. Closely monitor all antidepressant-treatedpatients for clinical worsening and emergence of suicidal thoughts andbehaviors. SPRAVATO is not approved for use in pediatric patients (5.5).

CONTRAINDICATIONSSPRAVATO is contraindicated in patients with:

Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial andperipheral arterial vessels) or arteriovenous malformation

History of intracerebral hemorrhage

Hypersensitivity to esketamine, ketamine, or any of the excipients

WARNINGS AND PRECAUTIONSSedation: In clinical trials, 49% to 61% of SPRAVATO -treated patients developed sedation and0.3% of SPRAVATO -treated patients experienced loss of consciousness.

Because of the possibility of delayed or prolonged sedation, patients must be monitored by ahealthcare provider for at least 2 hours at each treatment session, followed by an assessment todetermine when the patient is considered clinically stable and ready to leave the healthcaresetting.

Closely monitor for sedation with concomitant use of SPRAVATO with CNS depressants [seeDrug Interaction (7.1)].

SPRAVATO is available only through a restricted program under a REMS.  

Dissociation: The most common psychological e�ects of SPRAVATO were dissociative orperceptual changes (including distortion of time, space and illusions), derealization anddepersonalization (61% to 75% of SPRAVATO -treated patients developed dissociative orperceptual changes). Given its potential to induce dissociative e�ects, carefully assess patientswith psychosis before administering SPRAVATO ; treatment should be initiated only if thebene�t outweighs the risk.

Because of the risks of dissociation, patients must be monitored by a healthcare provider for atleast 2 hours at each treatment session, followed by an assessment to determine when thepatient is considered clinically stable and ready to leave the healthcare setting.

SPRAVATO is available only through a restricted program under a REMS.

Abuse and Misuse: SPRAVATO contains esketamine, a Schedule III controlled substance (CIII),and may be subject to abuse and diversion. Assess each patient’s risk for abuse or misuse priorto prescribing and monitor all patients for the development of these behaviors or conditions,including drug-seeking behavior, while on therapy. Individuals with a history of drug abuse ordependence are at greater risk; therefore, use careful consideration prior to treatment ofindividuals with a history of substance use disorder and monitor for signs of abuse ordependence.

SPRAVATO is available only through a restricted program under a REMS.

SPRAVATO Risk Evaluation and Mitigation Strategy (REMS): SPRAVATO is available onlythrough a restricted program called the SPRAVATO REMS because of the risks of seriousadverse outcomes from sedation, dissociation, and abuse and misuse.

Important requirements of the SPRAVATO REMS include the following:

Healthcare settings must be certi�ed in the program and ensure that SPRAVATO is:Only dispensed in healthcare settings and administered to patients who are enrolledin the program.

Administered by patients under the direct observation of a healthcare provider andthat patients are monitored by a healthcare provider for at least 2 hours afteradministration of SPRAVATO .

Pharmacies must be certi�ed in the REMS and must only dispense SPRAVATO tohealthcare settings that are certi�ed in the program.

Further information, including a list of certi�ed pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022.  

Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses ofplacebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) thatincluded adult and pediatric patients, the incidence of suicidal thoughts and behaviors inpatients age 24 years and younger was greater than in placebo-treated patients. SPRAVATO isnot approved in pediatric (<18 years of age) patients.

There was considerable variation in risk of suicidal thoughts and behaviors among drugs, butthere was an increased risk identi�ed in young patients for most drugs studied.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidalthoughts and behaviors, especially during the initial few months of drug therapy and at times ofdosage changes. Counsel family members or caregivers of patients to monitor for changes inbehavior and to alert the healthcare provider. Consider changing the therapeutic regimen,including possibly discontinuing SPRAVATO and/or the concomitant oral antidepressant, inpatients whose depression is persistently worse, or who are experiencing emergent suicidalthoughts or behaviors.

Increase in Blood Pressure: SPRAVATO causes increases in systolic and/or diastolic bloodpressure (BP) at all recommended dosages. Increases in BP peak approximately 40 minutesafter SPRAVATO administration and last approximately 4 hours.

Approximately 8% to 17% of SPRAVATO -treated patients experienced an increase of morethan 40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the �rst 1.5 hours afteradministration at least once during the �rst 4 weeks of treatment. A substantial increase inblood pressure could occur after any dose administered even if smaller blood pressure e�ectswere observed with previous administrations. SPRAVATO is contraindicated in patients forwhom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vasculardisease, arteriovenous malformation, history of intracerebral hemorrhage). Before prescribing,patients with other cardiovascular and cerebrovascular conditions should be carefully assessedto determine whether the potential bene�ts of SPRAVATO outweigh its risk.

Assess BP prior to administration of SPRAVATO . In patients whose BP is elevated prior toSPRAVATO administration (as a general guide: >140/90 mmHg), a decision to delay SPRAVATOtherapy should be taken into account to balance the bene�t and risk in individual patients.

BP should be monitored for at least 2 hours after SPRAVATO administration. Measure bloodpressure around 40 minutes post-dose and subsequently as clinically warranted until valuesdecline. If BP remains high, promptly seek assistance from practitioners experienced in BPmanagement. Refer patients experiencing symptoms of a hypertensive crisis (e.g., chest pain,shortness of breath) or hypertensive encephalopathy (e.g., sudden severe headache, visualdisturbances, seizures, diminished consciousness or focal neurological de�cits) immediately foremergency care.

Closely monitor blood pressure with concomitant use of SPRAVATO with psychostimulants ormonoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)].

In patients with history of hypertensive encephalopathy, more intensive monitoring, includingmore frequent blood pressure and symptom assessment, is warranted because these patientsare at increased risk for developing encephalopathy with even small increases in bloodpressure.  

Cognitive ImpairmentShort-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATOcaused cognitive performance decline 40 minutes post-dose. SPRAVATO -treated subjectsrequired a greater e�ort to complete the cognitive tests at 40 minutes post-dose. Cognitiveperformance and mental e�ort were comparable between SPRAVATO and placebo at 2 hourspost-dose. Sleepiness was comparable after 4 hours post-dose.

Long-Term Cognitive Impairment:  Long-term cognitive and memory impairment have beenreported with repeated ketamine misuse or abuse. No adverse e�ects of SPRAVATO nasalspray on cognitive functioning were observed in a one-year open-label safety study; however,the long-term cognitive e�ects of SPRAVATO have not been evaluated beyond one year.

Impaired Ability to Drive and Operate Machinery: Before SPRAVATO administration,instruct patients not to engage in potentially hazardous activities requiring complete mentalalertness and motor coordination, such as driving a motor vehicle or operating machinery, untilthe next day following a restful sleep. Patients will need to arrange transportation homefollowing treatment with SPRAVATO .

Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reportedin individuals with long-term o�-label use or misuse/abuse of ketamine. In clinical studies withSPRAVATO nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria,dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO -treated patients than inplacebo-treated patients. No cases of esketamine-related interstitial cystitis were observed inany of the studies, which involved treatment for up to a year.

Monitor for urinary tract and bladder symptoms during the course of treatment withSPRAVATO and refer to an appropriate healthcare provider as clinically warranted.

Embryo-fetal Toxicity: SPRAVATO may cause fetal harm when administered to pregnantwomen. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO inutero. Advise women of reproductive potential to consider pregnancy planning and prevention.  

DRUG INTERACTIONSCNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increasesedation. Closely monitor for sedation with concomitant use of CNS depressants.

Psychostimulants (e.g., amphetamines, methylphenidate, modanil,armodanil): Concomitant use may increase blood pressure. Closely monitor blood pressurewith concomitant use of psychostimulants.

Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure.Closely monitor blood pressure with concomitant use of MAOIs.  

USE IN SPECIFIC POPULATIONSPregnancy: SPRAVATO is not recommended during pregnancy. SPRAVATO may cause fetalharm when administered to pregnant women. Advise pregnant women of the potential risk toan infant exposed to SPRAVATO in utero. There are risks to the mother associated withuntreated depression in pregnancy. If a woman becomes pregnant while being treated withSPRAVATO , treatment with SPRAVATO should be discontinued and the patient should becounseled about the potential risk to the fetus.

Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancyoutcomes in women exposed to antidepressants, including SPRAVATO , during pregnancy.Healthcare providers are encouraged to register patients by contacting the National PregnancyRegistry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

Lactation: SPRAVATO is present in human milk. Because of the potential for neurotoxicity,advise patients that breastfeeding is not recommended during treatment with SPRAVATO .

Females and Males of Reproductive Potential: SPRAVATO may cause embryo-fetal harmwhen administered to a pregnant woman. Consider pregnancy planning and prevention forfemales of reproductive potential during treatment with SPRAVATO .

Pediatric Use: The safety and e�ectiveness of SPRAVATO in pediatric patients have not beenestablished.

Geriatric Use: Of the total number of patients in Phase 3 clinical studies exposed toSPRAVATO , 12% were 65 years of age and older, and 2% were 75 years of age and older. Nooverall di�erences in the safety pro�le were observed between patients 65 years of age andolder and patients younger than 65 years of age.

The mean esketamine C and AUC values were higher in elderly patients compared withyounger adult patients.

The treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blindstudy comparing �exibly-dosed intranasal SPRAVATO plus a newly initiated oral antidepressantcompared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 yearsof age. At the end of four weeks, there was no statistically signi�cant di�erence between groupson the primary e�cacy endpoint of change from baseline to Week 4 on the Montgomery-ÅsbergDepression Rating Scale (MADRS).

Hepatic Impairment: SPRAVATO -treated patients with moderate hepatic impairment mayneed to be monitored for adverse reactions for a longer period of time.

SPRAVATO has not been studied in patients with severe hepatic impairment (Child-Pugh classC). Use in this population is not recommended.  

DRUG ABUSE AND DEPENDENCEControlled Substance: SPRAVATO contains esketamine hydrochloride, the (S)-enantiomer ofketamine and a Schedule III controlled substance under the Controlled Substances Act.

Abuse: Individuals with a history of drug abuse or dependence may be at greater risk for abuseand misuse of SPRAVATO . Abuse is the intentional, non-therapeutic use of a drug, even once,for its psychological or physiological e�ects. Misuse is the intentional use, for therapeuticpurposes, of a drug by an individual in a way other than prescribed by a healthcare provider orfor whom it was not prescribed. Careful consideration is advised prior to use of individuals witha history of substance use disorder, including alcohol.

SPRAVATO may produce a variety of symptoms including anxiety, dysphoria, disorientation,insomnia, �ashback, hallucinations, and feelings of �oating, detachment and to be “spaced out.”Monitoring for signs of abuse and misuse is recommended.  

ADVERSE REACTIONSThe most common adverse reactions with SPRAVATO plus oral AD (incidence ≥5% and at leasttwice that of placebo nasal spray plus oral AD) were dissociation, dizziness, nausea, sedation,vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk.  

Please see full Prescribing Information, including Boxed WARNINGS, and MedicationGuide for SPRAVATO . cp-79821v2

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Patient insurance bene�ts investigation and other Janssen CarePath program o�erings are provided by third-party service providers for Janssen CarePath,under contract with Johnson & Johnson Health Care Systems Inc., on behalf of Janssen Pharmaceuticals, Inc., Janssen Biotech, Inc., and Janssen Products, LP(Janssen). Janssen CarePath is not available to patients participating in the Patient Assistance Program o�ered by Johnson & Johnson Patient AssistanceFoundation. The availability of information and assistance may vary based on the Janssen medication, geography and other program di�erences. JanssenCarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based oncoverage guidelines provided by the payer, and patient information provided by the healthcare provider under appropriate authorization following theprovider's exclusive determination of medical necessity. This information and assistance are made available as a convenience to patients, and there is norequirement that patients or HCPs use any Janssen product in exchange for this information or assistance. Janssen assumes no responsibility for and doesnot guarantee the quality, scope, or availability of the information and assistance provided. The third-party service providers, not Janssen, are responsible forthe information and assistance provided under this program. Each HCP and patient is responsible for verifying and con�rming any information provided. Allclaims and other submissions to payers should be in compliance with all applicable requirements. ©  Johnson & Johnson Health Care Systems Inc. 2019. All rights reserved. | 877-524-3579, Monday-Friday, 8:00 AM to 8:00 PM ET This site is published by Johnson & Johnson Health Care Systems Inc.Capitalized product names are trademarks of Johnson & Johnson or its a�liated companies. This site is intended for use in the United States.Third party trademarks used herein are trademarks of their respective owners. Last updated on October 25, 2019.The use of the information on this site is subject to the terms of our Legal Notice and Privacy Policy. Privacy Policy | Legal Notice | Site Map | Contact Us

2

Janssen CarePath provides additional support to your patients prescribed SPRAVATO®, including:

• Patient education materials

• Web-based resources

• Assistance finding a Risk Evaluation and Mitigation Strategy (REMS)-certified location that offers SPRAVATO® treatment

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking Janssen medications.

Support for patients using commercial or private insurance:

• Janssen CarePath Savings Program for SPRAVATO® allows eligible patients to pay $10 per treatment for SPRAVATO® medication costs with a $7,150 maximum program benefit per calendar year.* Treatment may include up to three devices administered on the same day. Program limits apply. Depending on how their insurance covers SPRAVATO®, there is a quantity limit of three devices per day or up to 23 devices per 24-day period and a program benefit limit of list price of the medication

° Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give patients their treatment

Support for patients using government-funded healthcare programs or patients without insurance coverage:

• JanssenPrescriptionAssistance.com provides information on

affordability programs that may be available

Treatment support to help your patients get informed and stay on prescribed treatment

Affordability support to help your patients start and stay on the Janssen treatment you prescribe

*See Spravato.JanssenCarePathSavings.com for program requirements.

Other resources

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 800-652-6227 (Monday–Friday, 9:00 am–6:00 pm ET) or visit the foundation website at JJPAF.org.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

3

Convenient online support for your practice on behalf of your patients

Resources are always available at JanssenCarePath.com

Forms available include:

• Benefits Investigation Form (BIF)

• Sample Letter of Medical Necessity

• Sample Exception Letter

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

Janssen Products General Resources Contact Us For Patients and Caregivers

Indication & Important Safety Information Prescribing Information

Insurance Coverage A�ordability Support Forms & Documents

Welcome to Janssen CarePath

We’re here to help with Janssen Medications

At Janssen CarePath, we’re committed to helping you get your patients started on the Janssen medications you prescribed, �nding �nancial

assistance options, and providing ongoing support to help them stay on prescribed Janssen therapy.

What Janssen CarePath can do for you on behalf of your patients:

Provide support with dedicated Care Coordinators for you and your patients

Conduct bene�ts investigations and provide health plan coverage information

Review and explain patients' coverage and out-of-pocket cost for SPRAVATO

Help identify �nancial assistance options for eligible patients

Provide patient support resources, including educational materials

SPRAVATO is marketed by Janssen Pharmaceuticals, Inc.

®

®

IndicationSPRAVATO (esketamine) CIII Nasal Sprayis indicated, in conjunction with an oralantidepressant (AD), for the treatment oftreatment-resistant depression (TRD) inadults.

SPRAVATO is not approved as ananesthetic agent. The safety ande�ectiveness of SPRAVATO as ananesthetic agent have not beenestablished.

Important Safety Information For SPRAVATO

WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTSAND BEHAVIORS

See full prescribing information for complete boxed warning  

Risk for sedation and dissociation after administration. Monitor patients forat least two hours after administration (5.1, 5.2).Potential for abuse and misuse. Consider the risks and benets of usingSPRAVATO prior to use in patients at higher risk of abuse. Monitor for signsand symptoms of abuse and misuse (5.3).SPRAVATO is only available through a restricted program called theSPRAVATO REMS (5.4).Increased risk of suicidal thoughts and behaviors in pediatric and young adultpatients taking antidepressants. Closely monitor all antidepressant-treatedpatients for clinical worsening and emergence of suicidal thoughts andbehaviors. SPRAVATO is not approved for use in pediatric patients (5.5).

CONTRAINDICATIONSSPRAVATO is contraindicated in patients with:

Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial andperipheral arterial vessels) or arteriovenous malformation

History of intracerebral hemorrhage

Hypersensitivity to esketamine, ketamine, or any of the excipients

WARNINGS AND PRECAUTIONSSedation: In clinical trials, 49% to 61% of SPRAVATO -treated patients developed sedation and0.3% of SPRAVATO -treated patients experienced loss of consciousness.

Because of the possibility of delayed or prolonged sedation, patients must be monitored by ahealthcare provider for at least 2 hours at each treatment session, followed by an assessment todetermine when the patient is considered clinically stable and ready to leave the healthcaresetting.

Closely monitor for sedation with concomitant use of SPRAVATO with CNS depressants [seeDrug Interaction (7.1)].

SPRAVATO is available only through a restricted program under a REMS.  

Dissociation: The most common psychological e�ects of SPRAVATO were dissociative orperceptual changes (including distortion of time, space and illusions), derealization anddepersonalization (61% to 75% of SPRAVATO -treated patients developed dissociative orperceptual changes). Given its potential to induce dissociative e�ects, carefully assess patientswith psychosis before administering SPRAVATO ; treatment should be initiated only if thebene�t outweighs the risk.

Because of the risks of dissociation, patients must be monitored by a healthcare provider for atleast 2 hours at each treatment session, followed by an assessment to determine when thepatient is considered clinically stable and ready to leave the healthcare setting.

SPRAVATO is available only through a restricted program under a REMS.

Abuse and Misuse: SPRAVATO contains esketamine, a Schedule III controlled substance (CIII),and may be subject to abuse and diversion. Assess each patient’s risk for abuse or misuse priorto prescribing and monitor all patients for the development of these behaviors or conditions,including drug-seeking behavior, while on therapy. Individuals with a history of drug abuse ordependence are at greater risk; therefore, use careful consideration prior to treatment ofindividuals with a history of substance use disorder and monitor for signs of abuse ordependence.

SPRAVATO is available only through a restricted program under a REMS.

SPRAVATO Risk Evaluation and Mitigation Strategy (REMS): SPRAVATO is available onlythrough a restricted program called the SPRAVATO REMS because of the risks of seriousadverse outcomes from sedation, dissociation, and abuse and misuse.

Important requirements of the SPRAVATO REMS include the following:

Healthcare settings must be certi�ed in the program and ensure that SPRAVATO is:Only dispensed in healthcare settings and administered to patients who are enrolledin the program.

Administered by patients under the direct observation of a healthcare provider andthat patients are monitored by a healthcare provider for at least 2 hours afteradministration of SPRAVATO .

Pharmacies must be certi�ed in the REMS and must only dispense SPRAVATO tohealthcare settings that are certi�ed in the program.

Further information, including a list of certi�ed pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022.  

Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses ofplacebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) thatincluded adult and pediatric patients, the incidence of suicidal thoughts and behaviors inpatients age 24 years and younger was greater than in placebo-treated patients. SPRAVATO isnot approved in pediatric (<18 years of age) patients.

There was considerable variation in risk of suicidal thoughts and behaviors among drugs, butthere was an increased risk identi�ed in young patients for most drugs studied.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidalthoughts and behaviors, especially during the initial few months of drug therapy and at times ofdosage changes. Counsel family members or caregivers of patients to monitor for changes inbehavior and to alert the healthcare provider. Consider changing the therapeutic regimen,including possibly discontinuing SPRAVATO and/or the concomitant oral antidepressant, inpatients whose depression is persistently worse, or who are experiencing emergent suicidalthoughts or behaviors.

Increase in Blood Pressure: SPRAVATO causes increases in systolic and/or diastolic bloodpressure (BP) at all recommended dosages. Increases in BP peak approximately 40 minutesafter SPRAVATO administration and last approximately 4 hours.

Approximately 8% to 17% of SPRAVATO -treated patients experienced an increase of morethan 40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the �rst 1.5 hours afteradministration at least once during the �rst 4 weeks of treatment. A substantial increase inblood pressure could occur after any dose administered even if smaller blood pressure e�ectswere observed with previous administrations. SPRAVATO is contraindicated in patients forwhom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vasculardisease, arteriovenous malformation, history of intracerebral hemorrhage). Before prescribing,patients with other cardiovascular and cerebrovascular conditions should be carefully assessedto determine whether the potential bene�ts of SPRAVATO outweigh its risk.

Assess BP prior to administration of SPRAVATO . In patients whose BP is elevated prior toSPRAVATO administration (as a general guide: >140/90 mmHg), a decision to delay SPRAVATOtherapy should be taken into account to balance the bene�t and risk in individual patients.

BP should be monitored for at least 2 hours after SPRAVATO administration. Measure bloodpressure around 40 minutes post-dose and subsequently as clinically warranted until valuesdecline. If BP remains high, promptly seek assistance from practitioners experienced in BPmanagement. Refer patients experiencing symptoms of a hypertensive crisis (e.g., chest pain,shortness of breath) or hypertensive encephalopathy (e.g., sudden severe headache, visualdisturbances, seizures, diminished consciousness or focal neurological de�cits) immediately foremergency care.

Closely monitor blood pressure with concomitant use of SPRAVATO with psychostimulants ormonoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)].

In patients with history of hypertensive encephalopathy, more intensive monitoring, includingmore frequent blood pressure and symptom assessment, is warranted because these patientsare at increased risk for developing encephalopathy with even small increases in bloodpressure.  

Cognitive ImpairmentShort-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATOcaused cognitive performance decline 40 minutes post-dose. SPRAVATO -treated subjectsrequired a greater e�ort to complete the cognitive tests at 40 minutes post-dose. Cognitiveperformance and mental e�ort were comparable between SPRAVATO and placebo at 2 hourspost-dose. Sleepiness was comparable after 4 hours post-dose.

Long-Term Cognitive Impairment:  Long-term cognitive and memory impairment have beenreported with repeated ketamine misuse or abuse. No adverse e�ects of SPRAVATO nasalspray on cognitive functioning were observed in a one-year open-label safety study; however,the long-term cognitive e�ects of SPRAVATO have not been evaluated beyond one year.

Impaired Ability to Drive and Operate Machinery: Before SPRAVATO administration,instruct patients not to engage in potentially hazardous activities requiring complete mentalalertness and motor coordination, such as driving a motor vehicle or operating machinery, untilthe next day following a restful sleep. Patients will need to arrange transportation homefollowing treatment with SPRAVATO .

Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reportedin individuals with long-term o�-label use or misuse/abuse of ketamine. In clinical studies withSPRAVATO nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria,dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO -treated patients than inplacebo-treated patients. No cases of esketamine-related interstitial cystitis were observed inany of the studies, which involved treatment for up to a year.

Monitor for urinary tract and bladder symptoms during the course of treatment withSPRAVATO and refer to an appropriate healthcare provider as clinically warranted.

Embryo-fetal Toxicity: SPRAVATO may cause fetal harm when administered to pregnantwomen. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO inutero. Advise women of reproductive potential to consider pregnancy planning and prevention.  

DRUG INTERACTIONSCNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increasesedation. Closely monitor for sedation with concomitant use of CNS depressants.

Psychostimulants (e.g., amphetamines, methylphenidate, modanil,armodanil): Concomitant use may increase blood pressure. Closely monitor blood pressurewith concomitant use of psychostimulants.

Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure.Closely monitor blood pressure with concomitant use of MAOIs.  

USE IN SPECIFIC POPULATIONSPregnancy: SPRAVATO is not recommended during pregnancy. SPRAVATO may cause fetalharm when administered to pregnant women. Advise pregnant women of the potential risk toan infant exposed to SPRAVATO in utero. There are risks to the mother associated withuntreated depression in pregnancy. If a woman becomes pregnant while being treated withSPRAVATO , treatment with SPRAVATO should be discontinued and the patient should becounseled about the potential risk to the fetus.

Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancyoutcomes in women exposed to antidepressants, including SPRAVATO , during pregnancy.Healthcare providers are encouraged to register patients by contacting the National PregnancyRegistry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

Lactation: SPRAVATO is present in human milk. Because of the potential for neurotoxicity,advise patients that breastfeeding is not recommended during treatment with SPRAVATO .

Females and Males of Reproductive Potential: SPRAVATO may cause embryo-fetal harmwhen administered to a pregnant woman. Consider pregnancy planning and prevention forfemales of reproductive potential during treatment with SPRAVATO .

Pediatric Use: The safety and e�ectiveness of SPRAVATO in pediatric patients have not beenestablished.

Geriatric Use: Of the total number of patients in Phase 3 clinical studies exposed toSPRAVATO , 12% were 65 years of age and older, and 2% were 75 years of age and older. Nooverall di�erences in the safety pro�le were observed between patients 65 years of age andolder and patients younger than 65 years of age.

The mean esketamine C and AUC values were higher in elderly patients compared withyounger adult patients.

The treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blindstudy comparing �exibly-dosed intranasal SPRAVATO plus a newly initiated oral antidepressantcompared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 yearsof age. At the end of four weeks, there was no statistically signi�cant di�erence between groupson the primary e�cacy endpoint of change from baseline to Week 4 on the Montgomery-ÅsbergDepression Rating Scale (MADRS).

Hepatic Impairment: SPRAVATO -treated patients with moderate hepatic impairment mayneed to be monitored for adverse reactions for a longer period of time.

SPRAVATO has not been studied in patients with severe hepatic impairment (Child-Pugh classC). Use in this population is not recommended.  

DRUG ABUSE AND DEPENDENCEControlled Substance: SPRAVATO contains esketamine hydrochloride, the (S)-enantiomer ofketamine and a Schedule III controlled substance under the Controlled Substances Act.

Abuse: Individuals with a history of drug abuse or dependence may be at greater risk for abuseand misuse of SPRAVATO . Abuse is the intentional, non-therapeutic use of a drug, even once,for its psychological or physiological e�ects. Misuse is the intentional use, for therapeuticpurposes, of a drug by an individual in a way other than prescribed by a healthcare provider orfor whom it was not prescribed. Careful consideration is advised prior to use of individuals witha history of substance use disorder, including alcohol.

SPRAVATO may produce a variety of symptoms including anxiety, dysphoria, disorientation,insomnia, �ashback, hallucinations, and feelings of �oating, detachment and to be “spaced out.”Monitoring for signs of abuse and misuse is recommended.  

ADVERSE REACTIONSThe most common adverse reactions with SPRAVATO plus oral AD (incidence ≥5% and at leasttwice that of placebo nasal spray plus oral AD) were dissociation, dizziness, nausea, sedation,vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk.  

Please see full Prescribing Information, including Boxed WARNINGS, and MedicationGuide for SPRAVATO . cp-79821v2

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Patient insurance bene�ts investigation and other Janssen CarePath program o�erings are provided by third-party service providers for Janssen CarePath,under contract with Johnson & Johnson Health Care Systems Inc., on behalf of Janssen Pharmaceuticals, Inc., Janssen Biotech, Inc., and Janssen Products, LP(Janssen). Janssen CarePath is not available to patients participating in the Patient Assistance Program o�ered by Johnson & Johnson Patient AssistanceFoundation. The availability of information and assistance may vary based on the Janssen medication, geography and other program di�erences. JanssenCarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based oncoverage guidelines provided by the payer, and patient information provided by the healthcare provider under appropriate authorization following theprovider's exclusive determination of medical necessity. This information and assistance are made available as a convenience to patients, and there is norequirement that patients or HCPs use any Janssen product in exchange for this information or assistance. Janssen assumes no responsibility for and doesnot guarantee the quality, scope, or availability of the information and assistance provided. The third-party service providers, not Janssen, are responsible forthe information and assistance provided under this program. Each HCP and patient is responsible for verifying and con�rming any information provided. Allclaims and other submissions to payers should be in compliance with all applicable requirements. ©  Johnson & Johnson Health Care Systems Inc. 2019. All rights reserved. | 877-524-3579, Monday-Friday, 8:00 AM to 8:00 PM ET This site is published by Johnson & Johnson Health Care Systems Inc.Capitalized product names are trademarks of Johnson & Johnson or its a�liated companies. This site is intended for use in the United States.Third party trademarks used herein are trademarks of their respective owners. Last updated on October 25, 2019.The use of the information on this site is subject to the terms of our Legal Notice and Privacy Policy. Privacy Policy | Legal Notice | Site Map | Contact Us

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Access support

Access to the benefits investigation support you may need for your patients

Investigate your patient’s medical and pharmacy benefits

• Fax completed Benefits Investigation Form (BIF) to Janssen CarePath at the fax number indicated on the form

• Form can be downloaded at JanssenCarePath.com/HCP/Spravato

• Patient signature is required on the HIPAA Patient Authorization section of the BIF

We complete the benefits investigation for your patient

• Verify medical and pharmacy benefits requests typically within 1 to 2 business days

• Review the benefits with you

• Inform your patient about cost support options and offer care coordination support

• Keep you informed of any issues that come up with timely alerts, such as prior authorizations

We can provide Prior Authorization (PA) assistance*

• Research patient’s health plan for PA requirements

• Provide payer-specific PA form

• Monitor status of the PA submission

• Notify your office 30 days before PA expiration

Other support resources

• Sample Letter of Medical Necessity and Exception Letter templates are available on JanssenCarePath.com

• Information on the appeals process for administrative denials†

• Request appeals research and tracking

• Coding and billing information†

*We do not fill out any information that requires the medical judgment of the prescriber, and only the prescriber can determine whether to pursue a prior authorization.

†Available at JanssenCarePath.com.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

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 Janssen Pharmaceuticals, Inc. (Janssen). Janssen CarePath is not available to patients participating in the Patient Assistance Program offered by Johnson & Johnson Patient Assistance Foundation. The availability of information and assistance may vary based on the Janssen medication, geography and other program differences. Janssen CarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the HCP under appropriate authorization following the provider’s exclusive determination of medical necessity. This information and assistance are made available as a convenience to patients, and there is no requirement that patients or HCPs use any Janssen product in exchange for this information or assistance. Janssen assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. Each HCP and patient is responsible for verifying or confirming any information provided. All claims and other submissions to payers should be in compliance with all applicable requirements.

After you submit your request, and we obtain patient authorization,we will fax you a verification of benefits, typically within 1-2 business days.

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Support for patients using commercial or private insurance to pay for medication• Janssen CarePath Savings Program can help eligible patients save on their out-of-pocket medication costs for their Janssen

medication. Depending on the health insurance plan, savings may apply toward co-pay, co-insurance, or deductible

• Patients must be enrolled in the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Learn more at SpravatoREMS.com/Patients

• Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give patients their treatment. See program requirements at Spravato.JanssenCarePathSavings.com

Please read the accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide for SPRAVATO®, and discuss any questions you have with your doctor.

You must be registered in the Savings Program before receiving your Janssen medication in order to qualify for out-of-pocket

cost savings. Once registered, share this card with your doctor or pharmacist to receive savings on your SPRAVATO® medication costs.

Register.JanssenCarePathSavings.com844-777-2828

Savings Programfor eligible commercially insured patients

Pay $10 per treatment for SPRAVATO® medication costs*

*$7,150 maximum program benefit per calendar year. Treatment may include up to three devices administered on the same day. Program limits apply. Depending on how your insurance covers SPRAVATO®, there is a quantity limit of three devices

per day or up to 23 devices per 24-day period and a program benefit limit of list price of the medication. Terms expire at the end of each calendar year

and may change. See program requirements on back.

Program does not cover the cost to give you your treatment.

Register

Please read the accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide for SPRAVATO®, and discuss any questions you have with your doctor.

Physicians: For medical claims, patient may direct payment to you or elect to receive a mailed rebate check. Call 855-872-1776 to understand payment selection made by patient.

PROGRAM REQUIREMENTS APPLY.

Pharmacy ClaimsBIN: 610020GROUP: 99994002Member:

Medical ClaimsPayer ID: 56155GROUP: 00003636Member:

Janssen CarePath Savings Program for

SPRAVATO®

Your eligible patients

pay $10 per treatment for SPRAVATO® medication costs with a $7,150 maximum program benefit

per calendar year. Treatment may

include up to three devices administered

on the same day. Program limits apply.

Depending on how their insurance covers

SPRAVATO®, there is a quantity limit

of three devices per day or up to 23 devices

per 24-day period and a program benefit

limit of list price of the medication.

Get information for your patients about the

Savings Program from your Janssen representative.

Help your patients save on their out-of-pocket medication costs

Affordability support

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

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At Register.JanssenCarePathSavings.com patients can:• Determine eligibility and register for the Janssen CarePath Savings Program

• Print a card online if they need one

Patients should bring their Janssen CarePath Savings Program card to their treatment appointment. Providers can process the card through their electronic billing system.

Your patients’ eligibility to use the Savings Program card is subject to meeting the program requirements at the time of each use.

If for any reason the card cannot be processed, patients can submit a Rebate Form to receive a check. Proof of medication payment is required.

Patients can register and activate a card online

Please read the full Prescribing Information, including Boxed WARNINGS andMedication Guide for SPRAVATO®, and discuss any questions you have with your doctor.

Physicians: For medical claims, patient may direct payment to you or elect to receive amailed rebate check. Call 855-872-1776 to understand payment selection made by patient.

PROGRAM REQUIREMENTS APPLY.

Pharmacy ClaimsBIN: 610020GROUP: 99994002Member:

Medical ClaimsPayer ID: 56155GROUP: 00003636Member:

Questions about the program? Get answers, including who is eligible.

Janssen CarePath Savings Program for SPRAVATO®

Eligible patients using commercial insurance can save on out-of-pocket medication costs for SPRAVATO®. Get started below to check eligibility and register.

Need help?

Call 844-777-2828Monday–Friday, 8:00 am–8:00 pm ET

I am a Healthcare

Provider

I am a Patient

Affordability support

Providers can also go to Register.JanssenCarePathSavings.com to determine patients’ eligibility and register them for the Janssen CarePath Savings Program

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

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How to submit a rebate request

The patient is responsible for submitting rebate requests, or may coordinate with their provider to determine who will submit the Savings Program request.

To submit a claim on behalf of the patient, providers must follow the instructions on the back of the Janssen CarePath Savings Program card to submit a CMS 1500 (HICF) or Uniform Billing Form—CMS 1450 (UB-04)—through their electronic billing system.

The patient can use their card at a pharmacy for instant savings on their SPRAVATO® medication costs.

Fax:844-584-1453

Mail:Janssen CarePath Savings Program

2250 Perimeter Park Drive, Suite 300Morrisville, NC 27560

Patient must be registered in the Savings Program before receiving their Janssen medication in order to qualify for out-of-pocket cost savings.

If the patient would like to receive a rebate check, the patient can submit a Rebate Form, including proof of payment. If the patient used medical insurance to pay for their medication, they will also need to submit an Explanation of Benefits (EOB).

The patient is responsible for submitting the EOB to Janssen CarePath Savings Program by mail or fax:

It is the patient’s responsibility to submit Savings Program rebate requests. Depending on the type of insurance used to pay for SPRAVATO®:

ORIf patient uses medical/primary insurance to pay for SPRAVATO® through their doctor, treatment provider, or pharmacy:

If patient uses pharmacy/prescription insurance to pay for SPRAVATO® from a pharmacy:

Affordability support

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

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We can help your patients with other affordability options

Support for patients using government-funded healthcare programs or patients without insurance coverage

• Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs:

° State Pharmaceutical Assistance Programs (SPAPs)

° State Health Insurance Programs (SHIPs)

° Medicare Savings Program

° Medicare Part D Extra Help—Low-Income Subsidy

• Call Janssen CarePath at 844-777-2828 to speak with a Care Coordinator or visit JanssenPrescriptionAssistance.com for more information on affordability programs that may be available

Other resources

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies. To see if they might qualify for assistance, please have your patient contact a JJPAF program specialist at 800-652-6227 (Monday–Friday, 9:00 am–6:00 pm ET) or visit the foundation website at JJPAF.org.

Affordability support

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

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Helping you help your patients get started with the Janssen treatment you prescribed and supporting them along the way

Care coordination Janssen CarePath provides additional support that your patients may need to get started with their treatment. A Janssen CarePath Care Coordinator will work closely with you and your patients to provide the support you direct.

Additional treatment support We understand how important it is for your patients to take their medication as you’ve prescribed. Janssen CarePath offers ongoing support that may help your patients stay on track with their treatment.

• Patient education materials

• Web-based resources

• Assistance finding a location that offers SPRAVATO® treatment

Internet resources for your patients Sometimes your patients need a little more information on their condition. Your patients can visit JanssenCarePath.com for links to useful educational resources that may be helpful.

Treatment support

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Provide the Medication Guide to your patients and encourage discussion.

Treatment support for your patients

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Helpful access and affordability resources are available on the General Resources tab at JanssenCarePath.com

Additional access & affordability resources

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© Janssen Pharmaceuticals, Inc. 2020 May 2020 cp-77181v4

We can help make it simple for you to help your patients

Treatment support to help your patients get informed and stay on prescribed treatment

Affordability support to help your patients start and stay on the Janssen medication you prescribe

Access support to help navigate payer processes

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO® (esketamine) Nasal Spray CIII. Provide the Medication Guide to your patients and encourage discussion.

Visit us online JanssenCarePath.com/HCP/Spravato

Single, dedicated Care Coordinator team supporting your patients and you

Need help?

Call 844-777-2828Monday–Friday, 8:00 am–8:00 pm ETMultilingual phone support available