qsymia.brochure

8/19/2019 Qsymia.brochure

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Your introductionto Qsymia®

(phentermine and topiramate

extended-release) capsules CIV

Congratulations! In this brochure, you will

find important information about treatment

with Qsymia. Please read through all of

the information, and ask your healthcare

provider to explain anything that seems

unclear to you.

Qsymia® (Kyoo sim ee' uh)

Text Hear to 99000 Standard text messaging rates may apply.



2

You and your healthcare provider have determined thatQsymia® (phentermine and topiramate extended-release) capsules CIV may help you with chronicweight management.1

Qsymia is a prescription medicine that may helpsome obese (BMI of 30 or greater) adults or someoverweight (BMI of 27 or greater) adults who also haveweight-related medical problems lose weight and keepthe weight off.

Qsymia should be used with a reduced-calorie diet andincreased physical activity.

It is not known if Qsymia changes your risk of heartproblems or stroke or of death due to heart problemsor stroke.

It is not known if Qsymia is safe and effective whentaken with other prescription, over-the-counter, orherbal weight loss products.

It is not known if Qsymia is safe and effective in childrenunder 18 years old.

Qsymia is available in different doses. Take Qsymiaexactly as your healthcare provider tells you to take it.Your healthcare provider will likely start you on Qsymia3.75 mg/23 mg (titration dose) for 14 days and then

increase to the recommended dose (7.5 mg/46 mg).(Please see page 10, “How to take Qsymia.”)1,2

Getting started

*Pills not shown as actual size.

Please see Qsymia Important Safety Informationon pages 4-7 and read the Qsymia Medication Guidein the enclosed Qsymia Full Prescribing Information.

STARTING

3.75 mg/23 mg

* *

RECOMMENDED

7.5 mg/46 mg

Qsymia is a federally controlled substance(CIV) because it contains phentermine andcan be abused or lead to drug dependence.1

Qsymia can cause serious side effects, including

1

:Birth defects (cleft lip/cleft palate)

Increases in heart rate

Suicidal thoughts or actions

Serious eye problems

Why Qsymia® (phentermine andtopiramate extended-release) capsules CIV?

In 1 clinical study1,3:

Overweight (BMI† of 27 or greater) and obesepatients received either Qsymia 7.5 mg/46 mg,Qsymia 15 mg/92 mg, or placebo

• Patients had two or more obesity-relatedconditions such as: elevated blood pressureor taking two or more antihypertensivemedications; high cholesterol or taking twoor more medications to treat high cholesterol;elevated blood sugar or diabetes; or a waistmeasurement of 40 inches or greater for menor 35 inches or greater for women

• It was recommended that patients reduce theircaloric intake by 500 kcal/day

• The average BMI of the patients at the start ofthe study was 37 kg/m2

• Depending on the strength of the dose, patientswho stayed on Qsymia treatment for 1 year lostan average of:

AVERAGE WEIGHTLOSS AFTER 1 YEAR

†Body mass index (BMI) is measured in kg/m2.

Questions?Visit www.Qsymia.com, or callVIVUS Medical Information at1-888-998-4887 (1-888-99VIVUS)

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Who should not use this medicine?

Do not take Qsymia® (phentermine and topiramateextended-release) capsules CIV if you1:

Are pregnant, planning to become pregnant, orbecome pregnant during Qsymia treatment

Have glaucoma

Have thyroid problems (hyperthyroidism)

Are taking certain medicines called monoamineoxidase inhibitors (MAOIs) or have taken MAOIs inthe past 14 days

Are allergic to topiramate, sympathomimetic aminessuch as phentermine, or any of the ingredients inQsymia. See the end of the Qsymia Medication

Guide for a complete list of ingredients in Qsymia

Important safety information

Qsymia can cause serious side effects, including1:

Birth defects (cleft lip/cleft palate). If you takeQsymia during pregnancy, your baby has a higherrisk for birth defects called cleft lip and cleft palate.These defects can begin early in pregnancy, evenbefore you know you are pregnant.

Women who are pregnant must not take Qsymia.

Women who can become pregnant should:

1. Have a negative pregnancy test before takingQsymia and every month while taking Qsymia.

2. Use effective birth control (contraception)consistently while taking Qsymia. Talk toyour healthcare provider about how to

prevent pregnancy.If you become pregnant while taking Qsymia,stop taking Qsymia immediately, and tell yourhealthcare provider right away. Healthcareproviders and patients should report all casesof pregnancy to:

• FDA MedWatch at 1-800-FDA-1088, and

• The Qsymia Pregnancy Surveillance Programat 1-888-998-4887

Important safety information(continued)

Increases in heart rate. Qsymia® can increase yourheart rate at rest. Your healthcare provider shouldcheck your heart rate while you take Qsymia. Tellyour healthcare provider if you experience, whileat rest, a racing or pounding feeling in your chestlasting several minutes when taking Qsymia.

Suicidal thoughts or actions. Topiramate, aningredient in Qsymia, may cause you to havesuicidal thoughts or actions.

Call your healthcare provider right away if youhave any of these symptoms, especially if theyare 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 andtalking (mania)

• Other unusual changes in behavior or mood

Serious eye problems which include:

• Any sudden decrease in vision, with or withouteye pain and redness

• A blockage of fluid in the eye causingincreased pressure in the eye (secondaryangle closure glaucoma)

These problems can lead to permanent visionloss if not treated. Tell your healthcare providerright away if you have any new eye symptoms.

Please read the Qsymia Medication Guide in theenclosed Qsymia Full Prescribing Information.



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Important safety information(continued)

Possible side effects of Qsymia® (phentermineand topiramate extended-release) capsulesCIV include1:

Mood changes and trouble sleeping. Qsymiamay cause depression or mood problems, andtrouble sleeping. Tell your healthcare provider

if symptoms occur.

Concentration, memory, and speech difficulties. Qsymia may affect how you think and causeconfusion, problems with concentration, attention,memory or speech. Tell your healthcare providerif symptoms occur.

Increases of acid in bloodstream (metabolicacidosis). If left untreated, metabolic acidosiscan cause brittle or soft bones (osteoporosis,osteomalacia, osteopenia), kidney stones, can slowthe rate of growth in children, and may possiblyharm your baby if you are pregnant. Metabolicacidosis 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 healthcare provider should do a blood test tomeasure the level of acid in your blood before andduring your treatment with Qsymia.

Low blood sugar (hypoglycemia) in people withtype 2 diabetes mellitus who also take medicinesused to treat type 2 diabetes mellitus. Weightloss can cause low blood sugar in people withtype 2 diabetes mellitus who also take medicinesused to treat type 2 diabetes mellitus (such asinsulin or sulfonylureas). You should check yourblood sugar before you start taking Qsymia andwhile you take Qsymia.

High blood pressure medicines. If you aretaking medicines for your blood pressure, yourdoctor may need to adjust these medicineswhile taking Qsymia.

Central nervous system (CNS) side effects. Theuse of prescription sleep aids, anxiety medicines,or drinking alcohol with Qsymia® may cause anincrease in CNS symptoms such as dizziness andlight-headedness. Do not drink alcohol with Qsymia.

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

Kidney stones. Drinking plenty of fluids whentaking Qsymia to help decrease your chances ofgetting kidney stones. If you get severe side orback pain, and/or blood in your urine, call yourhealthcare provider.

Decreased sweating and increased bodytemperature (fever). People should be watched forsigns of decreased sweating and fever, especially

in hot temperatures. Some people may need to behospitalized for this condition.

Common side effects of Qsymia include1:

Numbness or tingling in the hands,arms, feet, or face (paraesthesia)

Dizziness

Change in the way foods taste orloss of taste (dysgeusia)

Trouble sleeping (insomnia)

Constipation

Dry mouth

Tell your healthcare provider if you have any sideeffect that bothers you or does not go away.

These are not all of the possible side effects ofQsymia. For more information, ask your healthcareprovider or pharmacist.

Call your doctor for medical advice about sideeffects. You may report side effects to VIVUS at1-888-998-4887 or FDA at 1-800-FDA-1088.

Please read the Qsymia Medication Guide in theenclosed Qsymia Full Prescribing Information.



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Please see Qsymia® ImportantSafety Information on pages 4-7and read the Qsymia MedicationGuide in the enclosed Qsymia

Full Prescribing Information.

Support alongthe way

Join for free at www.Qsymia.comLearn more about2 money-savingprograms atwww.Qsymia.com TM

TM

How to get this medicine

Qsymia® (phentermine and topiramate extended-release) capsules CIV is available by prescriptionand only through Qsymia-certified pharmacies.

Qsymia is also available by mail order throughthe Qsymia Home Delivery Pharmacy Network.

The Q and Me™ Patient Support Program is a no-

cost online program that provides tools, resources,and step-by-step guidance to help you reach yourweight-loss goals. Q and Me is meant to be part of acomplete weight-loss program that also includes areduced-calorie diet and increased physical activity.As with any weight-loss program, you should discussyour weight-loss goals with your healthcare providerbefore beginning.

When you go online, enter your ZIP code toview an interactive map of the nearest locations.

Find a Qsymia-certified pharmacy

Download the free Q and MeTM

Mobile App

To find a local pharmacy near you, go to:

ZIP code



*Pills not shown as actual size.

Questions?

Visit www.Qsymia.com, or call

VIVUS Medical Information at

1-888-998-4887 (1-888-99VIVUS)

11

• Do not stop taking Qsymia® without talkingto your healthcare provider. Stopping Qsymiasuddenly can cause serious problems, such asseizures. Your healthcare provider will tell youhow to stop taking Qsymia slowly1

• Before you take Qsymia, check to make sure thatyou are taking the right dose1:

If you take too much Qsymia, call your healthcareprovider or go to the nearest emergency roomright away.1

What to avoid when taking Qsymia1

Do not get pregnant while taking Qsymia. See “Important Safety Information” on page 4

Do not drink alcohol while taking Qsymia. Qsymia and alcohol can affect each other, causingside effects such as sleepiness or dizziness

Do not drive a car or operate heavy machinery,or do other dangerous activities until you knowhow Qsymia affects you. Qsymia can slow yourthinking and motor skills, and may affect vision

Possible side effects of Qsymia include moodchanges and trouble sleeping; concentration,memory, and speech difficulties; increases of acid inbloodstream (metabolic acidosis); low blood sugar(hypoglycemia) in people with type 2 diabetesmellitus who also take medicines used to treat type2 diabetes mellitus; the possible need to adjustmedicines for high blood pressure; increases incentral nervous system (CNS) symptoms when usedwith prescription sleep aids, anxiety medicine, orwhen drinking alcohol; possible seizures if you stoptaking Qsymia too fast; kidney stones; and decreasedsweating and increased body temperature (fever).1

11.25 mg/69 mg 15 mg/92 mg

3.75 mg/23 mg 7.5 mg/46 mg

*

*

*

*

STARTING RECOMMENDED

TOPTITRATION

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Take Qsymia exactly as your healthcare

provider tells you to take it.1

Your healthcare provider shouldstart you on a diet and exerciseprogram when you start takingQsymia. Stay on this program whileyou are taking Qsymia.1

Your healthcare provider will tell youhow much Qsymia to take and whento take it.1

• Do not change your dose without

talking to your healthcare provider• Take Qsymia 1 time a day in

the morning

• Qsymia can be taken with orwithout food

• If you miss a dose of Qsymia,wait until the next morning totake your usual dose of Qsymia.Do not double your dose

Your healthcare provider should either(1) tell you to stop taking Qsymia or

(2) increase your dose of Qsymia if you donot lose a certain amount of weight withinthe first 12 weeks of treatment. If yourhealthcare provider increases your doseof Qsymia, he/she should tell you to stoptaking Qsymia if you have not lost a certainamount of weight after an additional 12weeks of treatment on the higher dose.1

How to takeQsymia® (phentermine andtopiramate extended-release) capsules CIV

References: 1. Qsymia [package insert]. Mountain View, CA:VIVUS, Inc; 2013. 2. Qsymia Risk Evaluation and MitigationStrategy (REMS). Prescriber Dosing and ManagementChecklist. Approved April 2013. 3. Data on file. VIVUS, Inc.

Please see Qsymia Important Safety Information onpages 4-7 and read the Qsymia Medication Guide inthe enclosed Qsymia Full Prescribing Information.



© 2012-2013 VIVUS, Inc. All rights reserved. 100012.02-USP

Talk to your healthcareprovider about settingrealistic goals

Starting weight: ___________ lb

Goal weight loss: ___________ lb

Goal weight: ___________ lb

Time frame: 6 months

12 months

F i nd o u t ab o u t M O N E Y - S AV I N G o ff e r s

w

w w . Q

s y m i a. c o m

Questions?

Visit www.Qsymia.com, or callVIVUS Medical Information at1-888-998-4887 (1-888-99VIVUS)

Please see Qsymia® ImportantSafety Information onpages 4-7 and read the

Qsymia Medication Guidein the enclosed Qsymia FullPrescribing Information.

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