Click here for more risk information.

What is SYNDROS?

  • SYNDROS is a prescription medicine used in adults to treat:
    • nausea and vomiting caused by anti-cancer medicine (chemotherapy) in adults whose nausea and vomiting have not improved with usual anti-nausea medicines.
    • loss of appetite (anorexia) in adults with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.
SYNDROS IS A CONTROLLED SUBSTANCE (CII) BECAUSE IT CONTAINS DRONABINOL WHICH CAN BE A TARGET FOR PEOPLE WHO ABUSE PRESCRIPTION MEDICINES OR STREET DRUGS. KEEP YOUR SYNDROS IN A SAFE PLACE TO PROTECT IT FROM THEFT. NEVER GIVE YOUR SYNDROS TO ANYONE ELSE BECAUSE IT MAY CAUSE DEATH OR HARM THEM. SELLING OR GIVING AWAY THIS MEDICINE IS AGAINST THE LAW.
IT IS NOT KNOWN IF SYNDROS IS SAFE AND EFFECTIVE IN CHILDREN.

Do not take SYNDROS if you:

  • had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.
  • had an allergic reaction to alcohol.
  • are using a medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) or have taken or received a medicine that contains disulfiram or metronidazole in the last 14 days.

Before taking SYNDROS, tell your doctor about all of your medical conditions, including if you:

  • have or had heart problems.
  • have or had problems with drug abuse or dependence.
  • have or had problems with alcohol abuse or dependence.
  • have or had mental health problems including mania, depression or schizophrenia.
  • have had a seizure or have a medical condition that may increase your risk of having a seizure.
  • are pregnant or plan to become pregnant. SYNDROS may harm your unborn baby. Avoid the use of SYNDROS if you are pregnant.
  • are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their breast milk to the baby. It is not known if SYNDROS passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SYNDROS. Do not breastfeed while taking SYNDROS and for 9 days after your last dose of SYNDROS if you are being treated for nausea and vomiting caused by anti-cancer medicine.
TELL YOUR DOCTOR ABOUT ALL THE MEDICINES YOU TAKE OR HAVE TAKEN IN THE LAST 14 DAYS, INCLUDING PRESCRIPTION AND OVER-THE-COUNTER MEDICINES, VITAMINS, AND HERBAL SUPPLEMENTS. SYNDROS AND CERTAIN OTHER MEDICINES CAN AFFECT EACH OTHER, CAUSING SERIOUS SIDE EFFECTS.

How should I take SYNDROS?

  • See the “Instructions for Use” at the end of the Patient Information for detailed instructions about the right way to take SYNDROS.
  • Always use the oral syringe that comes with your SYNDROS oral solution to measure your prescribed dose. Ask your doctor or pharmacist to show you how to measure your prescribed dose.
  • Take SYNDROS exactly as your doctor tells you to. Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.
  • Drink a full glass of water (6 to 8 ounces) right after you take your prescribed dose of SYNDROS oral solution.
  • If you are an adult with AIDS with loss of appetite and weight loss:
    • SYNDROS is usually taken 2 times each day, 1 hour before lunch and 1 hour before dinner. If you are elderly, or unable to tolerate this dose of SYNDROS, your doctor may prescribe SYNDROS to be taken 1 time each day, 1 hour before dinner or bedtime.
  • If you are an adult with nausea and vomiting caused by anti-cancer medicine:
    • SYNDROS is usually taken 1 to 3 hours before your chemotherapy treatment and then every 2 to 4 hours after chemotherapy for up to 4 to 6 doses each day. If you are elderly, your doctor may prescribe SYNDROS to be taken 1 to 3 hours before your chemotherapy, 1 time each day.
    • Take your first dose of SYNDROS on an empty stomach at least 30 minutes before eating. After your first dose of SYNDROS, you can take SYNDROS with or without food.
    • After your doctor has decided the dose of SYNDROS that is right for you, take SYNDROS exactly at the same time before or after meals during future chemotherapy treatment.
  • If you take too much SYNDROS, call your Poison Control Center at 1-800-222-1222 right away or go to the nearest emergency room.

What should I avoid while taking SYNDROS?

  • Do not drive, operate machinery, or do other dangerous activities until you know how SYNDROS affects you. SYNDROS taken with medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.

What is the most important information I should know about SYNDROS?

SYNDROS can cause serious side effects, including:

  • Worsening mental (psychiatric) symptoms. Psychiatric symptoms can worsen in adults who have mania, depression, or schizophrenia and who take SYNDROS. SYNDROS taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take SYNDROS may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.
  • Problems thinking clearly. Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.
  • Changes in your blood pressure. SYNDROS may increase or decrease your blood pressure, especially when you start taking SYNDROS or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.
  • Interactions with disulfiram or metronidazole. SYNDROS contains alcohol, which can cause you to have a reaction to medicines that contain disulfiram or metronidazole. You should not use any medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take SYNDROS. You should not use a medicine that contains disulfiram or metronidazole for at least 14 days before you start taking SYNDROS and within 7 days after your last dose of SYNDROS. Tell your doctor if you have signs or symptoms of a reaction to disulfiram or metronidazole including: stomach-area (abdominal) cramping, nausea, vomiting, headache, and flushing.

What are the possible side effects of SYNDROS?

SYNDROS may cause serious side effects, including:

  • See “What is the most important information I should know about SYNDROS?”
  • Seizures. SYNDROS may increase your risk of seizures. Stop taking SYNDROS and call your doctor and get medical care right away if you have a seizure during treatment with SYNDROS.
  • Drug and alcohol abuse. You may have an increased risk of abusing SYNDROS if you have a history of drug or alcohol abuse or dependence, including marijuana. Tell your doctor if you develop abuse behaviors such as increased irritability, nervousness, restlessness or want more or higher doses of SYNDROS during your treatment.
  • Nausea, vomiting, or stomach-area (abdominal) pain. Tell your doctor if you have nausea, vomiting, or abdominal pain or if your nausea, vomiting, or abdominal pain gets worse during treatment with SYNDROS.

THE MOST COMMON SIDE EFFECTS OF SYNDROS INCLUDE:

  • stomach-area (abdominal) pain
  • dizziness
  • feeling extremely happy (euphoria)
  • nausea
  • overly suspicious or feeling people want to harm you (paranoid reaction)
  • sleepiness
  • abnormal thoughts
  • vomiting

THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF SYNDROS. TELL YOUR DOCTOR IF YOU HAVE ANY SIDE EFFECT THAT BOTHERS YOU OR DOES NOT GO AWAY. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO FDA AT 1-800-FDA-1088.

General information about the safe and effective use of SYNDROS

MEDICINES ARE SOMETIMES PRESCRIBED FOR PURPOSES OTHER THAN THOSE LISTED IN A PATIENT INFORMATION LEAFLET. DO NOT USE SYNDROS FOR A CONDITION FOR WHICH IT WAS NOT PRESCRIBED. DO NOT GIVE SYNDROS TO OTHER PEOPLE, EVEN IF THEY HAVE THE SAME SYMPTOMS THAT YOU HAVE. IT MAY HARM THEM. YOU CAN ASK YOUR DOCTOR OR PHARMACIST FOR INFORMATION ABOUT SYNDROS THAT IS WRITTEN FOR HEALTH PROFESSIONALS.

What are the ingredients in SYNDROS?

ACTIVE INGREDIENT: DRONABINOL INACTIVE INGREDIENTS: DEHYDRATED ALCOHOL, POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL, SUCRALOSE, METHYL PARABEN, PROPYL PARABEN, BUTYLATED HYDROXYANISOLE, AND WATER

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.