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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.

Indication
SUBSYS® is indicated for the management of breakthrough pain in cancer patients 18 years of age and older 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 for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS.

This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, SUBSYS is contraindicated in the management of acute or postoperative pain.

Limitations of Use
Not for use in opioid non-tolerant patients.

Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room.

Because of the risk for misuse, abuse, addiction, and overdose, SUBSYS is available only as part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access Program. SUBSYS may be dispensed only to outpatients enrolled in the program. For inpatient administration (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use) of SUBSYS, patient enrollment is not required.

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IMPORTANT SAFETY INFORMATION

WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; REMS and NEONATAL OPIOID WITHDRAWAL SYNDROME 

  • Serious, life-threatening, and/or fatal respiratory depression has occurred. Monitor closely, especially upon initiation or following a dose increase. Due to the risk of fatal respiratory depression, SUBSYS is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.
  • Accidental ingestion of SUBSYS, especially by children, can result in a fatal overdose of fentanyl. Keep out of reach of children. Ensure proper storage and disposal.
  • Concomitant use with CYP3A4 inhibitors (discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.
  • When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS.
  • When dispensing, do not substitute with any other fentanyl products.
  • SUBSYS exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
  • SUBSYS is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.
  • Prolonged use of SUSYS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

WARNING: LIFE-THREATENING RESPIRATORY DEPRESSON; ACCIDENTAL INGESTION; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; REMS and NEONATAL OPIOID WITHDRAWAL SYNDROME

Life-Threatening Respiratory Depression

Serious, life-threatening, and/or fatal respiratory depression has occurred in patients treated with SUBSYS, including following use in opioid non-tolerant patients and improper dosing.  Monitor for respiratory depression, especially during initiation of SUBSYS or following a dose increase.  The substitution of SUBSYS for any other fentanyl product may result in fatal overdose [see Warnings and Precautions (5.1)].

Due to the risk of respiratory depression, SUBSYS is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients. [see Contraindications (4)].   

Accidental Ingestion

Accidental ingestion of even one dose of SUBSYS especially by children, can result in a fatal overdose of fentanyl [see Warnings and Precautions (5.2, 5.16)].

Death has been reported in children who have accidentally ingested transmucosal immediate-release fentanyl products. SUBSYS must be kept out of reach of children [see Warnings and Precautions (5.3); How Supplied/Storage and Handling (16.1)].

Cytochrome P450 3A4 Interaction

The concomitant use of SUBSYS with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving SUBSYS and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug Interactions (7), Clinical Pharmacology (12.3)].

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.5), Drug Interactions (7)].

  • Reserve concomitant prescribing of SUBSYS and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Risk of Medication Errors

Substantial differences exist in the pharmacokinetic profile of SUBSYS compared to other fentanyl products, including other TIRF formulations, that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose [see Dosage and Administration (2.1), Warnings and Precautions (5.5)].

  • When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to SUBSYS.
  • When dispensing, do not substitute a SUBSYS prescription for other fentanyl products.

Addiction, Abuse, and Misuse

SUBSYS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing SUBSYS, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.6)].

Risk Evaluation and Mitigation Strategy (REMS) Access Program

Because of the risk for misuse, abuse, addiction, and overdose, SUBSYS is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. [see Warnings and Precautions (5.7)]. Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of SUBSYS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.8)].

Contraindications

  • Opioid non-tolerant patients: Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients
  • Acute or postoperative pain including headache/migraine and dental pain, or in the emergency department
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
  • Known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Known hypersensitivity (e.g., anaphylaxis) to fentanyl or components of SUBSYS

Warnings and Precautions

  • Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of SUBSYS, the risk is greatest during the initiation of therapy or following a dosage increase.
  • In cancer patients with mucositis, exposure to SUBSYS was greater than in patients without mucositis. For patients with Grade 1 mucositis, the increased maximum serum concentration and overall exposure requires closer monitoring for respiratory depression and central nervous system depression, particularly during initiation of therapy with SUBSYS
  • For patients with Grade 2 mucositis or higher, avoid the use of SUBSYS unless the benefits outweigh the potential risk of respiratory depression from increased exposure
  • Patients and their caregivers must be instructed that SUBSYS contains a medicine in an amount that can be fatal to a child. Death has been reported in children who have accidentally ingested transmucosal immediate–release fentanyl products. While all units should be disposed of immediately after use, partially consumed units represent a special risk to children. In the event that a unit is not completely consumed it must be properly disposed of as soon as possible
  • Concomitant use of SUBSYS with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythmycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of fentanyl and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression [see Warnings and Precautions (5.5)], particularly when an inhibitor is added after a stable dose of SUBSYS is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in SUBSYS-treated patients may increase fentanyl plasma concentrations and prolong opioid adverse reactions. When using SUBSYS with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in SUBSYS-treated patients, monitor patients closely at frequent intervals and consider dosage reduction of SUBSYS until stable drug effects are achieved [see Drug Interactions (7)].
  • Profound sedation, respiratory depression, coma, and death may result from the concomitant use of SUBSYS with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • When prescribing, DO NOT convert a patient to SUBSYS from any other fentanyl product on a mcg per mcg basis as SUBSYS and other fentanyl products are not equivalent on a microgram per microgram basis. SUBSYS is NOT a generic version of other transmucosal immediate-release fentanyl (TIRF) formulations. When dispensing, DO NOT substitute a SUBSYS prescription for any other TIRF formulation under any circumstances. Other TIRF formulations and SUBSYS are not equivalent. Substantial differences exist in the pharmacokinetic profile of SUBSYS compared to other fentanyl products including other TIRF formulations that result in clinically important differences in the rate and extent of absorption of fentanyl. As a result of these differences, the substitution of SUBSYS for any other fentanyl product may result in a fatal overdose.
  • SUBSYS contains fentanyl, a Schedule II controlled substance. As an opioid, SUBSYS exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed SUBSYS. Addiction can occur at recommended dosages and if the drug is misused or abused. The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as SUBSYS, but use in such patients necessitates intensive counseling about the risks and proper use of SUBSYS along with intensive monitoring for signs of addiction, abuse, and misuse.
  • Because of the risk of misuse, abuse, addiction, and overdose [see Warnings and Precautions (5.1)], SUBSYS is available only through a restricted program called the TIRF REMS Access program. Under the TIRF REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. For inpatient administration (e.g. hospitals, hospices, and long-term care facilities that prescribe for inpatient use) of SUBSYS, patient and prescriber enrollment is not required.
  • Prolonged use of SUBSYS during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
  • The use of SUBSYS in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
    • Patients treated with SUBSYS who have significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of SUBSYS.
    • Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.
  • Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of SUBSYS with serotonergic drugs. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
  • Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
  • SUBSYS may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs.
  • Administer SUBSYS with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) as SUBSYS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure.
  • SUBSYS is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. The fentanyl in SUBSYS may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms.
  • The fentanyl in SUBSYS may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
  • Patients taking SUBSYS must be warned that opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Warn patients taking SUBSYS of these dangers and counsel them accordingly.
  • Intravenous fentanyl may produce bradycardia. Therefore, use SUBSYS with caution in patients with bradyarrhythmias.

Drug Interactions

  • Monitor patients for opioid toxicity who begin therapy with, or increase the dose of, inhibitors of CYP450 3A4, or stop therapy with, or decrease the dose of, inducers of CYP450 3A4.
  • Due to the additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death.
  • The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.
  • MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma).
  • Mixed agonist/antagonist and partial agonist opioid analgesics may reduce the analgesic effect of SUBSYS and/or precipitate withdrawal symptoms.
  • Fentanyl may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
  • The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Adverse Reactions

  • The most serious adverse reactions associated with all opioids including SUBSYS are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. Follow all patients for symptoms of respiratory depression.
  • The most common adverse events subsequent to titration (frequency ≥ 5%): nausea, vomiting, constipation, asthenia, dyspnea, and anxiety.
  • The most common adverse events during titration (frequency ≥ 5%): nausea, vomiting, constipation, somnolence, and dizziness.
  • The most common adverse reaction leading to discontinuation of SUBSYS was nausea.