Qsymia Engage: Home Delivery Pharmacy Program
I authorize Medvantx and its contractors and business partners, (Medvantx) to use and disclose my personal information, including my personal health information, which may include my name, address, telephone number, email address, birthdate, information about my health condition, my treatment and product information, treatment dates, eligible treatment type, my medical history and general health, my healthcare plan benefits and coverage, information about my adherence to my treatment, and other relevant personal and health information ("Personal Health Information"), to VIVUS for the following purposes:
(1) to operate, administer, enroll me in, and/or continue my participation in the Qsymia Engage Home Delivery Pharmacy Program and/or any other affiliated patient support services and activities related to my condition or treatment (for example, adherence programs, and disease management support); (2) to provide me with informational and promotional materials relating to VIVUS products and services, and/or my condition or treatment; and/or (3) to improve, develop, evaluate, and continue VIVUS products, services, materials, and programs related to my condition or treatment.
In order for Medvantx and VIVUS to provide the above services and programs to me, I understand they will need my Personal Health Information.
I understand that Medvantx may receive remuneration from VIVUS in exchange for disclosing my Personal Health Information and/or for using my information to contact me with communications about VIVUS products that have been prescribed to me and other patient support services.
Medvantx may release my Personal Health Information in whatever form and through whatever media, including the internet, as required by the purposes set forth.
I further understand that once Medvantx discloses my Personal Health Information to VIVUS, it may no longer be covered by federal privacy regulations, and, therefore, could be re-disclosed.
However, VIVUS agrees to protect my Personal Health Information by only using and disclosing it as stated in this Authorization or as otherwise allowed or required by law.
I understand that I may receive a copy of this authorization or revoke this authorization at any time by emailing [email protected] However, if I revoke this authorization, I understand I may no longer qualify for the Qsymia Engage Home Delivery Pharmacy Program and/or the other services described above. I further understand that if Medvantx is disclosing my Personal Health Information to VIVUS, my revocation of this authorization will only prevent further disclosure of my Personal Health Information to VIVUS by Medvantx after they receive notice of my revocation and will not affect any uses already made in reliance on my authorization.
I understand that this authorization is voluntary and I may refuse to sign it. My refusal to sign will not affect my ability to obtain treatment or payment for my treatment. But, I may be ineligible to qualify for the Qsymia Engage Home Delivery Pharmacy Program and the other programs and services set forth above.
I understand that this authorization for Medvantx to disclose my Personal Health Information will expire three (3) years from the date of my signature below, unless I notify Medvantx to terminate it earlier, or unless another date is required by state or other applicable law(s).
Electronic Authorization:
I understand that by entering my name and signing below and by checking the "I agree" box, I am consenting electronically and providing legal authorization for Medvantx, including any affiliates, subcontractors, and/or agents of Medvantx to use and share, my Personal Health Information for the purposes described within the above authorization. I am also indicating that I am at least
I am also indicating that I am at least 18 years old by checking the "Yes, I agree" box.
A copy of this authorization will be emailed to you upon successfully completing registration. You can print a copy of the email for your records or download and print a copy of this authorization from your Qsymia Engage profile page.
Risk of Birth Defects with Qsymia®
(phentermine and topiramate extended-release) capsules CIV
Please read the following important safety information about the use of Qsymia in females who can become pregnant.
You are considered a female who can become pregnant if this applies to you:
Talk to your healthcare provider to help decide what birth control options are best for you.
Please see the chart on the back to review birth control options.
Your Birth Control Options
Keep in mind, even the most effective birth control methods can fail. But your chances of getting pregnant are lowest if the methods you choose are always used correctly and every time you have sex.
Please read the accompanying Qsymia® Medication Guide as it contains additional important safety information about your treatment. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Qsymia, talk to your healthcare provider or pharmacist, contact VIVUS Medical Information at 1-888-998-4887, or visit the Web site www.QsymiaREMS.com.
© 2012-2014 VIVUS, Inc. All rights reserved. 08/2014 RE-03-005-02
MEDICATION GUIDE
QSYMIA® (Kyoo sim ee’ uh)
(phentermine and topiramate extended-release)
Capsules CIV
Read this Medication Guide before you start taking Qsymia and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Qsymia, talk to your healthcare provider or pharmacist.
What is the most important information I should know about Qsymia?
(For other side effects, also see "What are the possible side effects of Qsymia?")
Qsymia can cause serious side effects, including:
If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to:
What is Qsymia?
Qsymia is a prescription medicine that contains phentermine and topiramate extended-release that may help some obese adults or some overweight adults who also have weight-related medical problems lose weight and keep the weight off.
Qsymia should be used with a reduced calorie diet and increased physical activity.
It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if Qsymia is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.
It is not known if Qsymia is safe and effective in children under 18 years old.
Qsymia is a federally controlled substance (CIV) because it contains phentermine and can be abused or lead to drug dependence. Keep Qsymia in a safe place, to protect it from theft. Never give your Qsymia to anyone else, because it may cause death or harm them. Selling or giving away this medicine is against the law.
Who should not take Qsymia?
Do not take Qsymia if you:
What should I tell my healthcare provider before taking Qsymia?
Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Qsymia taken with other medicines may affect how each medicine works and may cause side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking to your healthcare provider.
How should I take Qsymia?
Your healthcare provider should tell you to stop taking Qsymia if you have not lost a certain amount of weight after an additional 12 weeks of treatment on the higher dose.
Do not stop taking Qsymia without talking to your healthcare provider. Stopping Qsymia suddenly can cause serious problems, such as seizures. Your healthcare provider will tell you how to stop taking Qsymia slowly.
If you take too much Qsymia, call your healthcare provider or go to the nearest emergency room right away.
What should I avoid while taking Qsymia?
What are the possible side effects of Qsymia?
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Qsymia.
Common side effects of Qsymia include:
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of Qsymia. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to VIVUS at 1-888-998-4887 or FDA at 1-800-FDA-1088.
How should I store Qsymia?
Keep Qsymia and all medicines out of the reach of children.
General Information about Qsymia
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Qsymia for a condition for which it was not prescribed. Do not give Qsymia to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes important information about Qsymia. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Qsymia that is written for healthcare professionals.
For more information, go to www.QsymiaREMS.com or call 1-888-998-4887.
What are the ingredients in Qsymia?
Active Ingredient: phentermine hydrochloride and topiramate extended-release
Inactive Ingredients: methylcellulose, sucrose, starch, microcrystalline cellulose, ethylcellulose, povidone, gelatin, talc, titanium dioxide, FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 and #6, and pharmaceutical black and white inks.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Copyright © 2012-2017 VIVUS, Inc. All rights reserved.
VIVUS, Inc
900 E. Hamilton Avenue, Suite 550
Campbell, CA 95008 USA
US Patent Numbers: 7,056,890; 7,553,818; 7,659,256; 7,674,776; 8,580,298; 8,580,299; 8,895,057; 8,895,0588; 9,011,905; and 9,011,906
Qsymia is a registered trademark of VIVUS, Inc.
ME-03-001-06