Important Safety Information for TIRFs
Selected Important Safety Information

IMPORTANCE OF PROPER PATIENT SELECTION, DOSING, and POTENTIAL FOR ABUSE

TIRF medicines contain fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. TIRF medicines can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the potential for abuse when prescribing or dispensing TIRF medicines in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Serious adverse events, including deaths, in patients treated with some oral transmucosal fentanyl medicines have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of a TIRF medicine for any other fentanyl medicine, including another TIRF medicine, may result in fatal overdose.

TIRF medicines are indicated only for the management of breakthrough pain in adult cancer patients 18 years of age and older (16 years of age and older for Actiq® brand and generic equivalents) who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Patients considered opioid-tolerant are those who are taking:

  • at least 60 mg of oral morphine/daily
  • at least 25 mcg transdermal fentanyl/hour
  • at least 30 mg of oral oxycodone daily
  • at least 8 mg oral hydromorphone daily
  • at least 25 mg oral oxymorphone daily
  • or an equianalgesic dose of another opioid daily for a week or longer.

TIRF medicines are contraindicated in opioid non-tolerant patients and are contraindicated in the management of acute or postoperative pain, including headache/migraine and dental pain, or use in the emergency room. Please see the individual medicine prescribing information for a full list of specific situations in which TIRF medicines are not indicated or are contraindicated. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with some TIRF medicines.

When prescribing, do not convert patients on a mcg per mcg basis from another fentanyl medicine to a TIRF medicine, except for substitutions between a branded TIRF medicine and its generic equivalent. Patients beginning treatment with TIRF medicines must begin with titration from the lowest available dose for that specific medicine. Carefully consult the Initial Dosing Instructions in the TIRF medicine-specific Full Prescribing Information.

When dispensing, TIRF medicines are not interchangeable with each other, regardless of route of administration. Differences exist in the pharmacokinetics of TIRF medicines resulting in clinically important differences in the amount of fentanyl absorbed that could cause a fatal overdose. Converting patients from one TIRF medicine to a different TIRF medicine must not be done on a microgram-per-microgram basis, and must be titrated according to the labeled dosing instructions each time they begin use of a new TIRF medicine. The only exception is for substitution between a branded TIRF medicine and its specific generic equivalent.

Special care must be used when dosing TIRF medicines. Refer to the Full Prescribing Information for the individual TIRF medicine for guidance on the maximum number of doses that can be taken per breakthrough pain episode and the time that patients must wait before treating another episode of breakthrough pain with the TIRF medicine.

TIRF medicines are intended to be used only in the care of opioid-tolerant cancer patients and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Patients and their caregivers must be instructed that TIRF medicines contain a medicine in an amount which can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid-tolerant. All medicines must be kept out of the reach of children.

The concomitant use of TIRF medicines with cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.

Adverse Reactions

The most commonly observed adverse reactions with TIRF medicines include typical opioid adverse reactions, such as nausea, vomiting, constipation, somnolence, dizziness, and headache. Refer to individual medicine prescribing information for all adverse reactions. Expect opioid side effects and manage them accordingly.

Please see the individual Full Prescribing Information for each TIRF medicine for all information including boxed warnings, and Medication Guide for important safety information for each TIRF medicine.

Adverse Event Reporting

Promptly report suspected adverse events including misuse, abuse, addiction and overdoses directly to the TIRF REMS Access program at 1-866-822-1483. You also may report adverse event information to the FDA MedWatch Reporting System by telephone at 1-800-FDA-1088 or by mail using Form 3500, available at www.fda.gov/medwatch.

Medication Guide

It is important that you discuss the risks of TIRF medicines with your patients and encourage them to read the relevant Medication Guide. The Medication Guide provides important information on the safe and effective use of TIRF medicine and you will need to review the appropriate Medication Guide for the TIRF medicines you prescribe to your patient. Patients should be counseled on the need to store TIRF medicines safely out of the reach of children and other persons for whom the medicine is not prescribed.

You must provide your patient with a copy of the appropriate Medication Guide for the TIRF medicine you prescribe. Medication Guides will be provided to you by the manufacturers of individual TIRF medicines. If you require additional Medication Guides you can:

  • Print copies from the TIRF REMS Access program website at www.TIRFREMSaccess.com.
  • Contact the TIRF REMS Access program at 1-866-822-1483.

For assistance, please call the TIRF REMS Access program at 1-866-822-1483.

Privacy Policy

The privacy of your personal information is important to INSYS Therapeutics, Inc. To better protect your privacy, we provide you with our privacy policy so that you will understand our commitment to you and to your privacy. This privacy policy describes what information we may collect about you; how we use your information; how we protect it; and what choices you have on how that information is used. At INSYS Therapeutics, Inc., we understand that health is a very personal, private subject, and we want you to feel as comfortable as possible visiting our various websites and using their respective services.

As our privacy policy changes in significant ways, we will post changes on our website in a timely manner. Minor changes to the policy may occur that will not affect our use of individually identifiable or personal health information. When the privacy policy changes in a way that significantly affects the way we handle personal information, we will not use the information we have previously gathered without providing notice or obtaining your consent when appropriate.

The following articles make up our privacy policy. We hope that reading them gives you a clear idea of how we manage information regarding you. For immediate access to a particular topic, click on the title of that topic.

When we refer to ourselves as "we" or "INSYS Therapeutics, Inc.," we mean our entire company, including any company that we control (for example, any subsidiary that we own). We may share information among companies that we own or control, and we may share information with our co-promotion partners, and companies working with INSYS Therapeutics, Inc. However, all information we share will always be protected under the terms of this privacy policy.

You should read the privacy policy at each website that you visit after you leave one of our sites. INSYS Therapeutics, Inc., is not responsible for how other websites treat your privacy once you leave an INSYS Therapeutics, Inc., site. By using any of our websites, you accept the practices described in this privacy policy.

 

Personal Information We Collect

Information we collect from visitors

Visitors to each of our websites can access the website's home page, and browse some areas of the site, without disclosing any personally identifiable information. We do track information provided to us by your browser, including the website you came from (known as the referring URL), the type of browser you use, the time and date of access, and other information that does not personally identify you. On some of our sites, you must register to access portions of the site.

In addition, we gather information about you that is automatically collected by our web server, such as your IP address and domain name. INSYS Therapeutics, Inc., may use web server and browser information to individually customize its offerings and presentations if you submit your personal information.

Children's privacy

We are committed to protecting the privacy of children. We do not knowingly collect personal information from children under the age of 13.

Information we collect when you register

Visitors registering for services on our websites are asked to provide identifying information, such as name, gender, and contact information. On the registration screen, we clearly label which information is required for registration, and which information is optional and may be given at your discretion. INSYS Therapeutics, Inc., websites obtain visitors' consent before collecting personally identifiable information.

Information from outside sources

We may also collect information about physicians or other healthcare professionals who register on our websites from other sources in order to verify their licensure status and identity. In some cases, we may ask customers for information after they register, such as credit card information. Where necessary (for example, to process an order for a purchase), our websites may contact financial or credit organizations to confirm customer credit card information.

From time to time, we may augment our existing user databases with legally obtained information from third parties. Some of this information may be personally identifiable, such as national change of address information. We do this to better target our information offerings and promotional campaigns and to provide pertinent offers in which we think you would be interested.

Other information

We also collect information that you voluntarily provide to us through responses to surveys, search functions, questionnaires, feedback, and the like.

On some of our websites, we offer health assessment tools that ask you to provide self-assessment information.

We may also ask you to provide additional information such as your email address if you want to obtain additional services or information or to resolve complaints or concerns.

Use of cookies and other tracking systems

Cookies, log files, and pixel tags (web beacons) are technologies used by the INSYS Therapeutics, Inc., websites to identify a user as the user moves through our websites. Your browser allows us to place some information (session-based IDs and/or persistent cookies) on your computer's hard drive that identifies the computer you are using. We may use cookies to personalize our websites and to track your usage across other INSYS Therapeutics, Inc., websites.

Your web browser can be set to allow you to control whether you will accept cookies, reject cookies, or to notify you each time a cookie is sent to you. If your browser is set to reject cookies, websites that are cookie-enabled will not recognize you when you return to the website, and some website functionality may be lost. The help section of your browser will tell you how to prevent your browser from accepting cookies.

On occasion, we may contract with third parties that have agreed to observe our privacy policy to place cookies on your computer's hard drive.

Although cookies do not normally contain personally identifiable information, if you have provided us information about you, we may associate your registration information with cookies or other tracking utilities our website places on your computer's hard drive. Associating a cookie with your registration data allows us to offer increased personalization and functionality. Without cookies, this functionality would not be possible.

Some of our business partners may use cookies on our sites (for example, links to business partners). We do not want our business partners to use cookies to track our customers' activities once they leave our sites. However, we may not have control over how our business partners use cookies on our websites. If you become aware that an INSYS Therapeutics, Inc., business partner is placing an unwanted cookie on your hard drive, please contact our Privacy Officer to assist us in resolving the problem.

In addition, we may use other tracking systems like pixel tags. Pixel tags, sometimes called web beacons, are similar in function to a cookie. But because of their insignificant size, they are not visible; though they are used to pass certain information to our servers to personalize our websites and to track your usage across other INSYS Therapeutics, Inc., websites. In addition, we may also use pixel tags in our HTML-based emails.

 

Use of Your Information

Aggregate data

We gather aggregate data about visitors to our websites for product and service development and improvement activities. We also use it for market analysis. We may provide information from our websites in aggregate form, with identifying information removed, to third parties. When aggregate health information is provided, we pool it from many individual records. Before it is used, we strip it of any data that could be used to identify an individual. Any third party that receives aggregated health-care data must agree not to attempt to re-identify the people the data belong to.

Marketing and healthcare messages

We may target our marketing and healthcare messaging depending on information we have about you. For example, a user whom we know is a woman may receive information on products targeted to women. A male user would not see this information. Or, a user whom we know is a healthcare professional who treats PHN, may receive information for new PHN therapies. We may send information to you that we may believe will benefit you, including information about any INSYS Therapeutics, Inc., product (see your Privacy Choices section).

We may also personalize our website based on your interests. For example, you may see different articles in different places on our website based on information you have shared with us, or information we have gained by reviewing your previous visits, or information we may have gained from your interactions with a third party that shares information with us.

When we share information with third parties working on behalf of INSYS Therapeutics, Inc., we use reasonable efforts to assure that they agree in writing to abide by INSYS Therapeutics, Inc., privacy policies.

If we discover that a third party working on behalf of INSYS Therapeutics, Inc., inappropriately disclosed personal information about any of our visitors, we will take immediate action to prevent further occurrences.

Other than as described above, INSYS Therapeutics, Inc., will not release personally identifiable information to a third party without your consent.

Tell a friend

If you choose to use a referral function on an INSYS Therapeutics, Inc., website to tell a friend about our site, our site may ask you for your friend's name and email address as well as your information. The form automatically sends your friend a one-time email inviting him or her to visit the site. We do not access or store this information, except to send this invitation.

 

How INSYS Therapeutics, Inc., Handles Privacy Internally

Our commitment to security

We have put in place appropriate physical, electronic, and managerial procedures to safeguard and help prevent unauthorized access, maintain data security, and correctly use the information we collect online.

General policies

We have implemented technology and security policies, rules, and other measures to protect the personal data that we have under our control from unauthorized access, improper use, alteration, unlawful or accidental destruction, and accidental loss. We also protect your information by requiring that all our employees and others who have access to, or are associated with, the processing of your data, respect your confidentiality.

INSYS Therapeutics, Inc., uses security methods to determine the identity of each registered user, so that appropriate rights and restrictions can be enforced for that user. Reliable verification of user identity is called authentication. INSYS Therapeutics, Inc., uses both passwords and usernames to authenticate users. Users are responsible for maintaining their own passwords.

Storage of health information

Personally identifiable health information you share with us is stored on our database servers. We have a firewall and other technology to prevent individuals from accessing information without authorization. Facilities where our servers are located are designed to be physically secure and protected from unauthorized access by unauthorized persons.

Information in our servers is backed up routinely in order to aid in the recovery of information in the event of accidental damage of information or due to a natural disaster. The backup media are stored in a physically secure storage facility.

Third parties

In addition to aggregate information (discussed previously), we may share some kinds of information with third parties as described below.

Companies and people who work for us:

We contract with other companies and individuals to help us provide services. For example, we may host some of our websites on another company's computers, hire technical consultants to maintain our web-based health sites, or work with companies to remove repetitive information from customer lists, analyze data, provide marketing assistance, and provide customer service. In addition, if you are a healthcare professional, we may validate your licensure status and other information against available databases that list licensed healthcare professionals. In order to perform their jobs, these other companies may have limited access to some of the personal information we maintain about our users. Other companies may collect information on our behalf through their sites. This occasionally incorporates the use of frames on the site that will not show the URL you are visiting in the browser address window. We require such companies to comply with the terms of our privacy policies, to limit their access to any personal information to the minimum necessary to perform their obligations, and not to use the information they may access for purposes other than fulfilling their responsibilities to us. We use our best efforts to limit other companies' use of personally identifiable or healthcare information.

Promotional and informational offers:

Sometimes we may send offers to selected groups of customers. To accomplish this, we may use third parties working on behalf of INSYS Therapeutics, Inc. We provide a variety of mechanisms for you to tell us you do not want to receive such promotional or informational offers. For example, we may provide an opt-in box for customers to receive information that is sent by a third-party fulfillment house, and we make clear that, by opting in, you are submitting your data to a third party. You can elect not to receive promotional or informational material from us by following the instructions to opt-out as mentioned or included in each of our programs we send to you.

Legal requirements:

We may release account and other personal information when we believe release is required to comply with applicable law. We may release personal health information if, in our judgment after review by an attorney, the release is compelled by law or regulation, or if the release may be necessary to prevent the death or serious injury of an individual.

Your Privacy Choices

If you register to receive recurring informational/promotional email from INSYS Therapeutics, Inc., or third parties working with INSYS Therapeutics, Inc., you may subsequently opt-out from receiving this email when you provide the information or follow the instructions as mentioned in the email or included in each program we send to you.

We will unsubscribe you from that newsletter or other programs within ten business days.

Choice

You will be given the opportunity to choose whether your personal information is (a) to be disclosed to a third party working with INSYS Therapeutics, Inc., or (b) to be used for a purpose that is different from the purpose originally intended or authorized. In addition, we will not request sensitive information that includes personal information specifying medical or health conditions without providing you with an affirmative or explicit opt-in choice.

Onward transfer (transfers to third parties)

We will provide you with notice and choice before either personal information or sensitive information is transferred by us to a third party.

 

Updating Your Personal Information and Contacting INSYS Therapeutics, Inc.

You can always contact us in order to (i) remove from our systems the personal information that you have provided to us, (ii) update the personal information that you have provided to us, and (iii) change your preferences with respect to marketing contacts by emailing us at privacy.officer@insysrx.com or if available also logging into your account to update your information.

INSYS Therapeutics, Inc., Privacy Policy updated August 2016.