Qsymia Engage: Register

What is Qsymia?

Qsymia is a prescription medicine that contains phentermine and topiramate extended-release. Qsymia may help adults and children 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body 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 and over-the-counter medicines, or herbal weight loss products.
It is not known if Qsymia is safe and effective in children under 12 years old.

Important Safety Information

Do not take Qsymia if you are pregnant, planning to become pregnant, or become pregnant during Qsymia treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia. See the end of the Medication Guide for a complete list of ingredients in Qsymia.

QSYMIA CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Birth defects (cleft lip/cleft palate). If you take Qsymia during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. Patients who are pregnant must not take Qsymia. Patients who can become pregnant should have a pregnancy test before taking Qsymia and every month while taking Qsymia and use effective birth control (contraception) consistently while taking Qsymia. Talk to your healthcare provider about how to prevent pregnancy.

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 FDA MedWatch at 1-800-FDA-1088, and the Qsymia Pregnancy Surveillance Program at 1-888-998-4887.

Qsymia may slow the increase in height in children 12 years and older.

Suicidal thoughts or actions. Topiramate, an ingredient in Qsymia, may cause you to have suicidal thoughts or actions. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity or talking (mania); other unusual changes in behavior or mood.

Serious eye problems, which include any sudden decrease in vision, with or without eye pain and redness or a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These problems can lead to permanent vision loss if not treated. Tell your healthcare provider right away if you have any new eye symptoms.

Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during treatment, consider discontinuing Qsymia.

Qsymia may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson Syndrome). Qsymia may also cause a rash with blisters and peeling skin over much of the body that may be life threatening (Toxic Epidermal Necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.

COMMON SIDE EFFECTS OF QSYMIA IN ADULTS INCLUDE:

Numbness or tingling in the hands, arms, feet, or face (paraesthesia); dizziness; changes in the way foods taste or loss of taste (dysgeusia); trouble sleeping (insomnia); constipation; and dry mouth.

COMMON SIDE EFFECTS OF QSYMIA IN CHILDREN 12 YEARS AND OLDER INCLUDE:

Depression, dizziness, joint pain, fever, flu, and ankle sprain.

POSSIBLE SIDE EFFECTS OF QSYMIA INCLUDE:

Mood changes and trouble sleeping. Qsymia may cause depression or mood problems, and trouble sleeping. Tell your healthcare provider if symptoms occur.

Concentration, memory, and speech difficulties. Qsymia may affect how you think and cause confusion, problems with concentration, attention, memory or speech. Tell your healthcare provider if symptoms occur.

Increases of acid in bloodstream (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: feel tired, not feel hungry (loss of appetite), feel changes in heartbeat, or have trouble thinking clearly. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Qsymia.

Central Nervous System (CNS) side effects. The use of prescription sleep aids, anxiety medicines, or drinking alcohol with Qsymia may cause an increase in CNS symptoms such as dizziness and light-headedness. Do not drink alcohol with Qsymia.

Possible seizures if you stop taking Qsymia too fast. Seizures may happen in people who may or may not have had seizures in the past if you stop Qsymia too fast. Your healthcare provider will tell you how to stop taking Qsymia slowly.

Kidney stones. Drink plenty of fluids when taking Qsymia to help decrease your chances of getting kidney stones. If you get severe side or back pain, and/or blood in your urine, call your healthcare provider.

Decreased sweating and increased body temperature (fever). People should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.

Qsymia capsules contain the inactive ingredient FD&C Yellow No. 5 (tartrazine) which can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all 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 LLC at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the Qsymia Medication Guide, Full Prescribing Information and Risk of Birth Defects with Qsymia Patient Brochure.

Qsymia Engage: Home Delivery Pharmacy Program

I authorize Medvantx and its contractors and business partners (Medvantx) to use and disclose my personal information or the personal information of the individual under my care. I understand that such personal health information may include name, address, telephone number, email address, birthdate, information about health conditions, treatment and product information, treatment dates, eligible treatment type, medical history and general health, healthcare plan benefits and coverage, information about adherence to treatment, and other relevant personal and health information about me or about the individual under my care (“Personal Health Information”). I further understand that such information may be disclosed to VIVUS for the following purposes:

(1) to operate, administer, enroll me or the individual under my care in, and/or continue my participation or the participation of the individual under my care in the Qsymia Engage: Home Delivery Pharmacy Program and/or any other affiliated patient support services and activities related to my condition or treatment or the condition or treatment of the individual under my care(for example, adherence programs, and disease management support); (2) to provide informational and promotional materials relating to VIVUS products and services or me or to the individual under my care, and/or my condition or treatment or the condition or treatment of the individual under my care; and/or (3) to improve, develop, evaluate, and continue VIVUS products, services, materials, and programs related to my condition or treatment or the condition or treatment of the individual under my care.

In order for Medvantx and VIVUS to provide the above services and programs to me or the individual under my care, I understand they will need my Personal Health Information or the Personal Health Information of the individual under my care.

I understand that Medvantx may receive remuneration from VIVUS in exchange for disclosing the Personal Health Information described herein and/or for using the information to contact me with communications about VIVUS products that have been prescribed to me of the individual under my care and other patient support services.

Medvantx may release my Personal Health Information or the Personal Health Information of the individual under my care 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 or the Personal Health Information of the individual under my care to VIVUS, it may no longer be covered by federal privacy regulations, and, therefore, could be redisclosed. However, VIVUS agrees to protect my Personal Health Information or the Personal Health Information of the individual under my care 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 or the individual under my care 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 or the Personal Health Information of the individual under my care to VIVUS, revocation of this authorization will only prevent further disclosure of my Personal Health Information or the Personal Health Information of the individual under my care to VIVUS by Medvantx after they receive notice of 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 or the ability of the individual under my care to obtain treatment or payment for treatment. But, I or the individual under my care 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 or the Personal Health Information of the individual under my care 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 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 or the Personal Health Information of the individual under my care for the purposes described within the above authorization. I am also indicating that I am at least 18 years old and either the patient or legal guardian of the patient by checking the “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 patients who can become pregnant.

You are considered a patient who can become pregnant if this applies to you:

You have never had a hysterectomy (uterus removed), surgical sterilization (tubes tied), or both ovaries removed and
You have not gone through menopause. Menopause should be confirmed by your healthcare provider

Qsymia can increase the risk of a birth defect called cleft lip or cleft palate (as shown in the picture)

These defects happen early in pregnancy, sometimes even before you know you are pregnant

You should have a pregnancy test taken BEFORE starting treatment with Qsymia and EVERY MONTH after that while on treatment
- Talk with your healthcare provider about when and where to have your pregnancy testing performed
- If you have a positive pregnancy test, or you miss a period, or you think you might be pregnant, you must not start Qsymia, or if you are already taking Qsymia, you should stop it immediately and tell your healthcare provider right away
While you are on Qsymia therapy, you should use effective birth control methods every time you have sex with a male
- Certain birth control methods are effective when used alone. Other birth control methods are not as effective by themselves, so you should use a second method of birth control

Talk to your healthcare provider to help decide what birth control options are best for you.

Please see the chart below to review birth control options.

Your Birth Control Options

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.

MEDICATION GUIDE

QSYMIA^® (Kyoo sim ee’ uh)

(phentermine and topiramate extended-release
capsules), for oral use, CIV

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

QSYMIA can cause serious side effects, including:

Birth defects. If you take QSYMIA during pregnancy, your baby has a higher risk for birth defects including cleft lip and cleft palate. Your baby may also be smaller than expected at birth. The long-term effects of this are not known. These defects can begin early in pregnancy, even before you know you are pregnant.

Patients who are pregnant must not take QSYMIA.

Patients who can become pregnant should:
1. Have a pregnancy test before taking QSYMIA and every month while taking QSYMIA.
2. Use effective birth control (contraception) consistently while taking QSYMIA. Talk to your health care provider about how to prevent pregnancy.
If you become pregnant while taking QSYMIA, stop taking QSYMIA immediately and tell your health care provider right away. Health care providers and patients who become pregnant should report all cases of pregnancy to:
- FDA MedWatch at 1-800-FDA-1088
Because of the risk for birth defects (cleft lip and cleft palate), QSYMIA is available through a restricted program called the QSYMIA Risk Evaluation and Mitigation Strategy (REMS). QSYMIA is only available through certified pharmacies that participate in the QSYMIA REMS program. Your health care provider can give you information about how to find a certified pharmacy. For more information, go to www.QSYMIAREMS.com or call 1-888-998-4887.
Suicidal thoughts or actions. Topiramate, an ingredient in QSYMIA, may cause you to have suicidal thoughts or actions.

Call your health care provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
Do not stop QSYMIA without first talking to a health care provider.
- Stopping QSYMIA suddenly can cause serious problems.
- Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your health care provider may check for ther causes.
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your health care provider as scheduled.
- Call your health care provider between visits as needed, especially if you are worried about symptoms.
Serious eye problems which include:
- any sudden decrease in vision, with or without eye pain and redness,
- a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).
These problems can lead to permanent vision loss if not treated. Tell your health care provider right away if you have any new eye symptoms.

QSYMIA can have other serious side effects. See “What are the possible side effects of QSYMIA?”

What is QSYMIA?

QSYMIA is a prescription medicine that contains phentermine and topiramate extended-release. QSYMIA may help adults and children 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body 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 and over-the-counter medicines, or herbal weight loss products.
It is not known if QSYMIA is safe and effective in children under 12 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 QSYMIA is against the law.

Who should not take QSYMIA? Do not take QSYMIA if you:

are pregnant, planning to become pregnant, or become pregnant during QSYMIA treatment.
have glaucoma.
have thyroid problems (hyperthyroidism).
are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days.
are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in QSYMIA.

See the end of this Medication Guide for a complete list of ingredients in QSYMIA.

Before taking QSYMIA, tell your health care provider about all of your medical conditions, including if you:

have or have had depression, mood problems, or suicidal thoughts or behavior.
have eye problems, especially glaucoma. See “Who should not take QSYMIA?”
have a history of too much acid in the blood (metabolic acidosis) or a condition that puts you at higher risk for metabolic acidosis such as
- chronic diarrhea, surgery, a diet high in fat and low in carbohydrates (ketogenic diet), weak, brittle, or soft bones (osteoporosis, osteomalacia (rickets), osteopenia), or decreased bone density.
have kidney problems, kidney stones, or are getting kidney dialysis.
have liver problems.
have seizures or convulsions (epilepsy).
are breastfeeding or plan to breastfeed. QSYMIA can pass into your breast milk and may harm your baby. You and your health care provider should decide if you will take QSYMIA or breastfeed. You should not do both.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QSYMIA taken with other medicines may affect how each medicine works and may cause side effects.

Especially tell your health care provider if you take:

Birth control pills. Tell your health care provider if your menstrual bleeding changes while you are taking birth control pills that contain both estrogen and progestin (combination oral contraceptives) and QSYMIA.
Water pills (diuretics) such as hydrochlorothiazide (HCTZ).
Any medicines that impair or decrease your thinking, concentration, or muscle coordination.
Carbonic anhydrase inhibitors such as ZONEGRAN (zonisamide), DIAMOX (acetazolamide) or NEPTAZANE (methazolamide).
Seizure medicines such as Valproic acid (DEPAKENE or DEPAKOTE).

Ask your health care 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 health care provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking to your health care provider

How should I take QSYMIA?

Your health care provider should start you on a diet and exercise program when you start taking QSYMIA. Stay on this program while you are taking QSYMIA.
Take QSYMIA exactly as your health care provider tells you to take it.
Do not change your dose without talking to your health care provider.
Take QSYMIA daily in the morning.
QSYMIA can be taken with or without food.
If you miss a dose of QSYMIA, wait until the next morning to take your usual dose of QSYMIA. Do not double your dose.
To start treatment with QSYMIA
- Take 1 QSYMIA 3.75 mg (phentermine)/23 mg (topiramate) capsule (Figure A) 1 time each morning for the first 14 days.
- After taking QSYMIA 3.75 mg/23 mg capsule for 14 days, then take 1 QSYMIA 7.5 mg/46 mg capsule (Figure B) 1 time each morning.
After taking QSYMIA for 12 weeks
- Your health care provider may tell you to increase your dose of QSYMIA if you do not lose a certain amount of weight or do not have a certain decrease in BMI for children 12 years and older, within the first 12 weeks of treatment at the recommended dose.
If your health care provider increases the dose of QSYMIA
- Take 1 QSYMIA 11.25 mg/69 mg capsule (Figure C) 1 time each morning for 14 days.
- After taking 14 days of QSYMIA 11.25 mg/69 mg capsule, then take 1 QSYMIA 15 mg/92 mg capsule (Figure D) 1 time each morning.
Stopping QSYMIA treatment

Your health care provider should tell you to stop taking QSYMIA if you have not lost a certain amount of weight or do not have a certain decrease in BMI for children 12 years and older, after an additional 12 weeks of treatment on the higher dose.

Do not stop taking QSYMIA without talking to your health care provider. Stopping QSYMIA suddenly can cause serious problems, such as seizures. Your health care provider will tell you how to stop taking QSYMIA slowly.

Figures A - D

If you take too much QSYMIA, call your health care provider or Poison Help line at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking Qsymia?

Do not get pregnant while taking QSYMIA. See “What is the most important information I should know about QSYMIA.”
Do not drink too much alcohol while taking QSYMIA. QSYMIA and alcohol can affect each other causing side effects such as sleepiness or dizziness.
Do not drive a car, operate heavy machinery, or do other dangerous activities until you know how QSYMIA affects you. QSYMIA can slow your thinking and motor skills and may affect vision.

What are the possible side effects of QSYMIA?

QSYMIA can cause serious side effects, including:

See “What is the most important information I should know about QSYMIA.”
Mood changes and trouble sleeping. QSYMIA may cause depression or mood problems, and trouble sleeping.
Tell your health care provider if symptoms occur.
Concentration, memory, and speech difficulties. QSYMIA may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. Tell your health care provider if symptoms occur.
Slowing of growth. QSYMIA may slow the increase in height in children 12 years and older, when used for a long time.
Increases of acid in bloodstream (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia (rickets), osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:
- feel tired
- not feel hungry (loss of appetite)
- feel changes in heartbeat
- have trouble thinking clearly
Your health care provider should do a blood test to measure the level of acid in your blood before and during your treatment with QSYMIA.
Decrease in kidney function. QSYMIA may cause a decrease in kidney function. Your health care provider should do a blood test to measure your kidney function before and during treatment with QSYMIA.
Possible seizures if you stop taking QSYMIA too fast. Seizures may happen in people who may or may not have had seizures in the past if you stop QSYMIA too fast. Your health care provider will tell you how to stop taking QSYMIA slowly.
Kidney stones. Drink plenty of fluids when taking QSYMIA to help decrease your chances of getting kidney stones. If you get severe side or back pain, or blood in your urine, call your health care provider.
Decreased sweating and increased body temperature (fever). People should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
Low potassium. QSYMIA can increase your risk of low potassium levels. Your health care provider should do a blood test to measure the level of potassium in your blood before and during treatment with QSYMIA.
Serious skin reactions. QSYMIA may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson Syndrome). QSYMIA may also cause a rash with blisters and peeling skin over much of the body that may cause death (Toxic Epidermal Necrolysis). Call your health care provider right away if you develop a skin rash or blisters.
Allergic reaction to FD&C Yellow No. 5. QSYMIA capsules contain the inactive ingredient FD&C Yellow No. 5 (tartrazine) which can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.

Common side effects of QSYMIA in adults include:

numbness or tingling in the hands, arms, feet, or face (paraesthesia)
dizziness
change in the way foods taste or loss of taste (dysgeusia)
trouble sleeping (insomnia)
constipation
dry mouth

Common side effects of QSYMIA in children 12 years and older include:

depression
dizziness
joint pain
fever
flu
ankle sprain

Tell your health care 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 health care provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You can also report side effects to VIVUS at 1-888-998-4887.

How should I store QSYMIA?

Store QSYMIA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep QSYMIA in a tightly closed container.
Keep QSYMIA dry and away from moisture.

Keep QSYMIA and all medicines out of the reach of children.

General Information about the safe and effective use of 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.

You can ask your pharmacist or health care provider for information about QSYMIA that is written for health professionals.

What are the ingredients in QSYMIA?

Active Ingredient: phentermine hydrochloride and topiramate extended-release.

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 and #6, ethylcellulose, gelatin, methylcellulose, microcrystalline cellulose, povidone, starch, sucrose, talc, titanium dioxide, and pharmaceutical black and white inks.

VIVUS LLC
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; 8,895,058; 9,011,905; and 9,011,906

Qsymia is a registered trademark of VIVUS LLC.

ME-03-001-11

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: 11/2024

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What is Qsymia?

Important Safety Information