Privacy Policy

Janssen Pharmaceuticals, Inc., is concerned about privacy issues and wants you to be familiar with how we collect, use, and disclose information. This Privacy Policy describes our practices in connection with information that we or our service providers collect through the Web site or Web property (including, for example, a mobile Web site or application) operated and controlled by us from which you are accessing this Privacy Policy (each, the “Site”). By providing personal information to us or by using the Site, you agree to the terms and conditions of this Privacy Policy.


INFORMATION COLLECTION


Information You Provide
Some areas of the Site may ask you to submit personal information in order for you to benefit from the specified features (such as newsletter subscriptions, tips/pointers, or order processing) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed what information is required and what information is optional.

We may combine the information you submit with other information we have collected from you, whether on- or offline, including, for example, your purchase history. We may also combine it with information we receive about you from other sources, such as other Johnson & Johnson Operating Companies, publicly available information sources (including information from your publicly available social media profiles), and other third parties.

Passive Information Collection and Use
As you navigate around the Site, certain information can be passively collected (that is, gathered without your actively providing the information), using various technologies. We and our third party service providers passively collect and use information in a variety of ways, including:

Through your browser: Certain information is collected by most browsers, such as your Media Access Control (MAC) address, computer type (Windows or Macintosh), screen resolution, operating system version, and Internet browser type and version. We may collect similar information, such as your device type and identifier, if you access the Site through a mobile device.

Using cookies: Cookies are pieces of information stored directly on the computer you are using. Cookies allow us to collect information such as browser type, time spent on the Site, pages visited, and language preferences. We and our service providers use the information for security purposes, to facilitate navigation, display information more effectively, and to personalize your experience while using the Site. We also use cookies to recognize your computer or device, which makes your use of the Site easier, such as to remember what is in your shopping cart. In addition, we use cookies to gather statistical information about Site usage in order to continually improve its design and functionality, understand how individuals use it, and to assist us with resolving questions regarding it. Cookies further allow us to select which of our advertisements or offers are most likely to appeal to you and display them while you are on the Site. We may also use cookies in online advertising to track consumer responses to our advertisements

You can refuse to accept these cookies by following your browser’s instructions; however, if you do not accept them, you may experience some inconvenience in your use of the Site. You may also not receive advertising or other offers from us that are relevant to your interests and needs. To learn more about cookies, please visit www.allaboutcookies.org.

Using Flash cookies: Our use of Adobe Flash technology (including Flash Local Stored Objects (“Flash LSOs”)) allows us to, among other things, serve you with more tailored information, facilitate your ongoing access to and use of the Site, and collect and store information about your use of the Site. If you do not want Flash LSOs stored on your computer, you can adjust the settings of your Flash player to block Flash LSO storage using the tools contained in the Website Storage Settings Panel. You can also control Flash LSOs by going to the Global Storage Settings Panel and following the instructions (which may include instructions that explain, for example, how to delete existing Flash LSOs (referred to as “information” on the Macromedia site), how to prevent Flash LSOs from being placed on your computer without your being asked, and (for Flash Player 8 and later) how to block Flash LSOs that are not being delivered by the operator of the page you are on at the time). Please note that setting the Flash Player to restrict or limit acceptance of Flash LSOs may reduce or impede the functionality of some Flash applications, including, potentially, Flash applications used in connection with the Site or our online content.

Using pixel tags, web beacons, clear GIFs, or other similar technologies: These may be used in connection with some Site pages and HTML-formatted e-mail messages to, among other things, track the actions of Site users and e-mail recipients, measure the success of our marketing campaigns, and compile statistics about Site usage and response rates.

Online behavioral advertising: The use of cookies, pixel tags, web beacons, clear GIFs, or other similar technologies allows our third-party vendors to deliver advertisements about our products and services when you visit the Site or other web sites or web properties across the Internet. These vendors may place pixel tags, web beacons, clear GIFs, or similar technologies on the Site and other websites or web properties, and also place or recognize third-party cookies when you visit the Site or other sites or web properties. They may use information about your visits to the Site and other web sites or web properties to provide advertisements about goods and services that may be of interest to you.

IP Address: Your IP Address is a number that is automatically assigned to the computer that you are using by your Internet Service Provider. An IP Address is identified and logged automatically in our server log files whenever a user visits the Site, along with the time of the visit and the page(s) that were visited. Collecting IP Addresses is standard practice on the Internet and is done automatically by many web sites. We use IP Addresses for purposes such as calculating Site usage levels, helping diagnose server problems, and administering the Site.

Device Information: We may collect information about your mobile device, such as a unique device identifier.

How We Use and Disclose Information
We use and disclose information you provide to us as described to you at the point of collection.

We also use information from or about you:

  • to respond to your inquiries and fulfill your requests, such as to send you documents you request or e-mail alerts;
  • for our business purposes, such as data analysis, audits, developing new products, enhancing our website, improving our products and services, identifying Site usage trends, personalizing your experience on the Site by presenting products and offers tailored to you, and determining the effectiveness of our promotional campaigns.

We also disclose information collected through the Site:

  • to our affiliates for the purposes described in this Privacy Policy. A list of our affiliates is available here (click on the link for Form 10K, Exhibit 21, under “SEC Filings”). Janssen Pharmaceuticals, Inc. is the party responsible for the management of the jointly-used Personal Information;
  • to our third party partners with whom we offer a co-branded or co-marketed promotion;
  • to our third party service providers who provide services such as website hosting and moderating, mobile application hosting, data analysis, payment processing, order fulfillment, infrastructure provision, IT services, customer service, e-mail and direct mail delivery services, credit card processing, auditing services, and other services, in order to enable them to provide services; and
  • to a third party in the event of any reorganization, merger, sale, joint venture, assignment, transfer, or other disposition of all or any portion of our business, assets, or stock (including in connection with any bankruptcy or similar proceedings).

In addition, we use and disclose information collected through the Site as we believe to be necessary or appropriate: (a) as permitted by applicable law, including laws outside your country of residence; (b) to comply with legal process; (c) to respond to requests from public and government authorities, including public and government authorities outside your country of residence; (d) to enforce our terms and conditions; (e) to protect our operations or those of any of our affiliates; (f) to protect our rights, privacy, safety, or property, and/or that of our affiliates, you, or others; and (g) to allow us to pursue available remedies or limit the damages that we may sustain. We may also use and disclose information collected through the Site in other ways, with your consent.

We also use and disclose information we collect passively as described above, under “Passive Information Collection and Use,” and for any other purpose, except where we are required to do otherwise under applicable law (for example, if we are required to treat such information as personal information). In addition, we may use and disclose information that is not in personally identifiable form for any purpose. If we combine information that is not in personally identifiable form with information that is (such as combining your name with your geographical location), we will treat the combined information as personal information as long as it is combined.


THIRD PARTY SITES AND SERVICES

This Privacy Policy does not address, and we are not responsible for, the privacy, information, or other practices of any third parties, including any third party operating any site or web property (including, without limitation, any application) that is available through this Site or to which this Site contains a link. The availability of, or inclusion of a link to, any such site or property on the Site does not imply endorsement of it by us or by our affiliates.


SECURITY

We use reasonable organizational, technical, and administrative measures to protect personal information under our control. Unfortunately, no data transmission over the Internet or data storage system can be guaranteed to be 100% secure. If you have reason to believe that your interaction with us is no longer secure (for example, if you feel that the security of any account you have with us has been compromised), please immediately notify us of the problem by contacting us in accordance with the “Contacting Us” section below.


CHOICES AND ACCESS

Your choices regarding our use and disclosure of your personal information


We give you choices regarding our use and disclosure of your personal information for marketing purposes. You may opt out from:


  • Receiving marketing communications from us: If you no longer want to receive marketing communications from us on a going-forward basis, you may opt out of receiving them by contacting us at 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. In your response to us, please provide your name, identify the form(s) of marketing communications that you no longer wish to receive, and include the address(es) to which it/they are sent. For example, if you no longer wish to receive marketing e-mails or direct mail from us, tell us that, and provide your name and e-mail or postal address.

  • Receiving reminders from us: If you no longer want to receive medical reminders from us on a going-forward basis, you may opt out of receiving them by contacting us  at 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical  Information, PO Box 200 Titusville, NJ 08560. In your response to us, please provide your name and the e-mail address or phone number at which you receive reminders from us.

  • Our sharing of your personal information with affiliates and third-party partners: If you would prefer that we not share your personal information on a going-forward basis with our affiliates and/or third-party partners for their marketing purposes, you may opt out of this sharing by contacting at 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. In your response to us, please state that we should no longer share your personal information with our affiliates and/or third-party partners for their marketing purposes, and include your name and e-mail address.

We will seek to comply with your request(s) as soon as reasonably practicable. Please note that if you opt out as described above, we will not be able to remove your personal information from the databases of our affiliates with which we have already shared your information (i.e., as of the date that we implement your opt-out request). Please also note that if you opt out of receiving marketing-related messages from us, we may still send you important transactional and administrative messages, from which you cannot opt out.

How you can access, change, or delete your personal information
If you would like to review, correct, update, or delete the personal information that you have provided via the Site, please contact us at 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. We will try to comply with your request as soon as reasonably practicable.


RETENTION PERIOD


We retain your personal information for the period necessary to fulfill the purposes outlined in this Privacy Policy, unless a longer retention period is required or allowed by law or to otherwise fulfill a legal obligation.


USE OF SITE BY MINORS


The Site is not directed to individuals under the age of 18, and we request that these individuals not provide Personal Information through the Site.


CROSS-BORDER TRANSFER


Your personal information may be stored and processed in any country where we have facilities or service providers, and by using our Site or by providing consent to us (where required by law), you agree to the transfer of information to countries outside of your country of residence, including to the United States, which may provide for different data protection rules than in your country.


SENSITIVE INFORMATION


Unless we specifically request or invite it, we ask that you not send us, and you not disclose, any sensitive personal information (e.g., information related to racial or ethnic origin, political opinions, religion or other beliefs, health, criminal background or trade union membership) on or through the Site or otherwise to us. In those cases where we may request or invite you to provide sensitive information, we will do so with your express consent.


UPDATES TO THIS PRIVACY POLICY


We may change this Privacy Policy. Any changes to this Privacy Policy will become effective when we post the revised Privacy Policy on the Site. Your use of the Site following these changes means that you accept the revised Privacy Policy. This Privacy Policy was last updated January 2019.


CONTACTING US


If you have any questions about this Privacy Policy, please contact us at 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560.

Indication
SPRAVATO™ (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults.

SPRAVATO™ is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO™ as an anesthetic agent have not been established.

Important Safety Information

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

See full prescribing information for complete boxed warning

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

CONTRAINDICATIONS
SPRAVATO™ is contraindicated in patients with:

  • Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation
  • History of intracerebral hemorrhage
  • Hypersensitivity to esketamine, ketamine, or any of the excipients


WARNINGS AND PRECAUTIONS

Sedation: In clinical trials, 49% to 61% of SPRAVATO™-treated patients developed sedation and 0.3% of SPRAVATO™-treated patients experienced loss of consciousness.

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.

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

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

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 75% of SPRAVATO™-treated patients developed dissociative or perceptual changes). Given its potential to induce dissociative effects, carefully assess patients with psychosis before administering SPRAVATO™; treatment should be initiated only if the benefit outweighs the risk.

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.

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 prior to 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 or dependence are at greater risk; therefore, use careful consideration prior to treatment of individuals with a history of substance use disorder and monitor for signs of abuse or dependence.

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

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

Important requirements of the SPRAVATO™ REMS include the following:

  • Healthcare settings must be certified in the program and ensure that SPRAVATO™ is:
    • Healthcare settings must be certified in the program and ensure that SPRAVATO™ is:
    • Pharmacies must be certified in the REMS and must only dispense SPRAVATO™ to healthcare settings that are certified in the program.
  • Pharmacies must be certified in the REMS and must only dispense SPRAVATO™ to healthcare settings that are certified in the program.


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

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. SPRAVATO™ is not approved in pediatric (<18 years of age) patients.

There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

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. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing SPRAVATO™ and/or the concomitant oral antidepressant, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

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

Approximately 8% to 17% 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. A substantial increase in blood pressure could occur after any dose administered even if smaller blood pressure effects were observed with previous administrations. 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). Before prescribing, patients with other cardiovascular and cerebrovascular conditions should be carefully assessed to determine whether the potential benefits of SPRAVATO™ outweigh its risk.

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

BP should be monitored for at least 2 hours after SPRAVATO™ administration. Measure blood pressure around 40 minutes post-dose and subsequently as clinically warranted until values decline. If BP remains high, promptly seek assistance from practitioners experienced in BP management. Refer patients experiencing symptoms of a hypertensive crisis (e.g., chest pain, shortness of breath) or hypertensive encephalopathy (e.g., sudden severe headache, visual disturbances, seizures, diminished consciousness or focal neurological deficits) immediately for emergency care.

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

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.

Cognitive Impairment

Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO™ caused cognitive performance decline 40 minutes post-dose. SPRAVATO™-treated subjects required a greater effort to complete the cognitive tests at 40 minutes post-dose. Cognitive performance and mental effort were comparable between SPRAVATO™ and placebo at 2 hours post-dose. Sleepiness was comparable after 4 hours post-dose.

Long-Term Cognitive Impairment: Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse. 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.

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. Patients will need to arrange transportation home following treatment with SPRAVATO™.

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. In clinical studies with SPRAVATO™ nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO™-treated patients than in placebo-treated patients. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year.

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

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

DRUG INTERACTIONS

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

Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. Closely monitor blood pressure with 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 POPULATIONS

Pregnancy: SPRAVATO™ is not recommended during pregnancy. SPRAVATO™ may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO™ in utero. There are risks to the mother associated with untreated depression in pregnancy. 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.

Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO™, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry 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 harm when administered to a pregnant woman. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO™.

Pediatric Use: The safety and effectiveness of SPRAVATO™ in pediatric patients have not been established.

Geriatric Use: Of the total number of patients in Phase 3 clinical studies exposed to SPRAVATO™, 12% were 65 years of age and older, and 2% were 75 years of age and older. No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age.

The mean esketamine Cmax and AUC values were higher in elderly patients compared with younger adult patients.

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. 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).

Hepatic Impairment: SPRAVATO™-treated patients with moderate hepatic impairment may need 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 class C). Use in this population is not recommended.

DRUG ABUSE AND DEPENDENCE

Controlled Substance: SPRAVATO™ contains esketamine hydrochloride, the (S)-enantiomer of ketamine 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 abuse and misuse of SPRAVATO™. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. 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. Careful consideration is advised prior to use of individuals with a history of substance use disorder, including alcohol.

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

ADVERSE REACTIONS

The most common adverse reactions with SPRAVATO™ plus oral AD (incidence ≥5% and at least twice 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 Medication Guide for SPRAVATO™.

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