Terms and Conditions of Use

LEGAL NOTICE

Copyright © Benuvia Therapeutics Inc., 2020 All Rights Reserved.

Before accessing the sites, please read the following Terms and Conditions of Use carefully as they govern your use of the sites. If you do not agree with these Terms and Conditions of Use, you are not granted permission by Benuvia Therapeutics Inc. to access or otherwise use the sites.

benuvia.com,  and SYNDROS.com User Agreements

Welcome to the benuvia.com and SYNDROS.com websites (also referred to as the “Sites”) owned and operated by Benuvia Therapeutics Inc. (“Benuvia”). These Terms and Conditions of Use contain the terms, covenants, conditions, and provisions (the “Terms and Conditions”) upon which you (“you”) may access and use the Sites.

Terms and Conditions of Use

By accessing, viewing, or using the Sites, you, the user, indicate that you understand and intend these Terms and Conditions to be the legal equivalent of a signed, written contract and equally binding, and that you accept such Terms and Conditions and agree to be legally bound by them. Please note that Benuvia reserves the right to change these Terms and Conditions without notice. Your continued use of the Sites following such modifications will be conclusively deemed acceptance of any changes to these Terms and Conditions.

License Grant

These Terms and Conditions provide you with a personal, revocable, nonexclusive, nontransferable license to use the Sites conditioned on your continued compliance with these Terms and Conditions. You may print and download materials and information on the Sites solely for personal and noncommercial use, provided that all hard copies contain all copyright and other applicable notices contained in such materials and information. As a further condition of use of the Sites, you warrant to Benuvia that you will not use the Sites for any purpose that is unlawful or otherwise prohibited by these Terms and Conditions.

Intellectual Property Rights

All materials contained in the Site are protected by law, including, but not limited to, United States copyright, trade secret, and trademark law, as well as other state, national, and international laws and regulations. The contents of the Site, as well as all materials distributed in conjunction with the Site, are Copyright © 2020 Benuvia Therapeutics Inc. or its affiliates, licensors or suppliers. All rights are reserved. Benuvia also owns a copyright in the Site as a collective work and/or compilation, and in the selection, coordination, arrangement, and enhancement of such content. Re-publication or citation of any other content generated by the Site without the written consent of Benuvia is expressly prohibited. You agree not to copy, modify, adapt, frame, mirror, reproduce, translate, distribute, transmit, reverse engineer, decompile, or disassemble any aspect of the Site, except as expressly allowed by these Terms and Conditions. All product names, whether or not appearing in large print, italics or with the trademark symbol, are trademarks of Benuvia, its affiliates, related companies or its licensors or joint venture partners and any use of such marks without the express written permission of Benuvia is strictly prohibited. Unauthorized use of any material contained on the Sites may violate copyright laws, trademark laws, trade secret laws, the laws of privacy and publicity, and communications regulations and statutes. Please be aware that Benuvia actively and aggressively enforces its intellectual property rights to the fullest extent of the law.

Copyright Owners’ Rights Under the Digital Millennium Copyright Act of 1998

The Digital Millennium Copyright Act of 1998 (the “DMCA”) provides recourse for copyright owners who believe that material appearing on the Internet infringes their rights under US copyright law. If you believe, in good faith, that materials hosted by Benuvia infringe your copyright, you (or your agent) may send us a notice requesting that the materials be removed, or access to them blocked. If you believe, in good faith, that a notice of copyright infringement has been wrongly filed against you, the DMCA permits you to send us a counter-notice.

Notices and counter-notices must meet statutory requirements imposed by the DMCA. One place to find more information on the DMCA is the U.S. Copyright Office Web site. Notices and counter-notices for the Site should be sent to Benuvia Therapeutics Inc., Attn. Legal Department, 444 S Ellis St, Chandler, AZ 85224.

Submissions

Benuvia Therapeutics Inc., welcomes your feedback and suggestions about how to improve the Sites. Any ideas, suggestions, information, know-how, material, or other content (collectively, “Content”) received through the Sites, however, will be deemed to include a royalty-free, perpetual, irrevocable, transferable, worldwide, nonexclusive right and license for Benuvia to adopt, publish, reproduce, disseminate, transmit, distribute, copy, use, create derivative works, display, (in whole or part), or act on such content without additional approval or consideration, in any form, media, or technology now known or later developed for the full term of any rights that may exist in such content. Any communications or information that you send to Benuvia through the internet, electronic mail, post on our Site or otherwise, including questions, comments, suggestions or the like, are deemed to be non-confidential and Benuvia shall have no obligation with respect to such information.

Jurisdiction and Indemnification

The information provided on the Sites is intended for U.S. audiences and has been designed to comply with U.S. regulatory guidelines. These Terms and Conditions of Use and your use of our Sites shall be governed by the laws of the United States and the State of Arizona without regard to conflict of law principles. By using our Sites, you agree that any legal action shall be brought exclusively in a federal or state court of competent jurisdiction sitting in the U.S. state of Arizona. If any provision of these Terms and Conditions of Use is held to be unlawful or unenforceable, then such provision shall be severable without affecting the enforceability of all remaining provisions. By using any of our Sites, you agree to indemnify, defend and hold harmless Benuvia, its officers, directors, managers, employees, agents, consultants and third-party affiliates from and against any and all losses, expenses, damages, and costs, including reasonable attorney’s fees, resulting from any violation by you of these Terms of Use.

Disclaimer

Medical information that appears on this website is for informational purposes only and is not, nor is intended to be, a medical diagnosis or a replacement for advice given by a physician or other medical professional. Any reliance on the information provided on this website is solely the responsibility of the individual. While Benuvia makes reasonable efforts to ensure the timeliness and accuracy of the materials present on this Web site, it makes no assurances or warranties (express or implied) as to the accuracy of the information provided on this website and shall not be liable for any direct, indirect, incidental, consequential or otherwise special damages or injuries resulting from the use of this website and reliance on the materials contained here. This limitation includes damages arising from any viruses or other harmful code that may infect your computer equipment. Benuvia may make changes to these materials at any time without notice, and makes no commitment to update the information contained herein.

This website may link you to other websites that are not owned or controlled by Benuvia. These links are provided for your convenience only. These sites are maintained by entities over which Benuvia exercises no control. Accordingly, Benuvia expressly disclaims any responsibility for the content, the accuracy of the information, and/or quality of products or services provided by or advertised on these third-party sites. If you choose to hyperlink to another website, you do so at your own risk.

Important Safety Information

Important Safety Information

What is SYNDROS?

  • SYNDROS is a prescription medicine used in adults to treat:
    • Nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.
    • Loss of appetite (anorexia) in people 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.

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.

General information about the safe and effective use of SYNDROS

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.
Tell your healthcare provider about all the medicines and supplements you take, as some medicines may affect how SYNDROS works. Benuvia encourages you to report negative side effects of prescription drugs. To report SUSPECTED ADVERSE REACTIONS, contact Benuvia Operations, LLC at 1-844-558-8289 or to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is SYNDROS?

SYNDROS is a prescription medicine used in adults to treat:
  • Nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.
  • Loss of appetite (anorexia) in people 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.

Important Safety Information

What is SYNDROS?

  • SYNDROS is a prescription medicine used in adults to treat:
    • Nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.
    • Loss of appetite (anorexia) in people 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.

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.

General information about the safe and effective use of SYNDROS

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.
Tell your healthcare provider about all the medicines and supplements you take, as some medicines may affect how SYNDROS works. Benuvia encourages you to report negative side effects of prescription drugs. To report SUSPECTED ADVERSE REACTIONS, contact Benuvia Operations, LLC at 1-844-558-8289 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SYNDROS® is a registered trademark of Benuvia Operations, LLC.
©2023 Benuvia Operations, LLC. All rights reserved.

SYNDROS® is a registered trademark of Benuvia Operations, LLC.
©2023 Benuvia Operations, LLC. All rights reserved.
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