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Learn more about Janssen’s COVID-19 response and our continued support to help
patients afford and access our medicines.

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For US Healthcare Professionals

* Important Safety Information
* Prescribing Information
* Full Prescribing Information
* Medication Guide
* For US Patients

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* About PONVORY™
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* Relapsing MS

Supplemental Privacy Notices
Privacy Notice for California Residents
Privacy Notice for Nevada Residents

Janssen Pharmaceuticals, Inc. respects your privacy 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 website or application (hereinafter the “Service”)
operated and controlled by us from which you are accessing this Privacy Policy.
We encourage you to read the full Privacy Policy before using this Service or
providing any personal information. By providing personal information to us or
by using the Service, you acknowledge that you have read and understand this
Privacy Policy.

USE BY MINORS

The Service is not directed to individuals under the age of 18, and we request
that these individuals not provide personal information through the Service. If
your child has submitted Personal Information and you would like to request that
such Personal Information be removed, please contact us as explained below under
“Contacting Us.”

INFORMATION COLLECTION

We may ask you to submit personal information in order for you to benefit from
certain 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 Affiliates, publicly available
information sources (including information from your publicly available social
media profiles), and other third-party information providers.

If you submit any personal information relating to another individual to us, you
represent that you have the authority to do so and to permit us to use the
information in accordance with this Privacy Policy.

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., Social Security
numbers, information related to racial or ethnic origin, political opinions,
religion or philosophical beliefs, health or medical condition, sex life or
sexual orientation, criminal background, or trade union membership, or biometric
or genetic data) on or through the Service or otherwise directly to us.

AUTOMATIC INFORMATION COLLECTION AND USE

We and our service providers may automatically collect and use information in
the following ways as you navigate around the Service:

Through your browser: Certain information is collected by most browsers, such as
your Media Access Control (MAC) address, computer type (Windows or Mac), screen
resolution, operating system name and version, and Internet browser type and
version. We may collect similar information, such as your device type and
identifier, if you access the Service through a mobile device. We use this
information to ensure that the Service functions properly.

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 Service, 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 Service. We also use cookies to recognize your
computer or device, which makes your use of the Service easier, such as to
remember what is in your shopping cart. In addition, we use cookies to gather
statistical information about Service 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 Service. 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 Service. 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 http://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
Service, and collect and store information about your use of the Service. 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. 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.

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

Interest-based advertising: We may use third-party advertising companies to
serve advertisements regarding goods and services. that may be of interest to
you when you access and use the Service and other online services, based on
information relating to your access and use of the Service and other online
services on any of your devices. To do so, these companies may place or
recognize a unique cookie on your browser (including through the use of pixel
tags). They may also use these technologies, along with information they collect
about your online use, to recognize you across the devices you use, such as a
mobile phone and a laptop.

If you would like more information about this practice, and to learn how to
opt-out of it, in desktop and mobile browsers on the particular device on which
you are accessing this Privacy Policy, please visit
http://optout.aboutads.info/#/ and http://optout.networkadvertising.org/#/. You
may download the AppChoices app at http://www.aboutads.info/appchoices to
opt-out in mobile apps.

IP address: Your IP address is a number that is automatically assigned to your
computer by your Internet Service Provider. An IP address is identified and
logged automatically in our server log files whenever a user visits the Service,
along with the time of the visit and the pages visited. Collecting IP addresses
is standard practice and is done automatically by many online services. We use
IP addresses for purposes such as calculating Service usage levels, diagnosing
server problems, and administering the Service. We may also derive your
approximate location from your IP address.

Device Information: We may collect information about your mobile device, such as
a unique device identifier, to understand how you use the Service.

HOW WE USE AND DISCLOSE INFORMATION

We use and disclose information you provide to us as described to you at the
point of collection. Please see the section entitled “Choices and Access” below
to learn how you may opt-out of certain of our uses and disclosures.

Where required by applicable law, we will obtain your consent to our use of your
personal information at the point of information collection. We may also rely on
other legal bases, specifically for:

* Providing the functionality of the Service and fulfilling your requests.
* to provide the functionality of the Service to you and providing you with
related customer service;
* to respond to your inquiries and fulfill your requests, such as to send you
documents you request or to e-mail alerts;
* to send you important information regarding our relationship with you or
regarding the Service, changes to our terms, conditions, and policies
and/or other administrative information.

We will engage in these activities to manage our contractual relationship with
you and/or to comply with a legal obligation.

* Accomplishing our business purposes.
* for data analysis, for example, to improve the efficiency of the Service;
* for audits, to verify that our internal processes function as intended and
are compliant with legal, regulatory, or contractual requirements;
* for fraud and security monitoring purposes, for example, to detect and
prevent cyberattacks or attempts to commit identity theft;
* for developing new products and services;
* for enhancing, improving or modifying our website or products and services;
* for identifying Service usage trends, for example, understanding which
parts of our Service are of most interest to users; and
* for determining the effectiveness of our promotional campaigns so that we
can adapt our campaigns to the needs and interests of our users.

We will engage in these activities to manage our contractual relationship with
you, to comply with a legal obligation, and/or because we have a legitimate
interest.

* Analysis of Personal Information to provide personalized services.
* to better understand you so that we can personalize our interactions with
you and provide you with information and/or offers tailored to your
interests;
* to better understand your preferences so that we can deliver content via
the Service that we believe will be relevant and interesting to you.

We will provide personalized services either with your consent or because we
have a legitimate interest.

We also disclose information collected through the Service:

* to our affiliates for the purposes described in this Privacy Policy. A list
of our affiliates is available at
https://johnsonandjohnson.gcs-web.com/financial-information/sec-filings 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, auditing, and
other services, in order to enable them to provide services; and
* as permitted by applicable law, 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 may use and disclose your information as we believe to be
necessary or appropriate: (a) to comply with legal process or applicable law
which may include laws outside your country of residence; (b) as permitted by
applicable law to respond to requests from public and government authorities,
which may include authorities outside your country of residence; (c) to enforce
our terms and conditions; and (d) to protect our rights, privacy, safety, or
property, and/or that of our affiliates, you, or others. We may also use and
disclose your information in other ways after obtaining your consent to do so.

We may use and disclose information we collect automatically as described above
under “Automatic Information Collection and Use.”

In addition, where allowed by applicable law, 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 identifiable (such as combining your name with your geographical
location), we will treat the combined information as personal information as
long as it is combined.

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 via 1-800-JANSSEN (526-7736) or send a
written request to Janssen Medical Information, PO BOX 200 Titusville, NJ
08560. In your request 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. In addition, you may opt-out
of receiving marketing e‑mails from us by following the unsubscribe
instructions provided in any such message.
* 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 via 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 previously opted-in to receiving marketing communications
from our affiliates or third party partners, you may opt-out of our sharing
of your personal information with those parties for their direct marketing
purposes on a going‑forward basis by contacting us via 1-800-JANSSEN
(526-7736) or send a written request to Janssen Medical Information, PO BOX
200 Titusville, NJ 08560. In your communication 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 may not be able to
directly 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). However, we will make reasonable efforts to
inform our affiliates of your 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, restrict, or delete your personal
information, or if you would like to request an electronic copy of your personal
information for purposes of transmitting it to another company (to the extent
these rights are provided to you by applicable law), please contact us via
1-800-JANSSEN (526-7736) or send a written request to Janssen Medical
Information, PO BOX 200 Titusville, NJ 08560. We will respond to your request as
soon as reasonably practicable and no later than one month after receipt. If
circumstances cause any delay in our response, you will be promptly notified and
provided a date for our response.

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 Service or by providing
consent to us (where required by law), your information may be transferred 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 of
residence. Nonetheless, appropriate contractual and other measures are in place
to protect personal information when it is transferred to our affiliates or
third parties in other countries.

SECURITY

We seek to use reasonable organizational, technical, and administrative measures
designed to protect personal information under our control. However, 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 in accordance
with the “Contacting Us” section below.

RETENTION PERIOD

We will retain your personal information for as long as needed or permitted in
light of the purpose(s) for which it was obtained. The criteria used to
determine our retention periods include: (i) the length of time we have an
ongoing relationship with you and provide the Service to you; (ii) whether there
is a legal obligation to which we are subject; and (iii) whether retention is
advisable in light of our legal position (such as, in regard to applicable
statutes of limitations, litigation or regulatory investigations).

THIRD PARTY SITES AND SERVICES

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

CONTACTING US

Janssen Pharmaceuticals, Inc., located at , is the company responsible for
collection, use, and disclosure of personal information under this Privacy
Policy.

If you have any questions about this Privacy Policy, please contact us via
1-800-JANSSEN (526-7736), or please write to the following address:

Janssen Medical Information
PO Box 200
Titusville, NJ 08560

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 Service. Your
use of the Service following these changes means that you accept the revised
Privacy Policy. We recommend that you regularly review the Privacy Policy when
you visit the Service. This policy was last updated on November 2019.

PRIVACY NOTICE FOR CALIFORNIA RESIDENTS

Effective: January 1, 2020

This Privacy Notice for California Residents supplements the information
contained in the Johnson & Johnson Global Privacy Policy (above), and applies
only to California residents (“You,” “your” or “consumer”).

Personal Information Collection and Purposes of Use

We collect and use information that identifies, relates to, describes,
references, is capable of being associated with, or could reasonably be linked,
directly or indirectly, to you or your devices when you visit this website,
provide us your personal information, or have a contractual or business
relationship with us or any of our affiliates, (“Personal Information”). Such
Personal Information includes direct identifiers like a name, postal address,
email address, social security number or other government identifier, and
indirect identifiers that may identify, relate to, or be associated with a
particular individual, such as a telephone number, device identifier, IP address
and browsing history, credit card information, or inferences about consumer
preferences or characteristics.

We collect this Personal Information for the following purposes:

* to respond to your inquiries and to fulfill your requests;
* to send you important information regarding our relationship with you or
regarding this website, changes to our terms, conditions, and policies and/or
other administrative information;
* for audits, to verify that our internal processes function as intended and
are compliant with legal, regulatory, or contractual requirements;
* for fraud or crime prevention, and for technical security monitoring
purposes;
* to facilitate the development of new products and services;
* to enhance, improve or modify our website or products and services;
* for data analysis that will allow us to understand website usage trends;
* to determine the effectiveness of our promotional campaigns, so that we can
adapt our campaigns to the needs and interests of our users.
* to better understand you, so that we can personalize our interactions with
you and provide you with information and/or offers tailored to your
interests;

Our Personal Information Handling Practices

In the preceding 12 months, we have collected the following categories of
Personal Information from California residents who have visited this website,
provided us their Personal Information, or had or have a contractual or business
relationship with us or any of our affiliates:

* Direct identifiers as described above
* Indirect identifiers as described above.

We have collected such Personal Information from one or more of the following
categories of sources:

* Information that you submit or share directly with us, through registrations,
surveys, applications, or telephone calls, and email and postal
communications;
* Information passively collected from cookies and other website analytics;
* Information collected through third parties or from your browsing activity on
other sites, such as on social media platforms, and public databases;
* From one or more of our affiliates with which you have a business
relationship;
* Service providers with which we have a contractual relationship and to which
you have provided your Personal Information

We collected such Personal Information for the purposes noted above (see
“Personal Information Collection and Purposes of Use”) and in the J&J Global
Privacy Policy (see “How We Use and Disclose Information”):

We may have shared such Personal Information with the following categories of
third parties:

* Service providers that help us to run our business, such as call centers and
order fulfillment and distribution companies, credit card processing
companies, web hosting and development companies, and direct marketing
agencies
* Vendors that help us track the effectiveness of advertisements on our Sites
* Vendors that help us to provide you with program, services or educational
information we believe may be of interest to you
* Third parties with which we jointly market a product
* Affiliates and subsidiaries that may have or may want to seek a business
relationship with you

We collected one or more of the following specific pieces of personal
information:

* Legal name, nickname, signature, email address, postal address, social
security number, date of birth, driver’s license number, physical
characteristics or description, educational level, current employment or
employment history, biometric information, and/or geolocation data
* Account name, bank account number, credit card number, debit card number, or
any other financial information, medical information and/or health insurance
information
* Online identifier, Internet Protocol address, Internet or other electronic
network activity information, including, but not limited to, browsing
history, search history, and information regarding a consumer’s interaction
with an Internet Web site, application, or advertisement

Unless specifically stated, we do not share, disclose or sell personal
information to third parties for their own use, but we do share your personal
information with our affiliates and trusted partners in arrangements that may
meet the broad definition of “sale” under California law. In these arrangements,
use of the information we share is limited by policies, contracts, or similar
restrictions.

In the preceding 12 months we may have disclosed, shared or sold, as defined by
California law, one or more of the above categories of personal information.

Your Privacy Rights

You have the following rights regarding our collection and use of your personal
information. To exercise those rights, you must submit a request by either
calling us at 1-800-JANSSEN (526-7736) or through
https://www.janssen.com/us/privacy-request/. We may ask you to provide
additional information to verify your request. We may not discriminate against
you if you exercise your rights as described in this notice. For example, we may
not deny goods or services to you, or charge you different prices or rates, or
provide a different level of quality of products or services.

Right to Information

You have the right to request the following information regarding the personal
information we have collected about you:

* Categories of personal information collected about you, and sources from
which collected;
* Our purpose for collecting personal information;
* Categories of third parties with which the personal information was shared;
and
* Specific pieces of personal information collected about consumers.

You have the right to request the following information regarding the personal
information we have sold or disclosed about you:

* Categories of your personal information sold in the preceding 12 months;
* Categories of third parties to whom your personal information has been
disclosed;
* Categories of personal information that we disclosed about consumers for a
business purpose.

Right to Opt Out of Sharing, Disclosure, or Sale of Personal Information

You have the right to direct us to not share, disclose, or sell your personal
information. To exercise this right, you or your authorized representative may
submit a request by clicking on the following link:

Do Not Sell My Personal Information

Right to Request Deletion

You have the right to request that we delete the personal information we have
about you. However, we are not required to delete information if it is necessary
to retain your information to:

* Complete the transaction for which the personal information was collected,
provide a good or service requested by you, or a transaction reasonably
anticipated within the context of our or one of our affiliate’s ongoing
business relationship with you, or to otherwise perform a contract we have
with you.
* Detect security incidents, protect against malicious, deceptive, fraudulent
or illegal activity or prosecute those responsible for that activity.
* Debug to identify and repair errors that impair existing intended
functionality.
* Exercise free speech, ensure the right of another consumer to exercise his or
her right of free speech, or exercise another right provided for by law.
* Comply with the California Electronic Communications Privacy Act pursuant to
Chapter 3.6 (commencing with Section 1546) of Title 12 of Part 2 of the Penal
Code.
* Engage in public or peer-reviewed scientific, historical, or statistical
research in the public interest that adheres to all other applicable ethics
and privacy laws, when deletion of the information is likely to render
impossible or seriously impact the achievement of such research, if you have
provided informed consent.
* Facilitate solely internal uses that are reasonably aligned with your
expectations based on your relationship with us or one of our affiliates.
* Comply with a legal obligation.
* Otherwise use the personal information, internally, in a lawful manner that
is compatible with the context in which it was provided.

You can contact us with questions about this Privacy Notice for California
Residents or to exercise your rights as described in this Notice.

Telephone number: 1-800-JANSSEN (526-7736)
Web address: https://www.janssen.com/us/privacy-request/
Postal address: Janssen Medical Information, PO Box 200, Titusville, NJ 08560
Contact Title: Privacy Manager

SUPPLEMENTAL PRIVACY NOTICE FOR NEVADA RESIDENTS

Effective: October 1, 2019

This Supplemental Privacy Notice for Nevada Residents adds to the information
contained in the Johnson & Johnson Global Privacy Policy (above), and applies
only to Nevada residents (“You,” “your” or “consumer”).

Personal Information Collection and Purposes of Use

We collect certain personal information of Nevada consumers through our Internet
websites or other online service. This information includes one or more of the
following elements of personally identifiable information:

1. A first and last name.
2. A home or other physical address that includes the name of a street and the
name of a city or town.
3. An electronic mail address.
4. A telephone number.
5. A Social Security Number.
6. An identifier that allows a specific person to be contacted either
physically or online.
7. Any other information concerning a person collected from the person through
the Internet website or online service of the operator, and maintained by
the operator in combination with an identifier in a form that makes the
information personally identifiable.

We collect this personal information for the following purposes:

Your Privacy Rights

Right to access and/or correct your personal information, or opt out of sale of
personal information

If you would like to review, correct, or update your personal information, you
or your authorized representative may submit your request to
https://www.janssen.com/us/privacy-request/. We will respond to your verified
request as soon as reasonably practicable, but no later than sixty (60) days
after receipt. If circumstances cause any delay in our response, you will be
promptly notified and provided a date for our response.

We generally do not disclose or share personal information for profit. Under
Nevada law, you have the right to direct us to not sell or license your personal
information to third parties. To exercise this right, if applicable, you or your
authorized representative may submit a request to
https://www.janssen.com/us/privacy-request/. We will respond to your verified
request as soon as reasonably practicable, but no later than sixty (60) days
after receipt. If circumstances cause any delay in our response, you will be
promptly notified and provided a date for our response.

You can contact us with questions about this Privacy Notice for Nevada Residents
or to exercise your rights as described in this Notice.

Web address: https://www.janssen.com/us/privacy-request/

INDICATION

PONVORY™ is a sphingosine 1-phosphate receptor modulator indicated for the
treatment of relapsing forms of multiple sclerosis (MS), to include clinically
isolated syndrome, relapsing-remitting disease, and active secondary progressive
disease, in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

PONVORY™ is contraindicated in patients who:

* In the last 6 months experienced myocardial infarction, unstable angina,
stroke, transient ischemic attack (TIA), decompensated heart failure
requiring hospitalization, or Class III or IV heart failure.
* Have presence of Mobitz Type II second-degree, third-degree atrioventricular
(AV) block, or sick sinus syndrome, or sino-atrial block, unless patient has
a functioning pacemaker.

WARNINGS AND PRECAUTIONS

Risk of Infections

PONVORY™ causes a dose-dependent reduction in peripheral lymphocyte count to
30-40% of baseline values because of reversible sequestration of lymphocytes in
lymphoid tissues. PONVORY™ may increase the susceptibility to infections.
Life-threatening and rare fatal infections have been reported in association
with other sphingosine 1-phosphate (S1P) receptor modulators. Before initiating
treatment with PONVORY™, results from a recent complete blood count including
lymphocyte count should be reviewed.

Herpes Viral Infections

Cases of herpes viral infection have been reported in the development program of
PONVORY™; herpes simplex encephalitis and varicella zoster meningitis have been
reported with other S1P receptor modulators. Patients without a healthcare
professional confirmed history of varicella (chickenpox) or without
documentation of a full course of vaccination should be tested for antibodies to
VZV prior to initiating PONVORY™.

Cryptococcal Infections

Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal
infections have been reported with other S1P receptor modulators. Physicians
should be vigilant for clinical symptoms or signs of CM. Patients with symptoms
or signs consistent with a cryptococcal infection should undergo prompt
diagnostic evaluation and treatment. PONVORY™ treatment should be suspended
until a cryptococcal infection has been excluded. If CM is diagnosed,
appropriate treatment should be initiated.

Progressive Multifocal Leukoencephalopathy (PML)

PML has been reported in patients treated with a S1P receptor modulator and
other multiple sclerosis (MS) therapies and has been associated with some risk
factors (e.g., immunocompromised patients, polytherapy with immunosuppressants).
Physicians should be vigilant for clinical symptoms or magnetic resonance
imaging (MRI) findings that may be suggestive of PML. MRI findings may be
apparent before clinical signs or symptoms. If PML is suspected, treatment with
PONVORY™ should be suspended until PML has been excluded.

If PML is confirmed, treatment with PONVORY™ should be discontinued.

Prior and Concomitant Treatment with Anti-neoplastic, Immune-Modulating, or
Immunosuppressive Therapies

Anti-neoplastic, immune-modulating, or immunosuppressive therapies (including
corticosteroids) should be co-administered with caution because of the risk of
additive immune system effects.

Vaccinations

Patients without a confirmed history of chickenpox or without documentation of a
full course of vaccination against VZV should be tested for antibodies to VZV
before initiating PONVORY™ treatment. A full course of vaccination for
antibody-negative patients with varicella vaccine is recommended prior to
commencing treatment with PONVORY™, following which initiation of treatment
should be postponed for 4 weeks to allow the full effect of vaccination to
occur.

No clinical data are available on the efficacy and safety of vaccinations in
patients taking PONVORY™. Vaccinations may be less effective if administered
during PONVORY™ treatment. If live attenuated vaccines are required, administer
at least 1 month prior to initiation of PONVORY™. Avoid the use of live
attenuated vaccines during and for 1 to 2 weeks after treatment of PONVORY™.

Bradyarrhythmia and Atrioventricular Conduction Delays

Since initiation of PONVORY™ treatment results in a transient decrease in heart
rate and atrioventricular (AV) conduction delays, an up-titration scheme must be
used to reach the maintenance dosage of PONVORY™ (20 mg).

Reduction in Heart Rate

Initiation of PONVORY™ may result in a transient decrease in heart rate. After
the first titration dose of PONVORY™, the decrease in heart rate typically
begins within an hour and reaches its nadir within 2-4 hours. The heart rate
typically recovers to baseline levels 4-5 hours after administration.

Atrioventricular Conduction Delays

Initiation of PONVORY™ treatment has been associated with transient
atrioventricular conduction delays that follow a similar temporal pattern as the
observed decrease in heart rate during dose titration. If treatment with
PONVORY™ is considered, advice from a cardiologist should be sought for
individuals:

* With significant QT prolongation (QTc greater than 500 msec).
* With atrial flutter/fibrillation or arrhythmia treated with Class Ia or Class
III anti-arrhythmic drugs.
* With unstable ischemic heart disease, cardiac decompensated failure occurring
more than 6 months prior to treatment initiation, history of cardiac arrest,
cerebrovascular disease (TIA, stroke occurring more than 6 months prior to
treatment initiation), or uncontrolled hypertension.
* With a history of Mobitz Type II second degree AV block or higher-grade AV
block, sick-sinus syndrome, or sino-atrial heart block.

Obtain an ECG in all patients to determine whether preexisting conduction
abnormalities are present. For patients taking other drugs that decrease heart
rate, treatment with PONVORY™ should generally not be initiated without
consultation from a cardiologist because of the potential effect on heart rate.
In all patients, a dose titration is recommended for initiation of PONVORY™
treatment to help reduce cardiac effects.

Respiratory Effects

Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) and
reductions in diffusion lung capacity for carbon monoxide (DLCO) were observed
in PONVORY™-treated patients mostly occurring in the first month after treatment
initiation. Spirometric evaluation of respiratory function should be performed
during therapy with PONVORY™ if clinically indicated.

Liver Injury

Elevations of transaminases may occur in PONVORY™-treated patients. Obtain
transaminase and bilirubin levels, if not recently available (i.e., within last
6 months) before initiation of PONVORY™ therapy.

Patients who develop symptoms suggestive of hepatic dysfunction, such as
unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, rash with
eosinophilia, or jaundice and/or dark urine during treatment, should have
hepatic enzymes checked. PONVORY™ should be discontinued if significant liver
injury is confirmed.

No dosage adjustment is necessary in patients with mild hepatic impairment
(Child-Pugh class A). PONVORY™ is not recommended in patients with moderate or
severe hepatic impairment (Child-Pugh class B and C, respectively).

Increased Blood Pressure

PONVORY™-treated patients had an average increase of 2.9 mmHg in systolic blood
pressure and 2.8 mmHg in diastolic blood pressure. Blood pressure should be
monitored during treatment with PONVORY™ and managed appropriately.

Cutaneous Malignancies

Cases of basal cell carcinoma and other skin malignancies have been reported in
patients treated with S1P receptor modulators, including PONVORY™. Periodic skin
examination is recommended for all patients, particularly those with risk
factors for skin cancer. Providers and patients are advised to monitor for
suspicious skin lesions. If a suspicious skin lesion is observed, it should be
promptly evaluated. As usual for patients with increased risk for skin cancer,
exposure to sunlight and ultraviolet light should be limited by wearing
protective clothing and using a sunscreen with a high protection factor.
Concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy is not
recommended in patients taking PONVORY™.

Fetal Risk

Based on animal studies, PONVORY™ may cause fetal harm. Because it takes
approximately 1 week to eliminate PONVORY™ from the body, women of childbearing
potential should use effective contraception to avoid pregnancy during and for 1
week after stopping PONVORY™ treatment.

Macular Edema

S1P receptor modulators, including PONVORY™, have been associated with an
increased risk of macular edema. An ophthalmic evaluation of the fundus,
including the macula, is recommended in all patients before starting treatment
and again at any time if a patient reports any change in vision while on
PONVORY™ therapy. Continuation of therapy in patients with macular edema has
not been evaluated.

Macular Edema in Patients with a History of Uveitis or Diabetes Mellitus

Patients with a history of uveitis and patients with diabetes mellitus are at
increased risk of macular edema during therapy with S1P receptor modulators,
including PONVORY™. Therefore, these patients should have regular follow-up
examinations of the fundus, including the macula, during treatment with
PONVORY™.

Posterior Reversible Encephalopathy Syndrome

Rare cases of posterior reversible encephalopathy syndrome (PRES) have been
reported in patients receiving a sphingosine 1-phosphate (S1P) receptor
modulator. Such events have not been reported for PONVORY™-treated patients in
the development program. However, should a PONVORY™-treated patient develop any
unexpected neurological or psychiatric symptoms/signs (e.g., cognitive deficits,
behavioral changes, cortical visual disturbances, or any other neurological
cortical symptoms/signs), any symptom/sign suggestive of an increase of
intracranial pressure, or accelerated neurological deterioration, the physician
should promptly schedule a complete physical and neurological examination and
should consider an MRI. Symptoms of PRES are usually reversible but may evolve
into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment
may lead to permanent neurological sequelae. If PRES is suspected, PONVORY™
should be discontinued.

Unintended Additive Immunosuppressive Effects from Prior Treatment with
Immunosuppressive or Immune-Modulating Therapies

When switching from drugs with prolonged immune effects, the half-life and mode
of action of these drugs must be considered in order to avoid unintended
additive effects on the immune system while at the same time minimizing risk of
disease reactivation, when initiating PONVORY™. Initiating treatment with
PONVORY™ after treatment with alemtuzumab is not recommended.

Severe Increase in Disability After Stopping PONVORY™

Severe exacerbation of disease, including disease rebound, has been rarely
reported after discontinuation of a S1P receptor modulator. The possibility of
severe exacerbation of disease should be considered after stopping PONVORY™
treatment. Patients should be observed for a severe increase in disability upon
PONVORY™ discontinuation and appropriate treatment should be instituted, as
required.

Immune System Effects After Stopping PONVORY™

After stopping PONVORY™ therapy, ponesimod remains in the blood for up to 1
week.

Starting other therapies during this interval will result in concomitant
exposure to ponesimod. Lymphocyte counts returned to the normal range in 90% of
patients within 1 week of stopping therapy, however, residual pharmacodynamics
effects, such as lowering effects on peripheral lymphocyte count, may persist
for 1 to 2 weeks after the last dose. Use of immunosuppressants within this
period may lead to an additive effect on the immune system, and therefore
caution should be applied 1 to 2 weeks after the last dose of PONVORY™.

OVERDOSAGE

In patients with overdosage of PONVORY™, especially upon
initiation/re-initiation of treatment, it is important to observe for signs and
symptoms of bradycardia as well as AV conduction blocks, which may include
overnight monitoring. Regular measurements of pulse rate and blood pressure are
required, and ECGs should be performed.

There is no specific antidote to ponesimod. Neither dialysis nor plasma exchange
would result in meaningful removal of ponesimod from the body. The decrease in
heart rate induced by PONVORY™ can be reversed by atropine.

In the event of overdose, PONVORY™ should be discontinued, and general
supportive treatment given until clinical toxicity has been diminished or
resolved. It is advisable to contact a poison control center to obtain the
latest recommendations for the management of an overdose.

ADVERSE REACTIONS

Most common adverse reactions (incidence at least 10%) are upper respiratory
tract infection, hepatic transaminase elevation, and hypertension.

Please see full Prescribing Information and Medication Guide.

cp-214886v2

This site is published by Janssen Pharmaceuticals, Inc., which is solely
responsible for its contents. This site is intended for use by healthcare
professionals of the United States and Puerto Rico. Janssen Pharmaceuticals,
Inc., recognizes that the Internet is a global communications medium; however,
laws, regulatory requirements, and medical practices for pharmaceutical products
vary from country to country. The Prescribing Information included here may not
be appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

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Last Updated 7/21 | cp-198295v3

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Last updated: 7/21 | cp-198295v3

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INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

PONVORY™ is contraindicated in patients who:

WARNINGS AND PRECAUTIONS

Risk of Infections

Herpes Viral Infections

Cryptococcal Infections

Progressive Multifocal Leukoencephalopathy (PML)

If PML is confirmed, treatment with PONVORY™ should be discontinued.

Prior and Concomitant Treatment with Anti-neoplastic, Immune-Modulating, or
Immunosuppressive Therapies

Anti-neoplastic, immune-modulating, or immunosuppressive therapies (including
corticosteroids) should be co-administered with caution because of the risk of
additive immune system effects.

Vaccinations

Bradyarrhythmia and Atrioventricular Conduction Delays

Reduction in Heart Rate

Atrioventricular Conduction Delays

Respiratory Effects

Liver Injury

Increased Blood Pressure

Cutaneous Malignancies

Fetal Risk

Macular Edema

Macular Edema in Patients with a History of Uveitis or Diabetes Mellitus

Posterior Reversible Encephalopathy Syndrome

Unintended Additive Immunosuppressive Effects from Prior Treatment with
Immunosuppressive or Immune-Modulating Therapies

Severe Increase in Disability After Stopping PONVORY™

Immune System Effects After Stopping PONVORY™

After stopping PONVORY™ therapy, ponesimod remains in the blood for up to 1
week.

OVERDOSAGE

ADVERSE REACTIONS

Most common adverse reactions (incidence at least 10%) are upper respiratory
tract infection, hepatic transaminase elevation, and hypertension.

Please see full Prescribing Information and Medication Guide.

cp-214886v2

English
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